NCT01686360

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,560

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 28, 2012

Completed
4 days until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 18, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2012

Completed
Last Updated

July 21, 2017

Status Verified

July 1, 2017

Enrollment Period

4 months

First QC Date

August 28, 2012

Last Update Submit

July 20, 2017

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Behavioral intentions to get a mammogram

    All participants will be asked to report their behavioral intentions to obtain mammograms in their 40s and at age 50.

    immediately following intervention (time 0)

Secondary Outcomes (1)

  • Attitude about mammography

    immediately following intervention (time 0)

Other Outcomes (6)

  • Injunctive and descriptive norms about mammography

    immediately following intervention (time 0)

  • Decisional satisfaction

    immediately following intervention (time 0)

  • Risk perception

    immediately before and after intervention (time 0)

  • +3 more other outcomes

Study Arms (8)

Control group 1: pre/post-test

NO INTERVENTION

Group receives pre and post test questions only.

Control group 2: tool and pre/post-test

EXPERIMENTAL

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

Behavioral: Decision Aid

Gail score in a percentage format

EXPERIMENTAL

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

Behavioral: Decision Aid

Gail score in a frequency format

EXPERIMENTAL

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

Behavioral: Decision Aid

Frequency + Average 50 year old

EXPERIMENTAL

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)

Behavioral: Decision Aid

Frequency + Mammography Data

EXPERIMENTAL

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

Behavioral: Decision Aid

Frequency + Mortality Data

EXPERIMENTAL

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

Behavioral: Decision Aid

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

EXPERIMENTAL

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)

Behavioral: Decision Aid

Interventions

Decision AidBEHAVIORAL
Control group 2: tool and pre/post-testFrequency + Average 50 year oldFrequency + Avg 50 year old + Mamm Data + Mortality DataFrequency + Mammography DataFrequency + Mortality DataGail score in a frequency formatGail score in a percentage format

Eligibility Criteria

Age35 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Decision Support Techniques

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Joseph N Cappella, PhD

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 18, 2012

Study Start

September 1, 2012

Primary Completion

December 18, 2012

Study Completion

December 18, 2012

Last Updated

July 21, 2017

Record last verified: 2017-07

Locations

US(1)