- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07578376
Empowered Relief® for Cancer Survivors With Chronic Pain
Feasibility and Preliminary Efficacy of Empowered Relief® for Cancer Survivors With Chronic Pain
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sophia You, PhD, ABPP
- Phone Number: 918-660-3923
- Email: Dokyoung-You@ou.edu
Study Contact Backup
- Name: Jordan Keast, BS
- Email: jordan-keast@ou.edu
Study Locations
-
-
Oklahoma
-
Tulsa, Oklahoma, United States, 74135
- Recruiting
- University of Oklahoma Schusterman Center - Tulsa
-
Contact:
- Jordan Keast, BS
- Email: jordan-keast@ou.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Empowered Relief
Participants in this arm of the study will complete the one-time 2hr Empowered Relief zoom course.
They will also complete a post-course survey as well as the standardized 1, 2, and 3-month follow-up surveys.
|
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.
|
|
No Intervention: Wait-List Control
Participants in the Wait-List Control (WLC) arm will not have initial access to the empowered relief course. Additionally they will not have to complete a post-course survey. The WLC group will be asked to complete the 1, 2, and 3-month follow-up studies after no intervention. After this 3-month observatory period, WLC participants will have voluntary access to the Empowered Relief course. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall treatment satisfaction
Time Frame: Immediately after intervention
|
0-10 scale, higher scores indicate greater satisfaction, mean should be 8 or higher
|
Immediately after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 1 month after intervention
|
0-10 scale, higher scores indicate higher pain
|
1 month after intervention
|
|
Pain Interference
Time Frame: 1 month after intervention
|
T-scores, higher scores indicate higher pain interference
|
1 month after intervention
|
|
Pain Intensity
Time Frame: 3 months after intervention
|
0-10 Scale, higher scores indicate higher pain
|
3 months after intervention
|
|
Pain Interference
Time Frame: 3 months after intervention
|
T-scores, higher scores indicate higher pain interference
|
3 months after intervention
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sophia You, PhD, ABPP, University of Oklahoma
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18957P
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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