Lung CancerNCT02123797
Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology
An observational study of Lung Cancer, run by Baptist Memorial Health Care Corporation at 1 site in United States.
Trial summary
Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The overall year survival rate has only improved from 12% to 17% in 33 years. This failure reflects the innate lethality of lung cancer, but also reflects defects in patient care delivery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer
- How many people
- 781 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Oct 2014to 29 Feb 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Lung Cancer Patients coming through the Baptist health care system
Who may be able to join
- All patients who undergo care for lung cancer or an undiagnosed lung mass within the Baptist Memorial Health Care Corporation's hospitals from January 1, 2009 until the end of the defined study period will be eligible for inclusion in the data collection for this study. In addition, caregivers of patients within the same institution and within the study window, clinical care providers (doctors and nurses) who have taken care of patients within the eligible institutions during the study window.
Who cannot join
- Patients who do not have a radiology-identified lung lesion or lung cancer are excluded from this study.
- Patients not receiving care within the Baptist Memorial Healthcare Corporation are excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The overall year survival rate has only improved from 12% to 17% in 33 years. This failure reflects the innate lethality of lung cancer, but also reflects defects in patient care delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage), selection of appropriate treatment, and finally ends with patient outcomes. At each step are multiple options and independent specialists, each one engaged by a process of sequential referrals in the serial care model. This process is often not user-friendly, is riddled with inefficiency, delays, and outcome variances.
The coordinated multidisciplinary model, in which patients and their doctors collaborate to provide evidence-based care, is believed by experts to be superior, but has few examples of successful implementation. The implementation gap exists because of the paucity of good quality data, and lack of implementation know-how.
Read more
Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a racially, culturally, economically and geographically diverse population. The investigators research group has shown how poor quality care impairs patient survival in this region and in the greater US. The investigators have linked patient survival to compliance with multidisciplinary care plans. In this project, the investigators propose to rigorously test the impact of the multidisciplinary care model on patient outcomes in a community-based, private practice environment, similar to where 70% of lung cancer care is delivered in the US.
The objective of this study is to provide high-level evidence of the impact of multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as a model of care in which patients, their care-givers and key specialists concurrently and directly evaluate the same patients in the presence of the patients and their informal caregivers, in order to develop evidence-based consensus care plans
Read the detailed description
Within the Baptist Memorial Health Care system, the Multidisciplinary Thoracic Oncology Program has two components: Primarily, the program is centered in a multidisciplinary clinic, wherein patients and their informal caregivers are seen by multiple specialists at a single appointment time; secondarily, the program includes a multidisciplinary conference, wherein all of the specialists potentially involved in lung cancer care discuss patients referred for presentation and make consensus recommendations for care. This study focuses primarily on the experience and outcomes of care delivered to patients evaluated in the multidisciplinary clinic. However, data from the conference will also be included in some aspects of the study. The goal is to improve the access and quality of thoracic oncologic care delivery within the Baptist Healthcare System The investigators specific aim is to perform a prospective, matched cohort comparative effectiveness study of patients receiving serial vs. multidisciplinary care, with key patient-centered endpoints (survival, stakeholder satisfaction with the care experience, timeliness and stage-appropriateness of care, quality of staging). Serial care is defined as the current system of linear, sequential, referral-based care delivery.
- Conditions
- Lung Cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Multidisciplinary Clinic Patients | : 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients | |
| Serial Care Patients | 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients = 450 patients Since Baptist Health Care System manages >800 new cases each year, 300 of which are expected to be seen in multidisciplinary clinic, in practice, we conservatively expect to be able to recruit 150 cases from multidisciplinary clinic and 300 matched serial care controls (1:2 match) in 18 months. | |
| Multidisciplinary Caregivers | Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time). | |
| Serial Care Caregivers | Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery). | |
| Clinical Providers | Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC)
Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Thoroughness of Invasive Mediastinal Staging, MD vs SC
Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence of mediastinal nodal metastasis. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Thoroughness of Bi-Modal Staging Practice, MD vs SC
Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Thoroughness of Tri-Modal Staging Practice, MD vs SC
Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference)
Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion.
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference)
Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence mediastinal nodal metastasis.
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy.
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy.
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Stage-Appropriateness Treatment Selection, MD vs SC
Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy).
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference)
Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN).
For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy).
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Timeliness of Communication, MD vs SC(Conference)
Number of patients for whom formal, verified communication of care management decisions was made to all team members (providers inside and outside the multidisciplinary program, patients and their care-givers) within 48 hours of a care recommendation being made. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Measured: Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program
Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference)
Number of patients for whom all recommendations made at the initial multidisciplinary conference were completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.
Measured: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference)
Number of patients for whom all initial conference recommendations were completed, excluding conditional recommendations for which the prior condition was not met. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.
E.g., if a recommendation was to have a PET/CT and then a staging biopsy if the PET showed suspicious metastatic disease, the staging biopsy recommendation was excluded from the concordance measure if the PET/CT did not happen or was negative.
Measured: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Concordance Rate for Any Conference Recommendation, MD vs SC (Conference)
Number of patients for whom any initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.
Measured: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference)
Number of patients for whom the overall initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.
The hierarchy to rank recommendations, from highest priority to lowest, was (1) treatment, (2) staging, (3) diagnosis, (4) surveillance.
If a patient had a treatment recommendation and it happened, he/she was concordant. If treatment was recommended and it did not happen, he/she was discordant. If no treatment recommendation was made, then concordance was measured by whether or not the staging recommendation was met. If no staging recommendation was made, then the diagnostic recommendation was given priority for a concordance measurement. If no diagnostic recommendation, then a surveillance recommendation was used to measure overall concordance.
Measured: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference)
Number of patients for whom the treatment recommendation made at the initial conference presentation was completed, excluding any patient for whom prior recommendations (staging, diagnosis, surveillance) were not also completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Measured: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Baseline Patient Survey Response Rate, MD vs SC
Number of patients who completed a baseline patient survey
Measured: Baseline
3-month Patient Survey Response Rate, MD vs SC
Number of patients who completed a 3-month survey
Measured: Within 30 days of 3 months after baseline survey administration
6-Month Patient Survey Response Rate, MD vs SC
Number of patients who completed a 6-month survey
Measured: Within 30 days of 6 months after baseline survey administration
Patient Survey Scores at Baseline, MD vs SC
Scores from patient surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken.
Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range: 0-4 (higher is better) Financial burden of care - assessment of financial burden of care; range: 3-6 (sum of 3 items, higher is worse) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 1-5 (sum of 2 items, higher is better) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) (descriptions continued in 3 month survey description)
Measured: Baseline
Patient Survey Scores at 3 Months, MD vs SC
Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken.
(continued from baseline) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-21 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 0-18 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Physical/Social/Functional well-being - health-related quality of life relating to physical/social/functional well-being; range 0-28 (each a sum of 7 items, higher is better) (description continues in 6 month survey description)
Measured: Within 30 days of 3 months after baseline survey administration
Patient Survey Scores at 6 Months, MD vs SC
Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken.
(cont) Emotional well-being - health-related quality of life related to emotional well-being; range 0-30 (sum of 6 items, higher is better) Lung cancer specific QOL - health-related quality of life related to lung cancer diagnosis; range: 0-36 (sum of 9 items, higher is better) Total Summary Score FACTL - full survey, functional assessment of cancer therapy - lung; range: 0-136 (sum of 36 items, higher is better) Generic Score FACTG - full survey, functional assessment of cancer therapy - general; range: 0-108 (sum of 27 items, higher is better) Trial Outcome Index - health related quality of life - trial outcome index; range: 0-84 (sum of 23 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items each, higher is worse)
Measured: Within 30 days of 6 months after baseline survey administration
Baseline Caregiver Survey Response Rate, MD vs SC
Number of caregivers who completed a baseline patient survey
Measured: Baseline
3-month Caregiver Survey Response Rate, MD vs SC
Number of caregivers who completed a 3-month survey
Measured: Within 30 days of 3 months after baseline survey administration
6-Month Caregiver Survey Response Rate, MD vs SC
Number of caregivers who completed a 6-month survey
Measured: Within 30 days of 6 months after baseline survey administration
Caregiver Survey Scores at Baseline, MD vs SC
Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken.
Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range:0-4 (higher is better) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 0-2 (higher is better) Satisfaction patient can complete treatment plan; range: 0-2 (higher is better) (continued in 3 month survey description)
Measured: Baseline
Caregiver Survey Scores at 3 Months, MD vs SC
Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken.
