Back to resultsImplementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
Primary Purpose
Hereditary Breast and Ovarian Cancer, Lynch Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Families Accelerating Cascade Testing Toolkit
Sponsored by
About this trial
This is an interventional health services research trial for Hereditary Breast and Ovarian Cancer
Eligibility Criteria
Inclusion Criteria:
- Documentation of HBOC or Lynch-associated "pathogenic/ likely pathogenic" mutation per American College of Medical Genetics and Genomics criteria (1)
- Diagnosis of one or more invasive cancers: epithelial ovarian, fallopian tube, primary peritoneal, breast, colorectal, endometrial
- Mutation listed in NCCN guidelines with at least Category 2A evidence for intervention
- Over the age of 18
- Psychological ability and general health that permits completion of study requirements and follow-up
- Willingness to complete follow-up surveys in person, electronically, or by telephone for up to 6 months
Exclusion Criteria:
-"Variant of undetermined significance," "likely benign" or "benign" variant per ACMGG criteria
Sites / Locations
- Washington University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual Care
FACT Toolkit (FACTT)
Arm Description
For approximately the first 6 months of the study, or until 75 patient with cancer who is initially approached in clinic (probands) are enrolled, the investigators will be enrolling probands into the "Usual Care" group. During this time, the investigators will clarify usual care regarding cascade genetic testing for each participating clinic and proband participant. The investigators will do this by proband participant surveys, as well as initial provider semi-structured interviews. Proband: Complete Cascade Genetic Testing survey. The survey will also contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. At 6 months, there will be a follow-up survey Family Member: Complete survey at study entry and at 6 month follow-up
Proband: Introduced to FACTT and will complete Cascade Genetic Testing survey. The survey will contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. The probands will also fill out assessments of each FACTT component. At 6 months, there will be a follow-up survey. Family Member: Introduced to FACTT and will complete surveys at study entry and 6 month follow-up. They will also fill out assessments of each FACTT component
Outcomes
Primary Outcome Measures
Proband-reported cascade testing rates of first-degree relatives
-For each proband, this testing rate is defined as the number of first-degree relatives tested divided by the number of living first-degree relatives age-appropriate for testing, as determined by family surveys done by the proband. The investigators will calculate mean cascade genetic testing rates for both conditions (Usual Care and FACTT intervention).
Number of primary barriers to genetic testing for first-degree relatives
-The Cascade Genetic Testing survey will assess knowledge, perception, and personal experience with sharing germline mutation information with first-degree relatives
Family member-reported cascade testing rates
-This testing rate is defined by the number of family members tested divided by the number of living family members age-appropriate for testing
Number of primary barriers to genetic testing for family members
-The Family Member survey will assess experience with considering testing themselves, decisional regret regarding genetic testing, and if they have tested positive
Secondary Outcome Measures
Full Information
NCT ID
NCT04508764
First Posted
August 7, 2020
Last Updated
June 20, 2023
Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04508764
Brief Title
Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
Official Title
Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 9, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
The Foundation for Barnes-Jewish Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to learn how cancer care providers can help their patients communicate the need for genetic testing in families with inherited cancer syndromes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hereditary Breast and Ovarian Cancer, Lynch Syndrome
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
For approximately the first 6 months of the study, or until 75 patient with cancer who is initially approached in clinic (probands) are enrolled, the investigators will be enrolling probands into the "Usual Care" group. During this time, the investigators will clarify usual care regarding cascade genetic testing for each participating clinic and proband participant. The investigators will do this by proband participant surveys, as well as initial provider semi-structured interviews.
Proband: Complete Cascade Genetic Testing survey. The survey will also contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. At 6 months, there will be a follow-up survey
Family Member: Complete survey at study entry and at 6 month follow-up
Arm Title
FACT Toolkit (FACTT)
Arm Type
Experimental
Arm Description
Proband: Introduced to FACTT and will complete Cascade Genetic Testing survey. The survey will contain questions regarding willingness or not to invite each eligible 1st degree family member to participate in the family study. The probands will also fill out assessments of each FACTT component. At 6 months, there will be a follow-up survey.
Family Member: Introduced to FACTT and will complete surveys at study entry and 6 month follow-up. They will also fill out assessments of each FACTT component
Intervention Type
Other
Intervention Name(s)
Families Accelerating Cascade Testing Toolkit
Other Intervention Name(s)
FACTT
Intervention Description
-Online family history assessment, video of Siteman Cancer Center genetic counselors, physicians and patients highlighting the importance of cascade genetic testing, reviewing and receiving a family letter and gene information sheet, reviewing websites/online resources, and offering a family visit with a genetic counselor
Primary Outcome Measure Information:
Title
Proband-reported cascade testing rates of first-degree relatives
Description
-For each proband, this testing rate is defined as the number of first-degree relatives tested divided by the number of living first-degree relatives age-appropriate for testing, as determined by family surveys done by the proband. The investigators will calculate mean cascade genetic testing rates for both conditions (Usual Care and FACTT intervention).
Time Frame
From start of study through completion of 6 month follow-up (estimated to be 18 months)
Title
Number of primary barriers to genetic testing for first-degree relatives
Description
-The Cascade Genetic Testing survey will assess knowledge, perception, and personal experience with sharing germline mutation information with first-degree relatives
Time Frame
From start of study through completion of 6 month follow-up (estimated to be 18 months)
Title
Family member-reported cascade testing rates
Description
-This testing rate is defined by the number of family members tested divided by the number of living family members age-appropriate for testing
Time Frame
From start of study through completion of 6 month follow-up (estimated to be 18 months)
Title
Number of primary barriers to genetic testing for family members
Description
-The Family Member survey will assess experience with considering testing themselves, decisional regret regarding genetic testing, and if they have tested positive
Time Frame
From start of study through completion of 6 month follow-up (estimated to be 18 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Documentation of HBOC or Lynch-associated "pathogenic/ likely pathogenic" mutation per American College of Medical Genetics and Genomics criteria (1)
Diagnosis of one or more invasive cancers: epithelial ovarian, fallopian tube, primary peritoneal, breast, colorectal, endometrial
Mutation listed in NCCN guidelines with at least Category 2A evidence for intervention
Over the age of 18
Psychological ability and general health that permits completion of study requirements and follow-up
Willingness to complete follow-up surveys in person, electronically, or by telephone for up to 6 months
Exclusion Criteria:
-"Variant of undetermined significance," "likely benign" or "benign" variant per ACMGG criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea R Hagemann, M.D., MSCI
Phone
314-362-3181
Email
hagemanna@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Christine Marx
Phone
314-362-9656
Email
marxc@wustl.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Hagemann, M.D., MSCI
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Hagemann, M.D., MSCI
Phone
314-362-3181
Email
hagemanna@wustl.edu
First Name & Middle Initial & Last Name & Degree
Christine Marx
Phone
314-362-9656
Email
marxc@wustl.edu
First Name & Middle Initial & Last Name & Degree
Andrea Hagemann, M.D., MSCI
First Name & Middle Initial & Last Name & Degree
Amy Cyr, M.D.
First Name & Middle Initial & Last Name & Degree
Paul Wise, M.D.
First Name & Middle Initial & Last Name & Degree
Esther Lu, Ph.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
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