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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
100
Receive usual care
Ancillary studies
Receive an online mindfulness intervention
Ancillary studies
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
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.
Time frame: 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.
Time frame: At follow-up (1-2 days after the colonoscopy)
Colonoscopy nervousness
Anxiety specific to the bowel prep and colonoscopy will be assessed using a visual analogue scale. Will be analyzed using t-test.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 4 weeks
Cancellation/no-show
Will be measured by attendance. Will be analyzed using chi-square test.
Time frame: At pre-colonoscopy assessment
Heart rate
Will be measured in beats per minute using medical chart review. Will be analyzed using t-test.
Time frame: 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.
Time frame: Up to 4 weeks
Sedative dose
Will be measured in milligrams using chart review. Will be analyzed using t-test.
Time frame: Up to 4 weeks
Procedural time
Will be measured in minutes using medical chart review. Will be analyzed using t-test.
Time frame: Up to 4 weeks
Cecal intubation time
Will be measured in minutes using medical chart review. Will be analyzed using t-test.
Time frame: At post-colonoscopy
Endoscopy suite time
Will be measured in minutes using medical chart review. Will be analyzed using t-test.
Time frame: Up to 4 weeks
Procedure satisfaction
Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.
Time frame: 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.
Time frame: At follow up (1-2 days after the colonoscopy)
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