Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2012
End Date:July 2016

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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.

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.

Inclusion Criteria:

1. At least 18 years old

2. Kaiser Permanente member

3. Referral or scheduled colon surgery

4. No known cognitive impairments (e.g., Alzheimer's Disease) that would impact the
ability to be consented

5. English speaker

6. Diagnosis of colon cancer

Exclusion Criteria:

1. Under the age of 18

2. Known cognitive impairment

3. Inability to speak/understand English

4. On the research exclusion list

5. Known Lynch syndrome

6. No diagnosis of colon cancer

7. In hospice
We found this trial at
1
site
Portland, Oregon 97227
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from
Portland, OR
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