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

January 18, 2024 updated by: Huma Rana, MD, Dana-Farber Cancer Institute

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
269

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Dana-Farber Cancer Institute
      • Brighton, Massachusetts, United States, 02135
        • Dana-Farber Cancer Institute at St. Elizabeth's Medical Center
      • Milford, Massachusetts, United States, 01757
        • Dana-Farber/Brigham and Women's Cancer Center at Milford Regional Medical Center
      • Weymouth, Massachusetts, United States, 02190
        • Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
    • New Hampshire
      • Londonderry, New Hampshire, United States, 03053
        • Dana-Farber/New Hampshire Oncology-Hematology
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Lifespan Cancer Institute at Rhode Island Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Group A: Standard genetic counseling
Will receive standard genetic counseling prior to genetic testing.
Behavioral: Standard Genetic Counseling
Standard of care genetic counseling
Experimental: Group B: Educational video
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.
Behavioral: Educational Video
Video tutorial about genetic testing

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of patients who have germline genetic tests
Time Frame: Up to 3 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Satisfaction Survey following intervention
Time Frame: Immediately 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
Result Disclosure Preference following intervention
Time Frame: Immediately 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
Patient Satisfaction 2 months following intervention
Time Frame: after results have been received, two months post-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
Psychological distress following intervention
Time Frame: after results have been received, two months post-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
Knowledge about genetics testing
Time Frame: Immediately following intervention
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
Decisional Regret
Time Frame: after results have been received, two months post-intervention
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
Family communication of genetic test results
Time Frame: after results have been received, two months post-intervention
Measurement of family communication. Family communication survey is administered two months following the intervention.
after results have been received, two months post-intervention
Positive Results impact
Time Frame: after results have been received, four months post-intervention
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
Cascade testing in positives
Time Frame: after results have been received, four months post-intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Dana-Farber Cancer Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ambry Genetics

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Huma Rana, MD, Dana-Farber Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 1, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19-652

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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