Studies
| Study First Submitted Date | 2022-01-24 |
| Study First Posted Date | 2022-02-18 |
| Last Update Posted Date | 2023-02-01 |
| Start Month Year | April 28, 2022 |
| Primary Completion Month Year | March 2029 |
| Verification Month Year | January 2023 |
| Verification Date | 2023-01-31 |
| Last Update Posted Date | 2023-02-01 |
Detailed Descriptions
| Sequence: | 20781683 |
| Description | 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. |
Facilities
| Sequence: | 200602269 | Sequence: | 200602270 | Sequence: | 200602271 | Sequence: | 200602272 | Sequence: | 200602273 | Sequence: | 200602274 | Sequence: | 200602275 | Sequence: | 200602276 | Sequence: | 200602277 | Sequence: | 200602278 | Sequence: | 200602279 | Sequence: | 200602280 | Sequence: | 200602281 | Sequence: | 200602282 | Sequence: | 200602283 | Sequence: | 200602284 | Sequence: | 200602285 | Sequence: | 200602286 | Sequence: | 200602287 | Sequence: | 200602288 | Sequence: | 200602289 | Sequence: | 200602290 | Sequence: | 200602291 |
| Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Recruiting | Status | Terminated | Status | Recruiting | Status | Recruiting | Status | Recruiting |
| Name | Absolute Clinical Research | Name | Biopharma Informatic | Name | Saviers Medical Group | Name | Skylight Health Group | Name | Skylight Health Group | Name | I.V.A.M Clinical & Investigational Center | Name | ITB Research | Name | Emerald Coast OBGYN | Name | Pivotal Clinical Research & Associates, LLC | Name | Ascension DePaul Community Services of New Orleans | Name | Valley Ob-Gyn Clinic, PC | Name | Alliance Community Healthcare, INC | Name | North Hudson Community Action Corporation | Name | Niagara Falls Memorial Medical Center | Name | Skylight Health | Name | Center for Medical Research, LLC | Name | SPICA Clinical Research | Name | The Jackson Clinic, PA | Name | Clear Brook Medical Associates | Name | Family Practice Center | Name | BioPharma Informatic | Name | Valena Medical Research | Name | A & U Family Medicine |
| City | Phoenix | City | Los Angeles | City | Port Hueneme | City | Aurora | City | Jacksonville | City | Miami | City | Miami | City | Panama City | City | Marietta | City | New Orleans | City | Saginaw | City | Jersey City | City | Union City | City | Niagara Falls | City | Harrisburg | City | Providence | City | Columbia | City | Jackson | City | Houston | City | McAllen | City | Pharr | City | Spring | City | Sugar Land |
| State | Arizona | State | California | State | California | State | Colorado | State | Florida | State | Florida | State | Florida | State | Florida | State | Georgia | State | Louisiana | State | Michigan | State | New Jersey | State | New Jersey | State | New York | State | Pennsylvania | State | Rhode Island | State | South Carolina | State | Tennessee | State | Texas | State | Texas | State | Texas | State | Texas | State | Texas |
| Zip | 85323 | Zip | 90035 | Zip | 93041 | Zip | 80012 | Zip | 32218 | Zip | 33144 | Zip | 33173 | Zip | 32405 | Zip | 30062 | Zip | 70118 | Zip | 48602 | Zip | 07302 | Zip | 07087 | Zip | 14304 | Zip | 17109 | Zip | 02908 | Zip | 29322 | Zip | 38305 | Zip | 77089 | Zip | 78501 | Zip | 78577 | Zip | 77379 | Zip | 77479 |
| Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States | Country | United States |
Facility Contacts
| Sequence: | 28184397 | Sequence: | 28184398 | Sequence: | 28184399 | Sequence: | 28184400 | Sequence: | 28184401 | Sequence: | 28184402 | Sequence: | 28184403 | Sequence: | 28184404 | Sequence: | 28184405 | Sequence: | 28184406 | Sequence: | 28184407 | Sequence: | 28184408 | Sequence: | 28184409 | Sequence: | 28184410 | Sequence: | 28184411 | Sequence: | 28184412 | Sequence: | 28184413 | Sequence: | 28184414 | Sequence: | 28184415 | Sequence: | 28184416 | Sequence: | 28184417 | Sequence: | 28184418 |
| Facility Id | 200602269 | Facility Id | 200602270 | Facility Id | 200602271 | Facility Id | 200602272 | Facility Id | 200602273 | Facility Id | 200602274 | Facility Id | 200602275 | Facility Id | 200602276 | Facility Id | 200602277 | Facility Id | 200602278 | Facility Id | 200602279 | Facility Id | 200602280 | Facility Id | 200602281 | Facility Id | 200602282 | Facility Id | 200602283 | Facility Id | 200602284 | Facility Id | 200602285 | Facility Id | 200602286 | Facility Id | 200602287 | Facility Id | 200602289 | Facility Id | 200602290 | Facility Id | 200602291 |
| Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary | Contact Type | primary |
| Name | Bianca Garcia | Name | Delmy Cordova | Name | Eugene Soroka, MD | Name | Wolfgang Williamson | Name | Kierra Johnson | Name | Alfredo Martin Cruz | Name | Vivianne Zerquera | Name | Lauren Green | Name | Willisha Johnson | Name | Ascension DePaul Services Research Office | Name | Rachel Whitney | Name | Jose Flores | Name | Jose Flores | Name | Erika Barba | Name | Bonni Conrad | Name | Shayna Smith | Name | Lari Powell | Name | Kelly Croom | Name | Ashly Abraham | Name | Alberto Ayala | Name | Jorge Rodriguez | Name | Cecilia Valerio |
| [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | [email protected] | |||||||||||||||||||||||
| Phone | 281-944-3610 | Phone | 805-271-0708 | Phone | 720-316-5601 | Phone | 904-701-2124 | Phone | 404-838-3105 | Phone | 504-582-0710 | Phone | 737-236-4830 | Phone | 717-219-8279 | Phone | 401-821-3200 | Phone | 281-944-3610 | ||||||||||||||||||||||||
Facility Investigators
| Sequence: | 18378814 | Sequence: | 18378815 | Sequence: | 18378816 | Sequence: | 18378817 | Sequence: | 18378818 | Sequence: | 18378819 | Sequence: | 18378820 | Sequence: | 18378821 | Sequence: | 18378822 | Sequence: | 18378823 | Sequence: | 18378824 | Sequence: | 18378825 | Sequence: | 18378826 | Sequence: | 18378827 | Sequence: | 18378828 | Sequence: | 18378829 | Sequence: | 18378830 | Sequence: | 18378831 | Sequence: | 18378832 | Sequence: | 18378833 | Sequence: | 18378834 | Sequence: | 18378835 |
| Facility Id | 200602269 | Facility Id | 200602270 | Facility Id | 200602271 | Facility Id | 200602272 | Facility Id | 200602273 | Facility Id | 200602274 | Facility Id | 200602275 | Facility Id | 200602276 | Facility Id | 200602277 | Facility Id | 200602278 | Facility Id | 200602279 | Facility Id | 200602280 | Facility Id | 200602281 | Facility Id | 200602282 | Facility Id | 200602283 | Facility Id | 200602284 | Facility Id | 200602285 | Facility Id | 200602286 | Facility Id | 200602287 | Facility Id | 200602289 | Facility Id | 200602290 | Facility Id | 200602291 |
| Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
| Name | James Beach, DO | Name | Samuel Ross, MD | Name | Eugene Soroka, MD | Name | Marion Hufford, FNP-C | Name | Allen Okie, MD | Name | Maria del Carmen Curbelo Calleiro, MD | Name | Antonio Gordon, MD | Name | Samuel Wolf, DO | Name | Melinda Miller-Thrasher, MD | Name | Stacy Greene, MD | Name | Jacquelyn Robinson, MD | Name | Mansi Sarvaiya, MD | Name | Rita Knause, MD | Name | Jeffrey Burnett, DO | Name | Richard Rayner, MD | Name | Gregory Allen, MD | Name | Damon Daniels, MD | Name | Kellie Wallace-Wilding, MD | Name | Jawad Sarwar, MD | Name | Omar Gomez, MD | Name | Pablo Amador, MD | Name | Hammad Zaidi, MD |
Conditions
| Sequence: | 52324635 |
| Name | Colorectal Cancer |
| Downcase Name | colorectal cancer |
Id Information
| Sequence: | 40268481 |
| Id Source | org_study_id |
| Id Value | 2019-02 |
Countries
| Sequence: | 42687952 |
| Name | United States |
| Removed | False |
Design Groups
| Sequence: | 55764184 | Sequence: | 55764185 | Sequence: | 55764186 |
| Title | Arm 1 – Usual Care (No Video) | Title | Arm 2 – Brief Video | Title | Arm 3 – Brief Video Plus |
| Description | 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. | Description | Subjects will watch a video pertaining to the importance of CRC screening. | Description | 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. |
Interventions
| Sequence: | 52635718 | Sequence: | 52635719 |
| Intervention Type | Behavioral | Intervention Type | Behavioral |
| Name | Brief Video | Name | Brief Video Plus |
| Description | Videos about colorectal cancer screening. | Description | Videos about colorectal cancer screening and modalities. |
Keywords
| Sequence: | 80080490 | Sequence: | 80080491 | Sequence: | 80080492 | Sequence: | 80080493 | Sequence: | 80080494 | Sequence: | 80080495 | Sequence: | 80080496 | Sequence: | 80080497 |
| Name | CRC Screening | Name | Colonoscopy | Name | FIT | Name | Cologuard | Name | Screening Modality | Name | Survey | Name | Video | Name | sDNA-FIT |
| Downcase Name | crc screening | Downcase Name | colonoscopy | Downcase Name | fit | Downcase Name | cologuard | Downcase Name | screening modality | Downcase Name | survey | Downcase Name | video | Downcase Name | sdna-fit |
