Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers
GeneBOPP
1 other identifier
interventional
269
1 country
6
Brief Summary
This study is evaluating the effect of two pre-test education methods on participants interested in genetic testing for hereditary cancer risk.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Dec 2020
Typical duration for not_applicable breast-cancer
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2020
CompletedFirst Posted
Study publicly available on registry
April 1, 2020
CompletedStudy Start
First participant enrolled
December 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedJanuary 19, 2024
January 1, 2024
3.1 years
March 17, 2020
January 18, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Patient Satisfaction Survey following intervention
Immediately following intervention
Result Disclosure Preference following intervention
Immediately following intervention
Patient Satisfaction 2 months following intervention
after results have been received, two months post-intervention
Psychological distress following intervention
after results have been received, two months post-intervention
Knowledge about genetics testing
Immediately following intervention
- +4 more secondary outcomes
Study Arms (2)
Group A: Standard genetic counseling
ACTIVE COMPARATORWill receive standard genetic counseling prior to genetic testing.
Group B: Educational video
EXPERIMENTALWill 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.
Interventions
Standard of care genetic counseling
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant
- Prisoners
- Inability to understand English as a spoken language in a healthcare context
- Known hematologic malignancy (e.g. CLL)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Ambry Geneticscollaborator
Study Sites (6)
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
Brighton, Massachusetts, 02135, United States
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
Milford, Massachusetts, 01757, United States
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
Weymouth, Massachusetts, 02190, United States
Dana-Farber/New Hampshire Oncology-Hematology
Londonderry, New Hampshire, 03053, United States
Lifespan Cancer Institute at Rhode Island Hospital
Providence, Rhode Island, 02903, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Huma Rana, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
March 17, 2020
First Posted
April 1, 2020
Study Start
December 1, 2020
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
January 19, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.