Breast CancerNCT03180086
Breast Cancer Risk Assessment in Women Aged 40-49
A study testing Breast cancer risk report in people with Breast Cancer, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
In a randomized controlled trial, the investigators will test the effect of a novel strategy for breast cancer risk assessment and risk-based management of women in their 40s seen in primary care. Read more about this study
- Who is it for?
- Ages 40 to 49 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Breast cancer risk report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 338 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 25 Nov 2019
- 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 40 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women
- aged 40-49 years
- read and speak English
- scheduled for a routine visit or physical examination with a non-resident PCP in the next 4-12 weeks at HealthCare Associates (HCA, BIDMC's outpatient primary care practice).
Who cannot join
- women scheduled for acute care
- women who had or will have a mammogram within 6 months of their PCP visit
- women with a history of breast cancer or a BRCA mutation
- women already receiving screening breast MRIs
- women who have been referred to genetic counseling
- women who have taken or are taking tamoxifen or aromatase inhibitors for breast cancer prevention
- women with a history of an abnormal mammogram in the past two years
- women with a history of breast enlargement or reduction.
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
About this study
In a randomized controlled trial, the investigators will test the effect of a novel strategy for breast cancer risk assessment and risk-based management of women in their 40s seen in primary care. The investigators anticipate that this approach will lead to more optimal use of mammography screening and breast cancer prevention interventions in women in their 40s and as a result will improve care of these women.
Read the detailed description
There is currently no standardized practice for addressing breast cancer risk in primary care. While there are guidelines encouraging PCPs to assess patients' breast cancer risk, few PCPs assess patients' risk due to time constraints in primary care, lack of familiarity with risk calculators, and knowledge on how to incorporate risk into the care of women. Around 20% of PCPs have reported using a risk calculator but few routinely asses patients' risk. In HealthCare Associates (HCA), Beth Israel Deaconess Medical Center's primary-care based practice, the online medical record (OMR) has recently been edited to allow for PCPs to enter patients' breast cancer risk. However, it is not known whether PCPs are using this tab. To calculate patient's breast cancer risk, PCPs must go to web-based calculators, ask patients their risk factors, enter the information and then add the estimated risk to OMR. Previous studies suggest that leaving risk assessment to PCPs results in few women having their risk assessed. Instead, PCPs tend to simply use family history when deciding whether or not patients are at high risk. However, family history is only one risk factor for breast cancer. Therefore, the investigators will send women ages 40-49 participating in this study a questionnaire to complete before a visit to assess their risk factors for breast cancer. Using this information, the investigators will calculate patients' breast cancer risk using the available breast cancer risk assessment models and will present women with a personalized breast cancer risk report immediately before a visit with their PCP. After the visit, patients will be asked to complete a follow-up questionnaire about their experience and through their medical records will be followed to learn whether or not they are screened with mammography. The investigators will follow high-risk women to learn whether or not they receive a screening breast MRI, BRCA gene testing, and/or the option to take breast cancer prevention medications. The investigators aim to recruit 445 women 40-49 years seen at HCA into a single arm trial to learn the effect of our personalized risk based approach to breast cancer screening and prevention on women in their 40's intentions to be screened and knowledge of the pros and cons of screening.
Specific Aims: To determine the effect of a personalized risk based approach for breast cancer screening and prevention for women in their 40s seen in primary care on:
- women's intentions to be screened with mammography (primary outcome),
- knowledge of the pros and cons of mammography screening, and
- decisional conflict around screening; and on
- patient report of PCP discussion of their breast cancer risk and of the pros and cons of mammography screening.
