Strategies and Opportunities to Stop Colon Cancer in Priority Populations (STOP CRC)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Only an estimated 50 million US adults aged 50-75 are up-to-date on colorectal cancer (CRC) screening according to guidelines set by the federal government. CRC is 90% curable with timely detection and appropriate treatment of precancerous polyps; increased screening could reduce incidence by up to 50%. Groups least likely to undergo screening, those with minimal education, low income, low access to health care, recent immigrants or Hispanics, are the same people who frequently receive care at Federally Qualified Healthcare Center's (FQHCs). The use of fecal occult blood tests (FOBT) and fecal immunochemical tests (FIT) is exceedingly low in FQHCs (7-9% of patients in the past year) and far below national averages and target rates. Our results will provide valuable information on how to use electronic health record (EHR) resources to optimize guideline-based screening in FQHC clinics whose patient populations have disproportionately low CRC screening rates.
This project, in conjunction with the research team, will use an advisory panel to direct the research activities. The advisory panel will be made up of clinicians, leaders, researchers, and patients. The panel and team will guide the development of materials, the outreach to patients, and the research protocol to best reach FQHC patients who are due for colorectal cancer screening.
| Condition | Intervention | Phase |
|---|---|---|
|
Colorectal Cancer |
Behavioral: Auto Other: Auto Plus |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
| Official Title: | Strategies and Opportunities to Stop Colon Cancer in Priority Populations |
- Increased Screening Rates [ Time Frame: up to 4 years (study period) ] [ Designated as safety issue: No ]Investigators will determine if the auto and auto-plus interventions increase the rates of screening compared to usual care at FQHC clinics.
| Estimated Enrollment: | 2000 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | September 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Usual Care
Clinics in usual care will go about clinic practices to complete recommended screening for colorectal cancer.
|
|
|
Active Comparator: Auto
Clinics randomized to the Auto arm will send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit.
|
Behavioral: Auto
Clinics randomized to the Auto arm will send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit.
|
|
Active Comparator: Auto Plus
Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.
|
Other: Auto Plus
Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 50 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Patients aged 50-74 with no evidence of a colonoscopy within 9 years or a FIT within 11 months will be eligible to receive a mailed FIT.
Exclusion Criteria:
- Colonoscopy within 9 years
Contacts and Locations| Contact: Amanda F Petrik, MS | 503-335-2483 | amanda.f.petrik@kpchr.org |
| Contact: Jennifer J Sanchez, MS | Jennifer.J.Sanchez@kpchr.org |
| United States, Oregon | |
| Virginia Garcia Memorial Health Center | Not yet recruiting |
| Hillsboro, Oregon, United States, 97124 | |
| Contact: Tanya Kapka, MD tanya.kapka@kpchr.org | |
| Sub-Investigator: Tanya Kapka, MD | |
| Principal Investigator: | Gloria Coronado, PhD | The Center for Health Research, Kaiser Permanente Northwest |
| Principal Investigator: | Jennifer DeVoe, MD | OCHIN |
| Principal Investigator: | Beverly Green, PhD | Group Health Cooperative |
More Information
No publications provided
| Responsible Party: | Kaiser Permanente |
| ClinicalTrials.gov Identifier: | NCT01742065 History of Changes |
| Other Study ID Numbers: | 1UH2AT007782-01, 1UH2AT007782-01 |
| Study First Received: | December 3, 2012 |
| Last Updated: | December 4, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Kaiser Permanente:
|
Colorectal Cancer Screening Cancer Screening Pragmatic Trial |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on June 18, 2013