REmotely-delivered Supportive Programs for Improving Surgical Pain and disTrEss

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05625360
• Other study ID #: IRB00083414
• Secondary ID: WFBCCC 98422R01C
• Status: Recruiting
• Phase: Phase 3
• Start date: June 13, 2023
• Est. completion date: August 31, 2026

Study information

• Verified date: June 2023
• Source: Wake Forest University Health Sciences
• Contact: Study Coordinator
• Phone: 336-713-0677
• Email: radellin[@]wakehealth.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Anxiety
• Dyssomnias
• Genital Neoplasms, Female
• Malignant Female Reproductive System Neoplasm
• Pain, Postoperative
• Parasomnias
• Postoperative Depression
• Sleep Disturbance

Intervention

Other:
• eHealth Mindful Movement and Breathing
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
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
Various PROMIS questionnaires will be completed by participants (Pain Interference, Sleep Disturbance, Physical Function, Anxiety and Depression)

Locations

Country	Name	City	State
United States	Atrium Health - Levine Cancer Institute	Charlotte	North Carolina
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pain Intensity Scores - PROMIS Pain Intensity Questionnaire	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.	4 weeks postoperatively
Secondary	Change in Pain Intensity - PROMIS Pain Intensity Questionnaire	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.	At 2 weeks and 3 months postoperatively
Secondary	Change in Affective Pain - PROMIS Questionnaire	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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Secondary	Change in Postoperative Acute Pain - PROMIS Questionnaire	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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Secondary	Change in Pain Interference	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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Secondary	Emotional Distress-Depression - Short Form 4a Questionnaire	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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Secondary	Anxiety- Short Form 4a Questionnaire	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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively
Secondary	Sleep Disturbance Short Form 4a Questionnaire	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.	At baseline and 2 weeks, 4 weeks and 3 months postoperatively