Trial Outcomes & Findings for Understanding and Addressing Rejection of Personalized Breast Cancer Risk Information: Administrative Supplement Study (NCT NCT06975085)

Last Updated: 2026-08-03

Results Overview

Participants are asked whether they agree or disagree with their Gail Model risk estimate. Risk rejection was defined as disagreement the estimate. An open text box allows them to write the risk number that they believe is accurate for them.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

781 participants

Primary outcome timeframe

at baseline survey

Results posted on

2026-08-03

Participant Flow

Participants were recruited to this one-time online survey using Dynata, an online survey panel

There were 836 participants who were eligible to take the survey based on screener questions and began the survey. 781 participants met eligibility criteria and were included in the enrollment population.

Participant milestones

Participant milestones
Measure	Breast Cancer Risk Presentation All participants are presented with their personal breast cancer risk, estimated using the Gail Model
Overall Study STARTED	836
Overall Study COMPLETED	781
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Age was analyzed for participants included in final analytic dataset, which excluded due to missingness and speeders

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Breast Cancer Risk Presentation n=781 Participants All participants are presented with their personal breast cancer risk, estimated using the Gail Model
Age, Continuous	55.8 Years STANDARD_DEVIATION 9.63 • n=20 Participants • Age was analyzed for participants included in final analytic dataset, which excluded due to missingness and speeders
Sex: Female, Male Female	781 Participants n=20 Participants
Sex: Female, Male Male	0 Participants n=20 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=20 Participants
Race (NIH/OMB) Asian	0 Participants n=20 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=20 Participants
Race (NIH/OMB) Black or African American	781 Participants n=20 Participants
Race (NIH/OMB) White	0 Participants n=20 Participants
Race (NIH/OMB) More than one race	0 Participants n=20 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=20 Participants

PRIMARY outcome

Timeframe: at baseline survey

Population: Analyses were conducted among participants with complete data for each outcome.

Outcome measures

Outcome measures
Measure	Breast Cancer Risk Presentation n=694 Participants All participants are presented with their personal breast cancer risk, estimated using the Gail Model	Probably Not Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Maybe Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Probably Will Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Definitely Will Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will
Number of Participants Who Rejected the Cancer Risk Estimate	569 Participants	—	—	—	—

PRIMARY outcome

Timeframe: at baseline survey

Population: Analyses were conducted among participants with complete data for each outcome.

Participants will be given the opportunity to get more information about breast cancer screening, and will be given response options to receive information for women at lower than average risk, higher than average risk, or women with risk that is "about the same as a typical woman". Concordance is measured by agreement between the participants' actual risk estimate and the option that they choose.

Outcome measures

Outcome measures
Measure	Breast Cancer Risk Presentation n=694 Participants All participants are presented with their personal breast cancer risk, estimated using the Gail Model	Probably Not Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Maybe Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Probably Will Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Definitely Will Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will
Risk-concordant Information Seeking	328 Participants	—	—	—	—

PRIMARY outcome

Timeframe: at baseline survey

Population: A total of 688 participants responded to the screening intentions question (i.e., there was a small amount of missing data for this question)

Screening intentions were measured on a 5-point Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will. Higher scores indicate greater intention.

Outcome measures

Outcome measures
Measure	Breast Cancer Risk Presentation n=688 Participants All participants are presented with their personal breast cancer risk, estimated using the Gail Model	Probably Not n=688 Participants Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Maybe n=688 Participants Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Probably Will n=688 Participants Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will	Definitely Will n=688 Participants Participants are asked: In the next 12 months, do you plan to get a mammogram? The question is answered on a 5-point will-will not Likert scale. 1=definitely will not, 2=probably will not, 3=maybe, 4=probably will, 5=definitely will
Screening Intentions	31 Participants	25 Participants	77 Participants	91 Participants	464 Participants

Adverse Events

Breast Cancer Risk Presentation

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: 303-724-3278

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place