Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy
NCT ID: NCT06233253
Last Updated: 2025-02-24
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
NA
100 participants
INTERVENTIONAL
2023-09-29
2024-07-12
Brief Summary
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Detailed Description
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I. To establish intervention feasibility and acceptability, and to collect preliminary efficacy data on a developed online mindfulness-based intervention (MBI) to reduce pre-procedural anxiety before a first-time screening colonoscopy compared to usual care.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Patients receive usual care prior to their scheduled screening colonoscopy.
GROUP II: Patients receive an online mindfulness intervention including infographics and 5-minute meditations once daily (QD) for 5 days prior to their scheduled screening colonoscopy.
After completion of study intervention, patients are followed up 1-2 days post-colonoscopy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Group I (usual care)
Patients receive usual care prior to their scheduled screening colonoscopy.
Best Practice
Receive usual care
Medical Chart Review
Ancillary studies
Survey Administration
Ancillary studies
Group II (online mindfulness intervention)
Patients receive an online mindfulness intervention including infographics and 5-minute meditations QD for 5 days prior to their scheduled screening colonoscopy.
Medical Chart Review
Ancillary studies
Online Mindfulness Meditation
Receive an online mindfulness intervention
Survey Administration
Ancillary studies
Interventions
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Best Practice
Receive usual care
Medical Chart Review
Ancillary studies
Online Mindfulness Meditation
Receive an online mindfulness intervention
Survey Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must be at average risk for colorectal cancer (CRC)
* Patients must have scheduled their first-time screening colonoscopy as an outpatient at Ohio State University (OSU) at least 14 days in advance
* Patients must be able to speak and read English
* Patients must have daily access to a working telephone, email address, and internet connection
* Patients must provide consent
Exclusion Criteria
* Colonoscopy for diagnostic purposes
* Auditory or visual impairment that prevents internet use
* Previous cancer diagnosis (other than skin cancer)
* Previous diagnosis of a mental health disorder
* Current mental health treatment
* Family history of CRC
* Personal history of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
* Confirmed or suspected hereditary CRC syndrome, such as familial adenomatous polyposis or Lynch syndrome
45 Years
75 Years
ALL
Yes
Sponsors
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Ohio State University Comprehensive Cancer Center
OTHER
Responsible Party
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Mira Katz
Principal Investigator
Principal Investigators
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Katz
Role: PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center
Locations
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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Related Links
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The Jamesline
Other Identifiers
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NCI-2023-10496
Identifier Type: REGISTRY
Identifier Source: secondary_id
OSU-23136
Identifier Type: -
Identifier Source: org_study_id
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