RecruitingInterventional

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

NCT ID: NCT06047301Sponsor: Laurie McLouthLast updated: 2026-05-08

Summary

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.

Arms & interventions

BehavioralPathways
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.
BehavioralEnhanced Usual Care
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.

Outcome measures

Primary

Change in PROMIS Depression Short Form Scores
Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30. Higher scores indicate more depression.
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in State Hope scores
Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.
Time frame: 12 weeks (Baseline, Post-Intervention)

Secondary

Change in PROMIS Anxiety Short Form Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in Demoralization Scale II Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in PROMIS 15a positive affect scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in FACT-G7 Quality of Life Scores
Time frame: 12 weeks (Baseline, Post-Intervention)
Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores
Time frame: 12 weeks (Baseline, Post-Intervention)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * New or recurrent AJCC 8th edition stage 3b, 3c, or IV non-small cell lung cancer, extensive stage small cell lung cancer * 18 years of age or older * Eastern Cooperative Oncology Group (ECOG) performance status 0-2/Karnofsky 60-100 * 3-12 weeks into systemic, infusion-based treatment (chemotherapy, immunotherapy, chemo-immunotherapy) * Past month distress score (per electronic health record) of 3/10 or higher OR a Rotterdam Symptom item score of 2 or higher for psychological distress items. Exclusion Criteria: * Unstable brain metastases (i.e., progressive neurological deficits, inadequately controlled seizures, or requiring escalated steroid doses) * Cognitive (i.e., dementia) or psychiatric condition (e.g., psychotic disorder) for which participating would be inappropriate * Receiving overlapping palliative care or psychological services at the cancer center * Unable to speak and read English. * Hearing or visual impairment that precludes study participation

Study locations (1)

University of Kentucky

Lexington, Kentucky, 40506

Recruiting

Laurie McLouth, PhD · Contact