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

University of Michigan Rogel Cancer Center

Status and phase

Completed

Phase 2

Phase 1

Conditions

Breast Cancer

Treatments

Other: questionnaire administration

Other: informational intervention

Other: survey administration

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00967824

IRBMED-2004-0695 (Other Identifier)

P50CA101451 (U.S. NIH Grant/Contract)

CDR0000649906

P30CA046592 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,683 estimated patients

Sex

Female

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS: