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Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting (HNPCC)

Primary Purpose

Colon Cancer, Lynch Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MSI screening test
Sponsored by
Kaiser Permanente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colon Cancer focused on measuring Colon Cancer, Lynch Syndrome, Genetic Screening

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kaiser Permanente Northwest

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MSI testing

Usual care

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2011
Last Updated
August 29, 2016
Sponsor
Kaiser Permanente
Collaborators
Case Western Reserve University, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT01582841
Brief Title
Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting
Acronym
HNPCC
Official Title
Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaiser Permanente
Collaborators
Case Western Reserve University, M.D. Anderson Cancer Center, Dana-Farber Cancer Institute, Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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: (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer, Lynch Syndrome
Keywords
Colon Cancer, Lynch Syndrome, Genetic Screening

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
247 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSI testing
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
MSI screening test
Intervention Description
All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI.
Primary Outcome Measure Information:
Title
Implementation effectiveness
Description
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.
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 In hospice
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katrina AB Goddard, PhD
Organizational Affiliation
Kaiser Permanente
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaiser Permanente Northwest
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting

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