- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05838417
Promoting Informed Choice for Breast Cancer Screening: A Longitudinal Study
April 12, 2024 updated by: University of Colorado, Denver
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Estimated)
700
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Tamar Parmet
- Phone Number: 16102090652
- Email: tamar.parmet@cuanschutz.edu
Study Contact Backup
- Name: Kate Noonan
- Email: kate.noonan@cuanschutz.edu
Study Locations
-
-
Colorado
-
Aurora, Colorado, United States, 80045
- Recruiting
- University of Colorado Hospital
-
Principal Investigator:
- Laura Scherer
-
Contact:
- Tamar Parmet
- Phone Number: 610-209-0652
- Email: tamar.parmet@cuanschutz.edu
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Jemimah Frempong
-
Principal Investigator:
- Marilyn Schapira, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Study Population
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 will be recruited.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cohort-1
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.
|
R - Reactance, E - self-Exemption, D - Disbelief, S - Source derogation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography benefits
Time Frame: 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.
|
12 months
|
REDS (Reactance, self-Exemption, Disbelief and Source derogation) reactions to mammography harms
Time Frame: 12 months
|
Reactance, self-Exemption, Disbelief and Source derogation in reaction to evidence about mammography harms (over diagnosis and false positive results).
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.
Reactions to over diagnosis and false positives will be assessed separately.
|
12 months
|
Screening intentions question
Time Frame: 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
|
12 months
|
Number of participants who receive screening in the study period
Time Frame: 12 months
|
We will use medical records to identify whether the participant has received screening in the 12-month study period
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in breast cancer screening knowledge from pre- to post-decision aid
Time Frame: 12 months
|
Breast cancer screening knowledge is assessed immediately before and after the decision aid, and at follow up survey time points.
Screening knowledge is assessed with a 10-item multiple choice questionnaire developed in prior research (Hersch et al., 2015).
Minimum score=0/10 (0% correct), maximum score=10/10 (100% correct).
|
12 months
|
Whether the participant had a conversation with their doctor about screening
Time Frame: 12 months
|
Assessed after the clinic appointment, participants report whether they talked with their doctor about screening in that appointment using a 3-category response: 1. No, not at all, 2. Yes briefly, 3. Yes in some detail
|
12 months
|
Change in medical mistrust from pre- to post-decision aid
Time Frame: 12 months
|
Medical mistrust (Eaton et al. 2015) is a 6-item validated scale that is administered before the decision aid, after decision aid, and at follow up surveys.
Questions are answered using a 1-5 strongly disagree-strongly agree Likert scale.
Minimum score=1, maximum score=5.
|
12 months
|
Perceptions of breast cancer risk
Time Frame: 12 months
|
This is a multi-item validated scale to assess perceptions of personal risk, the TRIRISK measure (Ferrer et al. 2016).
Scale items are modified to assess perceived breast cancer risk.
In this study we assess only the deliberative and affective subscales.
Questions are answered using Likert scales.
Minimum score=1, maximum score=5.
|
12 months
|
Emotional responses to the decision aid
Time Frame: 12 months
|
The validated Berlin Emotional Responses to Risk Instrument (BERRI; Petrova et al., 2022) is used to assess emotional response to the decision aid.
Participants indicate how they felt when they read the decision aid (angry, worried, hopeful, etc.), responding on a 1-7 Likert scale.
Mean scores (min=1, max=7) are computed for positive emotion (assured, hopeful, relieved), anxiety (anxious, afraid, worried) and anger (angry, mad).
|
12 months
|
Whether the participant plans to talk to their doctor about screening in an upcoming appointment
Time Frame: 12 months
|
Assessed after the decision aid but before the clinic appointment.
Participants indicate whether they intend to discuss breast cancer screening with their doctor using a 4-category response: 1. Definitely not, Probably not, Probably yes, Definitely yes
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Laura Scherer, University of Colorado, Denver
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 22, 2022
Primary Completion (Estimated)
January 12, 2025
Study Completion (Estimated)
January 1, 2026
Study Registration Dates
First Submitted
March 27, 2023
First Submitted That Met QC Criteria
April 27, 2023
First Posted (Actual)
May 1, 2023
Study Record Updates
Last Update Posted (Actual)
April 16, 2024
Last Update Submitted That Met QC Criteria
April 12, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-0957.cc
- R37CA254926 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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