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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2023-10496 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (usual care) | Active Comparator | Patients receive usual care prior to their scheduled screening colonoscopy. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Receive usual care |
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| 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) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Katz | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41774215 | Derived | Emerson B, Reiter PL, Shoben AB, Klatt M, Chakraborty S, Katz ML. A pilot randomized controlled trial of an online mindfulness-based intervention to reduce patient anxiety before a first-time screening colonoscopy. Cancer Causes Control. 2026 Mar 3;37(4):55. doi: 10.1007/s10552-026-02129-0. |
| Label | URL |
|---|---|
| The Jamesline | View source |
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| Medical Chart Review | Other | Ancillary studies |
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| Online Mindfulness Meditation | Behavioral | Receive an online mindfulness intervention |
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| Survey Administration | Other | Ancillary studies |
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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) |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
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