AzTrials
AzTrials

Colorectal CarcinomaNCT06233253

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

A study testing Best Practice, Medical Chart Review and Online Mindfulness Meditation in people with Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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… Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Carcinoma
What is being tested?
Best Practice, Medical Chart Review and Online Mindfulness Meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
29 Sep 2023to 12 Jul 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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.

Being tested
Best Practice, Medical Chart Review, Online Mindfulness Meditation, Survey Administration
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Best PracticeOther

    Also called standard of care, standard therapy

    Receive usual care

  • Medical Chart ReviewOther

    Also called Chart Review

    Ancillary studies

  • Online Mindfulness MeditationBehavioural

    Also called Online MBSR, Online Mindful Meditation, Online Mindfulness Relaxation, Online Mindfulness-Based Stress Reduction

    Receive an online mindfulness intervention

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT06233253
Study groupRoleWhat they receive
Group I (usual care)Active comparatorPatients receive usual care prior to their scheduled screening colonoscopy.
Receives: Other: Best Practice; Other: Medical Chart Review; Other: Survey Administration
Group II (online mindfulness intervention)ExperimentalPatients receive an online mindfulness intervention including infographics and 5-minute meditations QD for 5 days prior to their scheduled screening colonoscopy.
Receives: Other: Medical Chart Review; Behavioral: Online Mindfulness Meditation; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 4 weeks

  2. 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.

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

Secondary outcomes (17)

  1. Colonoscopy nervousness

    Anxiety specific to the bowel prep and colonoscopy will be assessed using a visual analogue scale. Will be analyzed using t-test.

    Measured: At pre-colonoscopy assessment

  2. 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.

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

  3. 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.

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

  4. Colorectal screening knowledge

    Will be assessed using a 5-item score about colorectal (CRC) screening. Will be analyzed using t-test.

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

  5. Attitudes about CRC and CRC screening

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

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

  6. Bowel prep adherence

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using chi-square test.

    Measured: At pre-colonoscopy assessment

  7. Bowel prep difficulty

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

    Measured: At pre-colonoscopy assessment

  8. 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.

    Measured: Up to 4 weeks

  9. Cancellation/no-show

    Will be measured by attendance. Will be analyzed using chi-square test.

    Measured: At pre-colonoscopy assessment

  10. Heart rate

    Will be measured in beats per minute using medical chart review. Will be analyzed using t-test.

    Measured: Up to 4 weeks

  11. 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.

    Measured: Up to 4 weeks

  12. Sedative dose

    Will be measured in milligrams using chart review. Will be analyzed using t-test.

    Measured: Up to 4 weeks

  13. Procedural time

    Will be measured in minutes using medical chart review. Will be analyzed using t-test.

    Measured: Up to 4 weeks

  14. Cecal intubation time

    Will be measured in minutes using medical chart review. Will be analyzed using t-test.

    Measured: At post-colonoscopy

  15. Endoscopy suite time

    Will be measured in minutes using medical chart review. Will be analyzed using t-test.

    Measured: Up to 4 weeks

  16. Procedure satisfaction

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

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

  17. Intent for future CRC screening

    Will be self-reported and measured on a 5-point Likert scale. Will be analyzed using t-test.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jan 2024
  2. Study start29 Sep 2023
  3. Primary completion12 Jul 2024
  4. Study completion12 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06233253
Sponsor's protocol ID
OSU-23136
Other IDs
NCI-2023-10496
Status last verified
Feb 2025
First submitted
8 Jan 2024
Last updated
24 Feb 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41774215

Questions about this trial

What is this clinical trial studying?

A study testing Best Practice, Medical Chart Review and Online Mindfulness Meditation in people with Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Retention rate (Feasibility) (time frame: Up to 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06233253, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in