Support for mental health and quality of life in advanced lung cancer treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.