Clinical trial NCT06858202: Study to Determine How Different Types of Coping Strategies Can Help People Manage Pain and Distress After Surgery
Official title: Quality Improvement Project to Address Post Operative Distress and Pain for Patients Undergoing Surgery for Intra-Abdominal Malignancies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Psychological Distress
Intra-abdominal Cancer
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility and acceptability of delivering video based mindfulness interventions
timeFrame: From enrollment to 6 months post-enrollment.
Secondary outcomes:
measure: Participant-reported Global Impression of Change
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported pain intensity
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported pain interference
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported physical function
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported health engagement
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported depression
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported anxiety
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported social isolation
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant-reported quality of life
timeFrame: From enrollment to 6 months post-enrollment.
measure: Participant use of pain medicine
timeFrame: From enrollment to 6 months post-enrollment.
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health
state: Utah
Study officials:
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