Newly Diagnosed Carcinoma of Breast4RNCT01320540
4R for Guideline Indicated BRCA Testing of Breast Center Patients
An observational study of Newly Diagnosed Carcinoma of Breast and Genetic Predisposition to Disease, run by Northwestern University at 1 site in United States.
Trial summary
Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery or at a time point that does not allow them to use testing results in making their surgical decision. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Newly Diagnosed Carcinoma of Breast, Genetic Predisposition to Disease
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Jan 2016
- Phase
- Observational
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women newly diagnosed with breast cancer
Who may be able to join
- Retrospective chart review of 83 breast cancer patients:
- Female
- Age 18 and older
- Diagnosed with invasive breast cancer at Northwestern between 07/01/2008 and 06/30/2010
- Prospective chart review of 83 patients:
- Female
Show all 15Show fewer
- Age 18 and older
- Diagnosed with invasive breast cancer at Northwestern between 03/01/2011 and 05/31/2012
- For patient interviews:
- Female
- Age 18 and older
- Are not inpatients
- Patients seen at the Lynn Sage Comprehensive Breast Center
- For staff interviews:
- Members of the Northwestern staff to include but not limited the Lynn Sage Comprehensive Breast Cancer Center and/or Breast Cancer Genetics Program provider staff (including physicians, nurses, schedulers, physician assistants and/or genetic counselors)
Who cannot join
- Under 18 years of age
- To test the intervention, patients seen at the breast center:
- Are female
- Are age 18 and older
- Are not institutionalized
- Are being seen at the Lynn Sage Comprehensive Breast Center
- Have a positive family history per NCCN guidelines on genetic/familial high risk assessment for breast and ovarian cancer
- Under 18 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: 4R (Right Information and Right Care to the Right Patient at the Right Time) for Guideline Indicated BRCA Genetic Assessment of Breast Center Patients
Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery or at a time point that does not allow them to use testing results in making their surgical decision. Diagnostics, decisions and interventions are often out of sequence, resulting in test information not available in time for decisions. Tests are often repeated. Decisions and interventions are delayed, are not understood by breast cancer patients or proceed without the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005, Katz SJ 2007, IOM 2001).
In this study, BRCA testing information will be delivered to patients at the point of breast imaging. For patients that are diagnosed with breast cancer, this provides ample time to use the test results in making their surgical decision, if they elect to be tested. The investigators will work with health care providers to insure family history data are collected at the breast imaging visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population, and coordinate scheduling with genetic counseling services to insure patients are promptly seen.
The investigators hypothesis is that an intervention of providing patients indicated for genetic/familial risk with timely information and opportunity to access genetic counseling during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for patients with a breast cancer diagnosis, and could impact surgical decisions. The investigators will identify barriers to this intervention from the perspective of patients, physicians, nurses, and genetic counselors. The investigators will then adjust the intervention to overcome the barriers and will test the intervention at the point where genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at breast imaging. If indicated, patients will be provided information and will be referred to genetic counseling to consider BRCA tests.
Read the detailed description
This study is expected to involve a total of 2,101 individuals: 89 (83 for testing the intervention and 6 who participated in interviews like Northwestern staff participants) breast cancer patients, 12 Northwestern staff,and 2,000 women who consented and participated in the genetics assessment screening survey using the tool, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.
All subjects will be assigned a unique study number to minimize the risk of a breach of confidentiality. This is the only anticipated risk to subjects participating in this study utilizing retrospective and prospective chart reviews and interviews.
TESTING THE INTERVENTION
Investigators will collect retrospective data for 83 breast cancer patients diagnosed who underwent BRCA testing and definitive breast cancer surgery at Northwestern between 07/01/2008 to 06/30/2010. This baseline information detailed on the Data Collection Form will be collected using EDW and NMFF and NMH medical record systems.
The intervention involves radiologists who convey pathology results to patients with suspected breast cancers. At the time the patient with a familial/ genetic risk is informed of a positive test result for breast cancer, the radiologist will provide information about genetic counseling and offer to send an educational handout via e-mail or regular mail. This intervention will be conducted with newly diagnosed breast cancer patients between 03/01/2011and 05/31/2012.
Investigators will prospectively collect data on these 83 breast cancer patients who are diagnosed, received BRCA testing, and had definitive surgery at Northwestern during the time of the intervention, 03/01/2011 and 05/31/2012. The EDW and NMFF and NMH medical record systems will be used to collect this information.
Because the intervention and retrospective and prospective chart reviews pose minimal risk to the subjects and locating the patients or having access to the patients would be time and cost prohibitive, a waiver of consent and HIPAA is requested.
ASSESS IMPACT OF THE INTERVENTION
Study investigators will conduct interviews with a total of 6 breast cancer patients and 12 Northwestern staff to determine if the intervention improved the care process. Written consent will be obtained from all interview participants. Participants will have the option of being audiotaped. Audiotaping is not required.
