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Recruiting NCT06047301

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

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pathways, Enhanced Usual Care.
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Behavioral 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.
  • Behavioral 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 measures

  • 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)]
Secondary outcome measures (6)
  • Change in PROMIS Anxiety Short Form Scores [Time frame: 12 weeks (Baseline, Post-Intervention)]
  • Change in Demoralization Scale II Scores [Time frame: 12 weeks (Baseline, Post-Intervention)]
  • Change in PROMIS 15a positive affect scores [Time frame: 12 weeks (Baseline, Post-Intervention)]
  • Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores [Time frame: 12 weeks (Baseline, Post-Intervention)]
  • Change in FACT-G7 Quality of Life Scores [Time frame: 12 weeks (Baseline, Post-Intervention)]
  • Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores [Time frame: 12 weeks (Baseline, 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Kentucky — Lexington

Identifiers

NCT: NCT06047301 · 87901 · 1R01CA283929-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