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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05292521
Other study ID # I 2220321
Secondary ID NCI-2022-01257I
Status Recruiting
Phase N/A
First received
Last updated
Start date December 21, 2023
Est. completion date January 15, 2025

Study information

Verified date April 2024
Source Roswell Park Cancer Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date January 15, 2025
Est. primary completion date January 15, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age >= 18 years - Radiographic 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: - Radiographic 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 Design


Intervention

Other:
Best Practice
Receive usual care
Informational Intervention
Receive QOL fact sheet
Questionnaire Administration
Ancillary studies

Locations

Country Name City State
United States Roswell Park Cancer Institute Buffalo New York

Sponsors (2)

Lead Sponsor Collaborator
Roswell Park Cancer Institute National Comprehensive Cancer Network

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Decision regret 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. At 6 months
Secondary Quality of Life (EORTC QLQ-C30) Will compare QOL measures based on the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment. Up to 6 months
Secondary Quality of Life (QOL) Will compare QOL measures based on the lung cancer- specific questionnaire (EORTC QLQ-LC13) between the provision of QOL information versus usual care for standard of care surgery or SBRT treatment. Up to 6 months
Secondary Difference in consideration of regret Compare decisions about treatment for early stage lung cancer and examined whether regret is a consideration in treatment decisions between those who received the quality of life fact sheet and those who did not. Up to 6 months
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