Support for mental health and quality of life in advanced lung cancer treatment
Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer
This study tests if a new support program can improve mental health and quality of life for people receiving treatment for advanced lung cancer compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky Academic / other |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Lexington, Kentucky) |
| Trial ID | NCT06047301 on ClinicalTrials.gov |
What this trial studies
This study compares the effects of a supportive intervention called Pathways with enhanced usual care on the mental health and quality of life of patients undergoing treatment for advanced lung cancer. Participants will complete surveys at baseline and will be randomized to either the intervention or control group. Follow-up surveys will be conducted mid-intervention, post-intervention, and at 6- and 12-week intervals to assess changes in mental health and quality of life. The goal is to evaluate the effectiveness of the Pathways intervention in improving patient outcomes.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with advanced non-small cell lung cancer or extensive stage small cell lung cancer who are currently undergoing systemic treatment.
Not a fit: Patients with unstable brain metastases, significant cognitive or psychiatric conditions, or those receiving overlapping palliative care may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the mental health and quality of life for patients undergoing treatment for advanced lung cancer.
How similar studies have performed: Other studies have shown positive outcomes with psychosocial interventions in cancer care, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Lexington, Kentucky
- University of Kentucky — Lexington, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Laurie McLouth, PhD — University of Kentucky
- Study coordinator: Laurie McLouth, PhD
- Email: laurie.mclouth@uky.edu
- Phone: 859-562-2526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.