Clinical trial NCT05625360: REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss
Official title: REmotely-delivered Supportive Programs for Improving Surgical Pain Dnd disTrEss (RESPITE)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Postoperative Pain, Acute
Postoperative Depression
Anxiety
Sleep Disturbance
Malignant Female Reproductive System Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-11-22
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire
timeFrame: 4 weeks postoperatively
Secondary outcomes:
measure: Change in Pain Intensity - PROMIS Pain Intensity Questionnaire
timeFrame: At 2 weeks and 3 months postoperatively
measure: Change in Affective Pain - PROMIS Questionnaire
timeFrame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively
measure: Change in Postoperative Acute Pain - PROMIS Questionnaire
timeFrame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively
measure: Change in Pain Interference
timeFrame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively
measure: Emotional Distress-Depression - Short Form 4a Questionnaire
timeFrame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively
measure: Anxiety- Short Form 4a Questionnaire
timeFrame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively
measure: Sleep Disturbance Short Form 4a Questionnaire
timeFrame: At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: Atrium Health - Levine Cancer Institute
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest Baptist Comprehensive Cancer Center
name: Stephanie J Sohl, PhD
role: PRINCIPAL_INVESTIGATOR
References: