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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330716
Recruitment Status : Not yet recruiting
First Posted : April 1, 2020
Last Update Posted : April 1, 2020
Sponsor:
Collaborator:
Ambry Genetics
Information provided by (Responsible Party):
Huma Rana, Dana-Farber Cancer Institute

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

Condition or disease Intervention/treatment Phase
Breast Cancer Ovarian Cancer Pancreatic Cancer Metastatic Prostate Cancer Behavioral: In Person Counseling Behavioral: Educational Video Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Genetic Testing for Breast, Ovarian, Pancreatic and Prostate Cancers - GeneBOPP
Estimated Study Start Date : April 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2024


Arm Intervention/treatment
Active Comparator: Group A: In-person genetic counseling
Will receive in-person genetic counseling prior to genetic testing.
Behavioral: In Person Counseling
Standard of care in-person 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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Patient Satisfaction 2 months following intervention [ Time Frame: after results have been received, two months post-invervention ]
    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.

  4. Psychological distress following intervention [ Time Frame: after results have been received, two months post-invervention ]
    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.

  5. 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.

  6. Decisional Regret [ Time Frame: after results have been received, two months post-invervention ]
    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.

  7. Family communication of genetic test results [ Time Frame: after results have been received, two months post-invervention ]
    Measurement of family communication. Family communication survey is administered two months following the intervention.

  8. Positive Results impact [ Time Frame: after results have been received, four months post-invervention ]
    Measurement of impact of positive results for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.

  9. Cascade testing in positives [ Time Frame: after results have been received, four months post-invervention ]
    Measurement of cascade testing for patients who tested positive for a genetic mutation. This survey is administered four months post-intervention.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330716


Contacts
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Contact: Huma Rana, MD 617-632-6292 humaQ_rana@dfci.harvard.edu

Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Contact: Huma Rana, MD    617-632-6292    humaQ_rana@dfci.harvard.edu   
Principal Investigator: Huma Rana, MD         
Dana-Farber/Brigham and Women's Cancer Center in clinical affiliation with South Shore Hospital
Weymouth, Massachusetts, United States, 02190
Contact: Huma Rana, MD    617-632-6292    humaQ_rana@dfci.harvard.edu   
Sponsors and Collaborators
Dana-Farber Cancer Institute
Ambry Genetics
Investigators
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Principal Investigator: Huma Rana, MD Dana-Farber Cancer Institute
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Responsible Party: Huma Rana, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT04330716    
Other Study ID Numbers: 19-652
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: April 1, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Huma Rana, Dana-Farber Cancer Institute:
Breast Cancer
Ovarian Cancer
Pancreatic Cancer
Metastatic Prostate Cancer
Genetic Counseling
Genetic Testing
Additional relevant MeSH terms:
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Prostatic Neoplasms
Pancreatic Neoplasms
Ovarian Neoplasms
Neoplasms by Site
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Diseases
Digestive System Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Gonadal Disorders