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Early Detection of GEnetic Risk (EDGE)

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ClinicalTrials.gov Identifier: NCT04746794
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : February 10, 2021
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Deborah Bowen, University of Washington

Brief Summary:
The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A "previvor" plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified.

Condition or disease Intervention/treatment Phase
Genetic Predisposition Behavioral: Population-level screening Not Applicable

Detailed Description:

Current practice guidelines from ACMG provide referral indications for cancer predisposition assessment. Identifying patients with high genetic risk for breast, ovary, colon, or other cancers has important clinical ramifications for an individual's healthcare, but genetic risk if often not identified because of testing barriers at several levels. Barriers at the provider level include inadequacies in risk recognition, patient referrals and availability of genetic professionals to provide counseling in a traditional testing paradigm. Barriers at the level of the patient include poor understanding of the availability and benefits of testing and inadequate access to testing services. How to best implement appropriate genomic testing and follow-up care into an operating healthcare system is not known. Issues of communication, clinical flow, reportable actions, and transmission of information and support are of critical importance, and must change and grow to accommodate the new information contained within genomic testing. Studies to date of the implementation process have been conducted in high resourced facilities, under optimal conditions, often not at the system level. Aims include:

  1. Compare the efficacy and implementation of two strategies for identifying members of a primary care clinic's population who have a family or personal history of cancer and offering high-risk individuals to obtain genetic testing for cancer susceptibility mutations in a randomized trial. The two methods are: 1) Point of Care (POC) approach: A tablet-based screening for family/personal history of cancer will be offered to all patients aged 25 and up coming in for a routine appointment at the clinic. 2) Direct Patient Engagement (DPE): Letters will be sent to all individuals aged 25 and older in a clinic's population, inviting them to visit a web site for screening for family /personal history of cancer. In both strategies, those determined to be high-risk will receive online education about genetic testing and an invitation to obtain such testing through a web-based platform. Outcomes will be the fraction of the active clinic patient population that completes screening and the fraction of the active clinic patient population that undergoes testing.

    Hypothesis 1: DPE screening will result in a higher proportion of active patients who screen for familial cancer risk compared with POC screening.

    Hypothesis 2: Of screened patients, POC patients will produce a higher proportion of tested patients compared with DPE.

  2. Identify changes, problems, and inefficiencies in clinical flow and interactions during and after the implementation of genomic testing for cancer risk across primary care clinics.
  3. Evaluate the effects of two methods of implementation of genomic screening for cancer risk on patient, provider, and health system leader reports of benefits and harms, satisfaction, perceived quality of care, including across gender, racial/ethnic, socioeconomic, and genetic literacy divides.
  4. Evaluate the value (cost-effectiveness) and affordability (budget impact) of each screening strategy.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Implementing the Moon: Getting Genomic Testing to the Public
Actual Study Start Date : September 25, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : August 31, 2024

Arm Intervention/treatment
Experimental: Point of Care
In the point of care (POC) arm, patients will be approached at the time they come in to the clinic for a routine visit with their primary care provider. We will screen patients for familial cancer risk using electronic tablets in the waiting room or, in the case of a telehealth visit, through telephone contact before the visit. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers.
Behavioral: Population-level screening
The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A "previvor" plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified.

Experimental: Direct Patient Engagement
In the direct patient engagement (DPE) arm, patients will be identified by reviewing clinic records to create an "active" patient list (i.e., those who have had a visit in the past year). We will contact patients by postal mail and email to provide a link to the online risk screening tool. The patient outreach is not tied to a specific visit and the online screening can be completed at any time. Patients identified as high risk will be offered genetic testing for a panel of hereditary cancers.
Behavioral: Population-level screening
The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A "previvor" plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified.

No Intervention: Stakeholder Interviews and Surveys
Samples of patients, providers, and clinic leaders will be assessed at several points throughout the study - baseline and multiple follow-ups. We will use a mixed methods approach, with both quantitative assessments (surveys) and qualitative assessments (interviews). Baseline assessments will provide initial data on the patient population and current clinic functioning and help in implementation planning. The midpoint and final assessments will provide estimates of change in patients, providers, and clinic leaders as a result of the implementation.



Primary Outcome Measures :
  1. Rates of screening [ Time Frame: 1.5 years ]
    Fraction of the active clinic patient population that completes screening

  2. Rate of testing [ Time Frame: 1.5 years ]
    Fraction of the active clinic patient population that undergoes testing.


Secondary Outcome Measures :
  1. Implementation barriers on the clinic-level [ Time Frame: 1.5 years ]
    To identify changes, problems, and inefficiencies in clinical flow and interactions during and after the implementation of genomic testing for cancer risk across primary care clinics.

  2. Genetic Literacy and Comprehension (GLAC) [ Time Frame: up to 2 years ]
    GLAC scale for genetic literacy.

  3. Implementation Leadership Scale (ILS) [ Time Frame: up to 2 years ]
    ILS scale.

  4. Implementation Climate Scale (ICS) [ Time Frame: up to 2 years ]
    ICS scale.

  5. Organizational Readiness to Change Assessment (ORCA) [ Time Frame: up to 2 years ]
    ORCA scale.

  6. Intervention characteristics (ex: evidence strength and quality) [ Time Frame: up to 2 years ]
    Self-developed measure.

  7. Trust in Physician Scale (TIPS) [ Time Frame: up to 2 years ]
    TIPS scale for Physician trust.

  8. Patient Satisfaction Questionnaire Short-Form (PSQ-18) [ Time Frame: up to 2 years ]
    PSQ-18

  9. Communication with family members [ Time Frame: up to 2 years ]
    Self-developed measure.

  10. Reasons for completing (or not completing) genetic testing [ Time Frame: up to 2 years ]
    Self-developed measure.

  11. Reasons for completing (or not completing) screening. [ Time Frame: up to 1.5 years ]
    Self-developed measure.

  12. Quality of life scale [ Time Frame: up to 1.5 years ]
    Self-developed measure to measure patient quality of life.

  13. Health literacy [ Time Frame: up to 1.5 years ]
    Self-developed measure patient's health literacy.

  14. Cost-benefit analysis - cost-effectiveness [ Time Frame: up to 5 years ]
    Sel-developed measure to evaluate the value (cost-effectiveness) at each site

  15. Cost-benefit analysis - budget impact [ Time Frame: up to 5 years ]
    Self-developed measure to measure the affordability of each screening strategy at each site



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Patients:

  • Age 25 or older
  • An active patient at a participating clinic (had at least one visit in the past 12 months)
  • Comfortable reading and writing in English

Exclusion Criteria:

  • Those who do not meet inclusion criteria.

Information from the National Library of Medicine

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): NCT04746794


Contacts
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Contact: Helen Haile 206-616-0507 hghaile@uw.edu
Contact: Heather Harris gholston@uw.edu

Locations
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United States, Montana
Billings Clinic Recruiting
Billings, Montana, United States, 59101
Contact: Jeannine Brant, PhD, APRN         
United States, Washington
MultiCare Health System Recruiting
Tacoma, Washington, United States, 98405
Contact: Michael Raff, MD         
Sponsors and Collaborators
University of Washington
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Deborah J Bowen, PhD University of Washington
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Responsible Party: Deborah Bowen, Professor, School of Medicine, University of Washington
ClinicalTrials.gov Identifier: NCT04746794    
Other Study ID Numbers: STUDY00009476
1U01CA232795-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: February 10, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Deborah Bowen, University of Washington:
Primary Care
Genetic Testing
Risk Assessment
Hereditary Cancer
Implementation
Additional relevant MeSH terms:
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Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes