Lung CancerNCT03694054
Care Coordination in Oncology, Quality Among Patients With Lung Cancer and Their Caregivers
A study testing Care coordination tool in people with Lung Cancer, run by Geisinger Clinic at 1 site in United States.
Trial summary
The Oncology Care Coordination study is designed to evaluate use of a care coordination tool for lung cancer patients and their caregiver on quality of care and performance outcomes. Eligible patients need to be receiving treatment at Geisinger. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Care coordination tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jun 2018to 31 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients:
- Patients who are 18 years of age or older and diagnosed with lung cancer who 1) are scheduled to start Oncology Care (chemo and/or radiation-therapies) OR 2) on active Oncology Care and recently started within 3 weeks (<27 days for experimental arm; <56 days control arm)
- Receive care at GMC, GWV, or GCMC
- English-speaking
- Established/intends to establish a MyGeisinger Account (cases only)
- Caregivers:
Show all 10Show fewer
- Recognized/intends to be recognized as proxy for patient's MyGeisinger Account (cases only)
- English-speaking
- Providers:
- Any health care provider within Medical Oncology or Radiation Oncology at GMC, where care coordination tool is standard of care, who has a patient enrolled.
Who cannot join
- Patients:
- Patients who are not diagnosed with lung cancer.
- Patients who are diagnosed with lung cancer and are on active Oncology Care exceeding 3 weeks (>27 days experimental arm; >56 days control arm).
- Providers:
- Any healthcare provider not within the Medical Oncology or Radiation Oncology departments.
- Any healthcare provider within Medical Oncology or Radiation Oncology who does not have a patient enrolled (Case Dyad).
Trial locations and contacts
1 site in 1 country.
United States1 site
Geisinger Health System
Danville, Pennsylvania, 17822
About this study
Official title: Exploratory Evaluation of Family Caregiver Application (FCA) on Quality Among Persons With Lung Cancer and Their Family Caregivers
The Oncology Care Coordination study is designed to evaluate use of a care coordination tool for lung cancer patients and their caregiver on quality of care and performance outcomes. Eligible patients need to be receiving treatment at Geisinger. Participation in the study involves completion of surveys, permission to review information from the patient's electronic health record, and for some enrollment in the care coordination tool called Harmonized Care. Geisinger oncology care providers who have patients enrolled the study will be invited for interviews.
Read the detailed description
The case-matched controlled design, exploratory evaluation study will look at how exposure to a care coordination tool impacts quality and performance indicators associated with oncology care from the perspective of patients, caregivers, and providers.
Geisinger research staff will recruit lung cancer patients and their caregivers across three Geisinger locations: Geisinger Medical Center (GMC), Geisinger Wyoming Valley Medical Center (GWV) and Geisinger Community Medical Center (GCMC). GMC will serve as the intervention site and GWV and GCMC as control sites.
Eligible participants will be identified by the study staff through the electronic health record as well as through clinical staff and approached in the oncology clinic as part of a schedule office visit and/or treatment. For the purpose of study awareness, informational flyers will be available to patients in the exam rooms, waiting rooms, and through Oncology Care's Multi-Disciplinary clinic. Participants will asked to identify a caregiver who will participate in the study as well, however this is not required.
Case dyads enrolled at the intervention site (GMC) will be asked to complete a survey when they join the study and at the end of the study. Participants will also be asked to enroll in the care coordination tool, a health information solution that integrates the patient, caregiver, and clinical data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to give permission to the study team to access their health information via the e electronic health record. Participants will be in the research study for about 8-10 weeks.
Control dyads enrolled at the control site (GWV and GCMC) will be asked to complete a survey eight weeks after consenting to participate. Patients will be asked to give permission to the study team to access their health information via the electronic health record. Participants will be in the research study for about 8-10 weeks.
The study will also enroll oncology care providers within the Medical Oncology or Radiation Oncology departments at GMC and who have patients enrolled in the study. Providers will be asked to participate in a 30-minute interview to get their feedback and insights on the care coordination tool.
