Trial record 1 of 10 for:
COMPASS | CRC
Informed Choice - Compass
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT05246839 |
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Recruitment Status :
Active, not recruiting
First Posted : February 18, 2022
Last Update Posted : May 3, 2024
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Sponsor:
Exact Sciences Corporation
Collaborators:
Mayo Clinic
University of Utah
American Cancer Society, Inc.
F!ght Colorectal Cancer
Information provided by (Responsible Party):
Exact Sciences Corporation
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Brief Summary:
The primary objective of this study is to evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices on CRC screening rates and time adherent to CRC guidelines.
| Condition or disease | Intervention/treatment |
|---|---|
| Colorectal Cancer | Behavioral: Brief Video Behavioral: Brief Video Plus |
Subjects 45 to 70 years of age, scheduled for a primary care (index) appointment, at average risk for colorectal cancer (CRC), and due for CRC screening will be enrolled in the study. Subjects will be randomized to one of three intervention arms: no video (arm 1), brief CRC screening video (arm 2), or enhanced CRC screening video (arm 3). Subjects in all intervention arms will complete surveys regarding intention to screen for CRC and preference for screening modality prior to viewing the video, after the video, and after their index appointment. Subjects will be surveyed, and medical information collected, annually for up to six years to assess adherence to CRC screening and CRC screening outcomes.
| Study Type : | Observational |
| Estimated Enrollment : | 5280 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Informed Choice Intervention for Colorectal Cancer Screening: Compass |
| Actual Study Start Date : | April 28, 2022 |
| Estimated Primary Completion Date : | March 2029 |
| Estimated Study Completion Date : | March 2029 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Arm 1 - Usual Care (No Video)
Subjects will receive the usual care pertaining to colorectal cancer (CRC) screening according to their respective clinical site and will not view either of the study videos.
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Arm 2 - Brief Video
Subjects will watch a video pertaining to the importance of CRC screening.
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Behavioral: Brief Video
Videos about colorectal cancer screening. |
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Arm 3 - Brief Video Plus
Subjects will watch the same video as described in Arm 2, immediately followed by a second video pertaining to 3 CRC screening modalities: colonoscopy, FIT, and Cologuard.
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Behavioral: Brief Video Plus
Videos about colorectal cancer screening and modalities. |
Primary Outcome Measures :
- Impact of Brief Videos [ Time Frame: 1 year ]The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 1 year.
- Impact of Brief Videos [ Time Frame: 3 years ]The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 3 years.
- Impact of Brief Videos [ Time Frame: 6 years ]The percentage of time that subjects are colorectal cancer screening guideline adherent based on recommended screening interval for chosen method from the time of the index appointment to 6 years.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 45 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Study Population
Subjects will be 45 to 70 years of age, inclusive, who are scheduled for a primary care appointment, at average risk for colorectal cancer (CRC), and due for CRC screening. The study will enroll approximately 5,280 subjects.
Criteria
Inclusion Criteria:
- Subject is 45 to 70 years of age, inclusive.
- Subject presents for a primary care appointment.
- Subject understands the study procedures and can provide informed consent to participate in the study and authorization for release of relevant protected health information (PHI) to the study Investigator.
Exclusion Criteria:
- Subject has symptoms or signs that require immediate, or near term referral for diagnostic or therapeutic colonoscopy.
- Subject has a personal history of colorectal cancer (CRC) or colonic adenomatous or sessile serrated polyps.
- Subject has a personal history of inflammatory bowel disease.
- Subject has a family history of CRC in at least one first- or second-degree relative diagnosed prior to age 60 and/or at least 2 first-degree relatives diagnosed with CRC at any age.
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Subject has a personal diagnosis or family history of any of the following conditions:
- Familial adenomatous polyposis (also referred to as "FAP", including attenuated FAP and Gardner's syndrome),
- Hereditary non-polyposis CRC syndrome (also referred to as "HNPCC" or "Lynch Syndrome"),
- Other hereditary cancer syndromes including, but are not limited to Peutz-Jeghers Syndrome, MYH-Associated Polyposis (MAP), Turcot's (or Crail's) Syndrome, Cowden's Syndrome, Juvenile Polyposis, Neurofibromatosis, or Familial Hyperplastic Polyposis.
- Subject has a diagnosis of Cronkhite-Canada Syndrome
- Subject is current with CRC screening, including gFOBT or FIT within the preceding 12 months, Cologuard within the preceding 3 years, flexible sigmoidoscopy or CT colonography within the preceding 5 years, or colonoscopy within the preceding 10 years. Subjects can be enrolled up to 3 months prior to screening due date.
- Subject has any condition that in the opinion of the Investigator should preclude participation in the study, including comorbid illnesses precluding endoscopic evaluation or that limit life expectancy to less than 10 years.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05246839
Locations
Show 40 study locations
Sponsors and Collaborators
Exact Sciences Corporation
Mayo Clinic
University of Utah
American Cancer Society, Inc.
F!ght Colorectal Cancer
Investigators
| Principal Investigator: | Joan M. Griffin, PhD | Mayo Clinic College of Medicine | |
| Principal Investigator: | John Inadomi, MD | University of Utah | |
| Principal Investigator: | Charles R. Rogers, PhD | Rogers Solutions Group |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Exact Sciences Corporation |
| ClinicalTrials.gov Identifier: | NCT05246839 |
| Other Study ID Numbers: |
2019-02 |
| First Posted: | February 18, 2022 Key Record Dates |
| Last Update Posted: | May 3, 2024 |
| Last Verified: | May 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Individual participant data that underlie the results reported in publications of the study may be shared after deidentification. This may include text, tables, figures, and appendices. The study protocol, statistical analysis plan (when applicable), informed consent form (when applicable), and clinical study report (when applicable) may also be shared. Data will be available from 2 years and ending 4 years after publication. Data may be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal. |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Access Criteria: | Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research. Data will be available between 2 and 4 years after publication through the Sponsor. For IPD related to Exact Sciences clinical studies, the Clinical Affairs department will include the policy description and access criteria described above with study-specific postings on clinicaltrials.gov. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Exact Sciences Corporation:
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CRC Screening Colonoscopy FIT Cologuard |
Screening Modality Survey Video sDNA-FIT |
Additional relevant MeSH terms:
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Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |