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NCT Number: NCT05625360

REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Postoperative Pain, Acute Anxiety Anxiety Disorders Malignant Female Reproductive System Neoplasm Mental Disorders Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Parasomnias Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Depression Signs and Symptoms Sleep Disturbance Sleep Wake Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Atrium Health - Levine Cancer Institute, Charlotte, North Carolina, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

PROMIS Questionnaires

Other

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

Primary outcomes

  1. Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire

    Time frame: 4 weeks postoperatively

    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.

Secondary outcomes

  1. Change in Pain Intensity - PROMIS Pain Intensity Questionnaire

    Time frame: At 2 weeks and 3 months postoperatively

    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.

  2. Change in Affective Pain - PROMIS Questionnaire

    Time frame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively

    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.

  3. Change in Postoperative Acute Pain - PROMIS Questionnaire

    Time frame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively

    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.

  4. Change in Pain Interference

    Time frame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively

    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.

  5. Emotional Distress-Depression - Short Form 4a Questionnaire

    Time frame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively

    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.

  6. Anxiety- Short Form 4a Questionnaire

    Time frame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively

    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.

  7. Sleep Disturbance Short Form 4a Questionnaire

    Time frame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Nov 22, 2022
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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