Pathways Hope Intervention for Advanced Lung Cancer

This study is testing a supportive program called Pathways for people with advanced lung cancer who are receiving infusion-based treatments like chemotherapy or immunotherapy. Pathways involves two in-person sessions and phone check-ins, along with a toolkit to help with values, goal setting, symptom management, and communication. The study will compare Pathways to an "Enhanced Usual Care" group, which receives the toolkit and a review of its contents. Researchers want to see if Pathways can improve mental health and quality of life. You may be able to join if you are 18 or older, have advanced non-small cell or extensive small cell lung cancer, and are 3-12 weeks into your infusion treatment. The study aims to enroll 234 participants, but its current status is unclear.

Study design
This is an interventional study comparing two behavioral approaches, Pathways and Enhanced Usual Care, with a planned enrollment of 234 participants.
What's involved
Participants will complete surveys at the start, during, and after the intervention, and again at 6 and 12 weeks later. The Pathways intervention includes two in-person sessions and phone check-ins, primarily during infusion visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 12 weeks after the intervention.

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NCT06047301

Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment

Recruiting
NAAges 18+InterventionalSupportive care
Laurie McLouth
~234 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:PathwaysEnhanced Usual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in PROMIS Depression Short Form Scores
Measured over 12 weeks (Baseline, Post-Intervention)
+1 more outcome measured
Lung Cancer
1 sites across 1 states
Kentucky1
  • Laurie McLouth, PhD · PRINCIPAL_INVESTIGATOR · University of Kentucky

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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
  • Change in PROMIS Depression Short Form Scores12 weeks (Baseline, Post-Intervention)

    Depression symptoms will be measured using the PROMIS Depression Short Form 6a: 6 items are responded to on a scale of 1 = never to 5 = always. Raw scores range from 6 to 30. Higher scores indicate more depression.

  • Change in State Hope scores12 weeks (Baseline, Post-Intervention)

    Hope will be measured using Snyder's State Hope Scale. 6 items responded to on a scale of 1 = definitely false to 8 = definitely true. Raw scores range from 6 to 48. Items are summed for a total score. Higher scores indicate higher hope.