CClinicalTrials.gg
Active, not recruitingNCT07515846Updated Jun 23, 2026

Breast Cancer Screening Decision Aid

An interventional study of Video based decision aid and Written decision aid in Mammography Screening, Geriatrics and Decision Aid, sponsored by Yale University. Active, not recruiting at 1 site in United States. Open to female participants aged 75 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-23.

Sponsored by Yale University · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
75 Years and older
Sex
Female
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Study 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. 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.

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Conditions studied

  • Mammography Screening
  • Geriatrics
  • Decision Aid

Keywords

  • breast cancer screening
  • health-related beliefs
  • mammography
  • older women
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In context

Lead sponsor

Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.

Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
75 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Prior history of breast cancer or ductal carcinoma in situ
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
300 participants (actual)

Study arms

  • Experimental
    Video based decision aid

    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.

    Behavioral: Video based decision aid

  • Experimental
    Written decision aid

    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.

    Behavioral: Written decision aid

Interventions

  • BehavioralVideo based decision aid

    A \<4 minute video that describes the screening decision, risks, and benefits of screening

  • BehavioralWritten decision aid

    An electronic document that describes the screening decision, risks and benefits of screening

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What researchers measure

Primary outcomes

  1. 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).

    Time frame: Baseline and Immediately post intervention, about 20 minutes

Secondary outcomes

  1. 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.

    Time frame: Baseline and Immediately post intervention, about 20 minutes

  2. 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.

    Time frame: Baseline and Immediately post intervention, about 20 minutes

  3. Understanding of overdiagnosis

    Understanding of overdiagnosis will be quantified as proportion of correct responses out of 3 questions about overdiagnosis.

    Time frame: Baseline and Immediately post intervention, about 20 minutes

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Study locations

1 site
  • Yale School of Medicine
    New Haven, Connecticut 06511, United States
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References and documents

Individual participant data

Plan to share: Yes — Deidentified data

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07515846
Lead sponsor
Yale University
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Apr 7, 2026
Start date
Apr 28, 2026
Primary completion
Apr 2027 (estimated)
Completion
Apr 2027 (estimated)
Last update
Jun 23, 2026

Study contacts

Ilana Richman, MD
principal investigator · Yale University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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