RecruitingPhase 3NCT05625360

REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

REmotely-delivered Supportive Programs for Improving Surgical Pain Dnd disTrEss (RESPITE)


Sponsor

Wake Forest University Health Sciences

Enrollment

160 participants

Start Date

Jun 13, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a remotely delivered support program (delivered by phone or video) to help reduce pain and emotional distress for women who are about to undergo abdominal surgery to remove a suspected ovarian or uterine mass. The program aims to prepare patients mentally and emotionally before surgery. **You may be eligible if...** - You are 18 or older - You are scheduled for abdominal gynecological surgery (uterine or ovarian) to remove a mass suspected to be cancer - You are able to understand and communicate in English - You are generally functional and not severely limited in daily activities (ECOG ≤1) **You may NOT be eligible if...** - You have a diagnosed psychotic disorder, active suicidal ideation, or another unstable major psychiatric condition - You are unable or unwilling to follow study procedures Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEReHealth Mindful Movement and Breathing

The self-directed intervention includes an approximately 20-minute eMMB will teach synergistic components: (a) Mindful Meditation - 2 minutes of observing the current state of the body, emotions, thoughts, energy, and breath. Mindful attention may facilitate safe physical movements; (b) Mindful Movement - 10 minutes of gentle movements coordinated with and intended to enhance the breath; (c) Breathing and Relaxation - 3 minutes of placing the hands above the navel (rather than on the belly to avoid discomfort) and noticing them rise and fall with a focus on slightly extending the exhale, which will prepare participants for meditation); (d) Meditation - 5 minutes of observing the natural breath without reacting to it.

OTHERLife Impacts Reflection

This self-directed intervention will focus on active listening, reflection of statements, and avoiding negative judgments. Participants will write brief diary entries daily for four weeks postoperatively and as they choose thereafter. Participants will be given the option of completing diaries on the tablet computer or paper. The instructions for daily diary entries will be, "What were some of the events or circumstances that affected you in the past day? Think back over the past day and write down on the lines below up to five events that had an impact on you." A study team member will call participants to encourage diary completion two days (Postop Day 3) and two weeks after the synchronous session.

OTHERPROMIS Questionnaires

Various PROMIS questionnaires will be completed by participants (Pain Interference, Sleep Disturbance, Physical Function, Anxiety and Depression)


Locations(2)

Atrium Health - Levine Cancer Institute

Charlotte, North Carolina, United States

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

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NCT05625360


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