Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

Emory University

Status and phase: Completed; Early Phase 1

Conditions: Malignant Solid Neoplasm; Hematopoietic and Lymphoid System Neoplasm

Treatments: Other: Survey Administration; Other: Text Message-Based Navigation Intervention; Other: Interview

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05346692

EU5450-21 (Other Identifier)

P30CA138292 (U.S. NIH Grant/Contract)

STUDY00003299

Details and patient eligibility

About

This phase I trial tests a digital meditation for postoperative pain control after abdominal surgery for cancer. Mindfulness interventions such as guided meditation may improve pain control and decrease stress. Including a brief mindfulness intervention administered via test messages as part of postoperative care may improve pain severity, decrease opioid use, and improve patient responses to non-surgical treatments.

Full description

PRIMARY OBJECTIVES:

I. To investigate and define anticipated and unanticipated adverse events (AEs) related to a daily virtual mindfulness intervention delivered via short message service (SMS) text messaging and to test its safety in the postoperative period amongst patients with cancer.

II. To determine the feasibility and acceptability of a novel, brief mindfulness intervention delivered via SMS text messaging in the postoperative period amongst patients undergoing surgery for cancer.

III. To determine the feasibility and acceptability of an artificial intelligence platform to deliver and receive SMS text messages for the purpose of delivering pain assessment tools and collecting and storing pain-specific and patient reported outcomes.

OUTLINE: Patients are assigned to 1 of 2 arms. ARM I: Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

ARM II: Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Enrollment: 73 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients >= 18 years of age
• Open abdominal surgery for cancer
• Ownership of smartphone (iOS or Android operating systems) with SMS texting capabilities
• Ability to read
• Ability to understand the purposes and risk of the study and willingly give standard written informed consent for treatment established by each participating institution.

Exclusion criteria

• Patients with contraindications to abdominal surgery and/or general anesthesia

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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73 participants in 2 patient groups

Arm I (Pain Survey)

Active Comparator group

Description:

Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Treatment:

Other: Interview

Other: Survey Administration

Other: Interview

Arm 2 (Mindfulness Intervention)

Experimental group

Description:

Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Treatment:

Other: Interview

Other: Text Message-Based Navigation Intervention

Other: Interview