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

Roswell Park Comprehensive Cancer Center

Status: Enrolling

Conditions: Stage I Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IA2 Lung Cancer AJCC v8; Stage IB Lung Cancer AJCC v8; Stage IIA Lung Cancer AJCC v8; Stage IA3 Lung Cancer AJCC v8; Stage II Lung Cancer AJCC v8; Lung Non-Small Cell Carcinoma; Stage IA1 Lung Cancer AJCC v8

Treatments: Other: Questionnaire Administration; Other: Best Practice; Other: Informational Intervention

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT05292521

I 2220321 (Other Identifier)

NCI-2022-01257 (Registry Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Group A (QOL fact sheet)

Experimental group

Description:

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).

Treatment:

Other: Informational Intervention

Other: Questionnaire Administration

Group B (usual care)

Active Comparator group

Description:

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

Treatment:

Other: Best Practice

Other: Questionnaire Administration