Carcinoma, Non-Small-Cell-LungNCT02562027
SBRT (Stereotactic Body Radiation Therapy) vs. Surgery in High Risk Patients With Early Stage Lung Cancer
A study testing European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 and Modified Medical Research Council in people with Carcinoma, Non-Small-Cell-Lung and Non-Small Cell Lung Cancer, run by Washington University School of Medicine at 1 site in United States.
Trial summary
A principle objective of the study is to create a validated risk model for treatment selection. This will greatly enhance the ability to counsel patients regarding their specific risks/benefit ratio for surgery or SBRT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-Small-Cell-Lung, Non-Small Cell Lung Cancer, Nonsmall Cell Lung Cancer
- What is being tested?
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 and Modified Medical Research Council
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 217 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2015to 1 Nov 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly diagnosed suspected or proven clinical stage I NSCLC (T1 or T2, N0, M0) with no prior treatment for this disease.
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Objective Treatment Allocation With SBRT vs. Surgery in High Risk Patients With Early Stage Lung Cancer Within an Accountable Care Collaborative Effort Between Surgery and Radiation Oncology
A principle objective of the study is to create a validated risk model for treatment selection. This will greatly enhance the ability to counsel patients regarding their specific risks/benefit ratio for surgery or SBRT. This will improve informed decision making on the part of the patient, and remove much of the subjectivity of treatment selection.
Read the detailed description
The development of SBRT for treatment of stage I NSCLC (non-small cell lung cancer) inspired the collaboration between thoracic surgery and radiation oncology and has prompted the investigators to work closely together to evaluate the relative role of SBRT and surgery. Comparative studies of these modalities have been limited in number and are often difficult to interpret due to variability in methodological issues. The productive collaboration has resulted in publication of several studies comparing SBRT and surgery utilizing propensity score based analyses to match patients from each group. However, matching on limited numbers of variables between patients ultimately selected for therapy based largely on their real or perceived comorbidity leads to significant reporting bias, and therefore methods to comprehensively assess comorbidity are necessary.
As extension of above, a very real ongoing challenge that the investigators have evaluated within clinical practice is that current guidelines defining the high risk patient are subjective and prone to physician bias. A recent secondary analysis of clinical trial inclusion criteria for SBRT underscored this bias by demonstrating that many patients that were considered inoperable were perhaps reasonable surgical candidates. Based on standard pulmonary function tests the inoperable SBRT patients had a diffusion capacity 33% higher than the high risk surgical patients in ACOSOG Z4032. Conversely, stratification of high risk surgical patients within ACOSOG Z4032 trial identified an extremely high risk subset (median DLCO% 30%, FEV1% 39%) with a 90-day 3+ adverse event rate of 48% compared to the lowest risk subset (DLCO% 69%, FEV1% 56%) with a 90-day 3+ adverse event rate of only 24%. In the absence of a clinical trial or a prospective database, there is currently no objective algorithm to guide the assignment of surgery versus SBRT.
Attempts to objectively stratify risk within the surgical population have been challenging. Risk models based on the European Thoracic Database and the Society of Thoracic Surgeons Database are not yet robust enough to guide decision-making regarding treatment assignment or classification of the very high risk surgical patient where alternative therapies may be preferable. Unfortunately, one of the current limitations to stratifying these high risk patients is that these patients are followed by physicians in independent specialties. The STS Thoracic Surgical Database does not include patients that undergo SBRT therefore it is difficult to create an inclusive algorithm for operable and inoperable patients. A principle objective of the study is to create a validated risk model for treatment selection. This will greatly enhance the ability to counsel patients regarding their specific risks/benefit ratio for surgery or SBRT. This will improve informed decision making on the part of the patient, and remove much of the subjectivity of treatment selection. Inclusion of unique metrics such as HRQOL data will further bolster the benefit to the patient by making it more patient-centric, rather than focusing on cancer outcomes alone.
As the implementation of the Affordable HealthCare Act (AHCA) continues, physicians will experience additional pressure to cut costs while maintaining or improving the quality of care provided. The current fee-for-service system is often criticized for being compartmentalized and fragmented without well-defined incentives for quality improvement.
