Breast CancerBreastCARENCT01830933
Breast Cancer Risk Reduction: A Patient Doctor Intervention
A study testing BreastCARE in people with Breast Cancer, run by University of California, San Francisco at 2 sites in United States.
Trial summary
The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Breast Cancer
- What is being tested?
- BreastCARE
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,235 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient component:
- Women who visit the General Internal Medicine (GIM) practices at SFGH and UCSF during the study period
- Between the ages of 40 and 74
- Self-identify as Asian American, Spanish- and English-speaking Latinas, African American, or White
- Have no history of breast cancer are eligible to participate.
- Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF
Who cannot join
- Patient component: Women whose physicians object to their participation in the study
- Physician component: No exclusion criteria for physicians
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco General Hospital (SFGH)
San Francisco, California, 94110
University of California, San Francisco Mt. Zion campus
San Francisco, California, 94143
About this study
The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action.
- Conditions
- Breast Cancer
- Being tested
- BreastCARE
- Keywords
- Breast cancer concern, breast cancer risk perception, breast cancer risk
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BreastCAREOther
Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations.
| Study group | Role | What they receive |
|---|---|---|
| BreastCARE Intervention | Experimental | Intervention Clinic Patients: The RA will welcome the patient upon arrival at the clinic and again explain study procedures and field any questions. The RA will have the patient sign the HIPAA authorization form and then demonstrate how to enter information and answer questions on the tablet-PC and the patient will indicate their consent electronically before beginning the assessment.
Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patietns before she meets with her doctor. Receives: Other: BreastCARE |
| BreastCARE Comparison | No intervention | Patients will be randomized into the intervention or comparison groups at the time of recruitment. Block-randomization will be used to assign patients to intervention or comparison groups. Comparison Clinic Patients. Contact and baseline interview procedures will be the same for patients from the comparison clinics, however there will be no computer assessment at the time of their clinic visit. An RA will meet the patient 10 minutes prior to her appointment time to obtain written HIPAA authorization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge of Breast Cancer Risk Factors
Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O
Measured: one week post-initial visit (approximately one week)
Percentage of Participants With Correct Perception of Risk
This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.
Measured: baseline, one week post-initial visit (approximately one week)
Percentage of Participants Who Had a Discussion of Breast Cancer Risk
Self-reported discussion of breast cancer risk with physicians.
Measured: one week post-initial visit (approximately one week)
Percentage of Participants Who Reported Discussion of Mammography Screening
Self reported discussion of mammography with physician.
Measured: up to 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2013 (estimated)
- Study startJun 2011
- Primary completionAug 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 University of California, San FranciscoThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,235 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, California Breast Cancer Research Program
- Responsible party
- Sponsor
- Investigators
- Celia P Kaplan, DrPH, MA, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01830933
- Sponsor's protocol ID
- 150B-0158
- Acronym
- BreastCARE
- Status last verified
- Aug 2014
- First submitted
- 10 Apr 2013
- Last updated
- 19 Aug 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Livaudais-Toman J, Karliner LS, Tice JA, Kerlikowske K, Gregorich S, Perez-Stable EJ, Pasick RJ, Chen A, Quinn J, Kaplan CP. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial. Breast. 2015 Dec;24(6):758-66. doi: 10.1016/j.breast.2015.09.009. Epub 2015 Oct 21.
PubMed 26476466
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Risk Reduction: A Patient Doctor Intervention
- ClinicalTrials.gov ID
- NCT01830933
- Acronym / sponsor ID
- BreastCARE / 150B-0158
- Conditions
- Breast Cancer
- Keywords
- Breast cancer concern, breast cancer risk perception, breast cancer risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,235 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation, California Breast Cancer Research Program
- Study start
- Jun 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Apr 2013 (estimated)
- Results
- Posted 16 May 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed research combines the scientific advances in breast cancer research with health information technology (IT) to design a personalized intervention that assesses breast cancer risk for women, disseminates important breast health information, and facilitates discussion of breast cancer risk reduction practices. Our goal is to implement a tablet-PC (personal computer) based breast cancer risk education (BreastCare) intervention in the primary care setting that estimates a woman's individual risk for breast cancer and provides her and her physician with personalized breast cancer risk information and recommendations for action.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BreastCARE Intervention | Experimental | Other: BreastCAREIntervention Clinic Patients: The RA will welcome the patient upon arrival at the clinic and again explain study procedures and field any questions. The RA will have the patient sign the HIPAA authorization form and then demonstrate how to enter information and answer questions on the tablet-PC and the patient will indicate their consent electronically before beginning the assessment. Intervention Patient Report. Once the patient completes the BreastCare Computer survey, the program will immediately generate a personal feedback report containing information about her risk factors and recommendations to reduce her risk. This report will be printed and given to the patietns before she meets with her doctor. |
| BreastCARE Comparison | No intervention | –Patients will be randomized into the intervention or comparison groups at the time of recruitment. Block-randomization will be used to assign patients to intervention or comparison groups. Comparison Clinic Patients. Contact and baseline interview procedures will be the same for patients from the comparison clinics, however there will be no computer assessment at the time of their clinic visit. An RA will meet the patient 10 minutes prior to her appointment time to obtain written HIPAA authorization. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient component:
- Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF
Key exclusion criteria (2 listed)
- Patient component: Women whose physicians object to their participation in the study
- Physician component: No exclusion criteria for physicians
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 |
|---|---|---|
| BreastCAREPhysician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations. | Other | BreastCARE Intervention |
Primary outcome
Knowledge of Breast Cancer Risk Factors
Time frame: one week post-initial visit (approximately one week)
Risk knowledge was assessed using a post-survey. Participants could have scored 0-100 (with 0 meaning no correct answers, and 100 is all correct answers). This outcome was measured through a survey. Breast cancer risk knowledge was based on a series of eight questions in the survey. O
Percentage of Participants With Correct Perception of Risk
Time frame: baseline, one week post-initial visit (approximately one week)
This outcome was measured through a survey. Women were asked what they thought about their risk of getting breast cancer was compared to other women of the same age.
Percentage of Participants Who Had a Discussion of Breast Cancer Risk
Time frame: one week post-initial visit (approximately one week)
Self-reported discussion of breast cancer risk with physicians.
Percentage of Participants Who Reported Discussion of Mammography Screening
Time frame: up to 14 months
Self reported discussion of mammography with physician.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26476466Livaudais-Toman J, Karliner LS, Tice JA, Kerlikowske K, Gregorich S, Perez-Stable EJ, Pasick RJ, Chen A, Quinn J, Kaplan CP. Impact of a primary care based intervention on breast cancer knowledge, risk perception and concern: A randomized, controlled trial. Breast. 2015 Dec;24(6):758-66. doi: 10.1016/j.breast.2015.09.009. Epub 2015 Oct 21.
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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.
Celia P Kaplan, DrPH, MA principal investigator
University of California, San Francisco
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BreastCARE in people with Breast Cancer, run by University of California, San Francisco at 2 sites 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 6 inclusion and 2 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 19 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 16 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Knowledge of Breast Cancer Risk Factors (time frame: one week post-initial visit (approximately one week)). The study lists 4 primary outcomes in all. 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 NCT01830933, 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 19 Aug 2014.