Trial Outcomes & Findings for ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2 (NCT NCT03029286)
NCT ID: NCT03029286
Last Updated: 2025-04-30
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
995 participants
Primary outcome timeframe
12 months
Results posted on
2025-04-30
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
492
|
503
|
|
Overall Study
COMPLETED
|
492
|
503
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
Baseline characteristics by cohort
| Measure |
Personalized Web Intervention Arm
n=492 Participants
Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
|
Usual Care Arm
n=503 Participants
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.
|
Total
n=995 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 5.02 • n=5 Participants
|
61.9 Years
STANDARD_DEVIATION 5.15 • n=7 Participants
|
61.8 Years
STANDARD_DEVIATION 5.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
492 Participants
n=5 Participants
|
503 Participants
n=7 Participants
|
995 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
9 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
465 Participants
n=5 Participants
|
478 Participants
n=7 Participants
|
943 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
484 Participants
n=5 Participants
|
495 Participants
n=7 Participants
|
979 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Distress related to cancer risk
|
0.29 Distress thermometer (0-10)
STANDARD_DEVIATION 1.08 • n=5 Participants
|
0.21 Distress thermometer (0-10)
STANDARD_DEVIATION 1.05 • n=7 Participants
|
0.25 Distress thermometer (0-10)
STANDARD_DEVIATION 1.06 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsNumber 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.
Outcome measures
| Measure |
Personalized Web Intervention Arm
n=492 Participants
Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
|
Usual Care Arm
n=503 Participants
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.
|
|---|---|---|
|
Number of Participants Taking Chemoprevention at 12 Months
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 6 weeks and 12 monthsDistress 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)."
Outcome measures
| Measure |
Personalized Web Intervention Arm
n=492 Participants
Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
|
Usual Care Arm
n=503 Participants
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.
|
|---|---|---|
|
Distress Related to Cancer Risk
Distress at 6 weeks
|
0.72 score on a scale
Standard Deviation 1.66
|
0.61 score on a scale
Standard Deviation 1.51
|
|
Distress Related to Cancer Risk
Distress at 12 months
|
0.36 score on a scale
Standard Deviation 1.13
|
0.47 score on a scale
Standard Deviation 1.34
|
SECONDARY outcome
Timeframe: 12 monthsNumber of participants receiving breast MRI was assessed using EHR data on receipt of breast imaging within network or claims data from outside imaging facilities.
Outcome measures
| Measure |
Personalized Web Intervention Arm
n=492 Participants
Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
|
Usual Care Arm
n=503 Participants
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.
|
|---|---|---|
|
Number of Participants Receiving Breast MRI
|
16 Participants
|
3 Participants
|
Adverse Events
Personalized Web Intervention Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place