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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

499 participants

Primary outcome timeframe

12 months

Results posted on

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

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

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

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 months

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.

Outcome measures

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 months

This 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

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 months

We will use medical records to identify whether the participant has received screening in the 12-month study period

Outcome measures

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 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

Laura Scherer

University of Colorado

Phone: 303-724-5426

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place