- Conditions
- Breast Cancer
- Being tested
- Breast cancer risk report
- Keywords
- Breast cancer risk, Primary Care, Women
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breast cancer risk reportOther
An individualized report will inform women of their 5-year breast cancer risk using BCRAT or Tice (when breast density is available from a past mammogram), whichever is higher, and the average 5-year risk for women their age. The report will present 5-year risk as a frequency and in a pictograph and it will describe what experts recommend in terms of mammography screening, breast cancer prevention medications, breast MRIs, and BRCA testing, for women in their 40s based on their risk.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer risk report | Experimental | An individualized report will inform women of their 5-year breast cancer risk using BCRAT or Tice (when breast density is available from a past mammogram), whichever is higher, and the average 5-year risk for women their age. The report will present 5-year risk as a frequency and in a pictograph and it will describe what experts recommend in terms of mammography screening, breast cancer prevention medications, breast MRIs, and BRCA testing, for women in their 40s based on their risk. Receives: Other: Breast cancer risk report |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening intentions
Change in women's intentions to be screened with mammography after the intervention by 5-year breast cancer risk using a multivariable linear regression to examine the association between 5-year breast cancer risk and intentions to be screened after the intervention (as a continuous variable from 1 [not intending to be screened] to 15 [strongly intending to be screened]) adjusting for intentions to be screened at baseline as well as age, educational attainment, and race/ethnicity.
Measured: 1 week
Secondary outcomes (18)
Screening intentions within risk groups
The investigators will us the paired t-test (or Wilcoxon Signed Rank Test if data are not normal) to examine the differences in intentions to be screened with mammography after the intervention within each risk group.
Measured: 1 week
Knowledge of the pros and cons of mammography screening
The investigators will use the paired t-test (or Wilcoxon Signed Rank Test when data are not normal) to examine the effect of the intervention on participants' knowledge of the benefits and risks of mammography screening (mean score on knowledge test)
Measured: 1 week
Decisional conflict scale
The DCS is a validated 16 item scale to measure uncertainty around a decision, whether one feels informed, clear about their personal values, and supported in their decision-making (Cronbach's alpha=0.78 to 0.92); scores range 0-100 and lower scores indicate less conflict.
Measured: 1 week
Difference in PCP discussion of breast cancer risk
The investigators will use McNemar's test to examine patient reports of PCP discussions of breast cancer risk [yes/no] before and after the intervention.
Measured: 1 week
Difference in PCP discussion of pros/cons of mammography screening
The investigators will use McNemar's test to examine patient report of PCP discussion of the pros and cons of mammography screening [yes/no] before and after the intervention.
Measured: 1 week
PCP discussion of breast cancer prevention medications
The investigators will use descriptive statistics to examine the proportion of women with >1.7% 5-year breast cancer risk that report discussing breast cancer prevention medications with their PCP.
Measured: 1 week
PCP documentation of discussions of breast cancer medications
The investigators will use descriptive statistics to examine the proportion of women with >1.7% 5-year breast cancer whose PCPs document discussions about breast cancer prevention medications on the day of the visit.
Measured: 1 week
Prescription of breast cancer prevention medications
The investigators will use descriptive statistics to report proportion of women with >1.7% 5-year breast cancer risk who were prescribed breast cancer prevention medications through review of medication lists
Measured: 6 months
Time until breast screening MRI
The investigators will use the log-rank test to examine time until breast screening MRI among women with >20% lifetime breast cancer risk by lifetime breast cancer risk score as a continuous variable.
Measured: 6 months
Referral to genetic counseling
The investigators will examine the proportion of women who meet NCCN criteria for genetic counseling for a BRCA mutation that are referred for genetic counseling
Measured: 6 months
Attended genetic counseling
The investigators will examine the proportion of women who meet NCCN criteria for genetic counseling for a BRCA mutation that meet with a genetic counselor
Measured: 6 months
Time until next mammogram after intervention
The investigators will examine the time until next mammogram after our intervention stratified by women's 5-year risk of breast cancer (based on the Breast Cancer Risk Assessment Tool [BCRAT]/Tice model [whichever is higher]) using the log-rank test.
Measured: 21 months
Date of mammogram(s) after intervention
The investigators will document the date of mammogram performed on any women in the study during the study's follow-up time period.
Measured: 21 months
Type of mammogram(s) after intervention
The investigators will document the type of mammogram performed on any women in the study during the study's follow-up time period.
