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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-09

Study Completion Date

2024-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cascade Genetic Testing for Hereditary Breast/Ovarian Cancer and Lynch Syndrome in Switzerland

NCT03124212

Hereditary Breast and Ovarian Cancer Lynch Syndrome

RECRUITING

Cascade Testing in Families With Newly Diagnosed Hereditary Breast and Ovarian Cancer Syndrome

NCT04009148

BRCA-Mutated Ovarian Carcinoma BRIP1 Gene Mutation MSH2 A636P +5 more

ACTIVE_NOT_RECRUITING

Patient Centered Clinical Decision Support for Hereditary Cancer Syndromes

NCT06914726

Hereditary Breast/Ovarian Cancer (brca1, brca2) Lynch Syndrome Genetic Variation +2 more

ENROLLING_BY_INVITATION NA

Transcriptomes Breast, Ovarian and Leukocyte Hereditary Genes Predisposing to Breast and / or Ovarian Cancer

NCT02560818

Breast Cancer Transcriptomes Molecular Diagnostic +1 more

COMPLETED NA

Analysis of Tumors From Patients With Inherited Cancers Having Had Two Surgeries (Primary + Recurrent, or 2 Separate Types of Cancer)

NCT01167842

Breast Cancer Ovarian Cancer

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hereditary Breast and Ovarian Cancer Lynch Syndrome

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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

Group Type EXPERIMENTAL

Families Accelerating Cascade Testing Toolkit

Intervention Type OTHER

-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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FACTT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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