REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

PHASE3RecruitingINTERVENTIONAL
Enrollment

160

Participants

Timeline

Start Date

June 13, 2023

Primary Completion Date

August 31, 2026

Study Completion Date

August 31, 2026

Conditions
Postoperative Pain, AcutePostoperative DepressionAnxietySleep DisturbanceMalignant Female Reproductive System Neoplasm
Interventions
OTHER

eHealth 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.

OTHER

Life 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."

OTHER

PROMIS Questionnaires

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

Trial Locations (2)

27157

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem

28204

RECRUITING

Atrium Health - Levine Cancer Institute, Charlotte

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Wake Forest University Health Sciences

OTHER