Breast Cancer Female, Breast Density
Conditions
Keywords
Breast Cancer, Breast Density
Brief summary
This trial will test a decision support web based intervention for women at increased risk for breast cancer due to breast density and other risk factors (age, race/ethnicity, family history of breast cancer, history of prior breast biopsies), and to consider MRI and/or chemoprevention to manage their breast cancer risk.
Detailed description
Along with better-known risk factors such as family history having dense breasts is one of the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of women, with an additional third having heterogeneously dense breasts. Women in these categories have 3-6 times the risk of breast cancer as compared to women with least density. Although breast density is measured on routine screening mammograms, it is not typically communicated to patients. This is changing as a result of legal mandates and approaches need to be tested to effectively integrate this clinical information in care. Therefore,we have developed an intervention to support decision making about cancer risk management (MRI and chemoprevention) for women at clinically elevated risk using a web-based intervention that will evaluate the efficacy of a web based intervention with personalized risk information communication versus usual care.
Interventions
BEHAVIORALUsual Care Arm
Health information provided by the American Cancer Society Website
BEHAVIORALPersonalized Web Intervention Arm
Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
Sponsors
Kaiser Permanente
Georgetown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* Women, aged 40-69 * Enrolled at Group Health * Have had a negative mammogram as part of their routine care * Either (a) an intermediate 5-year risk (\>1.67%-2.49%) and extremely dense breasts or (b) a high 5-year risk (≥2.50%) and either heterogeneously dense or extremely dense breasts utilizing the Breast Cancer Surveillance Consortium Risk Calculator (http://tools.bcsc-scc.org/BC5yearRisk/) * Women must also have a valid email address.
Exclusion criteria
* Not able to speak and read English * History of LCIS * Prior cancer diagnosis (including DCIS) * Known BRCA1/2 family mutation, or previous receipt of cancer genetic counseling * Do not want to be contacted for research * Have previously participated in intervention development activities * Dis-enrolled from health plan between mammogram and start of recruitment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Taking Chemoprevention at 12 Months | 12 months | Number of Participants who initiated chemoprevention is measured as receipt of any prescription for tamoxifen or raloxifene, based on health plan pharmacy data at any time from consent through 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Distress Related to Cancer Risk | 6 weeks and 12 months | Distress was measured with the item, Please choose the number (from 0-10) that best describes how much distress you have been experiencing related to your cancer risk in the past week including today, from 0 (no distress) to 10 (extreme distress). |
| Number of Participants Receiving Breast MRI | 12 months | Number of participants receiving breast MRI was assessed using EHR data on receipt of breast imaging within network or claims data from outside imaging facilities. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Personalized Web Intervention Arm Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. | 492 |
| Usual Care Arm Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density. | 503 |
| Total | 995 |
Baseline characteristics
| Characteristic | Usual Care Arm | Total | Personalized Web Intervention Arm |
|---|---|---|---|
| Age, Continuous | 61.9 Years STANDARD_DEVIATION 5.15 | 61.8 Years STANDARD_DEVIATION 5.07 | 61.8 Years STANDARD_DEVIATION 5.02 |
| Distress related to cancer risk | 0.21 Distress thermometer (0-10) STANDARD_DEVIATION 1.05 | 0.25 Distress thermometer (0-10) STANDARD_DEVIATION 1.06 | 0.29 Distress thermometer (0-10) STANDARD_DEVIATION 1.08 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 16 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 495 Participants | 979 Participants | 484 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 14 Participants | 9 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 19 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants | 16 Participants | 8 Participants |
| Race (NIH/OMB) White | 478 Participants | 943 Participants | 465 Participants |
| Sex: Female, Male Female | 503 Participants | 995 Participants | 492 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 | 0 / 492 | 0 / 503 |
| other Total, other adverse events | 0 / 492 | 0 / 503 |
| serious Total, serious adverse events | 0 / 492 | 0 / 503 |
Outcome results
Primary
Number of Participants Taking Chemoprevention at 12 Months
Number of Participants who initiated chemoprevention is measured as receipt of any prescription for tamoxifen or raloxifene, based on health plan pharmacy data at any time from consent through 12 months.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Personalized Web Intervention Arm | Number of Participants Taking Chemoprevention at 12 Months | 1 Participants |
| Usual Care Arm | Number of Participants Taking Chemoprevention at 12 Months | 1 Participants |
Secondary
Distress Related to Cancer Risk
Distress was measured with the item, Please choose the number (from 0-10) that best describes how much distress you have been experiencing related to your cancer risk in the past week including today, from 0 (no distress) to 10 (extreme distress).
Time frame: 6 weeks and 12 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Personalized Web Intervention Arm | Distress Related to Cancer Risk | Distress at 6 weeks | 0.72 score on a scale | Standard Deviation 1.66 |
| Personalized Web Intervention Arm | Distress Related to Cancer Risk | Distress at 12 months | 0.36 score on a scale | Standard Deviation 1.13 |
| Usual Care Arm | Distress Related to Cancer Risk | Distress at 6 weeks | 0.61 score on a scale | Standard Deviation 1.51 |
| Usual Care Arm | Distress Related to Cancer Risk | Distress at 12 months | 0.47 score on a scale | Standard Deviation 1.34 |
Secondary
Number of Participants Receiving Breast MRI
Number of participants receiving breast MRI was assessed using EHR data on receipt of breast imaging within network or claims data from outside imaging facilities.
Time frame: 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Personalized Web Intervention Arm | Number of Participants Receiving Breast MRI | 16 Participants |
| Usual Care Arm | Number of Participants Receiving Breast MRI | 3 Participants |