REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

NCT ID: NCT05625360

Last Updated: 2025-10-27

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-13
• Study Completion Date: 2026-08-31

Brief 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.

Detailed Description

Primary Objective: To determine efficacy of eHealth Mindful Movement and Breathing (eMMB) as compared to Life Impact Reflection (LIR) for improving postoperative pain intensity 4-weeks postoperative in patients who received abdominal surgery for a suspected gynecologic malignancy.

Secondary Objectives:

• At week 2 and 3 months post-operative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving pain intensity in patients who received abdominal surgery for a suspected gynecologic malignancy.
• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving affective pain in patients who received abdominal surgery for a suspected gynecologic malignancy.
• To determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving post-operative acute pain (pain intensity within 1 week post-surgery) in patients who received abdominal surgery for a suspected gynecologic malignancy.
• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving pain interference in patients who received abdominal surgery for a suspected gynecologic malignancy.
• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving psychological distress symptoms (i.e., depression) in patients who received abdominal surgery for a suspected gynecologic malignancy.
• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving psychological distress symptoms (i.e., anxiety) in patients who received abdominal surgery for a suspected gynecologic malignancy.
• At week 2, week 4, and 3 months postoperative, to determine efficacy of eHealth Mindful Movement and Breathing as compared to LIR for improving sleep disturbances in patients who received abdominal surgery for a suspected gynecologic malignancy.

Conditions

Postoperative Pain, Acute; Postoperative Depression; Anxiety; Sleep Disturbance; Malignant Female Reproductive System Neoplasm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB)

Participants will be given access to 20-minute eMMB videos (either saved as a local files on an iPad or via links to watch on their own devices) with written instructions for eMMB and to watch a video at least once before surgery (videos have the same content, one is taught in a bed and one in a chair). The instructor will call participants before surgery to offer guidance upon request and meet with participants individually via a synchronous videoconference or telephone session, postoperative day 1 (the day after surgery), or as soon as feasible.

Group Type: EXPERIMENTAL

eHealth Mindful Movement and Breathing

Intervention Type: OTHER

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.

PROMIS Questionnaires

Intervention Type: OTHER

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

Arm 2 Life Impacts Reflection Group (LIR)

The format for interactions with an LIR interventionist, frequency of recommended home practice (brief diary entries), and home assessments will be matched to the eMMB group. LIR will not include active ingredients of eMMB.

Group Type: ACTIVE_COMPARATOR

Life Impacts Reflection

Intervention Type: OTHER

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.

PROMIS Questionnaires

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

PROMIS Questionnaires

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie J Sohl, PhD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest Baptist Comprehensive Cancer Center

Locations

Atrium Health - Levine Cancer Institute

Charlotte, North Carolina, United States

Site Status: RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Hannah O'Brien

Role: CONTACT

hobrien@wakehealth.edu

336-716-2498

Alicia Patrick, MA, CCRP

Role: CONTACT

980-292-1746

Facility Contacts

Alicia Patrick, MA, CCRP

Role: primary

980-292-1746

Hannah O'Brien

Role: primary

hobrien@wakehealth.edu

336-716-2498

Other Identifiers

WFBCCC 98422

Identifier Type: OTHER

Identifier Source: secondary_id

R01CA266995

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00083414

Identifier Type: -

Identifier Source: org_study_id