NCT06047301NARecruiting
Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment
Laurie McLouth
Start Date
11/29/2023
Completion Date
3/31/2028
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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
Interventions
BEHAVIORAL
Pathways
BEHAVIORAL
Enhanced Usual Care
Conditions
Lung Cancer
Locations
University of Kentucky
Lexington, Kentucky 40506
United States