REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

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.

Conditions

• Postoperative Pain, Acute
• Postoperative Depression
• Anxiety
• Sleep Disturbance
• Malignant 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)

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• Wake Forest University Health Sciences

  lead OTHER

Principal Investigators

• Stephanie J Sohl, PhD · Wake Forest Baptist Comprehensive Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-06-13

Primary Completion

2026-08-31

Completion

2026-08-31

Countries

• United States

Study Locations