Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

Early Phase 1

Completed

• Conditions: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm
• Interventions: Other: Survey Administration; Other: Text Message-Based Navigation Intervention; Other: Interview

• Registration Number: NCT05346692
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2022-03-28
• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-04-21
• Study First Posted: 2022-04-26
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (Pain Survey)	Survey Administration	Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
Arm I (Pain Survey)	Interview	Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
Arm 2 (Mindfulness Intervention)	Interview	Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.
Arm 2 (Mindfulness Intervention)	Text Message-Based Navigation Intervention	Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.

Primary Outcome Measures

Name	Time	Method
Feasibility of intervention and mode of delivery	Up to 12 months	Feasibility for each arm is defined as completion of at least 50% of the program.The proportion completing at least 50% of the program will be compared to a null proportion of 20% completing at least 50% of the program using a one-sample Z-test.
Incidence of adverse events	Up to 12 months	Adverse events (AEs) will be reported, and summarized using frequencies and percentages. An AE will be considered unexpected if the nature, severity, or frequency of the event is not consistent with the risk information previously described for the study intervention. Unexpected AEs will be summarized descriptively. The most common adverse events reported within the mindfulness literature anxiety, depression, and cognitive anomalies. The overall prevalence of meditation adverse events is 8%, which is similar to those reported for psychotherapy practice in general.

Secondary Outcome Measures

Name	Time	Method
Intervention and mode of delivery utilizing the Client Satisfaction Survey (CSQ-8)	Up to 12 months	Acceptability of intervention and mode of delivery will include quantitative and qualitative analyses. Quantitative analysis will include the Client Satisfaction Survey (CSQ-8). The CSQ-8 focuses on participant satisfaction with the intervention received, including: 1. the overall quality; 2. perception of the program's ability to meet their needs; 3. amount of help received; 4. the extent to which this program helped them deal with recovery after surgery. The CSQ-8 has demonstrated good internal consistency, test-retest reliability, and sensitivity10.
Intervention and mode of delivery utilizing the System Usability Scale (SUS)	Up to 12 months	Acceptability of intervention and mode of delivery will include quantitative and qualitative analyses. Quantitative analysis will include the System Usability Scale (SUS) administered to all participants at study completion of the study to all participants.; The SUS is a 10-item scale that examines the perceived usability of a technology and is commonly used in evaluating mobile apps. The SUS has demonstrated good reliability in other studies.

Trial Locations

Locations (1)

Emory University/Winship Cancer Institute; 🇺🇸 Atlanta, Georgia, United States