Breast Cancer Screening Decision Aid

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.

Study Overview

• Status: Recruiting
• Conditions: Geriatrics; Decision Aid; Mammography Screening
• Intervention / Treatment: Behavioral: Video based decision aid; Behavioral: Written decision aid

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ilana Richman, MD; Phone Number: 203 737 1024; Email: ilana.richman@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Recruiting
      • Yale School of Medicine
      • Contact: Ilana Richman, MD; Phone Number: 203-737-1024; Email: ilana.richman@yale.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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:

• Prior history of breast cancer or ductal carcinoma in situ

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A <4 minute video that describes the screening decision, risks, and benefits of screening
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; An electronic document that describes the screening decision, risks and benefits of screening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and Immediately post intervention, about 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	Baseline and Immediately post intervention, about 20 minutes

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Ilana Richman, MD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 30, 2026
• First Submitted That Met QC Criteria: March 30, 2026
• First Posted (Actual): April 7, 2026

Study Record Updates

• Last Update Posted (Actual): May 4, 2026
• Last Update Submitted That Met QC Criteria: April 28, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer screening; mammography; older women; health-related beliefs
• Other Study ID Numbers: 2000042321; K08CA248725 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified data
• IPD Sharing Time Frame: Supporting information is available immediately from investigators. Individual patient data will be available beginning one year after data collection.
• IPD Sharing Access Criteria: Available to qualified researchers upon request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No