NCT07515846

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
11mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Apr 2027

First Submitted

Initial submission to the registry

March 30, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 7, 2026

Completed
21 days until next milestone

Study Start

First participant enrolled

April 28, 2026

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2027

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

11 months

First QC Date

March 30, 2026

Last Update Submit

April 28, 2026

Conditions

Mammography ScreeningGeriatricsDecision Aid

Keywords

breast cancer screeninghealth-related beliefsmammographyolder women

Outcome Measures

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).

    Baseline and Immediately post intervention, about 20 minutes

Secondary Outcomes (3)

  • Mean Screening Intention score

    Baseline and Immediately post intervention, about 20 minutes

  • Percent correct knowledge of breast cancer screening score

    Baseline and Immediately post intervention, about 20 minutes

  • Understanding of overdiagnosis

    Baseline and Immediately post intervention, about 20 minutes

Study Arms (2)

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.

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.

Behavioral: Written decision aid

Interventions

Video based decision aidBEHAVIORAL

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

Video based decision aid
Written decision aidBEHAVIORAL

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

Written decision aid

Eligibility Criteria

Age75 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prior history of breast cancer or ductal carcinoma in situ

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

RECRUITING

Study Officials

  • Ilana Richman, MD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilana Richman, MD

CONTACT

203 737 1024ilana.richman@yale.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Participants are not blinded to group assignment. However, they are not aware of information shown to other groups.Investigators will be blinded to group assignment during data collection.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 7, 2026

Study Start

April 28, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Deidentified data

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Supporting information is available immediately from investigators. Individual patient data will be available beginning one year after data collection.
Access Criteria
Available to qualified researchers upon request.

Locations

US(1)