Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers (GeneBOPP)

Dana-Farber Cancer Institute

Status: Completed

Conditions: Breast Cancer; Metastatic Prostate Cancer; Ovarian Cancer; Pancreatic Cancer

Treatments: Behavioral: Standard Genetic Counseling; Behavioral: Educational Video

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04330716

19-652

Details and patient eligibility

About

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

Full description

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

Enrollment: 269 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Exclusion criteria

• Pregnant
• Prisoners
• Inability to understand English as a spoken language in a healthcare context
• Known hematologic malignancy (e.g. CLL)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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269 participants in 2 patient groups

Group A: Standard genetic counseling

Active Comparator group

Description:

Will receive standard genetic counseling prior to genetic testing.

Treatment:

Behavioral: Standard Genetic Counseling

Group B: Educational video

Experimental group

Description:

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.

Treatment:

Behavioral: Educational Video