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Digital Meditation for Postoperative Pain Control after Abdominal Surgery for Cancer

Status
Active
Cancer Type
Solid Tumor
Trial Phase
Phase I
Eligibility
18 Years and older, Male and Female
Study Type
Supportive care
NCT ID
NCT05346692
Protocol IDs
EU5450-21 (primary)
NCI-2022-01830
STUDY00003299
Study Sponsor
Emory University Hospital/Winship Cancer Institute

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.

Objectives

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.

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

Eligibility

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

 

Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.