Overdiagnosis and Breast Cancer Screening Decisions

NCT ID: NCT07071415

Last Updated: 2025-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

311 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-19

Study Completion Date

2025-10-20

Brief Summary

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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.

Detailed Description

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Conditions

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Mammography Screening Geriatrics Decision Aid

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Investigators

Study Groups

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Low risk of overdiagnosis

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

Group Type EXPERIMENTAL

Breast cancer screening decision aid -- low risk

Intervention Type 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.

Moderate risk of overdiagnosis

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

Group Type EXPERIMENTAL

Breast cancer decision aid -- moderate risk

Intervention Type 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.

High risk of overdiagnosis

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

Group Type EXPERIMENTAL

Breast cancer screening decision aid -- high risk

Intervention Type 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.

Control

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.

Group Type ACTIVE_COMPARATOR

Control condition

Intervention Type 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.

Interventions

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Breast cancer screening decision aid -- low risk

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.

Intervention Type BEHAVIORAL

Breast cancer decision aid -- moderate risk

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.

Intervention Type BEHAVIORAL

Breast cancer screening decision aid -- high risk

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.

Intervention Type BEHAVIORAL

Control condition

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Prior history of breast cancer or ductal carcinoma in situ
Minimum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilana Richman, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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K08CA248725

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000040131

Identifier Type: -

Identifier Source: org_study_id

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