Clinical trial NCT06047301: Pathways, a Hope Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Advanced Lung Cancer Treatment
Official title: Pathways, a Hope-Based Intervention to Support Personal Goal Pursuit, Mental Health, and Quality of Life During Treatment for Advanced Lung Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: advanced cancer
palliative
supportive oncology
psychosocial intervention
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2023-09-21
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Primary outcomes:
measure: Change in PROMIS Depression Short Form Scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
measure: Change in State Hope scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
Secondary outcomes:
measure: Change in PROMIS Anxiety Short Form Scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
measure: Change in Demoralization Scale II Scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
measure: Change in PROMIS 15a positive affect scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
measure: Change in FACIT-Spiritual Well-being Meaning/Peace Subscale Scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
measure: Change in FACT-G7 Quality of Life Scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
measure: Change in PROMIS Satisfaction with Participation in Social Roles 8a Short Form Scores
timeFrame: 12 weeks (Baseline, Post-Intervention)
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Laurie McLouth, PhD
role: PRINCIPAL_INVESTIGATOR
References: