Breast Cancer
Conditions
Keywords
Breast cancer concern, breast cancer risk perception, breast cancer risk
Brief 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 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.
Interventions
OTHERBreastCARE
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.
Sponsors
Susan G. Komen Breast Cancer Foundation
California Breast Cancer Research Program
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. Physician component: Primary care physicians currently practicing at the GIM clinics at SFGH and UCSF
Exclusion criteria
1. Patient component: Women whose physicians object to their participation in the study 2. Physician component: No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Knowledge of Breast Cancer Risk Factors | 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 | 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 | 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 | up to 14 months | Self reported discussion of mammography with physician. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Usual Care is the comparison Clinic Patients, where there is no change in their standard or usual care. | 655 |
| BreastCARE Intervention Intervention Clinic Patients: The participants will answer questions on the tablet-PC to calculate their breast cancer risk.
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 patients before she meets with her doctor.
BreastCARE : The physician will receive a physician report that contains information similar to the patient report. | 580 |
| Total | 1,235 |
Baseline characteristics
| Characteristic | Usual Care | BreastCARE Intervention | Total |
|---|---|---|---|
| Age, Customized <50 years | 183 participants | 182 participants | 365 participants |
| Age, Customized 51-65 years | 362 participants | 300 participants | 662 participants |
| Age, Customized >65 years | 110 participants | 98 participants | 208 participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 123 participants | 105 participants | 228 participants |
| Race/Ethnicity, Customized Black/ African American | 150 participants | 125 participants | 275 participants |
| Race/Ethnicity, Customized Latina | 144 participants | 141 participants | 285 participants |
| Race/Ethnicity, Customized Native American or Other | 9 participants | 7 participants | 16 participants |
| Race/Ethnicity, Customized Non-Latina White | 229 participants | 202 participants | 431 participants |
| Region of Enrollment United States | 655 participants | 580 participants | 1235 participants |
| Sex: Female, Male Female | 655 Participants | 580 Participants | 1235 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 655 | 0 / 580 |
| serious Total, serious adverse events | 0 / 655 | 0 / 580 |
Outcome results
Primary
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
Time frame: one week post-initial visit (approximately one week)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Knowledge of Breast Cancer Risk Factors | 48.9 units on a scale | Standard Deviation 24.3 |
| BreastCARE Intervention | Knowledge of Breast Cancer Risk Factors | 56.4 units on a scale | Standard Deviation 24.3 |
Primary
Percentage of Participants Who Had a Discussion of Breast Cancer Risk
Self-reported discussion of breast cancer risk with physicians.
Time frame: one week post-initial visit (approximately one week)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Participants Who Had a Discussion of Breast Cancer Risk | 15 percentage of participants |
| BreastCARE Intervention | Percentage of Participants Who Had a Discussion of Breast Cancer Risk | 41 percentage of participants |
Primary
Percentage of Participants Who Reported Discussion of Mammography Screening
Self reported discussion of mammography with physician.
Time frame: up to 14 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Percentage of Participants Who Reported Discussion of Mammography Screening | 51.6 percentage of participants |
| BreastCARE Intervention | Percentage of Participants Who Reported Discussion of Mammography Screening | 61.5 percentage of participants |
Primary
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.
Time frame: baseline, one week post-initial visit (approximately one week)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Usual Care | Percentage of Participants With Correct Perception of Risk | Baseline | 69.9 percentage of participants |
| Usual Care | Percentage of Participants With Correct Perception of Risk | Final (one week post-intial visit) | 73.3 percentage of participants |
| BreastCARE Intervention | Percentage of Participants With Correct Perception of Risk | Baseline | 65.9 percentage of participants |
| BreastCARE Intervention | Percentage of Participants With Correct Perception of Risk | Final (one week post-intial visit) | 71.1 percentage of participants |