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Supportive eHealth Programs for Postoperative Pain

Phase 3

Recruiting

Led By Stephanie J Sohl, PhD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Must not have

Unwillingness or inability to follow study procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline and 2 weeks, 4 weeks and 3 months postoperatively

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two types of programs to see which helps women feel better after surgery. #medicalresearch

Who is the study for?

This trial is for women over 18 who are about to have abdominal surgery for suspected malignant masses in the reproductive system. They must be able to perform daily activities with ease (ECOG ≤1), understand English, and consent to participate. Those with severe psychiatric conditions or suicidal thoughts, or who can't follow study procedures cannot join.

What is being tested?

The study compares two supportive programs delivered remotely: eHealth Mindful Movement and Breathing versus Life Impacts Reflection. It aims to determine which program better improves wellbeing after surgery using PROMIS Questionnaires for assessment.

What are the potential side effects?

Since this trial involves non-invasive supportive programs rather than medication, traditional side effects are not expected. However, participants may experience emotional discomfort when reflecting on life impacts or while practicing mindful movements.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am scheduled for surgery to remove a suspected cancerous mass in my abdomen.

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I am fully active and can carry on all pre-disease activities without restriction.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am unable or unwilling to follow the study's procedures.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline and 2 weeks, 4 weeks and 3 months postoperatively

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at baseline and 2 weeks, 4 weeks and 3 months postoperatively

This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline and 2 weeks, 4 weeks and 3 months postoperatively for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire

Secondary study objectives

Anxiety- Short Form 4a Questionnaire

Change in Affective Pain - PROMIS Questionnaire

Change in Pain Intensity - PROMIS Pain Intensity Questionnaire

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm 1 - eHealth Mindful Movement and Breathing Group (eMMB)Experimental Treatment2 Interventions

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 II: Arm 2 Life Impacts Reflection Group (LIR)Active Control2 Interventions

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.

0 / 3Eligibility criteria met