Measured: 21 months
No mammogram after intervention
The investigators will perform a chart review of women not identified as having had a mammogram during the study's follow-up time period to confirm that there is no mammogram noted in their screening sheet.
Measured: 21 months
Risk report acceptability
The investigators will ask whether patients and PCPs found our risk report acceptable and/or helpful.
Measured: 1 week
PCP facilitators and barriers
The investigators will examine facilitators and/or barriers noted by PCPs when assessing women's breast cancer risk and managing women based on their risk.
Measured: up to 24 months
PCP risk of malpractice/litigation
The investigators will ask whether PCPs feel that our intervention would help lower their risk of malpractice litigation.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start1 Jul 2017
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 338 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mara Schonberg, Beth Israel Deaconess Medical Center
- Investigators
- Mara Schonberg, MD, MPH, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180086
- Sponsor's protocol ID
- 2017P000129
- Status last verified
- Nov 2023
- First submitted
- 6 Jun 2017
- Last updated
- 14 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schonberg MA, Davis RB, Karamourtopoulos MC, Pinheiro A, Sternberg SB, Jacobson AR, Aliberti GM, Mehta TS, Cluett JL, Cohen ML, Atlas T, Tung NM. A Pre-Test-Post-Test Trial of a Breast Cancer Risk Report for Women in Their 40s. Am J Prev Med. 2020 Sep;59(3):343-354. doi: 10.1016/j.amepre.2020.04.014.
PubMed 32828322
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Risk Assessment in Women Aged 40-49
- ClinicalTrials.gov ID
- NCT03180086
- Acronym / sponsor ID
- 2017P000129
- Conditions
- Breast Cancer
- Keywords
- Breast cancer risk, Primary Care, Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 338 participants (actual)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 8 Jun 2017 (actual)
- 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.
In a randomized controlled trial, the investigators will test the effect of a novel strategy for breast cancer risk assessment and risk-based management of women in their 40s seen in primary care. The investigators anticipate that this approach will lead to more optimal use of mammography screening and breast cancer prevention interventions in women in their 40s and as a result will improve care of these women.
Detailed description
There is currently no standardized practice for addressing breast cancer risk in primary care. While there are guidelines encouraging PCPs to assess patients' breast cancer risk, few PCPs assess patients' risk due to time constraints in primary care, lack of familiarity with risk calculators, and knowledge on how to incorporate risk into the care of women. Around 20% of PCPs have reported using a risk calculator but few routinely asses patients' risk. In HealthCare Associates (HCA), Beth Israel Deaconess Medical Center's primary-care based practice, the online medical record (OMR) has recently been edited to allow for PCPs to enter patients' breast cancer risk. However, it is not known whether PCPs are using this tab. To calculate patient's breast cancer risk, PCPs must go to web-based calculators, ask patients their risk factors, enter the information and then add the estimated risk to OMR. Previous studies suggest that leaving risk assessment to PCPs results in few women having their risk assessed. Instead, PCPs tend to simply use family history when deciding whether or not patients are at high risk. However, family history is only one risk factor for breast cancer. Therefore, the investigators will send women ages 40-49 participating in this study a questionnaire to complete before a visit to assess their risk factors for breast cancer. Using this information, the investigators will calculate patients' breast cancer risk using the available breast cancer risk assessment models and will present women with a personalized breast cancer risk report immediately before a visit with their PCP. After the visit, patients will be asked to complete a follow-up questionnaire about their experience and through their medical records will be followed to learn whether or not they are screened with mammography. The investigators will follow high-risk women to learn whether or not they receive a screening breast MRI, BRCA gene testing, and/or the option to take breast cancer prevention medications. The investigators aim to recruit 445 women 40-49 years seen at HCA into a single arm trial to learn the effect of our personalized risk based approach to breast cancer screening and prevention on women in their 40's intentions to be screened and knowledge of the pros and cons of screening.
