Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients with Advanced Cancer

Pain, fatigue, and distress are highly prevalent co-occurring symptoms in patients with advanced cancer. When these symptoms interfere with patients’ daily lives, it can diminish their ability to live congruently with their values—greatly reducing quality of life (QoL). An exclusively medical approach to managing pain, fatigue, and

distress can have intolerable side effects and limited responsiveness. There is a need for psychosocial symptom management interventions designed specifically for patients living with advanced cancer. Emerging evidence suggests patients may benefit from Acceptance and Commitment Therapy (ACT), a third-wave Cognitive-

Behavioral Therapy (CBT) approach that emphasizes acceptance, mindfulness, and engagement in values- guided activity. Though pilot results in patients with advanced cancer have been promising, ACT-based interventions have rarely been tested in well-powered efficacy trials. Building on our team’s extensive prior work,

we developed a psychosocial intervention called ENGAGE. ENGAGE includes training in traditional CBT skills (e.g., activity pacing) to decrease symptom severity, when possible, and ACT skills (e.g., mindfulness) to promote acceptance of experiences that cannot be fully controlled (e.g., prognosis), with the goal of decreasing symptom

interference and improving QoL. Our two pilot trials of ENGAGE provide strong support for its feasibility, acceptability, and promise for improving patient-reported outcomes. This proposal progresses our work to an NIH Phase II randomized controlled trial (RCT) to evaluate ENGAGE's efficacy for reducing symptom

interference in patients receiving cancer care in medically underserved areas. Delivered through videoconferencing, this brief (4 weekly, 45-minute sessions) intervention has been designed to be acceptable for patients residing in medically underserved areas by including graphical displays of concepts, videos modeling

skills, and audio content summaries. In this RCT, we will randomize 190 patients with Stage IV cancer (breast, prostate, lung, or colorectal) and moderate-to-severe symptom interference to ENGAGE or Supportive Care control. 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 (i.e., self-efficacy for symptom management, acceptance, mindfulness, values-based activity, symptom severity, and QoL) 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. This trial will be one of the first to test the efficacy of an ACT-based intervention for patients with advanced cancer who are receiving care in medically underserved areas. ENGAGE is readily implementable and, if shown to be efficacious, our team is well positioned to move rapidly into implementation

work, with the long-term aim of reducing suffering in patients with life-threatening illnesses.