Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting (HNPCC)
|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: NCT01582841|
Recruitment Status : Completed
First Posted : April 23, 2012
Last Update Posted : August 31, 2016
|Condition or disease||Intervention/treatment|
|Colon Cancer Lynch Syndrome||Procedure: MSI screening test|
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: (revised and approved during year 1): To create, refine, and disseminate an implementation guide for HNPCC screening by combining the results from Aims 1-2 and the perspectives from informant interviews of key staff at future diverse dissemination-implementation sites: Case Western Reserve University, Oregon Health & Sciences University, MD Anderson Cancer Center, Dana-Farber Cancer Institute, Kaiser Permanente Georgia, Kaiser Permanente Hawaii, and Safety Net West Clinics. Addition to Aim 3: We will contribute materials to the LSSN website for dissemination of implementation materials.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||247 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting|
|Study Start Date :||February 2012|
|Primary Completion Date :||July 2016|
|Study Completion Date :||July 2016|
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. These patients receive a follow up letter a year after randomization, alerting them to the availability of clinical Lynch Syndrome screening.
- 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. ]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 (microsatellite instability-high) test results who are contacted by medical genetics.
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): NCT01582841
|United States, Oregon|
|Kaiser Permanente Northwest|
|Portland, Oregon, United States, 97227|
|Principal Investigator:||Katrina AB Goddard, PhD||Kaiser Permanente|