Status:
RECRUITING
Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
Lead Sponsor:
Roswell Park Cancer Institute
Collaborating Sponsors:
National Comprehensive Cancer Network
Conditions:
Lung Non-Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ra...
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...
Eligibility Criteria
Inclusion
- Age \>= 18 years
- Radiographic stage I-II non-small cell lung cancer (NSCLC)
- Of note, separate tumor nodule(s) in an ipsilateral lobe different from that of the primary is considered T4 disease. However, these are treated as separate stage I or II lesions and will be eligible for this study.
- 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
- Radiographic stage III-IV NSCLC except as noted above
- Eligible for either only surgery or SBRT, but not both
- Eligible for palliative-intent treatments or supportive care only.
- Pregnant female participants.
- Unwilling or unable to follow protocol requirements
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate
- Cognitively impaired adults/adults with impaired decision-making capacity
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Key Trial Info
Start Date :
December 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 21 2028
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05292521
Start Date
December 21 2023
End Date
December 21 2028
Last Update
October 20 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263