NCT05292521

Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer

Utilizing Patient Reported Quality of Life to Inform Patient Decision Making in Early-Stage Lung Cancer

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Roswell Park Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Lung Non-Small Cell Carcinoma
• Stage I Lung Cancer AJCC v8
• Stage IA1 Lung Cancer AJCC v8
• Stage IA2 Lung Cancer AJCC v8
• Stage IA3 Lung Cancer AJCC v8
• Stage IB Lung Cancer AJCC v8
• Stage II Lung Cancer AJCC v8
• Stage IIA Lung Cancer AJCC v8
• Stage IIB Lung Cancer AJCC v8

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual care
OTHER	Informational Intervention	Receive QOL fact sheet
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2023-12-21
• Primary completion: 2028-12-21
• Completion: 2028-12-21
• First posted: 2022-03-23
• Last updated: 2025-10-20

Locations

1 site across 1 country: United States