Support programs to improve recovery after gynecological surgery
REmotely-delivered Supportive Programs for Improving Surgical Pain Dnd disTrEss (RESPITE)
This study is testing two support programs to see if they can help women recover better after surgery for suspected gynecological cancers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 2 sites (Charlotte, North Carolina and 1 other locations) |
| Trial ID | NCT05625360 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two supportive programs, eHealth Mindful Movement and Breathing (eMMB) and Life Impact Reflection (LIR), in enhancing the recovery of women after abdominal surgery for suspected gynecologic malignancies. The study will measure various outcomes, including postoperative pain intensity, psychological distress, and overall wellbeing at multiple time points post-surgery. Participants will be monitored for improvements in pain and emotional health over a period of weeks and months following their surgical procedures.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older scheduled for abdominal gynecological surgery due to suspected malignancy.
Not a fit: Patients with severe psychiatric conditions or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide women with effective non-pharmacological strategies to manage postoperative pain and psychological distress.
How similar studies have performed: Other studies have shown promise in using supportive programs for postoperative recovery, suggesting this approach may be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: In order to be eligible to participate in this study, an individual must meet all of the following criteria: * Provision of signed and dated informed consent form * Participants age 18 years and older at time of consent. * Scheduled for an abdominal gynecological surgery (i.e., uterine, ovarian) to remove a mass that is suspected to be malignant * Have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤1 * Able to understand, read and write English (since the intervention is conducted in English) Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: * Presence of a psychotic disorder, current suicidal ideation, or other unstable major psychiatric condition documented by diagnosis in the medical chart. * Unwillingness or inability to follow study procedures
Where this trial is running
Charlotte, North Carolina and 1 other locations
- Atrium Health - Levine Cancer Institute — Charlotte, North Carolina, United States (Recruiting)
- Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Stephanie J Sohl, PhD — Wake Forest Baptist Comprehensive Cancer Center
- Study coordinator: Hannah O'Brien
- Email: hobrien@wakehealth.edu
- Phone: 336-716-2498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.