REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss (NCT05625360) | Clinical Trial Compass
Active — Not RecruitingPhase 3
REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
United States160 participantsStarted 2023-06-13
Plain-language summary
The purpose of this research study is to learn how two different supportive programs may help women feel better after surgery. This study will measure if one type of supportive program is more useful than the other for improving wellbeing after surgery.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is testing remotely-delivered support programs to help with pain, depression, anxiety, and sleep after surgery for gynecologic cancer — is this kind of program something that could actually help in my specific situation, and is it too late to join since the trial is no longer actively recruiting?
2Since this is a Phase 3 trial, what does my doctor think about the level of evidence already built up around these types of remote supportive care approaches, and does that change whether I should seek something similar outside of a trial?
3The trial is measuring changes in pain intensity using a questionnaire called the PROMIS Pain Intensity scale — can my doctor explain what that means for how my progress would be tracked, and whether that kind of outcome measurement is useful for someone at my stage of recovery?
4Given that this trial addresses postoperative depression, anxiety, and sleep disturbance alongside pain, should I be talking to my care team about getting support for all of those issues right now, even if I can't enroll in this specific study?
5Are there other remotely-delivered or in-person supportive care programs for gynecologic cancer patients that my doctor could refer me to, since this trial is no longer accepting new participants?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire