Actively Recruiting
REmotely-delivered Supportive Programs for Improving Surgical Pain and distress (RESPITE)
Led by Wake Forest University Health Sciences · Updated on 2025-10-27
160
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two different supportive programs to help women improve their wellbeing after abdominal surgery for suspected gynecologic malignancy. This Phase 3 study aims to compare the effects of an eHealth Mindful Movement and Breathing (eMMB) program with a Life Impact Reflection (LIR) program on reducing postoperative pain and psychological distress. Participants will be randomly assigned to either the eMMB group or the LIR group. The eMMB group will receive access to 20-minute videos teaching mindful meditation, gentle movement, breathing, relaxation, and meditation techniques. These videos can be watched on an iPad or personal devices, with additional support through calls and videoconferences around the time of surgery. The LIR group will engage in daily diary entries reflecting on life impacts, with encouragement calls matching the eMMB group's contact schedule. Participants will complete various assessments measuring pain intensity, affective pain, pain interference, depression, anxiety, and sleep disturbances at multiple time points: before surgery, and 2 weeks, 4 weeks, and 3 months after surgery. The primary outcome is the change in pain intensity four weeks postoperatively. The study includes monitoring of psychological and physical wellbeing through questionnaires and follow-ups over the three-month period.
CONDITIONS
Brief Title
REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Age 18 years or older at time of consent
- Scheduled for abdominal gynecological surgery to remove a mass suspected to be malignant
- Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less
- Able to understand, read, and write English
You will not qualify if you...
- Presence of psychotic disorder, current suicidal ideation, or unstable major psychiatric condition documented in medical chart
- Unwillingness or inability to follow study procedures
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or remote) for eligibility assessment
Duration - Approximately 5 weeks starting pre-surgery through 4 weeks post-surgery
Participants receive one of two self-directed supportive care interventions starting before abdominal surgery and continuing up to 4 weeks postoperatively. The eHealth Mindful Movement and Breathing group will practice guided mindful meditation, movement, breathing, and relaxation exercises. The Life Impacts Reflection group will complete daily diary entries reflecting on daily events. Participants receive guidance via calls and videoconferences around surgery.
1 baseline visit before surgery, 1 synchronous session around postoperative day 1, and daily self-practice for 4 weeks
Duration - Up to 3 months postoperatively
Participants complete assessments of pain intensity, affective pain, psychological distress, pain interference, and sleep disturbance up to 3 months after surgery to evaluate lasting effects of the interventions.
Visits or remote assessments at 2 weeks, 4 weeks, and 3 months post-surgery
Trial Site Locations
Total: 2 locations
1
Atrium Health - Levine Cancer Institute
Charlotte, North Carolina, United States, 28204
Actively Recruiting
2
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
H
Hannah O'Brien
A
Alicia Patrick, MA, CCRP
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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