Initiatives of the AHCA have included efforts to test care models to reduce hospital associated conditions, bundled payment plans for care improvement, and shared savings programs for accountable care organizations whereby participating providers who meet certain quality standards share in any savings achieved for the Medicare program. These are just some of the efforts designed to rein in the cost of medical care while improving the transparency and quality of care. Pilot efforts involving bundling of payments for coronary artery bypass grafting resulted in Medicare savings of $40 million with simultaneous reduced in-hospital mortality. These types of initiatives are likely to become more commonplace in the United States as efforts to create new models of care to constrain cost are introduced.
With the stimulus of these initiatives for novel systems of healthcare delivery the investigators recognized that a model of bundled payment for treatment of stage I NSCLC may not only reduce overall costs associated with treatment of stage I lung cancer but potentially improve the quality of care provided. At Washington University the investigators have taken a preemptive measure to create an accountable care organization (ACO) between the Department of Radiation Oncology and the Department of Thoracic Surgery with a focused approach on the treatment of stage I NSCLC. Important components of this collaborative effort include a bundled payment system for episodes of care involving the treatment selection, implementation, and follow up care of patients with stage I lung cancer as well as prospective assessment of quality of care measures.
The impetus for the development of this unique collaboration between radiation oncology and thoracic surgery stems from the ongoing interest in improving the quality of care for patients with early stage NSCLC. The clinical research focus has been on determining the best treatment strategies for the significant number of patients with stage I lung cancer considered medically inoperable or high risk surgical candidates. In the aging population, pulmonary insufficiency, cardiac disease, as well as other comorbidities may preclude surgery or place patients at significant risk for complications after surgery. The evolution of stereotactic body radiotherapy (SBRT) in the medically inoperable population has resulted in relatively low local recurrence rates ranging from 3-20% with favorable overall and disease-free survival in inoperable patients with Stage I NSCLC.
- Being tested
- European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13, Modified Medical Research Council, EQ-5D, Center for Epidemiological Studies Depression Scale
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30Behavioural
Also called EORTC QLQ-C30
- 30 quality of life questions for the participant to answer
- The first 28 questions have answers that range from 1 (Not at All) to 4 (Very Much)
- The final 2 questions answers range from 1 (Very Poor) to 7 (Excellent)
- Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13Behavioural
Also called EORTC QLQ-LC13
- 13 quality of life questions for the participant to answer
- The answers range from 1 (Not at All) to 4 (Very Much)
- Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
Modified Medical Research CouncilBehavioural
Also called mMRC
- Participants is given 5 grades to choose from ranging from 0 to 4 and participant will choose grade
- Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
EQ-5DBehavioural
Also called -Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
- 5 headings with 5 statements and the participant will check the box that best describes how he or she feels that day
- The second part shows a scale ranging from 0 (worst health) to 100 (best health) and the participant chooses the best number on the scale
- Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
Center for Epidemiological Studies Depression ScaleBehavioural
Also called CES-D
- 20 quality of life questions for the participant to answer
- Answers range from "Rarely or none of the time" to "Most or all of the time"
- Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
Medical Outcomes Study Social Support SurveyBehavioural
Also called MOS-SSS
- 19 quality of life questions for the participant to answer
- Answers from from 1 (None of the time) to 5 (All of the time)
- Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment
| Study group | Role | What they receive |
|---|---|---|
| High-risk NSCLC participants | Experimental | * Baseline assessment of demographics and comorbidities
* Comorbidity scoring by interview and chart review: the Adult Comorbidity Evaluation 27, Charlson Comorbidity Index, Global Initiative for Chronic Obstructive Lung Disease, Cumulative Illness Rating Scale, and COMorbidities in Chronic Obstructive Lung Disease.
* Katz Activities of Daily Living: assessment of grip strength, walk speed, and activities of daily living
* HRQOL questionnaires will also be administered prior to treatment and then repeated throughout follow-up: the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30, EORTC QLQ-LC13, Modified Medical Research Council, EQ-5D, CES-D, and Medical Outcomes Study Social Support Survey.
