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Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study

Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05838417
Enrollment
499
Registered
2023-05-01
Start date
2022-11-22
Completion date
2025-11-30
Last updated
2026-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

No known BCRA 1/2 gene mutation, Mammogram, Breast Cancer Screening

Brief summary

All participants will read a decision aid (DA) communicating evidence about mammography screening benefits and harms. Participants' evaluations of that evidence will be assessed, along with their screening intentions and receipt of screening. Participants will be sent 3 surveys via email and a final brief survey conducted by email or phone. The four surveys will be collected 1) upon enrollment and prior to the primary care appointment; 2) following the primary care appointment; 3) 3 months after enrollment; 4) 1 year after enrollment. The final 2 surveys will offer an increased incentive to increase retention rates.

Detailed description

All participants will read a decision aid (DA) communicating evidence about mammography screening benefits and harms. Participants' evaluations of that evidence will be assessed, along with their screening intentions and receipt of screening. Participants will also be asked to report on whether they talked about mammography screening and the content of the DA with their provider. Participants will be sent 3 surveys via email and a final brief survey conducted by email or phone. The four surveys will be collected 1) upon enrollment and prior to the primary care appointment; 2) following the primary care appointment; 3) 3 months after enrollment; 4) 1 year after enrollment. The final 2 surveys will offer an increased incentive to increase retention rates. Time 1 will be an online survey that addresses Aim 1, assessing participants' evaluations of mammography evidence conveyed in the DA. Time 2 will include repeated measures from Time 1 and additionally assess the following: 1. Whether screening was discussed with the provider. 2. If screening was not discussed, why not (e.g. did not want to, no time, other pressing issues, etc.). 3. If screening was discussed, (a) what content from the DA was discussed (i.e. benefits, false positives, overdiagnosis), (b) overall satisfaction with the discussion, (c) whether the provider offered a screening recommendation, (d) open-ended qualitative response eliciting how the discussion went. 4. Whether discussed the BCS-DA with anyone else (e.g., friends or family). 5. Patient activation. 6. Preferred role in decision-making. 7. Perceived barriers to screening. Finally, participants' information environment will be assessed using questions from Pearlman et al. (1997), 8. information seeking (e.g. to what extent the participant valued opinions from the provider, friends, and family), 9. information sharing and communication (e.g. screening attitudes of friends and family), and 10. perception of self as disseminator of mammography-related information. Time 3 will repeat the summary of mammography evidence and measures from Time 2. At Time 4 the team will assess whether screening was received up to one year after study enrollment using the participants' self reports and electronic medical record.

Interventions

BEHAVIORALREDS survey

R - Reactance, E - self-Exemption, D - Disbelief, S - Source derogation

Sponsors

University of Colorado, Denver
Lead SponsorOTHER
National Cancer Institute (NCI)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
39 Years to 49 Years
Healthy volunteers
No

Inclusion criteria

* Individuals who identify as female at birth * Ages 39-49 years old (inclusive) at the time of consent * English literacy * Internet access * No prior diagnosis of breast cancer, ductal carcinoma in situ (DCIS, also known as "stage zero breast cancer"), or lobular carcinoma in situ * No known BCRA1/2 gene mutation

Exclusion criteria

* Individuals who identify other than female at birth * Individuals who are currently pregnant * Individuals \< 39 years old or 50 years old and \> at the time of consent * Lack English literacy * Lack of internet access * Prior diagnosis of breast cancer, ductal carcinoma in situ (DCIS, also known as "stage zero breast cancer"), or lobular carcinoma in situ * Known BCRA1/2 gene mutation * Decisionally Challenged Individuals * Prisoners or those on alternative sentencing or probation

Design outcomes

Primary

MeasureTime frameDescription
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits12 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.
Screening Intentions Question12 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
Number of Participants Who Receive Screening in the Study Period12 monthsWe will use medical records to identify whether the participant has received screening in the 12-month study period

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORLaura Scherer

University of Colorado, Denver

Participant flow

Recruitment details

A total of 499 were enrolled but 466 completed survey 1, 397 completed survey 2, 338 completed survey 3 and 265 completed survey 4.

Baseline characteristics

Characteristic
Age, Continuous43.4 years
STANDARD_DEVIATION 3
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants
Race (NIH/OMB)
Asian
27 Participants
Race (NIH/OMB)
Black or African American
114 Participants
Race (NIH/OMB)
More than one race
41 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
7 Participants
Race (NIH/OMB)
White
274 Participants
Sex: Female, Male
Female
466 Participants
Sex: Female, Male
Male
0 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 499
other
Total, other adverse events
0 / 499
serious
Total, serious adverse events
0 / 499

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 1, 2026