Communicating Objective Risk for Personalized Decision Making About Mammography

NCT ID: NCT01686360

Last Updated: 2017-07-21

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

1560 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2012-12-18

Brief Summary

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The purpose of this study is to test the effects of objective risk information about breast cancer and mammography outcomes using a randomized control trial. Women between the ages of 35 and 49 will receive information about their personal risk for breast cancer and be randomly assigned to receive data about a woman who should be screened, data about the potential outcomes of screening, or data about breast cancer deaths. Two presentation formats will be tested and compared.

Detailed Description

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This study will compare alternative strategies for the presentation of individualized information about the risks and benefits of mammography screening. The purpose of this study is to understand how objective risk information influences outcomes including behavioral intentions, attitudes about mammography, and emotional responses.

After participants view objective risk information, a post-test survey will measure outcome variables including behavioral intentions, knowledge, and emotional responses.

After reading information based on their condition, study participants will be asked to complete a series of questions to measure their reactions based on their condition. Specifically, the investigators will be measuring the following dependent variables (primary outcomes): behavioral intentions to receive mammograms, attitudes about mammography, subjective norms about mammography and breast cancer screening, knowledge about mammography outcomes and screening recommendations, and emotional responses to the material including psychological reactance. These outcomes will be measured using self-reported questionnaire items.

In this project, the investigators will compare alternative communication strategies to determine which strategy or strategies result in the greatest level of understanding. The investigators also will examine if the various strategies differentially affect the primary outcomes listed above.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group 1: pre/post-test

Group receives pre and post test questions only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Control group 2: tool and pre/post-test

Group receives decision tool without personalized information. (Behavioral: Decision Aid)

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Gail score in a percentage format

Group receives Gail score in a percentage format. (Behavioral: Decision Aid)

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Gail score in a frequency format

Group receives Gail score in a frequency format. (Behavioral: Decision Aid)

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Frequency + Average 50 year old

Group receives Gail score in a frequency format as well as information about risk of breast cancer for the average 50 year old woman. (Behavioral: Decision Aid)

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Frequency + Mammography Data

Group receives Gail score in a frequency format as well as information about the risks of mammography. (Behavioral: Decision Aid)

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Frequency + Mortality Data

Group receives Gail score in a frequency format as well as information about mortality benefit of mammography. (Behavioral:Decision Aid)

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Frequency + Avg 50 year old + Mamm Data + Mortality Data

Group receives Gail score in a frequency format as well as information about breast cancer risk for the average 50 year old woman, information about the risks of mammography, risk of breast cancer for the average 50 year old woman, and information about the mortality benefit associated with mammography. (Behavioral: Decision Aid)

Group Type EXPERIMENTAL

Decision Aid

Intervention Type BEHAVIORAL

Interventions

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Decision Aid

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Adult women between the ages of 35 and 49 will be invited to participate in this study.

Exclusion Criteria

* Women who have been previously diagnosed with breast cancer or have tested positive for the breast cancer gene will not be included.
Minimum Eligible Age

35 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joseph N Cappella, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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816186

Identifier Type: -

Identifier Source: org_study_id

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