Tamoxifen Citrate Decision Aids for Women at Increased Risk of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Developing and Testing a Tamoxifen Prophylaxis Decision Aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967824
• Other study ID #: CDR0000649906
• Secondary ID: P50CA101451P30CA
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 27, 2009
• Last updated: March 22, 2011
• Start date: October 2005

Study information

• Verified date: March 2011
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

OBJECTIVES:

• To develop and test a decision aid for describing the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer in women at increased risk of breast cancer.

OUTLINE:

• Phase I: Patients are randomized to view 1 of 16 decision aids that vary in terms of how the information is presented based on 5 dimensions: 1) statistical information in pictographs vs plain text, 2) risk information presented with denominators of 100 vs 1000, 3) risk information presented in terms of total vs additional risk, 4) whether the risks of tamoxifen citrate are presented before or after the benefits are presented, and 5) contextual information about other risks the patient faces (all cause mortality, colon cancer, heart attack).

Patients complete baseline and post-test questionnaires.

• Phase II: Patients are randomized to 1 of 3 arms.

• Arm I (control): Patients do not view the decision aid, but complete baseline and post-test questionnaires.

• Arm II (control): Patients complete a baseline questionnaire only. They do not view the decision aid or complete the post-test questionnaire.

• Arm III (intervention): Patients view 1 of 16 decision aids that vary based on 5 factors: 1) providing (or not) comparative information about the average woman's breast cancer risk, 2) sequencing presentation of risks and benefits (risks first vs benefits first), 3) including (or not) a summary table following presentation of risks and benefits, 4) using second vs third person language ("your risk" vs "a person like you"), and 5) presenting the decision as having 2 vs 3 options (taking/not taking a breast cancer prevention drug vs taking tamoxifen citrate/raloxifene, or no drug). Patients also complete baseline and post-test questionnaires.

Patients in both phases complete an online follow-up survey at 3 months. Patients in arms I or II (of phase II) receive a decision aid after completion of the follow-up survey.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1683
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• informational intervention

• questionnaire administration

• survey administration

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development and testing of a decision aid that describes the risks and benefits of taking tamoxifen citrate to prevent primary breast cancer			No