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

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

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Best Practice — OTHER
  Receive usual care
• Informational Intervention — OTHER
  Receive QOL fact sheet
• Questionnaire Administration — OTHER
  Ancillary studies

Study Details

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.

Key Dates

Start date

Dec 21, 2023

Status verified

Oct 2025

Primary completion

Dec 21, 2028

Completion

Dec 21, 2028

Study Design

Enrollment

150 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Arms

• Experimental: Group A (QOL fact sheet)
  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).
• Active Comparator: Group B (usual care)
  Patients receive usual care during the initial consult that occurs 4 weeks prior to the standard of care surgery or SBRT.

Primary Outcome Measure

Decision regret [ Time Frame: At 6 months ]

Locations (1)

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