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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Provider Intervention
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring cluster, genetic counseling, breast cancer, HBOC, provider intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • SunCoast CCOP Research Base

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Active Provider Intervention

Passive Provider Intervention

Arm Description

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.

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.

Outcomes

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
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
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

Full Information

First Posted
February 7, 2013
Last Updated
January 28, 2021
Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01789684
Brief Title
Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients
Acronym
SCUSF 1102
Official Title
A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 2014 (undefined)
Primary Completion Date
September 2019 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
cluster, genetic counseling, breast cancer, HBOC, provider intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3780 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Provider Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Passive Provider Intervention
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Active Provider Intervention
Other Intervention Name(s)
Active Genetic Counseling Provider Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters
Description
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.
Time Frame
1 year post diagnosis
Secondary Outcome Measure Information:
Title
Rate of appropriate referral of newly diagnosed breast cancer patients at increased risk for HBOC to genetic counseling in Active vs. Passive Intervention Clusters
Description
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
Time Frame
12-15 months post diagnosis

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rebecca Sutphen, MD
Organizational Affiliation
University of South Florida
Official's Role
Study Chair
Facility Information:
Facility Name
SunCoast CCOP Research Base
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

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Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients

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