Trial Outcomes & Findings for Promoting Informed Choice for Breast Cancer Screening (NCT NCT05376241)
NCT ID: NCT05376241
Last Updated: 2025-10-24
Results Overview
In response to mammography evidence, feeling that the information is manipulative or biased. 4 questions total, each on a 7 point Likert scale, with mean scores that range from 1 to 5. Higher mean scores reflect greater reactance.
COMPLETED
637 participants
24 hours
2025-10-24
Participant Flow
Data were collected from January to April 2022 through the online survey research panel Ipsos KnowledgePanel. A total of 637 participants were identified for the survey, but 22 did not meet eligibility criteria, 103 did not complete the survey, and 17 were excluded for failing 2 attention check questions, resulting in a final analytic sample of 495 participants.
Participant milestones
| Measure |
Women Age 39-49 in the United States
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Overall Study
STARTED
|
637
|
|
Overall Study
COMPLETED
|
495
|
|
Overall Study
NOT COMPLETED
|
142
|
Reasons for withdrawal
| Measure |
Women Age 39-49 in the United States
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Overall Study
did not meet eligibility criteria after consenting
|
22
|
|
Overall Study
103 did not complete the survey
|
103
|
|
Overall Study
17 failed 2 attention check questions
|
17
|
Baseline Characteristics
Promoting Informed Choice for Breast Cancer Screening
Baseline characteristics by cohort
| Measure |
Women Age 39-49 in the United States
n=495 Participants
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Age, Continuous
|
43.9 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
495 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-hispanic white
|
327 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-hispanic Black
|
53 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-hispanic other race
|
25 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
non-hispanic >2 races
|
20 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
70 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The group is women aged 39-49 in the United States with no history of breast cancer or known BRCA1/2 mutation, who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
In response to mammography evidence, feeling that the information is manipulative or biased. 4 questions total, each on a 7 point Likert scale, with mean scores that range from 1 to 5. Higher mean scores reflect greater reactance.
Outcome measures
| Measure |
Women Age 39-49 in the United States
n=495 Participants
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Reactance
Response to screening benefits
|
2.28 score on a scale
Standard Deviation 0.71
|
|
Reactance
Response to false positives
|
2.45 score on a scale
Standard Deviation 0.75
|
|
Reactance
Response to overdiagnosis
|
2.55 score on a scale
Standard Deviation 0.80
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
In response to mammography evidence, feeling that the evidence is not accurate or believable. 4 questions total, each on a 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean score reflects more disbelief in the information.
Outcome measures
| Measure |
Women Age 39-49 in the United States
n=495 Participants
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Disbelief
Response to screening benefits
|
2.06 Score on a scale
Standard Deviation 0.61
|
|
Disbelief
Response to false positives
|
2.32 Score on a scale
Standard Deviation 0.63
|
|
Disbelief
Response to overdiagnosis
|
2.41 Score on a scale
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
In response to mammography evidence, feeling that the source of the evidence is not trustworthy or competent. 4 questions total, each on a 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean score reflects more source derogation.
Outcome measures
| Measure |
Women Age 39-49 in the United States
n=495 Participants
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Source Derogation
|
2.56 score on a scale
Standard Error 0.09
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Feeling that mammography evidence is not relevant to oneself.34 questions total, each on a 5 point Likert scale, with mean scores that range from 1 to 5. Higher mean scores indicate greater belief that the information is not self relevant.
Outcome measures
| Measure |
Women Age 39-49 in the United States
n=495 Participants
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Self Exemption
Response to screening benefits
|
2.20 score on a scale
Standard Deviation 0.70
|
|
Self Exemption
Response to false positives
|
2.21 score on a scale
Standard Deviation 0.71
|
|
Self Exemption
Response to overdiagnosis
|
2.32 score on a scale
Standard Deviation 0.72
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Intentions to engage in mammography screening. Options will include: 1. I am planning to start/continue having regular mammograms this year. 2. I am planning to wait until I'm older but before age 50 to have my first/next mammogram. 3. I am planning to wait until I am 50 to have my first/next mammogram. 4. I am not planning to have a mammogram in the future at any age
Outcome measures
| Measure |
Women Age 39-49 in the United States
n=495 Participants
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Screening Intentions
Have regular mammograms at current age
|
286 Participants
|
|
Screening Intentions
Wait until older but before age 50
|
100 Participants
|
|
Screening Intentions
Wait until age 50
|
88 Participants
|
|
Screening Intentions
never have a mammogram
|
21 Participants
|
SECONDARY outcome
Timeframe: 24 hoursPopulation: The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
6 question scale that assesses mistrust in healthcare providers. Calculated as mean trust (range 1-low trust to 5-high trust). Assessed both pre and post receipt of screening decision aid to evaluate change
Outcome measures
| Measure |
Women Age 39-49 in the United States
n=495 Participants
The group is women age 39-49 in the United States who receive a decision aid intervention. The intervention is a breast cancer screening decision aid with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
Decision aid: Mammography screening decision aid for women in their 40s with information about screening guidelines, breast cancer mortality reduction, false positives, overdiagnosis, and a personal breast cancer risk estimate.
|
|---|---|
|
Medical Mistrust Scale (Eaton et al., 2015)
Pre-DA trust
|
3.11 score on a scale
Standard Deviation 0.69
|
|
Medical Mistrust Scale (Eaton et al., 2015)
Post-DA trust
|
3.02 score on a scale
Standard Deviation 0.65
|
Adverse Events
Women Age 39-49 in the United States
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