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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
150
Roswell Park Cancer Institute
Buffalo, New York, United States
RECRUITINGDecision 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.
Time frame: At 6 months
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.
Time frame: Up to 6 months
Quality of Life (QOL)
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.
Time frame: 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.
Time frame: Up to 6 months
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