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

NCT ID: NCT05292521

Last Updated: 2025-10-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-21
• Study Completion Date: 2028-12-21

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.

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:

I. Determine the effect of provision of QOL information versus usual care for standard of care surgery or SBRT treatment on QOL measures.

II. Determine the influence of socioeconomic status on the relationship between decision regret and QOL information associated with each treatment modality.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP A: 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).

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

Patients are followed up at 1, 3, and 6 months after standard of care surgery or SBRT.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Informational Intervention

Intervention Type: OTHER

Receive QOL fact sheet

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

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.

Group Type: ACTIVE_COMPARATOR

Best Practice

Intervention Type: OTHER

Receive usual care

Questionnaire Administration

Intervention Type: OTHER

Ancillary studies

Interventions

Best Practice

Receive usual care

Intervention Type: OTHER

Informational Intervention

Receive QOL fact sheet

Intervention Type: OTHER

Questionnaire Administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

standard of care; standard therapy

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Comprehensive Cancer Network

NETWORK

Sponsor Role: collaborator

Roswell Park Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anurag K Singh

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Anurag K. Singh

Role: primary

Anurag.Singh@RoswellPark.org

716-845-1179

Other Identifiers

NCI-2022-01257

Identifier Type: REGISTRY

Identifier Source: secondary_id

I 2220321

Identifier Type: OTHER

Identifier Source: secondary_id

I 2220321

Identifier Type: -

Identifier Source: org_study_id