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Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04508764
Recruitment Status : Not yet recruiting
First Posted : August 11, 2020
Last Update Posted : August 11, 2020
Sponsor:
Collaborator:
Barnes-Jewish Hospital
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Hereditary Breast and Ovarian Cancer Lynch Syndrome Other: Families Accelerating Cascade Testing Toolkit Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Implementation of the Families Accelerating Cascade Testing Toolkit (FACTT) for Hereditary Breast and Ovarian Cancer and Lynch Syndrome
Estimated Study Start Date : August 31, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022


Arm Intervention/treatment
No Intervention: Usual Care
  • 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
Experimental: FACT Toolkit (FACTT)
  • 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
Other: Families Accelerating Cascade Testing Toolkit
-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
Other Name: FACTT




Primary Outcome Measures :
  1. Proband-reported cascade testing rates of first-degree relatives [ Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months) ]
    -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).

  2. Number of primary barriers to genetic testing for first-degree relatives [ Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months) ]
    -The Cascade Genetic Testing survey will assess knowledge, perception, and personal experience with sharing germline mutation information with first-degree relatives

  3. Family member-reported cascade testing rates [ Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months) ]
    -This testing rate is defined by the number of family members tested divided by the number of living family members age-appropriate for testing

  4. Number of primary barriers to genetic testing for family members [ Time Frame: From start of study through completion of 6 month follow-up (estimated to be 18 months) ]
    -The Family Member survey will assess experience with considering testing themselves, decisional regret regarding genetic testing, and if they have tested positive



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


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): NCT04508764


Contacts
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Contact: Andrea R Hagemann, M.D., MSCI 314-362-3181 hagemanna@wustl.edu
Contact: Christine Marx 314-362-9656 marxc@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Contact: Andrea Hagemann, M.D., MSCI    314-362-3181    hagemanna@wustl.edu   
Contact: Christine Marx    314-362-9656    marxc@wustl.edu   
Principal Investigator: Andrea Hagemann, M.D., MSCI         
Sub-Investigator: Amy Cyr, M.D.         
Sub-Investigator: Paul Wise, M.D.         
Sub-Investigator: Esther Lu, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Barnes-Jewish Hospital
Investigators
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Principal Investigator: Andrea Hagemann, M.D., MSCI Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT04508764    
Other Study ID Numbers: 202006168
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: August 11, 2020
Last Verified: August 2020
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
Additional relevant MeSH terms:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Colorectal Neoplasms, Hereditary Nonpolyposis
Hereditary Breast and Ovarian Cancer Syndrome
Syndrome
Disease
Pathologic Processes
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplastic Syndromes, Hereditary
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Genetic Diseases, Inborn
DNA Repair-Deficiency Disorders