Recruiting

Quality of Life

Sponsor:

Roswell Park Cancer Institute

Code:

NCT05292521

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Best Practice

Informational Intervention

Questionnaire Administration

Study Details

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 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.

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

Study ID

NCT05292521

Start date

Dec 21, 2023

Status verified date

Oct, 2025

Completion date

Dec 21, 2028

Anticipated

Primary completion date

Dec 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: Group A (QOL fact sheet)

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).

active comparator: Group B (usual care)

Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.

Interventions

Best Practice

Receive usual care

Informational Intervention

Receive QOL fact sheet

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Decision regret [ Time Frame: At 6 months ]

Central Contacts and Locations

Locations

Roswell Park Cancer Institute

Recruiting

Buffalo, New York, United States, 14263

Contacts

Anurag K. Singh

716-845-1179Anurag.Singh@RoswellPark.org

Principal Investigator:

Anurag K. Singh

More Information

Sponsor

Roswell Park Cancer Institute

Last update posted

Oct 20, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Roswell Park Cancer Institute on 2025-10-20.