Breast CancerSCUSF 1102NCT01789684
Cluster Randomized Trial Comparing Interventions to Enhance Genetic Counseling Among Breast Cancer Patients
A study testing Active Provider Intervention in people with Breast Cancer, run by University of South Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Active Provider Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,780 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Active Provider Intervention
- Keywords
- cluster, genetic counseling, breast cancer, HBOC, provider intervention
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Provider InterventionOther
Also called Active Genetic Counseling 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.
| Study group | Role | What they receive |
|---|---|---|
| Active Provider Intervention | Experimental | 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. Receives: Other: Active Provider Intervention |
| Passive Provider Intervention | No 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year post diagnosis
Secondary outcomes (1)
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
Measured: 12-15 months post diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startFeb 2014
- Primary completionSep 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,780 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Rebecca Sutphen, MD, Study chair, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789684
- Sponsor's protocol ID
- SCUSF 1102
- Other IDs
- SCUSF 1102, 5U10CA081920
- Acronym
- SCUSF 1102
- Status last verified
- Oct 2019
- First submitted
- 7 Feb 2013
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster Randomized Controlled Trial Comparing Interventions to Enhance Utilization of Genetics Services Among Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01789684
- Acronym / sponsor ID
- SCUSF 1102 / SCUSF 1102
- Conditions
- Breast Cancer
- Keywords
- cluster, genetic counseling, breast cancer, HBOC, provider intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,780 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2014
- Primary completion
- Sep 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Provider Intervention | Experimental | Other: Active Provider InterventionParticipating 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. |
| Passive Provider Intervention | No 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Provider InterventionAlso: Active Genetic Counseling Provider InterventionParticipating 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 | Active Provider Intervention |
Primary outcome
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
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 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rebecca Sutphen, MD study chair
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Provider Intervention in people with Breast Cancer, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.