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

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: Completed
• Conditions: Breast Cancer; Pancreatic Cancer; Ovarian Cancer; Metastatic Prostate Cancer
• Intervention / Treatment: Behavioral: Standard Genetic Counseling; Behavioral: Educational Video

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: Interventional
• Enrollment (Actual): 269
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huma Rana, MD; Phone Number: 617-632-6292; Email: humaQ_rana@dfci.harvard.edu
• Study Contact Backup: Name: Alex Husband, BA; Phone Number: 617-582-9320; Email: ahusband@partners.org

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Ambry Genetics
• Investigators: Principal Investigator: Huma Rana, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: March 30, 2020
• First Posted (Actual): April 1, 2020

Study Record Updates

• Last Update Posted (Estimated): January 19, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Breast Cancer; Pancreatic Cancer; Ovarian Cancer; Genetic Testing; Metastatic Prostate Cancer; Genetic Counseling
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Endocrine System Diseases; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Digestive System Neoplasms; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Prostatic Diseases; Pancreatic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Genital Diseases, Female; Prostatic Neoplasms; Ovarian Neoplasms; Pancreatic Neoplasms
• Other Study ID 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