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FACTT for Hereditary Breast and Ovarian Cancer

N/A

Recruiting

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

Over the age of 18

Psychological ability and general health that permits completion of study requirements and follow-up

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 below

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I am over 18 years old.

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I am mentally and physically able to follow the study's requirements.

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I have a confirmed genetic mutation linked to cancer.

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I have been diagnosed with ovarian, fallopian tube, peritoneal, breast, colorectal, or endometrial cancer.

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My cancer has a mutation that is recognized for treatment.

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I am willing to complete surveys for up to 6 months in any format.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of study through completion of 6 month follow-up (estimated to be 18 months) for reporting.

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 more

Trial 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

0 / 6Eligibility criteria met