Project Insight: Feasibility of a Breast Cancer Screening Decision Support Tool

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1277 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-19

Study Completion Date

2021-08-30

Brief Summary

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The purpose of this investigation is to conduct a feasibility study to evaluate the potential for implementing the developed decision support tool with Latina, Black, and non-Latina White women. The investigators will collect feasibility data and assess the use of the decision support tool with end-users. The aim is to determine if women using the decision support tool make more informed choices measured by knowledge, attitudes, and intentions.

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Detailed Description

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Conditions

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Breast Cancer Screening Oncology Preventative Medicine Mammography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Breast Cancer Screening Decision Support Tool

-After randomization, participants will complete pre-questionnaires, review the Breast Cancer Screening Decision support tool, and then complete the post-questionnaire.

Group Type EXPERIMENTAL

Breast Cancer Screening Decision Support Tool

Intervention Type OTHER

-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.

Standard Breast Cancer Screening Education

-After randomization, participants will complete pre-questionnaires, review the standard breast cancer screening education from the NCI, and then complete the post-questionnaire.

Group Type ACTIVE_COMPARATOR

National Cancer Institute Breast Cancer Screening PDQ

Intervention Type OTHER

-Provides current information about breast cancer screening and is meant to inform and help patients

Interventions

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Breast Cancer Screening Decision Support Tool

-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.

Intervention Type OTHER

National Cancer Institute Breast Cancer Screening PDQ

-Provides current information about breast cancer screening and is meant to inform and help patients

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Latina, Black, or non-Latina White women
* Between the ages of 40-49 years
* Can write, read, and understand English

Exclusion Criteria

-Women with greater than an average self-reported risk of breast cancer will be ineligible for participation, as evidenced by any of the following:

* Self-reported personal history of breast cancer (invasive, ductal carcinoma in situ \[DCIS\], or lobular carcinoma in situ\[LCIS\])
* Self-reported personal history of atypical hyperplasia
* Self-reported first degree family member with history of breast cancer (e.g., mother, sister)
* Self-reported known underlying genetic mutation such as a BRCA1/BRCA2 gene
* Self-reported prior thoracic or chest wall radiation therapy

Minimum Eligible Age

40 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes