Digital Meditation for Postoperative Pain Control After Abdominal Surgery for Cancer
NCT ID: NCT05346692
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
73 participants
INTERVENTIONAL
2022-03-28
2023-07-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Survey Administration
Complete Survey
Interview
Complete Interview
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.
Text Message-Based Navigation Intervention
Complete mindfulness intervention
Interview
Complete interview
Interventions
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Survey Administration
Complete Survey
Interview
Complete Interview
Text Message-Based Navigation Intervention
Complete mindfulness intervention
Interview
Complete interview
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Emory University
OTHER
Responsible Party
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Viraj Master
Principal Investigator
Principal Investigators
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Maggie Diller, MD
Role: PRINCIPAL_INVESTIGATOR
Emory University/Winship Cancer Institute
Locations
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Emory University/Winship Cancer Institute
Atlanta, Georgia, United States
Countries
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Other Identifiers
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EU5450-21
Identifier Type: OTHER
Identifier Source: secondary_id
STUDY00003299
Identifier Type: -
Identifier Source: org_study_id
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