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

> **NIH NIH R01** · DUKE UNIVERSITY · 2024 · $578,467

## Abstract

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...

## Key facts

- **NIH application ID:** 10936635
- **Project number:** 1R01CA291768-01
- **Recipient organization:** DUKE UNIVERSITY
- **Principal Investigator:** Joseph Giles Winger
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $578,467
- **Award type:** 1
- **Project period:** 2024-08-01 → 2029-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10936635

## Citation

> US National Institutes of Health, RePORTER application 10936635, Engage: A Randomized Controlled Trial Testing the Efficacy of a Telehealth-Delivered Psychosocial Intervention to Decrease Symptom Interference in Patients with Advanced Cancer (1R01CA291768-01). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10936635. Licensed CC0.

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