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

Laurie McLouth

Status: Enrolling

Conditions: Lung Cancer

Treatments: Behavioral: Enhanced Usual Care; Behavioral: Pathways

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06047301

87901

1R01CA283929-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 234 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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234 participants in 2 patient groups

Pathways

Experimental group

Description:

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

Treatment:

Behavioral: Pathways

Enhanced Usual Care

Active Comparator group

Description:

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).

Treatment:

Behavioral: Enhanced Usual Care