- Conditions
- Lung Cancer
- Being tested
- Care coordination tool
- Keywords
- Care Coordination, Oncology Care, 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.
Care coordination toolOther
Participants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record.
| Study group | Role | What they receive |
|---|---|---|
| Care coordination patients, caregivers | Experimental | Patients and caregivers enroll in using care coordination tool during oncology care and treatment. Receives: Other: Care coordination tool |
| Standard of care patients, caregivers | No intervention | Patients and caregivers receive oncology care and treatment. |
| Oncology Care Providers | Experimental | Oncology care providers with patients enrolled in care coordination tool. Receives: Other: Care coordination tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
To evaluate the difference in patient satisfaction associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of satisfaction associated with FCA exposure.To evaluate the association of the change in patient satisfaction associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in satisfaction perceptions based on role.
Measured: 8 weeks
Secondary outcomes (6)
Caregiver Satisfaction
To evaluate the difference in caregiver satisfaction associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control caregiver analyses will also be performed to detect role-level differences in perceptions of satisfaction associated with FCA exposure. To evaluate the association of the change in caregiver satisfaction associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in satisfaction perceptions based on role.
Measured: 8 weeks
Patient Quality of Life
To evaluate the difference in patient quality of life associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of quality of life associated with FCA exposure.To evaluate the association of the change in patient quality of life associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in quality of life perceptions based on role.
Measured: 8 weeks
Caregiver Quality of Life
To evaluate the difference in caregiver quality of life associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control caregiver analyses will also be performed to detect role-level differences in perceptions of quality of life associated with FCA exposure. To evaluate the association of the change in caregiver quality of life associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in quality of life perceptions based on role.
Measured: 8 weeks
Family Centered Care
To evaluate the difference in family centered care associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient and caregiver analyses will also be performed to detect role-level differences in perceptions of family centered care associated with FCA exposure. To evaluate the association of the change in family centered care associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in family centered care perceptions based on role.
Measured: 8 weeks
Patient Experience
To evaluate the difference in patient experience associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of experience associated with FCA exposure.To evaluate the association of the change in patient experience associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in experience perceptions based on role.
Measured: 8 weeks
Caregiver Burden
To evaluate the difference in caregiver burden associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control caregiver analyses will also be performed to detect role-level differences in perceptions of burden associated with FCA exposure.To evaluate the association of the change in caregiver burden associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. To evaluate the association of the change in caregiver burden associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2018
- Study start4 Jun 2018
- Primary completion28 Feb 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geisinger Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Sponsor
- Investigators
- Lisa Bailey-Davis, DEd, RD, Principal investigator, Geisinger Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03694054
- Sponsor's protocol ID
- 2018-0172
- Status last verified
- Apr 2019
- First submitted
- 11 Sep 2018
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Evaluation of Family Caregiver Application (FCA) on Quality Among Persons With Lung Cancer and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT03694054
- Acronym / sponsor ID
- 2018-0172
- Conditions
- Lung Cancer
- Keywords
- Care Coordination, Oncology Care, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Geisinger ClinicUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 4 Jun 2018 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 3 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Oncology Care Coordination study is designed to evaluate use of a care coordination tool for lung cancer patients and their caregiver on quality of care and performance outcomes. Eligible patients need to be receiving treatment at Geisinger. Participation in the study involves completion of surveys, permission to review information from the patient's electronic health record, and for some enrollment in the care coordination tool called Harmonized Care. Geisinger oncology care providers who have patients enrolled the study will be invited for interviews.
Detailed description
The case-matched controlled design, exploratory evaluation study will look at how exposure to a care coordination tool impacts quality and performance indicators associated with oncology care from the perspective of patients, caregivers, and providers.
Geisinger research staff will recruit lung cancer patients and their caregivers across three Geisinger locations: Geisinger Medical Center (GMC), Geisinger Wyoming Valley Medical Center (GWV) and Geisinger Community Medical Center (GCMC). GMC will serve as the intervention site and GWV and GCMC as control sites.
