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 — BEHAVIORALDelivered 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 — BEHAVIORALPathways 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: PathwaysPathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.
- Active Comparator: Enhanced Usual CareEnhanced 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
- Laurie McLouth, PhD859-562-2526
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Kentucky | Lexington | Kentucky | 40506 | Laurie McLouth, PhD |
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