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

Lung Non-Small Cell Carcinoma Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• 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

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