4R for Guideline Indicated BRCA Testing of Breast Center Patients
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Other Indications |
| Therapuetic Areas: | Oncology, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/4/2016 |
| Start Date: | March 2011 |
| End Date: | January 2016 |
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.
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.
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..
1. 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.
2. 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.
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..
1. 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.
2. 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.
Inclusion Criteria:
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
- 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)
Exclusion Criteria:
- 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
Exclusion Criteria:
- Under 18 years of age
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