search
Back to results

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

Primary Purpose

Breast Cancer, Ovarian Cancer, Pancreatic Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Genetic Counseling
Educational Video
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Breast Cancer focused on measuring Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Metastatic Prostate Cancer, Genetic Counseling, Genetic Testing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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)

Sites / Locations

  • Dana-Farber Cancer Institute
  • Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
  • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
  • Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
  • Dana-Farber/New Hampshire Oncology-Hematology
  • Lifespan Cancer Institute at Rhode Island Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Group A: Standard genetic counseling

Group B: Educational video

Arm Description

Will receive standard genetic counseling prior to genetic testing.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
Family communication of genetic test results
Measurement of family communication. Family communication survey is administered two months following the intervention.
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.
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.

Full Information

First Posted
March 17, 2020
Last Updated
January 25, 2023
Sponsor
Dana-Farber Cancer Institute
Collaborators
Ambry Genetics
search

1. Study Identification

Unique Protocol Identification Number
NCT04330716
Brief Title
Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers
Acronym
GeneBOPP
Official Title
Genetic Testing for Breast, Ovarian, Pancreatic, and Prostate Cancers - GeneBOPP
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Ambry Genetics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Metastatic Prostate Cancer
Keywords
Breast Cancer, Ovarian Cancer, Pancreatic Cancer, Metastatic Prostate Cancer, Genetic Counseling, Genetic Testing

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: Standard genetic counseling
Arm Type
Active Comparator
Arm Description
Will receive standard genetic counseling prior to genetic testing.
Arm Title
Group B: Educational video
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Genetic Counseling
Intervention Description
Standard of care genetic counseling
Intervention Type
Behavioral
Intervention Name(s)
Educational Video
Intervention Description
Video tutorial about genetic testing
Primary Outcome Measure Information:
Title
Rate of patients who have germline genetic tests
Description
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
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Patient Satisfaction Survey following intervention
Description
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.
Time Frame
Immediately following intervention
Title
Result Disclosure Preference following intervention
Description
Measurement and comparison by randomized arm and communication of results of patient disclosure preferences using survey instruments. Administered immediately following the intervention.
Time Frame
Immediately following intervention
Title
Patient Satisfaction 2 months following intervention
Description
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.
Time Frame
after results have been received, two months post-intervention
Title
Psychological distress following intervention
Description
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.
Time Frame
after results have been received, two months post-intervention
Title
Knowledge about genetics testing
Description
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.
Time Frame
Immediately following intervention
Title
Decisional Regret
Description
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.
Time Frame
after results have been received, two months post-intervention
Title
Family communication of genetic test results
Description
Measurement of family communication. Family communication survey is administered two months following the intervention.
Time Frame
after results have been received, two months post-intervention
Title
Positive Results impact
Description
Measurement of impact of positive results for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.
Time Frame
after results have been received, four months post-intervention
Title
Cascade testing in positives
Description
Measurement of cascade testing for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.
Time Frame
after results have been received, four months post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huma Rana, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Dana-Farber/New Hampshire Oncology-Hematology
City
Londonderry
State/Province
New Hampshire
ZIP/Postal Code
03053
Country
United States
Facility Name
Lifespan Cancer Institute at Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

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

We'll reach out to this number within 24 hrs