Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

A Prospective, Double-Arm Pilot Study to Investigate the Safety, Feasibility and Acceptability of a Digital Mindfulness Intervention Following Open Abdominal Surgery for Cancer

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Maggie Diller, MD; Phone Number: 404-778-3712; Email: maggie.l.diller@emory.edu
• Study Contact Backup: Name: Viraj Master, MD PhD FACS; Phone Number: 404-778-4898; Email: vmaster@emory.edu

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Recruiting
      • Emory University/Winship Cancer Institute
      • Contact: Sierra Williams; Phone Number: 404-778-4729; Email: sierra.williams@emory.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (Pain Survey); Patients complete pain survey via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.	Other: Survey Administration; Complete Survey; Other: Interview; Complete Interview; Other: Interview; Complete interview
Experimental: Arm 2 (Mindfulness Intervention); Patients complete mindfulness intervention via text message daily for 10 days after surgery. Patients also complete telephone interview 2 weeks after surgery.	Other: Interview; Complete Interview; Other: Interview; Complete interview; Other: Text Message-Based Navigation Intervention; Complete mindfulness intervention; Other Names: Automated Text Message-Based Navigation, Text Message-Based Navigation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events	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.	Up to 12 months
Feasibility of intervention and mode of delivery	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.	Up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention and mode of delivery utilizing the Client Satisfaction Survey (CSQ-8)	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: the overall quality; perception of the program's ability to meet their needs; amount of help received; 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.	Up to 12 months
Intervention and mode of delivery utilizing the System Usability Scale (SUS)	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.	Up to 12 months

Collaborators and Investigators

• Sponsor: Emory University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Maggie Diller, MD, Emory University/Winship Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2022
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 26, 2022

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: STUDY00003299; P30CA138292 (U.S. NIH Grant/Contract); EU5450-21 (Other Identifier: Emory University Hospital/Winship Cancer Institute)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No