(cont) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-28 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 6-24 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items, higher is worse) (continued in 6 month survey description)
Measured: Within 30 days of 3 months after baseline survey administration
Caregiver Survey Scores at 6 Months, MD vs SC
Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken.
(cont) Physical Functioning QOL - 10 items; Physical Health Problems QOL - 4 items; Pain QOL - 2 items; General health perceptions - 5 items; Energy/fatigue QOL - 4 items; Social Functioning QOL - 2 items; Emotional health problems QOL - 3 items; Emotional well-being QOL - 5 items.
All health related quality of life measures are from the SF-36 survey tool, and use a range of 0-100 mean score (higher is better).
Measured: Within 30 days of 6 months after baseline survey administration
Timeliness of Care, MD vs SC
Aggregate time in days from enrollment to a specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Measured: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
Timeliness of Care, MD vs SC (Conference) vs SC (no Conference)
Aggregate time in days from enrollment to specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment.
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
Clinical Provider Survey Responses - Ease of Referring Patients to the Conference
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Measured: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Measured: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Measured: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Measured: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Measured: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Measured: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Patient Overall Survival
Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
Measured: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Patient Overall Survival With SC Further Broken Down
Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Patient Disease/Progression Free Survival
Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
Measured: measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years
Patient Disease/Progression Free Survival With SC Further Broken Down
Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Measured: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2014 (estimated)
- Study start9 Oct 2014
- Primary completion31 Oct 2017
- Study completion29 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 781 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Memorial Health Care Corporation
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Raymond Osarogiagbon, MD, Baptist Memorial Health Care Corporation
- Investigators
- Raymond Osarogiagbon, Principal investigator, Baptist Memorial Health Care Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02123797
- Sponsor's protocol ID
- The Milestone Project
- Status last verified
- Jun 2020
- First submitted
- 22 Apr 2014
- Last updated
- 2 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Shao H, Faris NR, Ward KD, Chen W, McHugh L, Smeltzer M, Ray MA, Osarogiagbon RU. Lung Cancer Patients' and Caregivers' Satisfaction With Multidisciplinary Versus Serial Care in a Community Healthcare Setting: A Prospective Comparative-Effectiveness Cohort Study. Clin Lung Cancer. 2023 Nov;24(7):e267-e274. doi: 10.1016/j.cllc.2023.06.006. Epub 2023 Jun 20.
PubMed 37451932Smeltzer MP, Ray MA, Faris NR, Meadows-Taylor MB, Rugless F, Berryman C, Jackson B, Fehnel C, Pacheco A, McHugh L, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Prospective Comparative Effectiveness Trial of Multidisciplinary Lung Cancer Care Within a Community-Based Health Care System. JCO Oncol Pract. 2023 Jan;19(1):e15-e24. doi: 10.1200/OP.21.00815. Epub 2022 May 24.
PubMed 35609221Smeltzer MP, Rugless FE, Jackson BM, Berryman CL, Faris NR, Ray MA, Meadows M, Patel AA, Roark KS, Kedia SK, DeBon MM, Crossley FJ, Oliver G, McHugh LM, Hastings W, Osborne O, Osborne J, Ill T, Ill M, Jones W, Lee HK, Signore RS, Fox RC, Li J, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Pragmatic trial of a multidisciplinary lung cancer care model in a community healthcare setting: study design, implementation evaluation, and baseline clinical results. Transl Lung Cancer Res. 2018 Feb;7(1):88-102. doi: 10.21037/tlcr.2018.01.02.
PubMed 29535915
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Building a Multidisciplinary Bridge Across the Quality Chasm in Thoracic Oncology
- ClinicalTrials.gov ID
- NCT02123797
- Acronym / sponsor ID
- The Milestone Project
- Conditions
- Lung Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Baptist Memorial Health Care CorporationUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 9 Oct 2014 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 29 Feb 2020 (actual)
- First posted
- 28 Apr 2014 (estimated)
- Results
- Posted 2 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Lung cancer kills 160,000 patients annually; this represents 28% of all US cancer deaths. The overall year survival rate has only improved from 12% to 17% in 33 years. This failure reflects the innate lethality of lung cancer, but also reflects defects in patient care delivery. Care for the lung cancer patient starts with an abnormal radiologic scan, proceeds through a diagnostic biopsy, tests to determine the extent of spread of the disease (stage), selection of appropriate treatment, and finally ends with patient outcomes. At each step are multiple options and independent specialists, each one engaged by a process of sequential referrals in the serial care model. This process is often not user-friendly, is riddled with inefficiency, delays, and outcome variances.
