Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting (HNPCC)
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The investigators research mobilizes the resources of an integrated health-delivery system with extensive electronic clinical data to implement and evaluate a new strategy to maximize screening of Colorectal Cancer (CRC) patients for Lynch Syndrome.
Condition | Intervention |
---|---|
Colon Cancer Lynch Syndrome |
Procedure: MSI screening test |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Screening |
Official Title: | Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting |
- Implementation effectiveness [ Time Frame: All patients will be followed up to 5 years. Most active participation and chart review will take place within one year of surgery. ] [ Designated as safety issue: No ]The primary outcomes to assess implementation effectiveness are: number of patients who receive HNPCC screening test results; number of physicians who receive their patients HPNCC screening test results; completion of the educational session at three months of follow-up; and number of patients with MSI-H test results who are contacted by medical genetics.
Estimated Enrollment: | 1200 |
Study Start Date: | February 2012 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: MSI testing
All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI following surgery. Those with MSI-H results will receive a genetic counseling informational call.
|
Procedure: MSI screening test
All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI.
|
No Intervention: Usual care
These patients will be treated as usual by their oncologist and medical team.
|
Procedure: MSI screening test
All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI.
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Detailed Description:
Screening tests for Hereditary Non-Polyposis Colorectal Cancer (HNPCC) [also called Lynch Syndrome], are among the few available validated genetic tests that have been recommended as an evidence-based practice that can save lives. However, more than half of patients who meet well-established and accepted screening criteria do not receive screening. This is a critical failure for patients and for the health-care delivery system because HNPCC mutation carriers are at exceptionally high risk for colorectal and other HNPCC-related cancers, and because clinical strategies can prevent future cancers, or provide early detection, for individuals affected with HNPCC and their relatives. HNPCC testing is also cost-effective compared to treating individuals with a diagnosis of colorectal cancer (CRC).
To address this shortfall in practice, our proposed research mobilizes the resources of an integrated health-delivery system with extensive electronic clinical data to implement and evaluate a new strategy to maximize screening of CRC patients for HPNCC. The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) working group recommended that all newly diagnosed CRC patients be screened for HPNCC, but was not able to recommend a best-strategy to accomplish this aim. Therefore, using the Practical Robust Implementation and Sustainability Model (PRISM), developed by one of our co-investigators, to guide the analyses, the investigators will:
Aim #1: Conduct a randomized controlled trial to determine the effectiveness of a universal laboratory test-based HNPCC screening program compared to the current practice of physician referral and self-referral.
Aim #2: Elucidate patient, provider, and system factors important to success of implementation.
Aim #3: Create, refine, and disseminate an implementation guide for HNPCC screening including informant interviews of key staff at seven future diverse dissemination-implementation sites.
This study aims to evaluate implementation of a novel HNPCC screening program and assess, for all stakeholders, facilitators and barriers to program implementation and success. Results from this study will help achieve the Healthy People 2020 objective of reducing CRC mortality. It will add to the growing literature in the increasingly important area of translating research findings into real-world practice, a subject of the NIH Roadmap. Many of the findings will be useful in other clinical areas and will be broadly applicable to other health care organizations aiming to improve access to genetic tests for cancers.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- At least 18 years old
- Kaiser Permanente member
- Referral or scheduled colon surgery
- No known cognitive impairments (e.g., Alzheimer's Disease) that would impact the ability to be consented
- English speaker
- Diagnosis of colon cancer
Exclusion Criteria:
- Under the age of 18
- Known cognitive impairment
- Inability to speak/understand English
- On the research exclusion list
- Known Lynch syndrome
- No diagnosis of colon cancer
United States, Oregon | |
Kaiser Permanente Northwest | |
Portland, Oregon, United States, 97227 |
Principal Investigator: | Katrina AB Goddard, PhD | Kaiser Permanente |
No publications provided
Responsible Party: | Kaiser Permanente |
ClinicalTrials.gov Identifier: | NCT01582841 History of Changes |
Other Study ID Numbers: | 1RO1CA140377-01A2 |
Study First Received: | December 15, 2011 |
Last Updated: | April 20, 2012 |
Health Authority: | United States: Institutional Review Board |
Keywords provided by Kaiser Permanente:
Colon Cancer Lynch Syndrome Genetic Screening |
Additional relevant MeSH terms:
Colonic Neoplasms Colorectal Neoplasms, Hereditary Nonpolyposis Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn DNA Repair-Deficiency Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on October 17, 2012