Clinical trial NCT04330716: Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers
Official title: Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Metastatic Prostate Cancer
Keywords: Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Metastatic Prostate Cancer
Genetic Counseling
Genetic Testing
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Ambry Genetics
First posted: 2020-04-01
Enrollment: 269
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Detailed 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

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of patients who have germline genetic tests
timeFrame: Up to 3 years
Secondary outcomes:
measure: Patient Satisfaction Survey following intervention
timeFrame: Immediately following intervention
measure: Result Disclosure Preference following intervention
timeFrame: Immediately following intervention
measure: Patient Satisfaction 2 months following intervention
timeFrame: after results have been received, two months post-intervention
measure: Psychological distress following intervention
timeFrame: after results have been received, two months post-intervention
measure: Knowledge about genetics testing
timeFrame: Immediately following intervention
measure: Decisional Regret
timeFrame: after results have been received, two months post-intervention
measure: Family communication of genetic test results
timeFrame: after results have been received, two months post-intervention
measure: Positive Results impact
timeFrame: after results have been received, four months post-intervention
measure: Cascade testing in positives
timeFrame: after results have been received, four months post-intervention
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Brighton
country: United States
facility: Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
state: Massachusetts
city: Milford
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
state: Massachusetts
city: Weymouth
country: United States
facility: Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
state: Massachusetts
city: Londonderry
country: United States
facility: Dana-Farber/New Hampshire Oncology-Hematology
state: New Hampshire
city: Providence
country: United States
facility: Lifespan Cancer Institute at Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Huma Rana, MD
role: PRINCIPAL_INVESTIGATOR
References: