REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

Wake Forest University (WFU)

Status and phase: Enrolling; Phase 3

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

Treatments: Other: PROMIS Questionnaires; Other: eHealth Mindful Movement and Breathing; Other: Life Impacts Reflection

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05625360

WFBCCC 98422 (Other Identifier)

R01CA266995 (U.S. NIH Grant/Contract)

IRB00083414

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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160 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

Other: eHealth Mindful Movement and Breathing

Other: PROMIS Questionnaires

Arm 2 Life Impacts Reflection Group (LIR)

Active Comparator group

Description:

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.

Treatment:

Other: Life Impacts Reflection

Other: PROMIS Questionnaires