Eligible participants will be identified by the study staff through the electronic health record as well as through clinical staff and approached in the oncology clinic as part of a schedule office visit and/or treatment. For the purpose of study awareness, informational flyers will be available to patients in the exam rooms, waiting rooms, and through Oncology Care's Multi-Disciplinary clinic. Participants will asked to identify a caregiver who will participate in the study as well, however this is not required.
Case dyads enrolled at the intervention site (GMC) will be asked to complete a survey when they join the study and at the end of the study. Participants will also be asked to enroll in the care coordination tool, a health information solution that integrates the patient, caregiver, and clinical data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to give permission to the study team to access their health information via the e electronic health record. Participants will be in the research study for about 8-10 weeks.
Control dyads enrolled at the control site (GWV and GCMC) will be asked to complete a survey eight weeks after consenting to participate. Patients will be asked to give permission to the study team to access their health information via the electronic health record. Participants will be in the research study for about 8-10 weeks.
The study will also enroll oncology care providers within the Medical Oncology or Radiation Oncology departments at GMC and who have patients enrolled in the study. Providers will be asked to participate in a 30-minute interview to get their feedback and insights on the care coordination tool.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Care coordination patients, caregivers | Experimental | Other: Care coordination toolPatients and caregivers enroll in using care coordination tool during oncology care and treatment. |
| Standard of care patients, caregivers | No intervention | –Patients and caregivers receive oncology care and treatment. |
| Oncology Care Providers | Experimental | Other: Care coordination toolOncology care providers with patients enrolled in care coordination tool. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients who are 18 years of age or older and diagnosed with lung cancer who 1) are scheduled to start Oncology Care (chemo and/or radiation-therapies) OR 2) on active Oncology Care and recently started within 3 weeks (<27 days for experimental arm; <56 days control arm)
- Receive care at GMC, GWV, or GCMC
- English-speaking
- Established/intends to establish a MyGeisinger Account (cases only)
- Recognized/intends to be recognized as proxy for patient's MyGeisinger Account (cases only)
Key exclusion criteria (6 listed)
- Patients who are not diagnosed with lung cancer.
- Patients who are diagnosed with lung cancer and are on active Oncology Care exceeding 3 weeks (>27 days experimental arm; >56 days control arm).
- Any healthcare provider not within the Medical Oncology or Radiation Oncology departments.
- Any healthcare provider within Medical Oncology or Radiation Oncology who does not have a patient enrolled (Case Dyad).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care coordination toolParticipants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record. | Other | Care coordination patients, caregivers, Oncology Care Providers |
Primary outcome
Patient Satisfaction
Time frame: 8 weeks
To evaluate the difference in patient satisfaction associated with FCA exposure (Case v. Control) will be evaluated using chi-square test, t-tests and non-parametric univariate tests distribution dependent. Mean patient and caregiver scores will be calculated for each dyad and compared between groups. Sensitivity analyses may stratify by level of FCA use (low-moderate-high) per dyad and opportunity time for FCA exposure. Case to Control patient analyses will also be performed to detect role-level differences in perceptions of satisfaction associated with FCA exposure.To evaluate the association of the change in patient satisfaction associated with FCA use difference in response between pre- and post- surveys paired t-test or ANCOVA depending on data type and distribution. Within Case Dyads, patient means will be compared with caregiver means to detect difference in satisfaction perceptions based on role.
6 secondary outcomes
Caregiver Satisfaction
Time frame: 8 weeks
Patient Quality of Life
Time frame: 8 weeks
Caregiver Quality of Life
Time frame: 8 weeks
Family Centered Care
Time frame: 8 weeks
Patient Experience
Time frame: 8 weeks
Caregiver Burden
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Individual participant dataSharing planned: No
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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.
Lisa Bailey-Davis, DEd, RD principal investigator
Geisinger Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care coordination tool in people with Lung Cancer, run by Geisinger Clinic 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 10 inclusion and 6 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 9 Apr 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient Satisfaction (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2019.