- Prior to the intervention, investigators will interview 6 breast cancer patients and 12 Northwestern staff to find out about the current care process and opinions/feedback on proposed intervention.
- Following the intervention, 6 patients and 12 staff will be interviewed using the same questions and format. It is acceptable that the individuals participating in the post-intervention interview are not the same as those participating in the pre-intervention interview.
INTERVENTION TEST/INTERVENTION IMPLEMENTATION
The intervention will be tested with women age 18 and older who have a history of genetic/familial risk and patients at the Lynn Sage Comprehensive Breast Center between March 1, 2013 and February 28, 2014. There will be no follow up on these patients after March 31, 2014..
- Select breast center patients who consent to participate in this study will take a basic familial/genetic risk survey that follows NCCN guidelines (up to 2,000 patients will be consented into this study, with a sub-cohort of up to 300 who are identified to have a familial / genetic risk for breast cancer. If no risk is identified, the patient is not specifically informed of genetic counseling.
- For study consented breast center patients with familial / genetic risk, the cancer genetics program will provide information about genetic counseling. The research staff will track those patients who receive information about genetic counseling.
- Medical subject headings
- Genetic Predisposition to Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast Center Patients | Patients newly diagnosed with breast cancer who did or did not have genetic testing (retrospectively and prospectively). | |
| Staff from the Lynn Sage Comprehensive Breast Cancer Center | Members of the Northwestern staff to include but not limited the Lynn Sage Comprehensive Breast Cancer Center and/or Breast Cancer Genetics Program provider staff (including physicians, nurses, schedulers, physician assistants and/or genetic counselors). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The timing of genetic testing in regards to what kind of surgery was performed
To test an intervention for breast cancer patients with familial/genetic risk by obtaining data on 83 women with breast cancer who were tested before the intervention was implemented and comparing their outcomes to 83 women with breast cancer who were treated after the intervention was implemented. The primary endpoint is the timing of BRCA testing relative to (before or after) definitive breast cancer surgery and the surgical decision (lumpectomy, mastectomy, bi-lateral mastectomy).
Measured: 36 months
The timing of genetic testing in regards to what kind of surgery was performed
To test an intervention for breast center patients with familial/genetic risk by obtaining data on 2,000 women who consented and participated in the genetics assessment screening survey, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.
Measured: 12 months
Secondary outcomes (1)
Impact of the intervention
To assess the care process impact of the intervention on patients and provider staff through pre and post intervention interviews. The process impact will be assessed by comparing the questionnaires from the pre and post intervention interviews in 6 patients and 12 providers.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newly Diagnosed Carcinoma of BreastStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melissa Simon, Northwestern University
- Investigators
- Melissa Simon, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01320540
- Sponsor's protocol ID
- STU00041300
- Acronym
- 4R
- Status last verified
- Aug 2016
- First submitted
- 18 Mar 2011
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4R (Right Information and Right Care to the Right Patient at the Right Time) for Guideline Indicated BRCA Genetic Assessment of Breast Center Patients
- ClinicalTrials.gov ID
- NCT01320540
- Acronym / sponsor ID
- 4R / STU00041300
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 22 Mar 2011 (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.
Currently, many breast center patients with a positive family history receive information about BRCA testing after breast cancer diagnosis, typically after definitive breast surgery or at a time point that does not allow them to use testing results in making their surgical decision. Diagnostics, decisions and interventions are often out of sequence, resulting in test information not available in time for decisions. Tests are often repeated. Decisions and interventions are delayed, are not understood by breast cancer patients or proceed without the test information, resulting in suboptimal care and resource waste (Donaldson MS. 2005, Katz SJ 2007, IOM 2001).
In this study, BRCA testing information will be delivered to patients at the point of breast imaging. For patients that are diagnosed with breast cancer, this provides ample time to use the test results in making their surgical decision, if they elect to be tested. The investigators will work with health care providers to insure family history data are collected at the breast imaging visit, develop a standardized BRCA patient education handout, enlist health care providers to insure the information is delivered to the appropriate patient population, and coordinate scheduling with genetic counseling services to insure patients are promptly seen.
The investigators hypothesis is that an intervention of providing patients indicated for genetic/familial risk with timely information and opportunity to access genetic counseling during breast imaging will shift BRCA testing to before definitive breast cancer surgery, for patients with a breast cancer diagnosis, and could impact surgical decisions. The investigators will identify barriers to this intervention from the perspective of patients, physicians, nurses, and genetic counselors. The investigators will then adjust the intervention to overcome the barriers and will test the intervention at the point where genetic/familial risk assessment based on NCCN guidelines is (or should be) conducted at breast imaging. If indicated, patients will be provided information and will be referred to genetic counseling to consider BRCA tests.
Detailed description
This study is expected to involve a total of 2,101 individuals: 89 (83 for testing the intervention and 6 who participated in interviews like Northwestern staff participants) breast cancer patients, 12 Northwestern staff,and 2,000 women who consented and participated in the genetics assessment screening survey using the tool, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.