Specific Aims: To determine the effect of a personalized risk based approach for breast cancer screening and prevention for women in their 40s seen in primary care on:
- women's intentions to be screened with mammography (primary outcome),
- knowledge of the pros and cons of mammography screening, and
- decisional conflict around screening; and on
- patient report of PCP discussion of their breast cancer risk and of the pros and cons of mammography screening.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer risk report | Experimental | Other: Breast cancer risk reportAn individualized report will inform women of their 5-year breast cancer risk using BCRAT or Tice (when breast density is available from a past mammogram), whichever is higher, and the average 5-year risk for women their age. The report will present 5-year risk as a frequency and in a pictograph and it will describe what experts recommend in terms of mammography screening, breast cancer prevention medications, breast MRIs, and BRCA testing, for women in their 40s based on their risk. |
Who may qualify
- Ages
- 40 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women
- aged 40-49 years
- read and speak English
- scheduled for a routine visit or physical examination with a non-resident PCP in the next 4-12 weeks at HealthCare Associates (HCA, BIDMC's outpatient primary care practice).
Key exclusion criteria (8 listed)
- women scheduled for acute care
- women who had or will have a mammogram within 6 months of their PCP visit
- women with a history of breast cancer or a BRCA mutation
- women already receiving screening breast MRIs
- women who have been referred to genetic counseling
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 |
|---|---|---|
| Breast cancer risk reportAn individualized report will inform women of their 5-year breast cancer risk using BCRAT or Tice (when breast density is available from a past mammogram), whichever is higher, and the average 5-year risk for women their age. The report will present 5-year risk as a frequency and in a pictograph and it will describe what experts recommend in terms of mammography screening, breast cancer prevention medications, breast MRIs, and BRCA testing, for women in their 40s based on their risk. | Other | Breast cancer risk report |
Primary outcome
Screening intentions
Time frame: 1 week
Change in women's intentions to be screened with mammography after the intervention by 5-year breast cancer risk using a multivariable linear regression to examine the association between 5-year breast cancer risk and intentions to be screened after the intervention (as a continuous variable from 1 [not intending to be screened] to 15 [strongly intending to be screened]) adjusting for intentions to be screened at baseline as well as age, educational attainment, and race/ethnicity.
18 secondary outcomes
Screening intentions within risk groups
Time frame: 1 week
Knowledge of the pros and cons of mammography screening
Time frame: 1 week
Decisional conflict scale
Time frame: 1 week
Difference in PCP discussion of breast cancer risk
Time frame: 1 week
Difference in PCP discussion of pros/cons of mammography screening
Time frame: 1 week
PCP discussion of breast cancer prevention medications
Time frame: 1 week
PCP documentation of discussions of breast cancer medications
Time frame: 1 week
Prescription of breast cancer prevention medications
Time frame: 6 months
Time until breast screening MRI
Time frame: 6 months
Referral to genetic counseling
Time frame: 6 months
Attended genetic counseling
Time frame: 6 months
Time until next mammogram after intervention
Time frame: 21 months
Date of mammogram(s) after intervention
Time frame: 21 months
Type of mammogram(s) after intervention
Time frame: 21 months
No mammogram after intervention
Time frame: 21 months
Risk report acceptability
Time frame: 1 week
PCP facilitators and barriers
Time frame: up to 24 months
PCP risk of malpractice/litigation
Time frame: up to 24 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 14 Nov 2023.
- Derived from this study: PubMed 32828322Schonberg MA, Davis RB, Karamourtopoulos MC, Pinheiro A, Sternberg SB, Jacobson AR, Aliberti GM, Mehta TS, Cluett JL, Cohen ML, Atlas T, Tung NM. A Pre-Test-Post-Test Trial of a Breast Cancer Risk Report for Women in Their 40s. Am J Prev Med. 2020 Sep;59(3):343-354. doi: 10.1016/j.amepre.2020.04.014.
- Individual participant dataSharing planned: No
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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.
Mara Schonberg, MD, MPH principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast cancer risk report in people with Breast Cancer, run by Beth Israel Deaconess Medical Center 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 4 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 14 Nov 2023. 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?
Screening intentions (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03180086, which also lists 1 linked publication.
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 14 Nov 2023.