* All questionnaire responses will be obtained with the use of a computer assisted interview system which can be used to collect data in person or through telephone interviews Receives: Behavioral: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30; Behavioral: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13; Behavioral: Modified Medical Research Council; Behavioral: EQ-5D; Behavioral: Center for Epidemiological Studies Depression Scale; Behavioral: Medical Outcomes Study Social Support Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment selection model for high-risk early stage NSCLC patient population using comorbidity
- Comorbidity scoring will be performed by interview and chart review including the Adult Comorbidity Evaluation 27 (ACE-27), Charlson Comorbidity Index (CCI), Global Initiative for Chronic Obstructive Lung Disease (GOLD), Cumulative Illness Rating Scale (CIRS), and COMorbidities in Chronic Obstructive Lung Disease (COMCOLD)
- All of the comorbidity indices grade comorbidities from mild to severe. The investigators will use the data obtained from cumulative collected indices to determine the severity of patient comorbidities.
- The data obtained from this group of patients will be compared with the previously obtained data from patients who had surgery for their stage I NSCLC.
Measured: Up to 90 days post treatment
Treatment selection model for high-risk early stage NSCLC patient population using risk indices
- For determination of frailty, Fried's frailty criteria, a validated measurement tool which includes assessment of weight loss, exhaustion, activity level, grip strength, and walk speed. Fraility is classified using a validated score of 0-5 with patients scoring 4-5 considered frail, 2-3 considered intermediately frail, and 0-1 nonfrail.
- Activities of daily living (Katz Activities of Daily Living) and instrumental activities of daily living (IADL) will be assessed. Both the ADL and IADL look at independence. The ADL has 6 questions/the IADL has 8 questions and the patient will receive a point for each question if he or she is considered independent. A score of 0 means the person if very dependent and very frail. A score of 6 (ADL) or 8 (IADL) means a person if very independent and not frail.
- The data obtained from this group of patients will be compared with the previously obtained data from patients who had surgery for their stage I NSCLC.
Measured: Up to 90 days post treatment
Treatment selection model for high-risk early stage NSCLC patient population using HRQOL (health related quality of life) endpoints
- HRQOL will be measured by the European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ) C30, EORTC QLQ-LC13, Modified Medical Research Council (mMRC), EQ-5D, CES-D, and Medical Outcomes Study Social Support Survey (MOS-SSS).
- Utility assessments will also be used and will serve as a quantitative measure of patient preferences and will be utilized to estimate quality adjusted life years (QALYs) to better incorporate quantity of survival, as well as quality of life consequences of stage I lung cancer interventions.
Measured: Up to 24 months post treatment
Secondary outcomes (8)
Potential savings in cost using the model in this study
Cost savings will be described with both Medicare allowable dollars and actual professional and technical costs per patient through collaboration with the Siteman Cancer Center and Barnes Jewish Hospital. Cost savings will also be reviewed with regard to pre- vs. post-ACO utilization. Cost-effectiveness analyses with regard to toxicity and quality of life will be performed using a Markov decision model and estimated with a microsimulation process
Measured: Up to 90 days
Comprehensive collaborative REDCap database to support the retrospective and prospective data collection
- REDCap is a secure web application geared to support collection of research data
Measured: Up to 5 years post treatment
Costs of surgery
Measured: Up to 90 days
Costs of SBRT
Measured: Up to 90 days
Potential cost savings with implementation of a novel ACO for stage I NSCLC
Measured: Up to 90 days
Compare data between patients undergoing operative treatment and non-operative treatment for stage I NSCLC as measured by the combination of comorbidity, disability, and frailty indices
Measured: Up to 90 days post treatment
Quality of life indices as measured by the differences at baseline and after treatment using the implementation of the ACO
Measured: Up to 24 months post treatment
Knowledge-based treatment selection regression model for prediction of treatment-related outcomes
This model may be used for subsequent selection of patients for operative and nonoperative therapy in patients with Stage I NSCLC based on short-term morbidity, mortality, impact on qualify of life, and cost with the potential to construct a composite outcome index based on these variables
Measured: Up to 24 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start11 Sep 2015
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell-LungStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Varian Medical Systems
- Responsible party
- Sponsor
- Investigators
- Cliff Robinson, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562027
- Sponsor's protocol ID
- 201509035
- Status last verified
- Apr 2021
- First submitted
- 17 Sep 2015
- Last updated
- 8 Apr 2021
- 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 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Treatment Allocation With SBRT vs. Surgery in High Risk Patients With Early Stage Lung Cancer Within an Accountable Care Collaborative Effort Between Surgery and Radiation Oncology
- ClinicalTrials.gov ID
- NCT02562027
- Acronym / sponsor ID
- 201509035
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- Varian Medical Systems
- Study start
- 11 Sep 2015 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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.
