NCT05292521 · Roswell Park Cancer Institute
Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
What this study 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 the usual treatment 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.
View original scientific description
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.
Interventions
OTHER
Best Practice
Receive usual care
OTHER
Informational Intervention
Receive QOL fact sheet
OTHER
Questionnaire Administration
Ancillary studies
Primary outcome measures
Decision regret
Time frame: At 6 months
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Buffalo, New York
Collaborators
National Comprehensive Cancer Network
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 20, 2025 · Source of record for eligibility and locations