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

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)

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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