REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety; Sleep Disturbance; Malignant Female Reproductive System Neoplasm; Postoperative Pain, Acute; Postoperative Depression
• Intervention / Treatment: Other: PROMIS Questionnaires; Other: Life Impacts Reflection; Other: eHealth Mindful Movement and Breathing

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Study Coordinator; Phone Number: 336-713-0677; Email: radellin@wakehealth.edu

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Not yet recruiting
      • Atrium Health - Levine Cancer Institute
      • Contact: Study Coordinator; Phone Number: 336-713-0677; Email: radellin@wakehealth.edu
      • Principal Investigator: Stephanie J Sohl, PhD
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest Baptist Comprehensive Cancer Center
      • Contact: Study Coordinator; Phone Number: 336-713-0677; Email: radellin@wakehealth.edu
      • Principal Investigator: Stephanie J Sohl, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: PROMIS Questionnaires; Various PROMIS questionnaires will be completed by participants (Pain Interference, Sleep Disturbance, Physical Function, Anxiety and Depression); 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.
Active Comparator: 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.	Other: PROMIS Questionnaires; Various PROMIS questionnaires will be completed by participants (Pain Interference, Sleep Disturbance, Physical Function, Anxiety and Depression); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain Intensity - PROMIS Pain Intensity Questionnaire	Efficacy of the intervention in measuring pain intensity scores 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.	At 2 weeks and 3 months postoperatively
Change in Affective Pain - PROMIS Questionnaire	Efficacy of the intervention in affective pain will be assessed with one item (numeric rating scale) on a scale from 0 (not bad at all) to 10 (the most unpleasant feeling possible for me). 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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Change in Postoperative Acute Pain - PROMIS Questionnaire	Efficacy of the intervention in post-operative acute pain is defined as pain experienced daily over the first week after surgery and will be measured daily using the 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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Change in Pain Interference	Efficacy of the intervention in improving pain interference 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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Emotional Distress-Depression - Short Form 4a Questionnaire	Efficacy of the intervention in improving psychological distress symptoms 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. Scoring scale: 0 - never to 5 - always. The higher the score the greater the depression.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Anxiety- Short Form 4a Questionnaire	Efficacy of the intervention in improving psychological distress symptoms 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. Scoring scale: 0 - never to 5 - always. The higher the score the greater the anxiety.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Sleep Disturbance Short Form 4a Questionnaire	Efficacy of the intervention in improving sleep disturbances 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. Likert scoring scale: 5 - very poor to 1 - very good or reversed with 5 - not at all to 1 - very much.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Stephanie J Sohl, PhD, Wake Forest Baptist Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2023
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): June 15, 2023
• Last Update Submitted That Met QC Criteria: June 14, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neoplasms; Sleep Wake Disorders; Urogenital Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Pain, Postoperative; Dyssomnias; Parasomnias; Acute Pain; Genital Neoplasms, Female
• Other Study ID Numbers: IRB00083414; WFBCCC 98422 (Other Identifier: Wake Forest Baptist Comprehensive Cancer Center); R01CA266995 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No