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

Breast Cancer Clinical Trial

— GeneBOPP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04330716
• Other study ID #: 19-652
• Status: Completed
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 269
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Metastatic Prostate Cancer
• Ovarian Cancer
• Ovarian Neoplasms
• Pancreatic Cancer
• Pancreatic Neoplasms
• Prostatic Neoplasms

Intervention

Behavioral:
• Standard Genetic Counseling
Standard of care genetic counseling
• Educational Video
Video tutorial about genetic testing

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Dana-Farber Cancer Institute at St. Elizabeth's Medical Center	Brighton	Massachusetts
United States	Dana-Farber/New Hampshire Oncology-Hematology	Londonderry	New Hampshire
United States	Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center	Milford	Massachusetts
United States	Lifespan Cancer Institute at Rhode Island Hospital	Providence	Rhode Island
United States	Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital	Weymouth	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Ambry Genetics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients who have germline genetic tests	Measurement of genetic testing uptake in breast, ovarian, pancreatic, and prostate cancer patients randomized to pre-genetic test (pre-test) in-person counseling with a genetic counselor per standard of care or video education.This comparison will use a two-sided Fisher exact test	Up to 3 years
Secondary	Patient Satisfaction Survey following intervention	Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered immediately following the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms.	Immediately following intervention
Secondary	Result Disclosure Preference following intervention	Measurement and comparison by randomized arm and communication of results of patient disclosure preferences using survey instruments. Administered immediately following the intervention.	Immediately following intervention
Secondary	Patient Satisfaction 2 months following intervention	Measurement and comparison by randomized arm and communication of results of patient satisfaction using survey instruments. Administered two months after the intervention. The survey evaluates the subject's satisfaction with the genetic testing process for both arms.	after results have been received, two months post-intervention
Secondary	Psychological distress following intervention	MICRA is a widely used validated 25-item measure that assesses psychosocial consequences associated with genetic testing for cancer. Section 1 contains 3 sub-scales: the Positive sub-scale (4 items), the Distress sub-scale (6 items), and the Uncertainty sub-scale (9 items) and two other items that do not fit into either sub-scale. Section 2 contains two items for participants who have children. Section 3 contains 2 items for participants who have/have had cancer. Responses are indicated on a 4 point scale for experiences in the past week. A higher score in the sub-scales or total scale indicated greater distress. The positive sub-scale is reverse scored to reflect this.	after results have been received, two months post-intervention
Secondary	Knowledge about genetics testing	Measurement and comparison by randomized arm and communication of results of Patient knowledge about genetics testing using survey instruments. Knowledge about genetic testing is evaluated through a Knowledge of Multigene Panel Testing survey immediately following the intervention.	Immediately following intervention
Secondary	Decisional Regret	Measurement and comparison by randomized arm and communication of results of Patient decisional regret to have genetic testing. Decisional regret is evaluated through a decisional regret survey that is administered two months after intervention.	after results have been received, two months post-intervention
Secondary	Family communication of genetic test results	Measurement of family communication. Family communication survey is administered two months following the intervention.	after results have been received, two months post-intervention
Secondary	Positive Results impact	Measurement of impact of positive results for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.	after results have been received, four months post-intervention
Secondary	Cascade testing in positives	Measurement of cascade testing for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.	after results have been received, four months post-intervention