Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
Recruiting · NCT05292521 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Best PracticeInformational InterventionQuestionnaire Administration
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
1 location listed across 1 US state.
- Roswell Park Cancer Institute - Buffalo, New York, United States