Early Detection of GEnetic Risk (EDGE)

NCT04746794 | Completed Results DMC

• 3 other identifiers: STUDY000094761U01CA232795-01A1RG1123410
• Study Type: interventional
• Target: 20,184
• Locations: 1 country
• Sites: 2

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.

Conditions

Genetic Predisposition

Keywords

Primary Care; Genetic Testing; Risk Assessment; Hereditary Cancer; Implementation

Outcome Measures

Primary Outcomes (2)

• Rates of Screening

  Fraction of the active clinic patient population that completed screening

  1 year

• Rates of Testing

  Fraction of the active clinic patient population that completed genetic testing.

  1 year

Secondary Outcomes (5)

• Total Cost of Each Engagement Strategy

  2 years

• Incremental Cost When Comparing Two Engagement Strategies

  2 years

• Rates of Screening and Testing at Healthcare System A

  2 years

• Incremental Patients Screened; Incremental Patients Tested

  2 years

• Incremental Cost-effectiveness Ratio (ICER) Per Patient Screened; Incremental Cost-effectiveness Ratio Per Patient Tested

  2 years

Study Arms (3)

Point of Care

EXPERIMENTAL

For clinics 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

Direct Patient Engagement

EXPERIMENTAL

For clinics 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

Stakeholder Interviews and Surveys

NO INTERVENTION

Samples of patients, providers, and clinic leaders will be assessed at several points throughout the study - baseline and follow-up. 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 final assessments will provide estimates of change in patients, providers, and clinic leaders as a result of the implementation.

Interventions

Population-level screening BEHAVIORAL

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.

Direct Patient Engagement; Point of Care

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Billings Clinic

Billings, Montana, 59101, United States

Location

MultiCare Health System

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Swisher EM, Harris HM, Knerr S, Theoryn TN, Norquist BM, Brant J, Shirts BH, Beers F, Cameron D, Dusic EJ, Riemann LA, Devine B, Raff ML, Kadel R, Cabral HJ, Wang C. Strategies to Assess Risk for Hereditary Cancer in Primary Care Clinics: A Cluster Randomized Clinical Trial. JAMA Netw Open. 2025 Mar 3;8(3):e250185. doi: 10.1001/jamanetworkopen.2025.0185.

  PMID: 40053353 DERIVED

MeSH Terms

Conditions

Genetic Predisposition to Disease

Condition Hierarchy (Ancestors)

Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The COVID-19 pandemic affected the study as a whole, and the POC arm in particular. One of the healthcare systems shut down clinic waiting rooms and converted most appointments to telehealth. As a result, half of the POC clinics pivoted to telephone engagement. In the remaining POC clinics, genetic testing kits were not handed to eligible patients at the time the patient was found to be eligible, due to COVID precautions and time constraints in-clinic.

Results Point of Contact

• Title: Faith Beers
• Organization: University of Washington

fabeers@uw.edu

206-543-1733

Study Officials

• Elizabeth M Swisher, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecologic oncologist

Study Record Dates

• First Submitted: December 29, 2020
• First Posted: February 10, 2021
• Study Start: September 25, 2020
• Primary Completion: May 31, 2023
• Study Completion: June 1, 2023
• Last Updated: October 9, 2024
• Results First Posted: October 9, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)