Mammography ScreeningNCT07515846
Breast Cancer Screening Decision Aid
A study testing Video based decision aid and Written decision aid in people with Mammography Screening and Geriatrics, run by Yale University at 1 site in United States.
Trial summary
This is a randomized survey study of 2 decision aids for breast cancer screening. Decision aids are tools that present structured information to patients about a medical test or treatment. Read more about this study
- Who is it for?
- Ages 75 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mammography Screening, Geriatrics, Decision Aid
- What is being tested?
- Video based decision aid and Written decision aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Apr 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 75 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Who may be able to join
- No prior history of breast cancer or ductal carcinoma in situ
- Screened at least once before
- English-speaking
- Able to complete an online survey
- Did not opt out of participation
Who cannot join
- Prior history of breast cancer or ductal carcinoma in situ
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Breast Cancer Screening Decision Aid: A Survey-based Comparison of Video and Written Formats
This is a randomized survey study of 2 decision aids for breast cancer screening. Decision aids are tools that present structured information to patients about a medical test or treatment. The goal of this study is to compare a video-based decision aid to a written decision aid and assess the impact on intention to screen in the future, readiness to make a decision about screening, and knowledge of screening. The study will use an online survey platform (YouGov) and will include women 75 and older who have been previously screened for breast cancer and do not have a history of breast cancer.
- Conditions
- Mammography Screening, Geriatrics, Decision Aid
- Being tested
- Video based decision aid, Written decision aid
- Keywords
- breast cancer screening, health-related beliefs, mammography, older women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video based decision aidBehavioural
A <4 minute video that describes the screening decision, risks, and benefits of screening
Written decision aidBehavioural
An electronic document that describes the screening decision, risks and benefits of screening
| Study group | Role | What they receive |
|---|---|---|
| Video based decision aid | Experimental | Participants in this arm will be shown a video based decision aid about breast cancer screening that includes information about the potential benefits and potential risks. The video includes both information explaining these risks and benefits, along with quantitation of risks and benefits. Participants will answer questions before and after watching the video. Receives: Behavioral: Video based decision aid |
| Written decision aid | Experimental | Participants in this arm will be shown a written decision aid about breast cancer screening that includes information about the potential benefits and potential risks. The written decision aid includes both information explaining these risks and benefits, along with quantitation of risks and benefits. Participants will answer questions before and after viewing the written document. Receives: Behavioral: Written decision aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Decisional Conflict Scale (DCS) score
DCS is a 16-item scale measuring uncertainty in health choices, covering informedness, values, support, uncertainty, and effective decision-making. Total scores range from 0 (no conflict) to 100 (high conflict).
Measured: Baseline and Immediately post intervention, about 20 minutes
Secondary outcomes (3)
Mean Screening Intention score
Measures an individual's readiness or likelihood to undergo preventative health screenings. Total score range 1-15, higher scores indicate stronger intention.
Measured: Baseline and Immediately post intervention, about 20 minutes
Percent correct knowledge of breast cancer screening score
Knowledge of screening will be quantified as the proportion of correct answers out of a total possible 9 questions in the pre test and 12 questions in the post test.
Measured: Baseline and Immediately post intervention, about 20 minutes
Understanding of overdiagnosis
Understanding of overdiagnosis will be quantified as proportion of correct responses out of 3 questions about overdiagnosis.
Measured: Baseline and Immediately post intervention, about 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start28 Apr 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mammography ScreeningStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Ilana Richman, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515846
- Sponsor's protocol ID
- 2000042321
- Other IDs
- K08CA248725
- Status last verified
- Jun 2026
- First submitted
- 30 Mar 2026
- Last updated
- 23 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Screening Decision Aid: A Survey-based Comparison of Video and Written Formats
- ClinicalTrials.gov ID
- NCT07515846
- Acronym / sponsor ID
- 2000042321
- Conditions
- Mammography Screening, Geriatrics, Decision Aid
- Keywords
- breast cancer screening, health-related beliefs, mammography, older women
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 28 Apr 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized survey study of 2 decision aids for breast cancer screening. Decision aids are tools that present structured information to patients about a medical test or treatment. The goal of this study is to compare a video-based decision aid to a written decision aid and assess the impact on intention to screen in the future, readiness to make a decision about screening, and knowledge of screening. The study will use an online survey platform (YouGov) and will include women 75 and older who have been previously screened for breast cancer and do not have a history of breast cancer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video based decision aid | Experimental | Behavioral: Video based decision aidParticipants in this arm will be shown a video based decision aid about breast cancer screening that includes information about the potential benefits and potential risks. The video includes both information explaining these risks and benefits, along with quantitation of risks and benefits. Participants will answer questions before and after watching the video. |
| Written decision aid | Experimental | Behavioral: Written decision aidParticipants in this arm will be shown a written decision aid about breast cancer screening that includes information about the potential benefits and potential risks. The written decision aid includes both information explaining these risks and benefits, along with quantitation of risks and benefits. Participants will answer questions before and after viewing the written document. |
Who may qualify
- Ages
- 75 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- No prior history of breast cancer or ductal carcinoma in situ
- Screened at least once before
- English-speaking
- Able to complete an online survey
- Did not opt out of participation
Key exclusion criteria (1 listed)
- Prior history of breast cancer or ductal carcinoma in situ
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video based decision aidA <4 minute video that describes the screening decision, risks, and benefits of screening | Behavioural | Video based decision aid |
| Written decision aidAn electronic document that describes the screening decision, risks and benefits of screening | Behavioural | Written decision aid |
Primary outcome
Mean Decisional Conflict Scale (DCS) score
Time frame: Baseline and Immediately post intervention, about 20 minutes
DCS is a 16-item scale measuring uncertainty in health choices, covering informedness, values, support, uncertainty, and effective decision-making. Total scores range from 0 (no conflict) to 100 (high conflict).
3 secondary outcomes
Mean Screening Intention score
Time frame: Baseline and Immediately post intervention, about 20 minutes
Percent correct knowledge of breast cancer screening score
Time frame: Baseline and Immediately post intervention, about 20 minutes
Understanding of overdiagnosis
Time frame: Baseline and Immediately post intervention, about 20 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Individual participant dataSharing planned: Yes. Deidentified data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilana Richman, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video based decision aid and Written decision aid in people with Mammography Screening and Geriatrics, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Decisional Conflict Scale (DCS) score (time frame: Baseline and Immediately post intervention, about 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2026.