Design Outcomes
| Sequence: | 177946048 | Sequence: | 177946049 | Sequence: | 177946050 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | primary |
| Measure | Impact of Brief Videos | Measure | Impact of Brief Videos | Measure | Impact of Brief Videos |
| Time Frame | 1 year | Time Frame | 3 years | Time Frame | 6 years |
| Description | 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. | Description | 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. | Description | 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. |
Browse Conditions
| Sequence: | 194071359 | Sequence: | 194071360 | Sequence: | 194071361 | Sequence: | 194071362 | Sequence: | 194071363 | Sequence: | 194071364 | Sequence: | 194071365 | Sequence: | 194071366 | Sequence: | 194071367 | Sequence: | 194071368 | Sequence: | 194071369 |
| Mesh Term | Colorectal Neoplasms | Mesh Term | Intestinal Neoplasms | Mesh Term | Gastrointestinal Neoplasms | Mesh Term | Digestive System Neoplasms | Mesh Term | Neoplasms by Site | Mesh Term | Neoplasms | Mesh Term | Digestive System Diseases | Mesh Term | Gastrointestinal Diseases | Mesh Term | Colonic Diseases | Mesh Term | Intestinal Diseases | Mesh Term | Rectal Diseases |
| Downcase Mesh Term | colorectal neoplasms | Downcase Mesh Term | intestinal neoplasms | Downcase Mesh Term | gastrointestinal neoplasms | Downcase Mesh Term | digestive system neoplasms | Downcase Mesh Term | neoplasms by site | Downcase Mesh Term | neoplasms | Downcase Mesh Term | digestive system diseases | Downcase Mesh Term | gastrointestinal diseases | Downcase Mesh Term | colonic diseases | Downcase Mesh Term | intestinal diseases | Downcase Mesh Term | rectal diseases |
| Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 48463162 | Sequence: | 48463163 | Sequence: | 48463164 | Sequence: | 48463165 | Sequence: | 48463166 |
| Agency Class | INDUSTRY | Agency Class | OTHER | Agency Class | OTHER | Agency Class | OTHER | Agency Class | UNKNOWN |
| Lead Or Collaborator | lead | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator | Lead Or Collaborator | collaborator |
| Name | Exact Sciences Corporation | Name | Mayo Clinic | Name | University of Utah | Name | American Cancer Society, Inc. | Name | F!ght Colorectal Cancer |
Overall Officials
| Sequence: | 29367090 | Sequence: | 29367091 | Sequence: | 29367092 |
| Role | Principal Investigator | Role | Principal Investigator | Role | Principal Investigator |
| Name | Joan M. Griffin, PhD | Name | John Inadomi, MD | Name | Charles R. Rogers, PhD |
| Affiliation | Mayo Clinic College of Medicine | Affiliation | University of Utah | Affiliation | Rogers Solutions Group |
Central Contacts
| Sequence: | 12047004 |
| Contact Type | primary |
| Name | Haley Bowser |
| Phone | 608-381-8118 |
| [email protected] | |
| Role | Contact |
Design Group Interventions
| Sequence: | 68356559 | Sequence: | 68356560 |
| Design Group Id | 55764185 | Design Group Id | 55764186 |
| Intervention Id | 52635718 | Intervention Id | 52635719 |
Eligibilities
| Sequence: | 30854343 |
| Sampling Method | Probability Sample |
| Gender | All |
| Minimum Age | 45 Years |
| Maximum Age | 70 Years |
| Healthy Volunteers | Accepts Healthy Volunteers |
| 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. 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. |
| Adult | True |
| Child | False |
| Older Adult | True |
Calculated Values
| Sequence: | 254310844 |
| Number Of Facilities | 23 |
| Registered In Calendar Year | 2022 |
| Were Results Reported | False |
| Has Us Facility | True |
| Has Single Facility | False |
| Minimum Age Num | 45 |
| Maximum Age Num | 70 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 3 |
Designs
| Sequence: | 30600187 |
| Observational Model | Cohort |
| Time Perspective | Prospective |
Responsible Parties
| Sequence: | 28966690 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 52229262 |
| Pmid | 35842109 |
| Reference Type | derived |
| Citation | 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. |
Ipd Information Types
| Sequence: | 3346288 | Sequence: | 3346289 | Sequence: | 3346290 | Sequence: | 3346291 |
| Name | Study Protocol | Name | Statistical Analysis Plan (SAP) | Name | Informed Consent Form (ICF) | Name | Clinical Study Report (CSR) |