Breast Cancer Clinical Trial
— SCUSF 1102Official title:
A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients
Verified date | October 2019 |
Source | University of South Florida |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3780 |
Est. completion date | January 2020 |
Est. primary completion date | September 2019 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | SunCoast CCOP Research Base | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
University of South Florida | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 1 year post diagnosis | |
Secondary | 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 |
12-15 months post diagnosis |
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