Study to Determine How Different Types of Coping Strategies Can Help People Manage Pain and Distress After Surgery

Not Applicable

Recruiting

• Conditions: Psychological Distress; Intra-abdominal Cancer

• Registration Number: NCT06858202
• Lead Sponsor: University of Utah

Brief Summary

The purpose of this study is to determine if different video based coping strategies can help patients undergoing surgery for cancer can improve patients pain and distress after surgery for their cancer.

The main questions this study aims to answer are:

* Is it possible to use video-based coping strategies to help manage pain and distress after surgery?

* Is one type of coping strategy better than another?

Researchers will compare mindfulness-based coping strategies (e.g., guided meditation, expressive writing, etc.) with non-mindfulness coping strategies (e.g., support from social workers and the wellness center, health education, etc.) to understand how these can help in post-surgery recovery, pain management, and distress.

Participants will:

* Provide their full name, date of surgery, e-mail address, and phone number and agree to be contacted via email or text messaging.

* Fill out some questionnaires before surgery, which should take 10-15 minutes.

* Be assigned to one of three coping strategies.

* Review a video (about 15-20 minutes long) or links to online resources before surgery and respond to questions about pain and distress before and after viewing these materials.

* Review additional videos or links 2, 3, and 4 days after surgery and respond to questions about pain and distress before and after viewing these materials.

* Complete additional questionnaires 2 weeks, 3 months, and 6 months after surgery. These questionnaires will be sent by text or email and should take about 10-15 minutes to complete.

Detailed Description

We propose to conduct a quality improvement project to determine the impact of different types of psychosocial support for patients undergoing surgery for intrabdominal malignancies.

This project will consist of a program evaluation/quality improvement study of existing pain and psychosocial management programs within the University of Utah Hospital System, which currently employs Study staff to provide mindfulness and non-mindfulness interventions for patients preparing for surgery and recovering from surgery. We wish to evaluate the differential impact of mindfulness interventions (e.g., guided meditation, expressive writing, etc.) and non-mindfulness interventions (. g., cognitive-behaviorally based psychoeducation, health education, grounding/earthing, and sham grounding/earthing, etc., support via social work and the wellness center, etc.) by randomly assigning patients to one of these approaches.

Objectives:

Aim 1 To assess the feasibility and acceptability of an application-based mindfulness or expressive writing intervention designed to address post-operative pain and distress, such as anxiety or depression, for patients undergoing surgery for intrabdominal malignancies.

Hypotheses: Greater than 50% of patients assigned to a mindfulness intervention, either guided meditation or expressive writing, will engage with at least one intervention, and over 30% of patients will engage with all four interventions.

Aim 2 To assess the differential effects of mindfulness vs. non-mindfulness therapeutic approaches on pain, distress, patient health engagement, and pain medication usage for patients preparing for/recovering from surgery for intraabdominal malignancies and identify the most sensitive instruments to detect this change in this population.

Hypotheses: Mindfulness-based therapeutic approaches, including guided meditation and expressive writing, will decrease pain, distress, and pain medicine usage and increase patient health engagement significantly more than standard non-mindfulness-based therapeutic approaches. We predict narcotic requirements during the post-operative period, and patient-reported pain scores will be the most sensitive.

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-20
• Study First Submitted: 2025-02-21
• Study First Submitted QC: 2025-02-26
• Last Update Submitted: 2025-02-26
• Study First Posted: 2025-03-05
• Last Update Posted: 2025-03-05
• Primary Completion: 2026-02-20
• Study Completion: 2026-08-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• English-speaking males or females 18 or older within the University of Utah Hospital system being treated for an intrabdominal malignancy.
• Patients undergoing surgical treatment of cancer within the abdominal cavity.

Exclusion Criteria

• Altered mental status due to delirium or pharmacological sedation as determined by a clinical assessment conducted by a study staff.
• Non-English speaking.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility and acceptability of delivering video based mindfulness interventions	From enrollment to 6 months post-enrollment.	The frequency that patients start and complete at least one mindfulness intervention will be evaluated and compared to the other two cohorts. The frequency of engaging with and completing the interventions will be reported descriptively. The Chi2 for Fisher's will be used for exact test.

Secondary Outcome Measures

Name	Time	Method
Participant-reported Global Impression of Change	From enrollment to 6 months post-enrollment.	Patient global impression for change will be assessed using the PCIG (Rampakakis, Ste-Marie, et al. 2015, Perrot and Lantéri-Minet 2019) questionnaire. The questionnaire includes two items in which patients rate the change in their activity limitations, symptoms, and emotions on a descriptive scale from "No Change" = 1 to "A great deal better" = 7 and a visual scale from "Much better" = 0 to "Much worse" = 10.
Participant-reported pain intensity	From enrollment to 6 months post-enrollment.	Change in pain symptoms will be assessed using the PROMIS Scale v2.0 Pain Intensity 3a questionnaire. This measure includes three items rating pain from "Had no pain" = 1 to "Very severe" = 5.
Participant-reported pain interference	From enrollment to 6 months post-enrollment.	Change in pain interference will be assessed using the PROMIS Scale v1.1 Pain Interference 4a questionnaire. This measure includes three items rating the scale in which pain interferes with daily life from "Not at all" = 1 to "Very much" = 5.
Participant-reported physical function	From enrollment to 6 months post-enrollment.	Change in physical will be assessed using the PROMIS Scale v2.0 Physical Function Short Form 6b questionnaire. This measure includes six items rating difficulty of daily tasks related to physical function from "Without any difficulty" = 1 to "Unable to do" = 5.
Participant-reported health engagement	From enrollment to 6 months post-enrollment.	Participant health engagement will be assessed using the PHE questionnaire (Graffigna et. al 2015). This measure includes nine items in which patients rate how they feel about and engage with their disease. This scale has been adapted for study use to be rated on a scale from "never" = 1 to "always" = 5.
Participant-reported depression	From enrollment to 6 months post-enrollment.	Change in emotional distress symptoms for depression will be assessed using the PROMIS Scale v1.0 Emotional Distress-Depression Short form 6a questionnaire. The questionnaire includes six items rating occurrence of different depression related emotions from "Never" = 1 to "Always" = 5.
Participant-reported anxiety	From enrollment to 6 months post-enrollment.	Change in emotional distress symptoms for anxiety will be assessed using the PROMIS Scale v1.0 Emotional Distress-Anxiety Short form 6a questionnaire. The questionnaire includes six items rating occurrence of different anxiety related emotions from "Never" = 1 to "Always" = 5.
Participant-reported social isolation	From enrollment to 6 months post-enrollment.	Change in levels of social isolation will be assessed using the PROMIS Scale v2.0 Social Isolation Short form 4a questionnaire. The questionnaire includes four items rating the occurrence of different feelings regarding social isolation from "Never" = 1 to "Always" = 5.
Participant-reported quality of life	From enrollment to 6 months post-enrollment.	Participant quality of life will be assessed using the World Health Organization Quality of Life questionnaire. This questionnaire consists of two items that assess how patients feel about their quality of life on a scale from "Very poor" and "Very dissatisfied" =1 to "Very good" and "Very satisfied" = 5.
Participant use of pain medicine	From enrollment to 6 months post-enrollment.	Patient narcotic consumption in the post-operative period will be collected via chart abstraction. Use of pain medicine will be compared with intervention acceptability and frequency of use at the end of the study, which may help guide future studies.

Trial Locations

Locations (1)

University of Utah Health; 🇺🇸 Salt Lake City, Utah, United States