Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer

Malignant Solid Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346692
• Other study ID #: STUDY00003299
• Secondary ID: EU5450-21P30CA13
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 28, 2022
• Est. completion date: October 31, 2025

Study information

• Verified date: December 2023
• Source: Emory University
• Contact: Maggie Diller, MD
• Phone: 404-778-3712
• Email: maggie.l.diller[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematopoietic and Lymphoid System Neoplasm
• Malignant Solid Neoplasm
• Neoplasms

Intervention

Other:
• Survey Administration
Complete Survey
• Interview
Complete Interview
• Text Message-Based Navigation Intervention
Complete mindfulness intervention
• Interview
Complete interview

Locations

Country	Name	City	State
United States	Emory University/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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