The coordinated multidisciplinary model, in which patients and their doctors collaborate to provide evidence-based care, is believed by experts to be superior, but has few examples of successful implementation. The implementation gap exists because of the paucity of good quality data, and lack of implementation know-how.
Embedded in the highest US lung cancer mortality zone, the greater Memphis area has a racially, culturally, economically and geographically diverse population. The investigators research group has shown how poor quality care impairs patient survival in this region and in the greater US. The investigators have linked patient survival to compliance with multidisciplinary care plans. In this project, the investigators propose to rigorously test the impact of the multidisciplinary care model on patient outcomes in a community-based, private practice environment, similar to where 70% of lung cancer care is delivered in the US.
The objective of this study is to provide high-level evidence of the impact of multidisciplinary care on lung cancer patient outcomes. Multidisciplinary care is defined as a model of care in which patients, their care-givers and key specialists concurrently and directly evaluate the same patients in the presence of the patients and their informal caregivers, in order to develop evidence-based consensus care plans
Detailed description
Within the Baptist Memorial Health Care system, the Multidisciplinary Thoracic Oncology Program has two components: Primarily, the program is centered in a multidisciplinary clinic, wherein patients and their informal caregivers are seen by multiple specialists at a single appointment time; secondarily, the program includes a multidisciplinary conference, wherein all of the specialists potentially involved in lung cancer care discuss patients referred for presentation and make consensus recommendations for care. This study focuses primarily on the experience and outcomes of care delivered to patients evaluated in the multidisciplinary clinic. However, data from the conference will also be included in some aspects of the study. The goal is to improve the access and quality of thoracic oncologic care delivery within the Baptist Healthcare System The investigators specific aim is to perform a prospective, matched cohort comparative effectiveness study of patients receiving serial vs. multidisciplinary care, with key patient-centered endpoints (survival, stakeholder satisfaction with the care experience, timeliness and stage-appropriateness of care, quality of staging). Serial care is defined as the current system of linear, sequential, referral-based care delivery.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Multidisciplinary Clinic Patients | – | –: 150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients |
| Serial Care Patients | – | –150 multidisciplinary clinic patients matched 1:2 with 300 serial care patients = 450 patients Since Baptist Health Care System manages >800 new cases each year, 300 of which are expected to be seen in multidisciplinary clinic, in practice, we conservatively expect to be able to recruit 150 cases from multidisciplinary clinic and 300 matched serial care controls (1:2 match) in 18 months. |
| Multidisciplinary Caregivers | – | –Consenting caregivers of consented multidisciplinary clinic patients (patients seen by multiple specialists at a single appointment time). |
| Serial Care Caregivers | – | –Consenting caregivers of consented serial care patients (patients who receive the current system of linear, sequential, referral-based care delivery). |
| Clinical Providers | – | –Clinical providers who referred at least 5 patients to the multidisciplinary program and consented to the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Lung Cancer Patients coming through the Baptist health care system
Key inclusion criteria (1 listed)
- All patients who undergo care for lung cancer or an undiagnosed lung mass within the Baptist Memorial Health Care Corporation's hospitals from January 1, 2009 until the end of the defined study period will be eligible for inclusion in the data collection for this study. In addition, caregivers of patients within the same institution and within the study window, clinical care providers (doctors and nurses) who have taken care of patients within the eligible institutions during the study window.
Key exclusion criteria (2 listed)
- Patients who do not have a radiology-identified lung lesion or lung cancer are excluded from this study.
