Empowered Relief® for Cancer Survivors With Chronic Pain

Official title

Feasibility and Preliminary Efficacy of Empowered Relief® for Cancer Survivors With Chronic Pain

Overview

This randomized controlled study to examine the efficacy of ER class in cancer survivors with chronic pain. Eligible participants will be randomly assigned to a ER class or a waitlist control condition. We will recruit 250 participants with a goal of having 200 completers (20% attrition). Participants in the control condition will be invited to attend ER class after the 3-month observation period.

Detailed description

The Empowered Relief (ER) study is a Zoom-based, 1-session, 2-hour, skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily use and supportive daily text messages. Participants will fill out a series of follow-up surveys at the 1, 2, and 3-month post-class mark. These surveys will be directly compared to surveys given to participants that do not complete the course. Class admittance will be randomized, however, participants not in the treatment group will have the option to take the course after the 3-month observatory period. ER has demonstrated moderate efficacy in individuals with chronic non-cancer pain, reducing pain intensity, pain interference, pain-related distress (pain catastrophizing), sleep disturbance, and anxiety. Because of its brief, didactic nature and delivery via Zoom, ER can accommodate large class sizes and may address access disparities among underserved cancer survivors. ER is currently being studied across various non-cancer populations and has been adopted as standard of care in leading healthcare institutions in the U.S. and abroad. Yet, Empowered Relief has not been tested in cancer survivors.

Interventions

• Behavioral Empowered Relief Course (Zoom)
  This is a one-time 2 hour long skills-based pain management class delivered by certified instructors. Participants learn three core pain relief skills, develop a personalized plan, and receive access to a free binaural audio app for daily use and supportive daily text messages.

Primary outcome measures

• Overall treatment satisfaction [Time frame: Immediately after intervention]

Secondary outcome measures (4)

• Pain Intensity [Time frame: 1 month after intervention]
• Pain Interference [Time frame: 1 month after intervention]
• Pain Intensity [Time frame: 3 months after intervention]
• Pain Interference [Time frame: 3 months after intervention]

Eligibility criteria

Inclusion criteria

History of cancer diagnosis, completion of active cancer treatment, cancer free at the time of enrollment, experience of body pain most or every day, pain duration at least 3 months, and English fluency.

Exclusion criteria

Significant psychological and cognitive impairment that limits one's ability to complete study tasks (completion of online survey, attending the zoom-based ER class). Life-threatening acute illness (e.g., infection, heart attack, injury), and no access to a computer, a smartphone or a tablet.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Oklahoma Schusterman Center - Tulsa — Tulsa

Identifiers

NCT: NCT07578376 · 18957P

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