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

NCT06858202 | Recruiting

• 1 other identifier: 166993
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Intra-abdominal Cancer

Outcome Measures

Primary Outcomes (1)

• Feasibility and acceptability of delivering video based mindfulness interventions

  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.

  From enrollment to 6 months post-enrollment.

Secondary Outcomes (10)

• Participant-reported Global Impression of Change

  From enrollment to 6 months post-enrollment.

• Participant-reported pain intensity

  From enrollment to 6 months post-enrollment.

• Participant-reported pain interference

  From enrollment to 6 months post-enrollment.

• Participant-reported physical function

  From enrollment to 6 months post-enrollment.

• Participant-reported health engagement

  From enrollment to 6 months post-enrollment.

Study Arms (3)

Video-based Guided Mindfulness

EXPERIMENTAL

A 15-20-minute video based on previously tested and documented standards for guided meditation aimed at addressing pain and distress.

Behavioral: Mindfulness Intervention

Video-based Guided Expressive Writing

EXPERIMENTAL

A 15-20-minute video based on expressive writing prompts aimed at addressing pain and distress. If the patient is assigned expressive writing, they will be offered a blank journal to use for the expressive writing interventions after randomization.

Behavioral: Mindfulness Intervention

Non-Mindfulness Based Therapeutic Approaches

ACTIVE COMPARATOR

Standard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested.

Behavioral: Non-mindfulness Intervention

Interventions

Mindfulness Intervention BEHAVIORAL

Guided meditation or guided expressive writing

Video-based Guided Expressive Writing; Video-based Guided Mindfulness

Non-mindfulness Intervention BEHAVIORAL

Standard inpatient and outpatient resources available for Huntsman Cancer Institute patients through social work and the Wellness and Integrative Health Center. Participants will be encouraged to ask their providers for more information or if appropriate more consults to the appropriate resources if interested.

Non-Mindfulness Based Therapeutic Approaches

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Utah: lead

Study Sites (1)

University of Utah Health

Salt Lake City, Utah, 84132, United States

RECRUITING

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Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 5, 2025
• Study Start: February 20, 2025
• Primary Completion: February 20, 2026
• Study Completion (Estimated): August 20, 2026
• Last Updated: March 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)