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FACTT for Hereditary Breast and Ovarian Cancer
N/A
Waitlist Available
Led By Andrea Hagemann, M.D., MSCI
Research Sponsored by Washington University School of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from start of study through completion of 6 month follow-up (estimated to be 18 months)
Awards & highlights
Study Summary
This trial is testing how best to help patients communicate the need for genetic testing to their families.
Who is the study for?
This trial is for adults over 18 with certain inherited cancer syndromes (like Hereditary Breast and Ovarian Cancer or Lynch Syndrome) who've had specific cancers. They must have a mutation known to cause these conditions, be in good general health, mentally able to participate, and willing to do follow-up surveys for up to 6 months.Check my eligibility
What is being tested?
The study tests the Families Accelerating Cascade Testing Toolkit designed to help patients communicate about genetic testing needs within families at risk of hereditary cancers. It aims to understand how providers can support this process.See study design
What are the potential side effects?
Since this trial involves communication tools rather than medical treatments, traditional physical side effects are not expected. However, participants may experience emotional or psychological responses when discussing sensitive family health information.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a confirmed genetic mutation linked to cancer.
Select...
I have been diagnosed with ovarian, fallopian tube, peritoneal, breast, colorectal, or endometrial cancer.
Select...
My cancer has a mutation that is recognized for treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of study through completion of 6 month follow-up (estimated to be 18 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of study through completion of 6 month follow-up (estimated to be 18 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Family member-reported cascade testing rates
Number of primary barriers to genetic testing for family members
Number of primary barriers to genetic testing for first-degree relatives
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: FACT Toolkit (FACTT)Experimental Treatment1 Intervention
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
Group II: Usual CareActive Control1 Intervention
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
Find a Location
Who is running the clinical trial?
Washington University School of MedicineLead Sponsor
1,940 Previous Clinical Trials
2,303,299 Total Patients Enrolled
The Foundation for Barnes-Jewish HospitalOTHER
37 Previous Clinical Trials
6,694 Total Patients Enrolled
Andrea Hagemann, M.D., MSCIPrincipal InvestigatorWashington University School of Medicine
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am over 18 years old.I am mentally and physically able to follow the study's requirements.I have a confirmed genetic mutation linked to cancer.I have been diagnosed with ovarian, fallopian tube, peritoneal, breast, colorectal, or endometrial cancer.My cancer has a mutation that is recognized for treatment.I am willing to complete surveys for up to 6 months in any format.My genetic test shows a variant that is not clearly harmful.
Research Study Groups:
This trial has the following groups:- Group 1: Usual Care
- Group 2: FACT Toolkit (FACTT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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