- Patients not receiving care within the Baptist Memorial Healthcare Corporation are excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Thoroughness of Invasive Mediastinal Staging, MD vs SC
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence of mediastinal nodal metastasis. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Thoroughness of Bi-Modal Staging Practice, MD vs SC
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Thoroughness of Tri-Modal Staging Practice, MD vs SC
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Thoroughness of Invasive Staging, MD vs SC (Conference) vs SC (no Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients with a test that provides tissue confirmation of the stage-defining lesion. Tests include a biopsy of any identified suspicious metastatic lesion or the primary lesion in the absence of any other suspicious lesion. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Thoroughness of Invasive Mediastinal Staging, MD vs SC (no Conference) vs SC (Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients with a test (i.e., biopsy) that provides tissue confirmation of the presence or absence mediastinal nodal metastasis. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Thoroughness of Bi-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients receiving two forms of staging tests (bi-modal staging). Bi-modal staging is defined as a CT scan plus any other type of radiologic scan or any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Thoroughness of Tri-Modal Staging Practice, MD vs SC (Conference) vs SC (no Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients receiving three forms of staging tests (tri-modal staging). Tri-modal staging is defined as a CT scan plus any other type of radiologic scan plus any biopsy, or PET/CT plus any biopsy. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Stage-Appropriateness Treatment Selection, MD vs SC
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy).
Stage-Appropriateness Treatment Selection, MD vs SC (Conference) vs SC (no Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months
Number of patients for whom appropriate treatment was given, as determined by the patients' clinical stage and treatment guidelines stipulated by the National Comprehensive Cancer Network (NCCN). For Stage I or II: surgery (or radiation therapy with documented contraindication to surgery or patient refusal); for Stage III: chemotherapy and radiation therapy with or without surgery; for Stage IV: systemic therapy (or palliative care with documented patient refusal or contraindication to systemic therapy). This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Timeliness of Communication, MD vs SC(Conference)
Time frame: Within 48 hours of a documented care recommendation made through the multidisciplinary thoracic oncology program
Number of patients for whom formal, verified communication of care management decisions was made to all team members (providers inside and outside the multidisciplinary program, patients and their care-givers) within 48 hours of a care recommendation being made. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Concordance Rate for Initial Conference Recommendations, MD vs SC (Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Number of patients for whom all recommendations made at the initial multidisciplinary conference were completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.
Concordance Rate for Initial Conference Recommendation(s) With Prior Condition Met, MD vs SC (Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Number of patients for whom all initial conference recommendations were completed, excluding conditional recommendations for which the prior condition was not met. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. E.g., if a recommendation was to have a PET/CT and then a staging biopsy if the PET showed suspicious metastatic disease, the staging biopsy recommendation was excluded from the concordance measure if the PET/CT did not happen or was negative.
Concordance Rate for Any Conference Recommendation, MD vs SC (Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Number of patients for whom any initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome.
Overall Concordance Rate Using a Hierarchy of Initial Conference Recommendations, MD vs SC (Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Number of patients for whom the overall initial conference recommendation was completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients. Note that two patients (one from the MD arm and one from the SC arm) have died before receiving recommendations and therefore were not analyzed for this outcome. The hierarchy to rank recommendations, from highest priority to lowest, was (1) treatment, (2) staging, (3) diagnosis, (4) surveillance. If a patient had a treatment recommendation and it happened, he/she was concordant. If treatment was recommended and it did not happen, he/she was discordant. If no treatment recommendation was made, then concordance was measured by whether or not the staging recommendation was met. If no staging recommendation was made, then the diagnostic recommendation was given priority for a concordance measurement. If no diagnostic recommendation, then a surveillance recommendation was used to measure overall concordance.
