Trial Outcomes & Findings for Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study (NCT NCT05838417)
NCT ID: NCT05838417
Last Updated: 2026-08-31
Results Overview
Reactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography benefits. This is a multi-item measure (3-4 questions per subscale) and assessed on a 1 (strongly disagree) to 5 (strongly agree) Likert scale. Averages will be computed to create for scores (corresponding to each sub scale), with a maximum score of 5 and minimum score of 1. Higher scores indicate more reactance, self-exemption and disbelief.
COMPLETED
NA
499 participants
12 months
2026-08-31
Participant Flow
A total of 499 were enrolled but 466 completed survey 1, 397 completed survey 2, 338 completed survey 3 and 265 completed survey 4.
Participant milestones
| Measure |
Decision Aid Group
This was a single-arm study in which all participants received a breast cancer screening decision aid in survey 1, and then were followed-up for 12 months.
|
|---|---|
|
Overall Study
STARTED
|
499
|
|
Overall Study
COMPLETED
|
265
|
|
Overall Study
NOT COMPLETED
|
234
|
Reasons for withdrawal
| Measure |
Decision Aid Group
This was a single-arm study in which all participants received a breast cancer screening decision aid in survey 1, and then were followed-up for 12 months.
|
|---|---|
|
Overall Study
Lost to Follow-up
|
234
|
Baseline Characteristics
Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
Baseline characteristics by cohort
| Measure |
Decision Aid Group
n=466 Participants
This was a single-arm study in which all participants received a breast cancer screening decision aid in survey 1, and then were followed-up for 12 months.
|
|---|---|
|
Race (NIH/OMB)
White
|
274 Participants
n=14 Participants
|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 3.0 • n=14 Participants
|
|
Sex: Female, Male
Female
|
466 Participants
n=14 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Asian
|
27 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Black or African American
|
114 Participants
n=14 Participants
|
|
Race (NIH/OMB)
More than one race
|
41 Participants
n=14 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=14 Participants
|
PRIMARY outcome
Timeframe: 12 monthsReactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography benefits. This is a multi-item measure (3-4 questions per subscale) and assessed on a 1 (strongly disagree) to 5 (strongly agree) Likert scale. Averages will be computed to create for scores (corresponding to each sub scale), with a maximum score of 5 and minimum score of 1. Higher scores indicate more reactance, self-exemption and disbelief.
Outcome measures
| Measure |
Cohort-1
n=466 Participants
Individuals who identify as female at birth age 39-49 without a prior breast cancer diagnosis (including DCIS or LCIS) or known BCRA1/2 gene mutations.
|
|---|---|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
disbelief toward benefit information
|
2.20 Units on a scale
Standard Deviation 0.95
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
disbelief toward over diagnosis information
|
2.69 Units on a scale
Standard Deviation 1.13
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
Reactance toward screening benefit information
|
2.55 Units on a scale
Standard Deviation 1.30
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
Reactance toward over diagnosis information
|
2.91 Units on a scale
Standard Deviation 1.34
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
Reactance toward false positive information
|
2.80 Units on a scale
Standard Deviation 1.31
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
Self exemption toward screening benefit information
|
2.25 Units on a scale
Standard Deviation 1.21
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
self exemption toward over diagnosis information
|
2.36 Units on a scale
Standard Deviation 1.21
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
self exemption toward false positive information
|
2.20 Units on a scale
Standard Deviation 1.19
|
|
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
disbelief toward false positive information
|
3.62 Units on a scale
Standard Deviation 1.37
|
PRIMARY outcome
Timeframe: 12 monthsThis is a single item question in which participants will indicated their intentions to initiate regular screening with mammograms, using a 4 category response: 1. screen now, 2. wait until they are older but before age 50, 3. wait until age 50, or 4. do not intend to screen in the future at any age
Outcome measures
| Measure |
Cohort-1
n=466 Participants
Individuals who identify as female at birth age 39-49 without a prior breast cancer diagnosis (including DCIS or LCIS) or known BCRA1/2 gene mutations.
|
|---|---|
|
Screening Intentions Question
wait until age 50
|
23 Participants
|
|
Screening Intentions Question
never screen
|
7 Participants
|
|
Screening Intentions Question
missing
|
1 Participants
|
|
Screening Intentions Question
screen at current age
|
399 Participants
|
|
Screening Intentions Question
wait until older but before age 50
|
36 Participants
|
PRIMARY outcome
Timeframe: 12 monthsWe will use medical records to identify whether the participant has received screening in the 12-month study period
Outcome measures
| Measure |
Cohort-1
n=280 Participants
Individuals who identify as female at birth age 39-49 without a prior breast cancer diagnosis (including DCIS or LCIS) or known BCRA1/2 gene mutations.
|
|---|---|
|
Number of Participants Who Receive Screening in the Study Period
|
175 Participants
|
Adverse Events
Cohort-1
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