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

NCT06233253 | Completed DMC

• 2 other identifiers: OSU-23136NCI-2023-10496
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (17)

• Colonoscopy nervousness

  At pre-colonoscopy assessment

• Mindfulness

  At follow-up (1-2 days after the colonoscopy)

• Mindfulness knowledge

  At follow up (1-2 days after the colonoscopy)

• Colorectal screening knowledge

  At follow up (1-2 days after the colonoscopy)

• Attitudes about CRC and CRC screening

  At follow up (1-2 days after the colonoscopy)

Study Arms (2)

Group I (usual care)

ACTIVE COMPARATOR

Patients receive usual care prior to their scheduled screening colonoscopy.

Other: Best Practice; Other: Medical Chart Review; Other: Survey Administration

Group II (online mindfulness intervention)

EXPERIMENTAL

Patients receive an online mindfulness intervention including infographics and 5-minute meditations QD for 5 days prior to their scheduled screening colonoscopy.

Other: Medical Chart Review; Behavioral: Online Mindfulness Meditation; Other: Survey Administration

Interventions

Best Practice OTHER

Receive usual care

Also known as: standard of care, standard therapy

Group I (usual care)

Medical Chart Review OTHER

Ancillary studies

Also known as: Chart Review

Group I (usual care); Group II (online mindfulness intervention)

Online Mindfulness Meditation BEHAVIORAL

Receive an online mindfulness intervention

Also known as: Online MBSR, Online Mindful Meditation, Online Mindfulness Relaxation, Online Mindfulness-Based Stress Reduction, Web-Based Mindfulness Meditation

Group II (online mindfulness intervention)

Survey Administration OTHER

Ancillary studies

Group I (usual care); Group II (online mindfulness intervention)

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Study Officials

• Katz

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 8, 2024
• First Posted: January 31, 2024
• Study Start: September 29, 2023
• Primary Completion: July 12, 2024
• Study Completion: July 12, 2024
• Last Updated: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)