Concordance Rate for Treatment Recommendations With Prior Recommendations Completed, MD vs SC (Conference)
Time frame: From the time of a patient's positive lung cancer diagnosis, to the end of a patient's last line of treatment, an average of 1-2 months
Number of patients for whom the treatment recommendation made at the initial conference presentation was completed, excluding any patient for whom prior recommendations (staging, diagnosis, surveillance) were not also completed. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Baseline Patient Survey Response Rate, MD vs SC
Time frame: Baseline
Number of patients who completed a baseline patient survey
3-month Patient Survey Response Rate, MD vs SC
Time frame: Within 30 days of 3 months after baseline survey administration
Number of patients who completed a 3-month survey
6-Month Patient Survey Response Rate, MD vs SC
Time frame: Within 30 days of 6 months after baseline survey administration
Number of patients who completed a 6-month survey
Patient Survey Scores at Baseline, MD vs SC
Time frame: Baseline
Scores from patient surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken. Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range: 0-4 (higher is better) Financial burden of care - assessment of financial burden of care; range: 3-6 (sum of 3 items, higher is worse) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 1-5 (sum of 2 items, higher is better) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) (descriptions continued in 3 month survey description)
Patient Survey Scores at 3 Months, MD vs SC
Time frame: Within 30 days of 3 months after baseline survey administration
Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken. (continued from baseline) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-21 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 0-18 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Physical/Social/Functional well-being - health-related quality of life relating to physical/social/functional well-being; range 0-28 (each a sum of 7 items, higher is better) (description continues in 6 month survey description)
Patient Survey Scores at 6 Months, MD vs SC
Time frame: Within 30 days of 6 months after baseline survey administration
Scores from patient surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken. (cont) Emotional well-being - health-related quality of life related to emotional well-being; range 0-30 (sum of 6 items, higher is better) Lung cancer specific QOL - health-related quality of life related to lung cancer diagnosis; range: 0-36 (sum of 9 items, higher is better) Total Summary Score FACTL - full survey, functional assessment of cancer therapy - lung; range: 0-136 (sum of 36 items, higher is better) Generic Score FACTG - full survey, functional assessment of cancer therapy - general; range: 0-108 (sum of 27 items, higher is better) Trial Outcome Index - health related quality of life - trial outcome index; range: 0-84 (sum of 23 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items each, higher is worse)
Baseline Caregiver Survey Response Rate, MD vs SC
Time frame: Baseline
Number of caregivers who completed a baseline patient survey
3-month Caregiver Survey Response Rate, MD vs SC
Time frame: Within 30 days of 3 months after baseline survey administration
Number of caregivers who completed a 3-month survey
6-Month Caregiver Survey Response Rate, MD vs SC
Time frame: Within 30 days of 6 months after baseline survey administration
Number of caregivers who completed a 6-month survey
Caregiver Survey Scores at Baseline, MD vs SC
Time frame: Baseline
Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the baseline survey was taken. Overall quality of health care - satisfaction with overall quality of health care since lung cancer diagnosis; range:0-4 (higher is better) Treatment decision-making: Surgery/Radiation/Chemotherapy - each 1 item; satisfaction with treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Treatment decision-making: family role - satisfaction with family role in treatment decision-making; range: 0-2 (0=patient controlled; 1=shared decision; 2-physician decision; closer to 1 is best) Satisfaction with treatment plan - satisfaction with overall treatment plan; range: 0-2 (higher is better) Satisfaction patient can complete treatment plan; range: 0-2 (higher is better) (continued in 3 month survey description)
Caregiver Survey Scores at 3 Months, MD vs SC
Time frame: Within 30 days of 3 months after baseline survey administration
Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 3-month survey was taken. (cont) Satisfaction with quality of care - overall satisfaction with care received from all care team members; range: 0-18 (sum of 6 items, higher is better) Satisfaction with physician communication - overall satisfaction with physician communication; range: 0-28 (sum of 7 items, higher is better) Satisfaction with nurse communication - overall satisfaction with nurse communication; range: 6-24 (sum of 6 items, higher is better) Overall team satisfaction - CAHPS satisfaction with care from team as a whole; range: 0-15 (sum of 4 items, higher is better) Depression/Anxiety - depression/anxiety measured by Hospital Anxiety and Depression Scale; range: 0-21 (sum of 7 items, higher is worse) (continued in 6 month survey description)
Caregiver Survey Scores at 6 Months, MD vs SC
Time frame: Within 30 days of 6 months after baseline survey administration
Scores from caregiver surveys that measure quality of life and satisfaction with care received at the time the 6-month survey was taken. (cont) Physical Functioning QOL - 10 items; Physical Health Problems QOL - 4 items; Pain QOL - 2 items; General health perceptions - 5 items; Energy/fatigue QOL - 4 items; Social Functioning QOL - 2 items; Emotional health problems QOL - 3 items; Emotional well-being QOL - 5 items. All health related quality of life measures are from the SF-36 survey tool, and use a range of 0-100 mean score (higher is better).
Timeliness of Care, MD vs SC
Time frame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
Aggregate time in days from enrollment to a specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. 2 group comparison between Multidisciplinary Clinic Patients and Serial Care Patients.