A principle objective of the study is to create a validated risk model for treatment selection. This will greatly enhance the ability to counsel patients regarding their specific risks/benefit ratio for surgery or SBRT. This will improve informed decision making on the part of the patient, and remove much of the subjectivity of treatment selection.
Detailed description
The development of SBRT for treatment of stage I NSCLC (non-small cell lung cancer) inspired the collaboration between thoracic surgery and radiation oncology and has prompted the investigators to work closely together to evaluate the relative role of SBRT and surgery. Comparative studies of these modalities have been limited in number and are often difficult to interpret due to variability in methodological issues. The productive collaboration has resulted in publication of several studies comparing SBRT and surgery utilizing propensity score based analyses to match patients from each group. However, matching on limited numbers of variables between patients ultimately selected for therapy based largely on their real or perceived comorbidity leads to significant reporting bias, and therefore methods to comprehensively assess comorbidity are necessary.
As extension of above, a very real ongoing challenge that the investigators have evaluated within clinical practice is that current guidelines defining the high risk patient are subjective and prone to physician bias. A recent secondary analysis of clinical trial inclusion criteria for SBRT underscored this bias by demonstrating that many patients that were considered inoperable were perhaps reasonable surgical candidates. Based on standard pulmonary function tests the inoperable SBRT patients had a diffusion capacity 33% higher than the high risk surgical patients in ACOSOG Z4032. Conversely, stratification of high risk surgical patients within ACOSOG Z4032 trial identified an extremely high risk subset (median DLCO% 30%, FEV1% 39%) with a 90-day 3+ adverse event rate of 48% compared to the lowest risk subset (DLCO% 69%, FEV1% 56%) with a 90-day 3+ adverse event rate of only 24%. In the absence of a clinical trial or a prospective database, there is currently no objective algorithm to guide the assignment of surgery versus SBRT.
Attempts to objectively stratify risk within the surgical population have been challenging. Risk models based on the European Thoracic Database and the Society of Thoracic Surgeons Database are not yet robust enough to guide decision-making regarding treatment assignment or classification of the very high risk surgical patient where alternative therapies may be preferable. Unfortunately, one of the current limitations to stratifying these high risk patients is that these patients are followed by physicians in independent specialties. The STS Thoracic Surgical Database does not include patients that undergo SBRT therefore it is difficult to create an inclusive algorithm for operable and inoperable patients. A principle objective of the study is to create a validated risk model for treatment selection. This will greatly enhance the ability to counsel patients regarding their specific risks/benefit ratio for surgery or SBRT. This will improve informed decision making on the part of the patient, and remove much of the subjectivity of treatment selection. Inclusion of unique metrics such as HRQOL data will further bolster the benefit to the patient by making it more patient-centric, rather than focusing on cancer outcomes alone.
As the implementation of the Affordable HealthCare Act (AHCA) continues, physicians will experience additional pressure to cut costs while maintaining or improving the quality of care provided. The current fee-for-service system is often criticized for being compartmentalized and fragmented without well-defined incentives for quality improvement.
