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Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy

The Ohio State University logo

The Ohio State University

Status

Enrolling

Conditions

Colorectal Carcinoma

Treatments

Behavioral: Online Mindfulness Meditation
Other: Best Practice
Other: Survey Administration
Other: Medical Chart Review

Study type

Interventional

Funder types

Other

Identifiers

NCT06233253
NCI-2023-10496 (Registry Identifier)
OSU-23136

Details and patient eligibility

About

This clinical trial tests how well an online mindfulness-based intervention (MBI) works to decrease anxiety in patients before a first-time screening colonoscopy. Elevated pre-procedural anxiety can affect patient outcomes including bowel preparation adherence and quality, the amount of sedation required, procedure time, patient satisfaction, cancellation or no-shows, and intention for future cancer screening. Mindfulness is a form of meditation that focuses on staying within the present moment to reduce anxiety. Previous research supports mindfulness practice among cancer survivors to decrease anxiety, fear of cancer re-occurrence, and to improve quality of life. Online MBIs have the potential to include targeted meditations and educational information designed to promote behavior change. This study may help researchers learn whether a mindfulness intervention works to decrease anxiety in patients before a first-time screening colonoscopy.

Full description

PRIMARY OBJECTIVE:

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.

Enrollment

100 estimated patients

Sex

All

Ages

45 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Patients must be ages 45-75
  • 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

  • Previous colonoscopy
  • 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Group I (usual care)
Active Comparator group
Description:
Patients receive usual care prior to their scheduled screening colonoscopy.
Treatment:
Other: Survey Administration
Other: Medical Chart Review
Other: Best Practice
Group II (online mindfulness intervention)
Experimental group
Description:
Patients receive an online mindfulness intervention including infographics and 5-minute meditations QD for 5 days prior to their scheduled screening colonoscopy.
Treatment:
Other: Survey Administration
Other: Medical Chart Review
Behavioral: Online Mindfulness Meditation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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