Timeliness of Care, MD vs SC (Conference) vs SC (no Conference)
Time frame: From the time of a patient's initial lesion detection to the designated step in the care process, as noted per row below
Aggregate time in days from enrollment to specific care delivery endpoint including: from initial detection of lesion to initial biopsy, from initial detection to non-invasive staging, from initial detection to invasive staging, and from initial detection to definitive treatment. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Clinical Provider Survey Responses - Ease of Referring Patients to the Conference
Time frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Clinical Provider Survey Responses - How Quickly my Patients Get Scheduled to be Discussed at the Conference
Time frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Clinical Provider Survey Responses - The Helpfulness of the Staff in Scheduling Patients
Time frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Clinical Provider Survey Responses - The Quality of Treatment Recommendations That I Received for my Patient
Time frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Clinical Provider Survey Responses - How Quickly I Receive Feedback on my Patient
Time frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Clinical Provider Survey Responses - The Consistency With Which my Patients Are Sent Back for Further Treatment
Time frame: After a provider referred their 5th patient to the multidisciplinary conference (baseline), then within 30 days of 6 months and 12 months, respectively, after baseline survey was completed
Responses from clinical providers will measure provider satisfaction and obstacles to institutional multidisciplinary care.
Patient Overall Survival
Time frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
Patient Overall Survival With SC Further Broken Down
Time frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Overall survival, defined as the time from cancer diagnosis to death from any cause or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Patient Disease/Progression Free Survival
Time frame: measured from the time from cancer diagnosis to disease progression, death, or data censoring, up to 6 years
Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals.
Patient Disease/Progression Free Survival With SC Further Broken Down
Time frame: As measured from the time from cancer diagnosis to death or data censor, up to 6 years
Event-free survival (EFS), as measured from the time from cancer diagnosis to disease progression, death, or data censoring, is analyzed and summarized with the survival probabilities over time using the Kaplan-Meier method. Confidence intervals for the 1- and 3- year survival probabilities are reported. Additionally, the Cox proportional hazard model was used to estimate hazard ratios which are reported in the statistical analyses with 95% confidence intervals. This measure compares 3 groups, instead of 2, because some patients in the serial care group were presented for discussion in a multidisciplinary thoracic oncology conference while still not being seen in the multidisciplinary clinic setting. Therefore, we split the serial care group in two in order to measure the potential impact of a multidisciplinary conference model, separate from the multidisciplinary clinic model.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37451932Shao H, Faris NR, Ward KD, Chen W, McHugh L, Smeltzer M, Ray MA, Osarogiagbon RU. Lung Cancer Patients' and Caregivers' Satisfaction With Multidisciplinary Versus Serial Care in a Community Healthcare Setting: A Prospective Comparative-Effectiveness Cohort Study. Clin Lung Cancer. 2023 Nov;24(7):e267-e274. doi: 10.1016/j.cllc.2023.06.006. Epub 2023 Jun 20.
- Derived from this study: PubMed 35609221Smeltzer MP, Ray MA, Faris NR, Meadows-Taylor MB, Rugless F, Berryman C, Jackson B, Fehnel C, Pacheco A, McHugh L, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Prospective Comparative Effectiveness Trial of Multidisciplinary Lung Cancer Care Within a Community-Based Health Care System. JCO Oncol Pract. 2023 Jan;19(1):e15-e24. doi: 10.1200/OP.21.00815. Epub 2022 May 24.
- Derived from this study: PubMed 29535915Smeltzer MP, Rugless FE, Jackson BM, Berryman CL, Faris NR, Ray MA, Meadows M, Patel AA, Roark KS, Kedia SK, DeBon MM, Crossley FJ, Oliver G, McHugh LM, Hastings W, Osborne O, Osborne J, Ill T, Ill M, Jones W, Lee HK, Signore RS, Fox RC, Li J, Robbins ET, Ward KD, Klesges LM, Osarogiagbon RU. Pragmatic trial of a multidisciplinary lung cancer care model in a community healthcare setting: study design, implementation evaluation, and baseline clinical results. Transl Lung Cancer Res. 2018 Feb;7(1):88-102. doi: 10.21037/tlcr.2018.01.02.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raymond Osarogiagbon principal investigator
Baptist Memorial Health Care Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Baptist Memorial Health Care Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoroughness of Invasive Staging, Multidisciplinary (MD) vs Serial Care (SC) (time frame: From the time of a patient's positive lung cancer diagnosis, to the start of a patient's first-line of treatment, an average of 1-2 months). The study lists 40 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02123797, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.