REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

NCT05625360 | Recruiting Phase 3

• 3 other identifiers: IRB00083414WFBCCC 98422R01CA266995
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire

  Efficacy of the intervention will be evaluated by measuring pain intensity scores between the two groups from the Patient Reported Outcomes Measurement Information System (PROMIS) pain intensity item (How would you rate your pain on average?), which is validated for assessing pain on a numeric rating scale from 0 (no pain) to 10 (worst imaginable pain). Models will be adjusted for the three randomization stratification variables (study site, type of cancer, type of surgery). Linear contrasts will be used to estimate the difference between the two groups.

  4 weeks postoperatively

Secondary Outcomes (7)

• Change in Pain Intensity - PROMIS Pain Intensity Questionnaire

  At 2 weeks and 3 months postoperatively

• Change in Affective Pain - PROMIS Questionnaire

  At baseline and 2 weeks, 4 weeks and 3 months postoperatively

• Change in Postoperative Acute Pain - PROMIS Questionnaire

  At baseline and 2 weeks, 4 weeks and 3 months postoperatively

• Change in Pain Interference

  At baseline and 2 weeks, 4 weeks and 3 months postoperatively

• Emotional Distress-Depression - Short Form 4a Questionnaire

  At baseline and 2 weeks, 4 weeks and 3 months postoperatively

Study Arms (2)

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

EXPERIMENTAL

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.

Other: eHealth Mindful Movement and Breathing; Other: PROMIS Questionnaires

Arm 2 Life Impacts Reflection Group (LIR)

ACTIVE COMPARATOR

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.

Other: Life Impacts Reflection; Other: PROMIS Questionnaires

Interventions

eHealth Mindful Movement and Breathing 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.

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

Life Impacts Reflection 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.

Arm 2 Life Impacts Reflection Group (LIR)

PROMIS Questionnaires OTHER

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

Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB); Arm 2 Life Impacts Reflection Group (LIR)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Atrium Health - Levine Cancer Institute

Charlotte, North Carolina, 28204, United States

RECRUITING

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Anxiety Disorders; Parasomnias

Interventions

Respiration

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Respiratory Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Stephanie J Sohl, PhD

  Wake Forest Baptist Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah O'Brien

CONTACT

336-716-2498; hobrien@wakehealth.edu

Alicia Patrick, MA, CCRP

CONTACT

980-292-1746

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 22, 2022
• Study Start: June 13, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)