Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality
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 b
| Condition(s) | Lung Cancer |
|---|---|
| Status | Recruiting |
| Phase | NA |
| Study type | Interventional |
| 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. |
| Who can participate | 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 inappr |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Laurie McLouth |
| Locations | Lexington, Kentucky, United States |
| Start date | 2023-11-29 |
| NCT ID | NCT06047301 |
| Official listing | https://clinicaltrials.gov/study/NCT06047301 |