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Supportive Programs for Post-Surgery Pain and Distress

This study is looking at two different supportive programs to help women feel better after abdominal surgery for suspected gynecological cancer. It compares "eHealth Mindful Movement and Breathing" (eMMB), which involves short mindful meditation and breathing exercises, with "Life Impacts Reflection" (LIR), where you write daily diary entries reflecting on your experiences. The main goal is to see if one program is better at reducing pain intensity four weeks after surgery. You may be able to join if you are an adult woman (18 years or older) scheduled for this type of surgery. The current status of the study is unclear, but it plans to enroll 160 participants.

Study design
This interventional study plans to enroll 160 adult women. It compares two different supportive programs to see which is more effective.
What's involved
You would participate in either the eHealth Mindful Movement and Breathing program or the Life Impacts Reflection program, which includes daily diary entries for four weeks. You would also complete various PROMIS questionnaires at different times.
Compensation
Not stated in the trial record.
Follow-up
Your pain intensity will be measured at 2 weeks, 4 weeks, and 3 months after surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05625360

REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

Active, Not Recruiting
PHASE3Ages 18+InterventionalSupportive care
Wake Forest University Health Sciences
~160 participants
Updated 2026-07-24 on ClinicalTrials.gov
What's tested:eHealth Mindful Movement and BreathingLife Impacts ReflectionPROMIS Questionnaires

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire
Measured over 4 weeks postoperatively

Conditions

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

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Malignant Female Reproductive System Neoplasm

Where it's being run

2 sites across 1 states
North Carolina2

Study leadership

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

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire4 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.