Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

269 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-12-31

Brief Summary

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This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.

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Detailed Description

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This prospective, randomized controlled trial will evaluate the effect of two pre-test education methods on the level of participation in genetic testing for hereditary cancer risk. A prospective study examines outcomes before the development of a disease.

* The research study procedures include screening for eligibility, randomization and a series of questionnaires.
* Participants will be randomized, or assigned by chance, to one of two methods of pre-genetic test education and after completing either pre-test education participants will be offered the opportunity to have genetic testing performed

Two methods of pre-genetic test education:

* video education
* in-person counseling
* Genetic testing will be performed by blood draw.
* It is expected that 500 people will participate in this study
* Participants will be in the research study for up to 5 yrs after enrollment

Conditions

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Breast Cancer Ovarian Cancer Pancreatic Cancer Metastatic Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group A: Standard genetic counseling

Will receive standard genetic counseling prior to genetic testing.

Group Type ACTIVE_COMPARATOR

Standard Genetic Counseling

Intervention Type BEHAVIORAL

Standard of care genetic counseling

Group B: Educational video

Will watch a brief educational video that is approximately 8 minutes in length about the genetic testing process and what to expect prior to genetic testing.

Group Type EXPERIMENTAL

Educational Video

Intervention Type BEHAVIORAL

Video tutorial about genetic testing

Interventions

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Standard Genetic Counseling

Standard of care genetic counseling

Intervention Type BEHAVIORAL

Educational Video

Video tutorial about genetic testing

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Potentially eligible participants will be identified via medical record screening and/or in accordance with their clinical visit. A HIPAA waiver of authorization will be obtained by the enrolling Institution as needed to have access to the subject's medical record information for screening of eligibility.
* A member of the study team will approach the potentially eligible participant in clinic and discuss the trial. Potentially eligible participants may choose to discuss participation further with their physician at their appointment
* Age ≥ 18 years
* Breast, ovarian, pancreatic, or metastatic prostate cancer
* No prior cancer genetic testing
* Ability to understand and the willingness to sign an informed consent document