Initiatives of the AHCA have included efforts to test care models to reduce hospital associated conditions, bundled payment plans for care improvement, and shared savings programs for accountable care organizations whereby participating providers who meet certain quality standards share in any savings achieved for the Medicare program. These are just some of the efforts designed to rein in the cost of medical care while improving the transparency and quality of care. Pilot efforts involving bundling of payments for coronary artery bypass grafting resulted in Medicare savings of $40 million with simultaneous reduced in-hospital mortality. These types of initiatives are likely to become more commonplace in the United States as efforts to create new models of care to constrain cost are introduced.
With the stimulus of these initiatives for novel systems of healthcare delivery the investigators recognized that a model of bundled payment for treatment of stage I NSCLC may not only reduce overall costs associated with treatment of stage I lung cancer but potentially improve the quality of care provided. At Washington University the investigators have taken a preemptive measure to create an accountable care organization (ACO) between the Department of Radiation Oncology and the Department of Thoracic Surgery with a focused approach on the treatment of stage I NSCLC. Important components of this collaborative effort include a bundled payment system for episodes of care involving the treatment selection, implementation, and follow up care of patients with stage I lung cancer as well as prospective assessment of quality of care measures.
The impetus for the development of this unique collaboration between radiation oncology and thoracic surgery stems from the ongoing interest in improving the quality of care for patients with early stage NSCLC. The clinical research focus has been on determining the best treatment strategies for the significant number of patients with stage I lung cancer considered medically inoperable or high risk surgical candidates. In the aging population, pulmonary insufficiency, cardiac disease, as well as other comorbidities may preclude surgery or place patients at significant risk for complications after surgery. The evolution of stereotactic body radiotherapy (SBRT) in the medically inoperable population has resulted in relatively low local recurrence rates ranging from 3-20% with favorable overall and disease-free survival in inoperable patients with Stage I NSCLC.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| High-risk NSCLC participants | Experimental | Behavioral: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, Behavioral: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13, Behavioral: Modified Medical Research Council, Behavioral: EQ-5D, Behavioral: Center for Epidemiological Studies Depression Scale, Behavioral: Medical Outcomes Study Social Support Survey* Baseline assessment of demographics and comorbidities * Comorbidity scoring by interview and chart review: the Adult Comorbidity Evaluation 27, Charlson Comorbidity Index, Global Initiative for Chronic Obstructive Lung Disease, Cumulative Illness Rating Scale, and COMorbidities in Chronic Obstructive Lung Disease. * Katz Activities of Daily Living: assessment of grip strength, walk speed, and activities of daily living * HRQOL questionnaires will also be administered prior to treatment and then repeated throughout follow-up: the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30, EORTC QLQ-LC13, Modified Medical Research Council, EQ-5D, CES-D, and Medical Outcomes Study Social Support Survey. * All questionnaire responses will be obtained with the use of a computer assisted interview system which can be used to collect data in person or through telephone interviews |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Newly diagnosed suspected or proven clinical stage I NSCLC (T1 or T2, N0, M0) with no prior treatment for this disease.
- At least 18 years of age.
