Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Laurie McLouth
Study ID
NCT06047301
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pathways — BEHAVIORAL
    Delivered by a nurse or other healthcare provider, includes 2 in-person sessions, and phone check-ins, and occurs primarily during infusion visits. Includes a Pathways Toolkit with handouts on values and goal setting, as well as resources on symptom management, lung cancer stigma, communication strategies, and other cancer center resources.
  • Enhanced Usual Care — BEHAVIORAL
    Pathways Toolkit handouts on symptom management, lung cancer stigma, communication strategies, and other cancer center resources provided to participants. The Toolkit will be reviewed with patients in person to orient them to its purpose and contents.

Study Details

This study will compare the effects of a brief supportive intervention, called Pathways, against enhanced usual care on the mental health and quality of life of people undergoing treatment for advanced lung cancer. Patients will complete baseline survey measures and be randomized to intervention. Survey measures will be collected again mid-intervention, post-intervention and at 6- and 12-week follow-up, with analyses focused on changes pre- to post-intervention.

Key Dates

Start date
Nov 29, 2023
Status verified
May 2026
Primary completion
Mar 31, 2028
Completion
Mar 31, 2028

Study Design

Enrollment
234 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Pathways
    Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.
  • Active Comparator: Enhanced Usual Care
    Enhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center).

Primary Outcome Measure

Change in PROMIS Depression Short Form Scores [ Time Frame: 12 weeks (Baseline, Post-Intervention) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of KentuckyLexingtonKentucky40506
Laurie McLouth, PhD

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