Clinical trial NCT05292521: Quality of Life Intervention to Inform Patient Decision-Making in Early-Stage Lung Cancer
Official title: Utilizing Patient Reported Quality of Life to Inform Patient Decision Making in Early-Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Comprehensive Cancer Network
First posted: 2022-03-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Decision regret
timeFrame: At 6 months
Secondary outcomes:
measure: Quality of Life (EORTC QLQ-C30)
timeFrame: Up to 6 months
measure: Quality of Life (QOL)
timeFrame: Up to 6 months
measure: Difference in consideration of regret
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Anurag K Singh
role: PRINCIPAL_INVESTIGATOR
References: