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

A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy: A Pilot Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Carcinoma
• Intervention / Treatment: Other: Best Practice; Other: Survey Administration; Other: Medical Chart Review; Behavioral: Online Mindfulness Meditation

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I (usual care); Patients receive usual care prior to their scheduled screening colonoscopy.	Other: Best Practice; Receive usual care; Other Names: standard of care; standard therapy; Other: Survey Administration; Ancillary studies; Other: Medical Chart Review; Ancillary studies; Other Names: Chart Review
Experimental: 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.	Other: Survey Administration; Ancillary studies; Other: Medical Chart Review; Ancillary studies; Other Names: Chart Review; Behavioral: Online Mindfulness Meditation; Receive an online mindfulness intervention; Other Names: Online MBSR; Online Mindful Meditation; Web-Based Mindfulness Meditation; Online Mindfulness Relaxation; Online Mindfulness-Based Stress Reduction

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention rate (Feasibility)	Feasibility will be assessed by the number of patients referred, number of participants recruited, and missing data from surveys and medical records. Feasibility will be achieved with a retention rate of 90% throughout the intervention. An independent samples t-test will be conducted to compare State-Trait Anxiety Inventory: State-Subscale (STAI-S) scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.	Up to 4 weeks
Satisfaction with the intervention (Acceptability)	Acceptability will be assessed by the number of intervention materials accessed and time to complete study activities (infographics, meditations, and surveys) via embedded REDCap metrics. Participants within the MBI group will also report meditation satisfaction and state mindfulness immediately after each meditation in addition to intervention satisfaction during the follow-up survey. Will report an average satisfaction score with the intervention >= 6.0, measured using a 7-point Likert scale. An independent samples t-test will be conducted to compare STAI-S scores. Linear regression will be conducted to assess the difference when controlling for potential confounding variables of interest.	At follow-up (1-2 days after the colonoscopy)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Colonoscopy nervousness	Anxiety specific to the bowel prep and colonoscopy will be assessed using a visual analogue scale. Will be analyzed using t-test.	At pre-colonoscopy assessment
Mindfulness	Will measure the trait mindfulness using The Philadelphia Mindfulness Scale, a 20-item self-report with subscales of awareness and acceptance. Will be analyzed using t-test.	At follow-up (1-2 days after the colonoscopy)
Mindfulness knowledge	Will be assessed using a 5-item score about mindfulness. An independent samples t-test will be conducted to compare STAI-S scores.	At follow up (1-2 days after the colonoscopy)
Colorectal screening knowledge	Will be assessed using a 5-item score about colorectal (CRC) screening. Will be analyzed using t-test.	At follow up (1-2 days after the colonoscopy)
Attitudes about CRC and CRC screening	Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.	At follow up (1-2 days after the colonoscopy)
Bowel prep adherence	Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using chi-square test.	At pre-colonoscopy assessment
Bowel prep difficulty	Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.	At pre-colonoscopy assessment
Bowel prep quality	Will be measured using the Boston Bowel Preparation Scale or 5-point Likert scale and medical chart review. Will be analyzed using t-test.	Up to 4 weeks
Cancellation/no-show	Will be measured by attendance. Will be analyzed using chi-square test.	At pre-colonoscopy assessment
Heart rate	Will be measured in beats per minute using medical chart review. Will be analyzed using t-test.	Up to 4 weeks
Blood pressure	Will be measured in millimeter of mercury using chart review at time of check-in (the first recorded) to the endoscopy suite holding area. Will be analyzed using t-test.	Up to 4 weeks
Sedative dose	Will be measured in milligrams using chart review. Will be analyzed using t-test.	Up to 4 weeks
Procedural time	Will be measured in minutes using medical chart review. Will be analyzed using t-test.	Up to 4 weeks
Cecal intubation time	Will be measured in minutes using medical chart review. Will be analyzed using t-test.	At post-colonoscopy
Endoscopy suite time	Will be measured in minutes using medical chart review. Will be analyzed using t-test.	Up to 4 weeks
Procedure satisfaction	Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.	At follow up (1-2 days after the colonoscopy)
Intent for future CRC screening	Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.	At follow up (1-2 days after the colonoscopy)

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Katz, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): September 29, 2023
• Primary Completion (Actual): July 12, 2024
• Study Completion (Actual): July 12, 2024

Study Registration Dates

• First Submitted: January 8, 2024
• First Submitted That Met QC Criteria: January 22, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 20, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: OSU-23136; NCI-2023-10496 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No