All subjects will be assigned a unique study number to minimize the risk of a breach of confidentiality. This is the only anticipated risk to subjects participating in this study utilizing retrospective and prospective chart reviews and interviews.
TESTING THE INTERVENTION
Investigators will collect retrospective data for 83 breast cancer patients diagnosed who underwent BRCA testing and definitive breast cancer surgery at Northwestern between 07/01/2008 to 06/30/2010. This baseline information detailed on the Data Collection Form will be collected using EDW and NMFF and NMH medical record systems.
The intervention involves radiologists who convey pathology results to patients with suspected breast cancers. At the time the patient with a familial/ genetic risk is informed of a positive test result for breast cancer, the radiologist will provide information about genetic counseling and offer to send an educational handout via e-mail or regular mail. This intervention will be conducted with newly diagnosed breast cancer patients between 03/01/2011and 05/31/2012.
Investigators will prospectively collect data on these 83 breast cancer patients who are diagnosed, received BRCA testing, and had definitive surgery at Northwestern during the time of the intervention, 03/01/2011 and 05/31/2012. The EDW and NMFF and NMH medical record systems will be used to collect this information.
Because the intervention and retrospective and prospective chart reviews pose minimal risk to the subjects and locating the patients or having access to the patients would be time and cost prohibitive, a waiver of consent and HIPAA is requested.
ASSESS IMPACT OF THE INTERVENTION
Study investigators will conduct interviews with a total of 6 breast cancer patients and 12 Northwestern staff to determine if the intervention improved the care process. Written consent will be obtained from all interview participants. Participants will have the option of being audiotaped. Audiotaping is not required.
- Prior to the intervention, investigators will interview 6 breast cancer patients and 12 Northwestern staff to find out about the current care process and opinions/feedback on proposed intervention.
- Following the intervention, 6 patients and 12 staff will be interviewed using the same questions and format. It is acceptable that the individuals participating in the post-intervention interview are not the same as those participating in the pre-intervention interview.
INTERVENTION TEST/INTERVENTION IMPLEMENTATION
The intervention will be tested with women age 18 and older who have a history of genetic/familial risk and patients at the Lynn Sage Comprehensive Breast Center between March 1, 2013 and February 28, 2014. There will be no follow up on these patients after March 31, 2014..
- Select breast center patients who consent to participate in this study will take a basic familial/genetic risk survey that follows NCCN guidelines (up to 2,000 patients will be consented into this study, with a sub-cohort of up to 300 who are identified to have a familial / genetic risk for breast cancer. If no risk is identified, the patient is not specifically informed of genetic counseling.
- For study consented breast center patients with familial / genetic risk, the cancer genetics program will provide information about genetic counseling. The research staff will track those patients who receive information about genetic counseling.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Center Patients | – | –Patients newly diagnosed with breast cancer who did or did not have genetic testing (retrospectively and prospectively). |
| Staff from the Lynn Sage Comprehensive Breast Cancer Center | – | –Members of the Northwestern staff to include but not limited the Lynn Sage Comprehensive Breast Cancer Center and/or Breast Cancer Genetics Program provider staff (including physicians, nurses, schedulers, physician assistants and/or genetic counselors). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women newly diagnosed with breast cancer
Key inclusion criteria (15 listed)
- Female
- Age 18 and older
- Diagnosed with invasive breast cancer at Northwestern between 07/01/2008 and 06/30/2010
- Female
- Age 18 and older
Key exclusion criteria (8 listed)
- Under 18 years of age
- Are female
- Are age 18 and older
- Are not institutionalized
- Are being seen at the Lynn Sage Comprehensive Breast Center
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The timing of genetic testing in regards to what kind of surgery was performed
Time frame: 36 months
To test an intervention for breast cancer patients with familial/genetic risk by obtaining data on 83 women with breast cancer who were tested before the intervention was implemented and comparing their outcomes to 83 women with breast cancer who were treated after the intervention was implemented. The primary endpoint is the timing of BRCA testing relative to (before or after) definitive breast cancer surgery and the surgical decision (lumpectomy, mastectomy, bi-lateral mastectomy).
The timing of genetic testing in regards to what kind of surgery was performed
Time frame: 12 months
To test an intervention for breast center patients with familial/genetic risk by obtaining data on 2,000 women who consented and participated in the genetics assessment screening survey, with a sub-cohort of 300 that may benefit from genetic assessment and/or testing based on the screening tool results.
1 secondary outcome
Impact of the intervention
Time frame: 36 months
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 3 Aug 2016.
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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.
Melissa Simon, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Newly Diagnosed Carcinoma of Breast and Genetic Predisposition to Disease, run by Northwestern University 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?
The sponsor lists 15 inclusion and 8 exclusion criteria. 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 3 Aug 2016. 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?
The timing of genetic testing in regards to what kind of surgery was performed (time frame: 36 months). The study lists 2 primary outcomes in all. 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 3 Aug 2016.