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Quality of Life Intervention for Early-Stage Lung Cancer

This study is for people with early-stage non-small cell lung cancer (NSCLC) who are deciding between surgery or stereotactic body radiation therapy (SBRT). It's testing if providing a special "QOL fact sheet" (quality of life information) during your initial doctor's visit helps you feel better about your treatment choice. You would either receive this fact sheet and discuss it with your doctor, or receive usual care. Researchers want to see if the QOL fact sheet reduces "decision regret" (feeling bad about your choice) six months after treatment. They also want to see how it affects your overall quality of life and if your background plays a role. About 150 people are expected to join this study.

Study design
This is an interventional study where participants are randomly assigned to one of two groups. It aims to enroll about 150 participants.
What's involved
You would have an initial consult about 4 weeks before your standard treatment. You will then have follow-up visits at 1, 3, and 6 months after your treatment.
Compensation
Not stated in the trial record.
Follow-up
Participants are followed for 6 months after their standard of care surgery or SBRT.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05292521

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

Recruiting
NAAges 18+InterventionalHealth services
Roswell Park Cancer Institute
~150 participants
Updated 2025-10-20 on ClinicalTrials.gov
What's tested:Best PracticeInformational InterventionQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Decision regret
Measured over At 6 months

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

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • Anurag K Singh · PRINCIPAL_INVESTIGATOR · Roswell Park Cancer Institute

Who to contact

Anurag K. Singh
[email protected]
716-845-1179
Email the study team

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Do you actually qualify for this trial?

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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

What this trial measures

  • Decision regretAt 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.