Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

NCT05346692 | Completed Early Phase 1 DMC

• 3 other identifiers: STUDY00003299EU5450-21P30CA138292
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Intervention and mode of delivery utilizing the Client Satisfaction Survey (CSQ-8)

  Up to 12 months

• Intervention and mode of delivery utilizing the System Usability Scale (SUS)

  Up to 12 months

Study Arms (2)

Arm I (Pain Survey)

ACTIVE COMPARATOR

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; Other: Interview

Arm 2 (Mindfulness Intervention)

EXPERIMENTAL

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

Other: Text Message-Based Navigation Intervention; Other: Interview

Interventions

Survey Administration OTHER

Complete Survey

Arm I (Pain Survey)

Interview OTHER

Complete Interview

Arm I (Pain Survey)

Text Message-Based Navigation Intervention OTHER

Complete mindfulness intervention

Also known as: Automated Text Message-Based Navigation, Text Message-Based Navigation

Arm 2 (Mindfulness Intervention)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Emory University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Emory University/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Maggie Diller, MD

  Emory University/Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 26, 2022
• Study Start: March 28, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)