NCT00967824

Brief Summary

RATIONALE: Evaluating a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent breast cancer may be helpful for women at increased risk of breast cancer. PURPOSE: This randomized phase I/II trial is studying tamoxifen citrate decision aids for women at increased risk of breast cancer.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1,683

participants targeted

Target at P75+ for phase_1 breast-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 28, 2009

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

2.8 years

First QC Date

August 27, 2009

Last Update Submit

March 22, 2011

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

  • Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer

Interventions

informational interventionOTHER
questionnaire administrationOTHER
survey administrationOTHER

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Believed to be at increased risk of breast cancer (risk of ≥ 1.66% over 5 years) according to electronic-based medical data PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (2)

  • Korfage IJ, Fuhrel-Forbis A, Ubel PA, Zikmund-Fisher BJ, Greene SM, McClure JB, Smith DM, Alford SH, Fagerlin A. Informed choice about breast cancer prevention: randomized controlled trial of an online decision aid intervention. Breast Cancer Res. 2013;15(5):R74. doi: 10.1186/bcr3468.

    PMID: 24004815DERIVED

  • Banegas MP, McClure JB, Barlow WE, Ubel PA, Smith DM, Zikmund-Fisher BJ, Greene SM, Fagerlin A. Results from a randomized trial of a web-based, tailored decision aid for women at high risk for breast cancer. Patient Educ Couns. 2013 Jun;91(3):364-71. doi: 10.1016/j.pec.2012.12.014. Epub 2013 Feb 8.

    PMID: 23395006DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Angela Fagerlin, PhD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 27, 2009

First Posted

August 28, 2009

Study Start

October 1, 2005

Primary Completion

August 1, 2008

Last Updated

March 24, 2011

Record last verified: 2011-03