Breast CancerNCT05838417
Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
A study testing REDS survey in people with Breast Cancer, run by University of Colorado, Denver at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 39 to 49 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- REDS survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Nov 2022to 30 Nov 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 39 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- Known BCRA1/2 gene mutation
- Decisionally Challenged Individuals
- Prisoners or those on alternative sentencing or probation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Hospital
Aurora, Colorado, 80045
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- REDS survey
- Keywords
- No known BCRA 1/2 gene mutation, Mammogram, Breast Cancer Screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REDS surveyBehavioural
R - Reactance, E - self-Exemption, D - Disbelief, S - Source derogation
| Study group | Role | What they receive |
|---|---|---|
| Cohort-1 | Experimental | 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. Receives: Behavioral: REDS survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
REDS (Reactance, Self-Exemption, Disbelief and Source Derogation) Reactions to Mammography Benefits
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.
Measured: 12 months
Screening Intentions Question
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
Measured: 12 months
Number of Participants Who Receive Screening in the Study Period
We will use medical records to identify whether the participant has received screening in the 12-month study period
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2023
- Study start22 Nov 2022
- Primary completion28 Apr 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Laura Scherer, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05838417
- Sponsor's protocol ID
- 22-0957.cc
- Other IDs
- R37CA254926
- Status last verified
- Aug 2026
- First submitted
- 27 Mar 2023
- Last updated
- 31 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Scherer LD, Parmet T, Schapira MM, Cappella JN, Hersch J, McCaffery K, Lewis CL, Tate CE, Morse B. Women in their 40s responding to the 2024 United States Preventive Services Task Force mammography guideline update: a focus group study. BMJ Open. 2026 Sep 28;16(9):e117793. doi: 10.1136/bmjopen-2026-117793.
PubMed 42805646