Clinical trial NCT06233253: Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy
Official title: A Brief Online Mindfulness-Based Intervention to Decrease Pre-Procedural Anxiety Before a First-Time Screening Colonoscopy: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Carcinoma
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2024-01-31
Enrollment: 100
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention rate (Feasibility)
timeFrame: Up to 4 weeks
measure: Satisfaction with the intervention (Acceptability)
timeFrame: At follow-up (1-2 days after the colonoscopy)
Secondary outcomes:
measure: Colonoscopy nervousness
timeFrame: At pre-colonoscopy assessment
measure: Mindfulness
timeFrame: At follow-up (1-2 days after the colonoscopy)
measure: Mindfulness knowledge
timeFrame: At follow up (1-2 days after the colonoscopy)
measure: Colorectal screening knowledge
timeFrame: At follow up (1-2 days after the colonoscopy)
measure: Attitudes about CRC and CRC screening
timeFrame: At follow up (1-2 days after the colonoscopy)
measure: Bowel prep adherence
timeFrame: At pre-colonoscopy assessment
measure: Bowel prep difficulty
timeFrame: At pre-colonoscopy assessment
measure: Bowel prep quality
timeFrame: Up to 4 weeks
measure: Cancellation/no-show
timeFrame: At pre-colonoscopy assessment
measure: Heart rate
timeFrame: Up to 4 weeks
measure: Blood pressure
timeFrame: Up to 4 weeks
measure: Sedative dose
timeFrame: Up to 4 weeks
measure: Procedural time
timeFrame: Up to 4 weeks
measure: Cecal intubation time
timeFrame: At post-colonoscopy
measure: Endoscopy suite time
timeFrame: Up to 4 weeks
measure: Procedure satisfaction
timeFrame: At follow up (1-2 days after the colonoscopy)
measure: Intent for future CRC screening
timeFrame: At follow up (1-2 days after the colonoscopy)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Katz
role: PRINCIPAL_INVESTIGATOR
References: