Identification and Referral of Women at Risk for Hereditary Breast/Ovarian Cancer

NCT02786147 | Completed

• 1 other identifier: IRB00084985
• Study Type: observational
• Target: 665
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to identify the most effective means of follow-up for women who screen positive on B-RST (Breast Cancer Genetics Referral Screening Tool) applied in the standard clinical setting of mammography, to maximize the number who are referred to and receive cancer genetic counseling services. The clinical utility of B-RST 3.0 will also be evaluated by determining the number seen who are appropriate for genetic testing, undergo genetic testing and are found to carry a hereditary cancer gene mutations with medical management implications for the patient and family. The long-term goal is to reduce the morbidity and mortality associated with hereditary causes of breast and ovarian cancer among patients seen in the Emory/Winship system.

Conditions

Hereditary Breast and Ovarian Cancer

Keywords

Breast Cancer; Ovarian Cancer; B-RST

Outcome Measures

Primary Outcomes (2)

• Number of B-RST screen positive participants who are referred to cancer genetic counseling via Self-Referral, Physician Notification by EeMR, Direct Contact by Cancer Genetics Program

  18 Months from Baseline

• Number of participants who complete cancer genetic counseling after Self-Referral, Physician Notification by EeMR, Direct Contact by Cancer Genetics Program

  18 Months from Baseline

Secondary Outcomes (4)

• Number of participants who underwent genetic testing after genetic counseling

  18 Months from Baseline

• Number of participants who were identified with a BRCA1/2 mutation

  18 Months from Baseline

• Number of participants who were identified with a mutation in a different hereditary cancer gene

  18 Months from Baseline

• Number of participants who were not appropriate for genetic testing, but were appropriate for referral to high-risk follow-up services

  18 Months from Baseline

Study Arms (3)

Patient Initiated

Patients randomized into this group will receive a standard handout explaining their result, which includes information on how to obtain cancer genetics services through Winship. However, neither the patient nor their ordering clinician will be directly contacted regarding the B-RST result.

Other: Breast Cancer Genetics Referral Screening Tool 3.0; Other: Standard Handout

Physician Notification

Patients randomized into this group will also receive the standard handout explaining their result. In addition, their primary care physician or ordering physician will be notified via Emory Electronic Medical Record (EeMR) that the patient screened positive on the B-RST. The note will provide specific instructions on how to refer the patient for cancer genetic counseling services.

Other: Breast Cancer Genetics Referral Screening Tool 3.0; Other: Standard Handout; Other: Physician Notification

Automatic Follow-Up By Genetic Counseling Staff

Patients randomized into this group will also receive the standard handout explaining their result. Within 1-2 weeks after their mammogram appointment, patients will receive a phone call from a genetics counseling staff person to explain their screening result and to offer to set up a genetics counseling appointment. This call may take up to 10 - 15 minutes.

Other: Breast Cancer Genetics Referral Screening Tool 3.0; Other: Standard Handout; Other: Automatic Follow-Up by Genetic Counseling Staff

Interventions

Breast Cancer Genetics Referral Screening Tool 3.0 OTHER

The B-RST is a simple yet effective validated screening tool to quickly identify individuals who may be at risk for hereditary breast and ovarian cancer and should be referred for cancer genetic counseling to formally evaluate their family history and discuss the benefits and limitations of genetic testing for hereditary breast and ovarian cancer. Clinic staff will give each patient arriving for a screening mammogram appointment a packet and briefly inform them about the opportunity to participate in a research study and that these materials can help them decide whether or not to participate. Patients who indicate that they are interested in completing the B-RST screening while in the clinic will be provided with an electronic tablet that has a secure internet browser tab open to the web-based study version of the screening tool (the B-RST 3.0).

Also known as: B-RST 3.0

Automatic Follow-Up By Genetic Counseling Staff; Patient Initiated; Physician Notification

Standard Handout OTHER

A document explaining the patient's positive test result indicating that they are at increased risk for HBOC (Hereditary Breast or Ovarian Cancer) which includes information on how to obtain cancer genetics services through Winship.

Automatic Follow-Up By Genetic Counseling Staff; Patient Initiated; Physician Notification

Physician Notification OTHER

Primary care physician or ordering physician will be notified vie EeMR that the patient screened positive on the B-RST. The note provides specific instructions on how to refer the patient for cancer genetic counseling services.

Physician Notification

Automatic Follow-Up by Genetic Counseling Staff OTHER

Within 1-2 weeks after the mammogram appointment, patients will receive a phone call from a genetics counseling staff person to explain their screening result and to offer to set up a genetics counseling appointment.

Automatic Follow-Up By Genetic Counseling Staff

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Female adult patients of the Winship Cancer Institute or Emory University Hospital Midtown that arrive for screening (non-diagnostic) mammogram appointments will be selected will be invited for participation.

You may qualify if:

• Patient at one of the participating clinics (Winship Cancer Institute and Emory University Hospital Midtown) who arrive for a screening mammogram appointment.

You may not qualify if:

• Patients receiving a diagnostic mammogram will not be invited to participate in the study.

Sponsors & Collaborators

• Emory University: lead

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Related Links

• Online B-RST tool

MeSH Terms

Conditions

Hereditary Breast and Ovarian Cancer Syndrome; Breast Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Neoplastic Syndromes, Hereditary; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Cecelia Bellcross, PhD, MS, CGC

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 30, 2016
• Study Start: April 1, 2016
• Primary Completion: February 28, 2018
• Study Completion: February 28, 2018
• Last Updated: April 20, 2018

Record last verified: 2018-04

Locations

US (2)