NCT06047301 Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment
| NCT ID | NCT06047301 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Laurie McLouth |
| Condition | Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 234 participants |
| Start Date | 2023-11-29 |
| Primary Completion | 2028-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 234 participants in total. It began in 2023-11-29 with a primary completion date of 2028-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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
Contact & Investigator
Laurie McLouth, PhD
PRINCIPAL INVESTIGATOR
University of Kentucky
Frequently Asked Questions
Who can join the NCT06047301 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06047301 currently recruiting?
Yes, NCT06047301 is actively recruiting participants. Contact the research team at laurie.mclouth@uky.edu for enrollment information.
Where is the NCT06047301 trial being conducted?
This trial is being conducted at Lexington, United States.
Who is sponsoring the NCT06047301 clinical trial?
NCT06047301 is sponsored by Laurie McLouth. The principal investigator is Laurie McLouth, PhD at University of Kentucky. The trial plans to enroll 234 participants.
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