Lung Cancer Clinical Trial

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

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Age >= 18 years of age
Diagnosed with biopsy-proven stage I-II non-small cell lung cancer (NSCLC)
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:

Diagnosed with stage III-IV NSCLC
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 is for people with:

Lung Cancer

Estimated Enrollment:

150

Study ID:

NCT05292521

Recruitment Status:

Not yet recruiting

Sponsor:

Roswell Park Cancer Institute

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There is 1 Location for this study

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Roswell Park Cancer Institute
Buffalo New York, 14263, United States More Info
Anurag K. Singh
Contact
716-845-1179
[email protected]
Anurag K. Singh
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

150

Study ID:

NCT05292521

Recruitment Status:

Not yet recruiting

Sponsor:


Roswell Park Cancer Institute

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