Overdiagnosis and Breast Cancer Screening Decisions

NCT07071415 | Completed

• 2 other identifiers: 2000040131K08CA248725
• Study Type: interventional
• Target: 311
• Locations: 1 country
• Sites: 1

Brief Summary

This is a survey-based study using an online panel. The goal of the study is to understand whether information about overdiagnosis influences breast cancer screening intention among older women. Participants are first asked a series of questions about breast cancer screening including their intention to continue screening, knowledge of screening, and beliefs about screening. They are then shown one of three videos about breast cancer screening that contain information about overdiagnosis or a fourth control video that is identical but contains no information about overdiagnosis. Participants are then again asked about screening intention, along with knowledge of screening, overdiagnosis, and questions around trust.

Conditions

Mammography Screening; Geriatrics; Decision Aid

Keywords

breast cancer screening; health-related beliefs; overdiagnosis; mammography; older women

Outcome Measures

Primary Outcomes (1)

• Participants intention to screen

  Intention to screen, measured on a 15 point scale. Total score range 1-15, lower score means less likely to screen.

  Day 1

Secondary Outcomes (2)

• Knowledge of breast cancer screening

  Day 1

• Understanding of overdiagnosis

  Day 1

Study Arms (4)

Low risk of overdiagnosis

EXPERIMENTAL

Participants in this arm will be shown a decision aid in which risk of overdiagnosis is low.

Behavioral: Breast cancer screening decision aid -- low risk

Moderate risk of overdiagnosis

EXPERIMENTAL

Participants in this arm will be shown a decision aid in which risk of overdiagnosis is moderate.

Behavioral: Breast cancer decision aid -- moderate risk

High risk of overdiagnosis

EXPERIMENTAL

Participants in this arm will be shown a decision aid in which risk of overdiagnosis is high.

Behavioral: Breast cancer screening decision aid -- high risk

Control

ACTIVE COMPARATOR

Participants in this arm will be shown a video about breast cancer screening that is identical in all ways but contains no information about overdiagnosis.

Other: Control condition

Interventions

Breast cancer screening decision aid -- low risk BEHAVIORAL

Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the low risk of overdiagnosis arm will view a version of the decision aid the describes a low risk of overdiagnosis.

Low risk of overdiagnosis

Breast cancer decision aid -- moderate risk BEHAVIORAL

Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the moderate risk of overdiagnosis arm will view a version of the decision aid the describes a moderate risk of overdiagnosis.

Moderate risk of overdiagnosis

Breast cancer screening decision aid -- high risk BEHAVIORAL

Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the high risk of overdiagnosis arm will view a version of the decision aid the describes a high risk of overdiagnosis.

High risk of overdiagnosis

Control condition OTHER

Participants in this study will view a video-based decision aid that describes the risks and benefits of breast cancer screening for older women. Participants assigned to the control arm will view a version of the decision aid that does not contain any information about overdiagnosis.

Control

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• and older
• Able to participate in an English-language web-based survey

You may not qualify if:

• Prior history of breast cancer or ductal carcinoma in situ

Sponsors & Collaborators

• Yale University: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Yale School of Medicine

New Haven, Connecticut, 06511, United States

Location

Study Officials

• Ilana Richman, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2025
• First Posted: July 17, 2025
• Study Start: August 19, 2025
• Primary Completion: October 20, 2025
• Study Completion: October 20, 2025
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• 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)