Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting

Colon Cancer Clinical Trial

— HNPCC  

Official title:

Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01582841
• Other study ID #: 1RO1CA140377-01A2
• Status: Completed
• Phase: N/A
• First received: December 15, 2011
• Last updated: August 29, 2016
• Start date: February 2012
• Est. completion date: July 2016

Study information

• Verified date: August 2016
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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: (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Colorectal Neoplasms, Hereditary Nonpolyposis
• Lynch Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Northwest	Portland	Oregon

Sponsors (5)

Lead Sponsor	Collaborator
Kaiser Permanente	Case Western Reserve University, Dana-Farber Cancer Institute, M.D. Anderson Cancer Center, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implementation effectiveness	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.	All patients will be followed up to 5 years. Most active participation and chart review will take place within one year of surgery.	No