Recruiting

Hope Intervention

Sponsor:

Laurie McLouth

Code:

NCT06047301

Conditions

Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Pathways

Enhanced Usual Care

Study Details

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.

Conditions

Lung Cancer

Study ID

NCT06047301

Start date

Nov 29, 2023

Status verified date

May, 2026

Completion date

Mar 31, 2028

Anticipated

Primary completion date

Mar 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

234 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Pathways

Pathways focuses on increasing patient hope to support personal goal pursuit during treatment for advanced lung cancer.

active comparator: Enhanced Usual Care

Enhanced Usual Care focuses on providing patients with education around common lung cancer concerns (e.g., pain and fatigue management) and resources to support them (e.g., supportive services available nationally and at the treating cancer center).

Interventions

Pathways

Delivered by a nurse or other healthcare provider, includes 2 in-person sessions, and phone check-ins, and occurs primarily during infusion visits. Includes a Pathways Toolkit with handouts on values and goal setting, as well as resources on symptom management, lung cancer stigma, communication strategies, and other cancer center resources.

Enhanced Usual Care

Pathways Toolkit handouts on symptom management, lung cancer stigma, communication strategies, and other cancer center resources provided to participants. The Toolkit will be reviewed with patients in person to orient them to its purpose and contents.

Primary outcome measure

  • Change in PROMIS Depression Short Form Scores [ Time Frame: 12 weeks (Baseline, Post-Intervention) ]
  • Change in State Hope scores [ Time Frame: 12 weeks (Baseline, Post-Intervention) ]

Central Contacts and Locations

Central contacts

Laurie McLouth, PhD

859-562-2526laurie.mclouth@uky.edu

Locations

University of Kentucky

Recruiting

Lexington, Kentucky, United States, 40506

More Information

Sponsor

Laurie McLouth

Last update posted

May 8, 2026

Last verified

May, 2026

Keywords

  • advanced cancer
  • palliative
  • supportive oncology
  • psychosocial intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Laurie McLouth on 2026-05-08.