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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-01257 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 2220321 | Other Identifier | Roswell Park Cancer Institute |
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| Name | Class |
|---|---|
| National Comprehensive Cancer Network | NETWORK |
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This clinical trial studies the effect of a quality of life intervention on decision-making in patients with early-stage lung cancer who are undergoing standard of care surgery or stereotactic body radiation therapy (SBRT). Providing quality of life outcome data to patients deciding between surgery and SBRT may help decrease decision regret and increase patient satisfaction with their care.
PRIMARY OBJECTIVE:
I. Determine the effect of provision of quality-of-life (QOL) information versus usual care for standard of care surgery or SBRT treatment on decision regret.
SECONDARY OBJECTIVES:
I. Determine the effect of provision of QOL information versus usual care for standard of care surgery or SBRT treatment on QOL measures.
II. Determine the influence of socioeconomic status on the relationship between decision regret and QOL information associated with each treatment modality.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients receive study QOL intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Patients have an opportunity to review the QOL fact sheet in person and discuss any questions with the treating physician(s).
GROUP B: Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.
Patients are followed up at 1, 3, and 6 months after standard of care surgery or SBRT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A (QOL fact sheet) | Experimental | Patients receive study QOL intervention fact sheet during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. Patients have an opportunity to review the QOL fact sheet in person and discuss any questions with the treating physician(s). |
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| Group B (usual care) | Active Comparator | Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| Measure | Description | Time Frame |
|---|---|---|
| Decision regret | Compare the extent of decision regret based on Decision Regret Scale between the provision of quality of life (QOL) information versus usual care for standard of care surgery or stereotactic body radiation therapy (SBRT) treatment. The five-point decision regret score will be converted to a 100-point score as described by others, where a higher score reflects an increased decision regret. In this schema, a decision regret score > 25 % is deemed moderate to severe regret. The dichotomized decision regret will be modeled as a function of group, time, and their interaction using a generalized estimating equations (GEE) logistic regression model with an autoregressive covariance structure. The rates of less than moderate to severe regret will be compared between groups at 6-months using a one-sided test about the appropriate contrast of model estimates. | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (EORTC QLQ-C30) | Will compare QOL measures based on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment. | Up to 6 months |
| Quality of Life (QOL) |
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Inclusion Criteria:
Age >= 18 years
Radiographic stage I-II non-small cell lung cancer (NSCLC)
Eligible for both surgery and SBRT
Able to provide informed consent in English
Have verbal fluency in English
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anurag K Singh | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Recruiting | Buffalo | New York | 14263 | United States |
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| Informational Intervention | Other | Receive QOL fact sheet |
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| Questionnaire Administration | Other | Ancillary studies |
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Will compare QOL measures based on the lung cancer- specific questionnaire (EORTC QLQ-LC13) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment. |
| Up to 6 months |
| Difference in consideration of regret | Compare decisions about treatment for early stage lung cancer and examined whether regret is a consideration in treatment decisions between those who received the quality of life fact sheet and those who did not. | Up to 6 months |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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