Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients (SCUSF 1102)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01789684
First received: February 7, 2013
Last updated: August 19, 2014
Last verified: August 2014
  Purpose

RATIONALE: Multi-faceted provider education and decision support intervention will increase the rate of appropriate referral of breast cancer patients at increased risk for hereditary breast and ovarian cancer (HBOC) to genetic counseling.

PURPOSE: This cluster randomized controlled trial will compare active and passive interventions to increase the rate of appropriate genetic counseling referrals of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in the community oncology setting.


Condition Intervention
Breast Cancer
Other: Active Provider Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters [ Time Frame: 1 year post diagnosis ] [ Designated as safety issue: No ]
    Site providers will be randomized and receive either the active or passive genetic counseling intervention. Post intervention, site providers will maintain a database of all newly diagnosed breast cancer patients that meet the study eligibility criteria. One year post diagnosis, subjects will be mailed an informed consent form including questionnaires from their providers. Returned patient questionnaire data along with information provided directly from site providers will be utilized to determine the rate of appropriate referral for genetic counseling.


Secondary Outcome Measures:
  • Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters [ Time Frame: 12-15 months post diagnosis ] [ Designated as safety issue: No ]

    Secondary outcomes will be assessed by patient questionnaire and medical record documentation, where appropriate, and include evaluation of:

    • The rate of pre-surgical referral of appropriate patients to genetic counseling
    • The rate of referral of newly diagnosed breast cancer patients who are not appropriate for genetic counseling referral
    • The rate of genetic counseling uptake
    • The rate of bilateral mastectomy, including the rate of bilateral mastectomy among patients receiving different genetic test results

    Psychosocial outcomes:

    • Perceived risk for future primary breast cancer and for ovarian cancer will be assessed
    • Knowledge of hereditary breast and ovarian cancer will be measured
    • Cancer-related distress will be assessed using answers from the patient questionnaire
    • Satisfaction with the decision regarding surgical treatment will be assessed
    • Provider knowledge outcomes from the educational session will also be assessed


Estimated Enrollment: 3780
Study Start Date: February 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Provider Intervention
Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients. They will also receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.
Other: Active Provider Intervention
Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve appropriate referral of breast cancer patients at risk for HBOC to genetic counseling and pre-surgical referral among newly diagnosed patients.
Other Name: Active Genetic Counseling Provider Intervention
No Intervention: Passive Provider Intervention
Participating Sites assigned to the passive intervention cluster will only receive the National Comprehensive Cancer Network (NCCN) guidelines and Commission on Cancer definition of qualified genetics professional.

Detailed Description:

Approximately 5-10% of all breast cancer patients have hereditary breast cancer, the majority due to an inherited mutation in the BRCA1 or BRCA2 genes (BRCA mutation carriers). Breast cancer patients who are BRCA mutation carriers have up to a 65% risk for a new primary breast cancer in the future. Additionally, BRCA mutation carriers have a 10-45% lifetime risk for ovarian cancer.

Effective options to decrease these high future cancer risks are available to breast cancer patients who learn they carry a BRCA mutation - including prophylactic mastectomy and oophorectomy. Prophylactic mastectomy and oophorectomy reduce the risks for future primary breast cancer and ovarian cancer, respectively, by more than 90%. Because of the high risks for future cancer and the opportunity for effective risk reduction among mutation carriers, national guidelines consistently recommend referral of breast cancer patients at increased risk for hereditary breast cancer and ovarian cancer (HBOC) to genetic counseling by a qualified genetics professional. Lack of implementation of this standard of care constitutes an error of omission and jeopardizes patient outcomes.

We propose a cluster randomized controlled trial to compare a "passive intervention" - dissemination of professional guidelines - with an "active intervention" - a multi-faceted provider education and decision support intervention to improve 1) appropriate referral of breast cancer patients at risk for HBOC to genetic counseling in the community cancer center setting and 2) pre-surgical referral among newly diagnosed patients. Ultimately, these results will lead to decreased breast and ovarian cancer incidence and mortality among breast cancer patients and their family members, as well as improved outcomes of and satisfaction with surgical decision-making.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Participant Inclusion Criteria:

  • Females 18 years of age or greater
  • Newly diagnosed primary breast cancer prior to initial definitive surgical treatment, including In situ and Invasive cancer, Stages 0 - III. Pathologic confirmation of diagnosis is required.
  • Able to read and write in English or Spanish

Participant Exclusion Criteria:

  • Any previous diagnosis of cancer except for non-melanoma skin cancer
  • Stage IV breast cancer
  • Received HBOC genetic counseling or mutation testing prior to diagnosis. If the patient was previously tested only for a variant of uncertain clinical significance (i.e., not for known familial mutation, Jewish ethnicity panel/Multisite 3 or comprehensive sequencing) and documentation is provided, they remain eligible.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01789684

Locations
United States, Florida
SunCoast CCOP Research Base Recruiting
Tampa, Florida, United States, 33612
Contact: Rebecca Sutphen, MD    800-909-1242    ccop@epi.usf.edu   
Principal Investigator: Rebecca Sutphen, MD         
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Rebecca Sutphen, MD University of South Florida
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01789684     History of Changes
Other Study ID Numbers: SCUSF 1102, SCUSF 1102, 5U10CA081920
Study First Received: February 7, 2013
Last Updated: August 19, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Institutional Review Board

Keywords provided by University of South Florida:
cluster
genetic counseling
breast cancer
HBOC
provider intervention

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014