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Business decision to terminate the study early. Primary endpoint will not be assessed.
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| Name | Class |
|---|---|
| Mayo Clinic | OTHER |
| University of Utah | OTHER |
| American Cancer Society, Inc. | OTHER |
| F!ght Colorectal Cancer |
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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. The results will not be posted because the study terminated early and the primary endpoint was not analyzed.
Participants 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. Participants 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). Participants 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. Participants will be surveyed, and medical information collected, for 1 year after randomization to assess adherence to CRC screening and CRC screening outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 - Usual Care (No Video) | Participant 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. | ||
| Arm 2 - Brief Video | Participant will watch a video pertaining to the importance of CRC screening. |
| |
| Arm 3 - Brief Video Plus | Participant 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Video | Behavioral | Videos about colorectal cancer screening. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of Brief Videos | To evaluate the impact of a theoretically grounded video that includes information about CRC screening modality choices (colonoscopy, FIT, and Cologuard) on CRC screening rates and the proportion of time adherent to CRC guidelines. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Screening Preferences | To examine initial mode preferences between participants viewing a theoretically grounded video that includes information about CRC screening modality choices (colonoscopy, FIT, and Cologuard) compared to those receiving only a brief informational video about CRC screening or receiving only usual care. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Exploratory Objective- Participant | Evaluate participant knowledge, attitudes, and intentions related to CRC screening and assess personal and environmental factors associated with screening intentions and completion by modality. | 1 year |
| Exploratory Objective- Provider |
Inclusion Criteria:
Exclusion Criteria:
Participant has symptoms or signs that require immediate, or near-term referral for diagnostic or therapeutic colonoscopy.
Participant is due for CRC screening within three months and is already scheduled for colonoscopy.
Participant has a personal history of CRC or colonic adenomatous or sessile serrated polyps.
Participant has a personal history of inflammatory bowel disease.
Participant 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.
Participant has a personal diagnosis or family history of any of the following conditions:
Participant has a diagnosis of Cronkhite-Canada Syndrome.
Participant 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. Participants can be enrolled up to 3 months prior to screening due date.
Participant has any condition that in the opinion of the Investigators should preclude participation in the study, including comorbid illnesses precluding endoscopic evaluation or that limit life expectancy to less than 10 years.
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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 1,851 subjects.
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Absolute Clinical Research | Phoenix | Arizona | 85323 | United States | ||
| Biopharma Informatic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35842109 | Derived | Griffin JM, Finney Rutten LJ, Zhu X, Feng Z, Rogers CR, Marsh TL, Inadomi JM. The COMPASS study: A prospective, randomized, multi-center trial testing the impact of a clinic-based intervention informing patients of colorectal cancer screening options on screening completion. Contemp Clin Trials. 2022 Aug;119:106852. doi: 10.1016/j.cct.2022.106852. Epub 2022 Jul 13. |
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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.
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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.
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| UNKNOWN |
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| Brief Video Plus |
| Behavioral |
Videos about colorectal cancer screening and modalities. |
|
Characterize provider, system, and site-level factors associated with CRC screening rates and use of various screening modalities at different times throughout the intervention (prior to and after recruitment is completed). |
| 1 year |
| Los Angeles |
| California |
| 90035 |
| United States |
| Saviers Medical Group | Port Hueneme | California | 93041 | United States |
| Skylight Health Group | Aurora | Colorado | 80012 | United States |
| Skylight Health Group | Jacksonville | Florida | 32218 | United States |
| I.V.A.M Clinical & Investigational Center | Miami | Florida | 33144 | United States |
| ITB Research | Miami | Florida | 33173 | United States |
| Emerald Coast OBGYN | Panama City | Florida | 32405 | United States |
| ClinCept, LLC | Columbus | Georgia | 31904 | United States |
| Pivotal Clinical Research & Associates, LLC | Marietta | Georgia | 30062 | United States |
| Herman Clinical Research, LLC | Suwanee | Georgia | 30013 | United States |
| Sheridan Medical Center, S.C | Chicago | Illinois | 60613 | United States |
| Ascension DePaul Community Services of New Orleans | New Orleans | Louisiana | 70118 | United States |
| Annapolis Internal Medicine | Annapolis | Maryland | 21401 | United States |
| Advanced Primary and Geriatric Care | Rockville | Maryland | 20850 | United States |
| Valley Ob-Gyn Clinic, PC | Saginaw | Michigan | 48602 | United States |
| St. Louis Medical Professionals | St Louis | Missouri | 63119 | United States |
| Barrett Clinic | La Vista | Nebraska | 68128 | United States |
| Alliance Community Healthcare, INC | Jersey City | New Jersey | 07302 | United States |
| North Hudson Community Action Corporation | Union City | New Jersey | 07087 | United States |
| Ellipsis Research Group, LLC | Brooklyn | New York | 11215 | United States |
| Niagara Falls Memorial Medical Center | Niagara Falls | New York | 14304 | United States |
| Laurelton Heart Specialist PC | Rosedale | New York | 11422 | United States |
| OnSite Clinical Solutions, LLC | Charlotte | North Carolina | 28208 | United States |
| Hightower Clinical OKC | Oklahoma City | Oklahoma | 73134 | United States |
| Skylight Health | Harrisburg | Pennsylvania | 17109 | United States |
| Mercado Medical Practice | Philadelphia | Pennsylvania | 19111 | United States |
| Pottstown Medical Specialists Inc | Pottstown | Pennsylvania | 19464 | United States |
| Center for Medical Research, LLC | Providence | Rhode Island | 02908 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| SPICA Clinical Research | Columbia | South Carolina | 29322 | United States |
| The Jackson Clinic, PA | Jackson | Tennessee | 38305 | United States |
| Clear Brook Medical Associates | Houston | Texas | 77089 | United States |
| BioPharma Informatic | Pharr | Texas | 78577 | United States |
| Valena Medical Research | Spring | Texas | 77379 | United States |
| A & U Family Medicine | Sugarland | Texas | 77479 | United States |
| Ogden Clinic - Mountain View | Pleasant View | Utah | 84404 | United States |
| Ogden Clinic - Grand View | Roy | Utah | 84067 | United States |
| South Ogden Family Medicine | South Ogden | Utah | 84405 | United States |
| 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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