This clinical trial evaluates different types of support and coping strategies for improving pain and distress for patients undergoing surgery for intra-abdominal (within the abdomen) malignancies. Psychologic distress has been associated with worse surgical and cancer outcomes for patients with cancer. These patients often have significant physical symptoms from their cancer, such as fatigue, pain, and difficulty eating. Mindfulness interventions can positively impact positive psychological growth, symptom reduction, and biological outcomes. It has been shown that introducing techniques such as mindfulness and guided expressive writing can serve as effective coping mechanisms to help reduce physical ailments and pain medication requirements and help improve quality of life measures. Expressive writing interventions have been shown to be an effective therapeutic tool to help patients process their experience and help alleviate cancer-related stress, improve self-affirmation, and positively impact functional status. Mindfulness interventions may improve pain and distress for patients undergoing surgery for intra-abdominal malignancies.
Additional locations may be listed on ClinicalTrials.gov for NCT06858202.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Erin P Ward
Phone: 801-646-4365
PRIMARY OBJECTIVES:
I. 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 intra-abdominal malignancies.
II. To assess the differential effects of mindfulness versus (vs.) non-mindfulness therapeutic approaches on pain, distress, patient health engagement, and pain medication usage for patients preparing for/recovering from surgery for intra-abdominal malignancies and identify the most sensitive instruments to detect this change in this population.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients participate in video-based guided expressive writing over 15–20-minutes prior to surgery and on days 2-4 after surgery.
ARM II: Patients participate in video-based guided mindfulness over 15–20-minutes prior to surgery and on days 2-4 after surgery.
ARM III: Patients receive standard non-mindfulness interventions such as social work consults during in-patient post-operative care.
After completion of study intervention, patients are followed up at 2 weeks, 3 months, and 6 months after surgery.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorErin P Ward