- Ability to understand and willingness to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30Also: EORTC QLQ-C30* 30 quality of life questions for the participant to answer * The first 28 questions have answers that range from 1 (Not at All) to 4 (Very Much) * The final 2 questions answers range from 1 (Very Poor) to 7 (Excellent) * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment | Behavioural | High-risk NSCLC participants |
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13Also: EORTC QLQ-LC13* 13 quality of life questions for the participant to answer * The answers range from 1 (Not at All) to 4 (Very Much) * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment | Behavioural | High-risk NSCLC participants |
| Modified Medical Research CouncilAlso: mMRC* Participants is given 5 grades to choose from ranging from 0 to 4 and participant will choose grade * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment | Behavioural | High-risk NSCLC participants |
| EQ-5DAlso: -Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment* 5 headings with 5 statements and the participant will check the box that best describes how he or she feels that day * The second part shows a scale ranging from 0 (worst health) to 100 (best health) and the participant chooses the best number on the scale * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment | Behavioural | High-risk NSCLC participants |
| Center for Epidemiological Studies Depression ScaleAlso: CES-D* 20 quality of life questions for the participant to answer * Answers range from "Rarely or none of the time" to "Most or all of the time" * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment | Behavioural | High-risk NSCLC participants |
| Medical Outcomes Study Social Support SurveyAlso: MOS-SSS* 19 quality of life questions for the participant to answer * Answers from from 1 (None of the time) to 5 (All of the time) * Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment | Behavioural | High-risk NSCLC participants |
Primary outcome
Treatment selection model for high-risk early stage NSCLC patient population using comorbidity
Time frame: Up to 90 days post treatment
* Comorbidity scoring will be performed by interview and chart review including the Adult Comorbidity Evaluation 27 (ACE-27), Charlson Comorbidity Index (CCI), Global Initiative for Chronic Obstructive Lung Disease (GOLD), Cumulative Illness Rating Scale (CIRS), and COMorbidities in Chronic Obstructive Lung Disease (COMCOLD) * All of the comorbidity indices grade comorbidities from mild to severe. The investigators will use the data obtained from cumulative collected indices to determine the severity of patient comorbidities. * The data obtained from this group of patients will be compared with the previously obtained data from patients who had surgery for their stage I NSCLC.
Treatment selection model for high-risk early stage NSCLC patient population using risk indices
Time frame: Up to 90 days post treatment
* For determination of frailty, Fried's frailty criteria, a validated measurement tool which includes assessment of weight loss, exhaustion, activity level, grip strength, and walk speed. Fraility is classified using a validated score of 0-5 with patients scoring 4-5 considered frail, 2-3 considered intermediately frail, and 0-1 nonfrail. * Activities of daily living (Katz Activities of Daily Living) and instrumental activities of daily living (IADL) will be assessed. Both the ADL and IADL look at independence. The ADL has 6 questions/the IADL has 8 questions and the patient will receive a point for each question if he or she is considered independent. A score of 0 means the person if very dependent and very frail. A score of 6 (ADL) or 8 (IADL) means a person if very independent and not frail. * The data obtained from this group of patients will be compared with the previously obtained data from patients who had surgery for their stage I NSCLC.
Treatment selection model for high-risk early stage NSCLC patient population using HRQOL (health related quality of life) endpoints
Time frame: Up to 24 months post treatment
* HRQOL will be measured by the European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire (QLQ) C30, EORTC QLQ-LC13, Modified Medical Research Council (mMRC), EQ-5D, CES-D, and Medical Outcomes Study Social Support Survey (MOS-SSS). * Utility assessments will also be used and will serve as a quantitative measure of patient preferences and will be utilized to estimate quality adjusted life years (QALYs) to better incorporate quantity of survival, as well as quality of life consequences of stage I lung cancer interventions.
8 secondary outcomes
Potential savings in cost using the model in this study
Time frame: Up to 90 days
Comprehensive collaborative REDCap database to support the retrospective and prospective data collection
Time frame: Up to 5 years post treatment
Costs of surgery
Time frame: Up to 90 days
Costs of SBRT
Time frame: Up to 90 days
Potential cost savings with implementation of a novel ACO for stage I NSCLC
Time frame: Up to 90 days
Compare data between patients undergoing operative treatment and non-operative treatment for stage I NSCLC as measured by the combination of comorbidity, disability, and frailty indices
Time frame: Up to 90 days post treatment
Quality of life indices as measured by the differences at baseline and after treatment using the implementation of the ACO
Time frame: Up to 24 months post treatment
Knowledge-based treatment selection regression model for prediction of treatment-related outcomes
Time frame: Up to 24 months post treatment
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 8 Apr 2021.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Cliff Robinson, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13 and Modified Medical Research Council in people with Carcinoma, Non-Small-Cell-Lung and Non-Small Cell Lung Cancer, run by Washington University School of Medicine 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 3 inclusion and 0 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 8 Apr 2021. 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?
Treatment selection model for high-risk early stage NSCLC patient population using comorbidity (time frame: Up to 90 days post treatment). The study lists 3 primary outcomes in all. 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 8 Apr 2021.