Engage Psychosocial Intervention for Cancer Symptoms

Summary

The goal of this clinical trial is to test the efficacy a new psychosocial symptom management intervention called ENGAGE for patients with Stage IV breast, prostate, lung, or colorectal cancer. Participants will be randomized to ENGAGE or a Supportive Care intervention. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months.

Detailed Description

Pain, fatigue, and distress are highly prevalent, co-occurring, and interfering symptoms in patients with advanced cancer. This trial will test a brief telehealth delivered psychosocial intervention called ENGAGE. ENGAGE aims to help patients decrease symptom interference and improve their quality of life. Patients with Stage IV cancer (breast, prostate, lung, or colorectal) and moderate-to-severe symptom interference will be randomized to ENGAGE or Supportive Care. Patient-reported outcomes will be assessed at baseline, 2 months, and 4 months. Aim 1 is to determine ENGAGE's efficacy for reducing symptom interference (primary outcome) at 2 months (primary endpoint). Aim 2 is to determine ENGAGE's efficacy for improving secondary outcomes at 2 months. Aim 3 is to test the maintenance of ENGAGE's effects on primary and secondary outcomes at 4 months. An exploratory aim seeks insights for future implementation efforts using mixed-methods data collection from patients, oncology providers, and clinic leaders.

Eligibility Criteria

Interventions