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

Colorectal Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06233253
• Other study ID #: OSU-23136
• Secondary ID: NCI-2023-10496
• Status: Recruiting
• Phase: N/A
• Start date: September 29, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Carcinoma
• Colorectal Neoplasms

Intervention

Other:
• Best Practice
Receive usual care
• Medical Chart Review
Ancillary studies

Behavioral:
• Online Mindfulness Meditation
Receive an online mindfulness intervention

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Cancellation/no-show	Will be measured by attendance. Will be analyzed using chi-square test.	At pre-colonoscopy assessment
Secondary	Heart rate	Will be measured in beats per minute using medical chart review. Will be analyzed using t-test.	Up to 4 weeks
Secondary	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
Secondary	Sedative dose	Will be measured in milligrams using chart review. Will be analyzed using t-test.	Up to 4 weeks
Secondary	Procedural time	Will be measured in minutes using medical chart review. Will be analyzed using t-test.	Up to 4 weeks
Secondary	Cecal intubation time	Will be measured in minutes using medical chart review. Will be analyzed using t-test.	At post-colonoscopy
Secondary	Endoscopy suite time	Will be measured in minutes using medical chart review. Will be analyzed using t-test.	Up to 4 weeks
Secondary	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)
Secondary	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)

External Links

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