Trial Information

A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer

OBJECTIVES:

Primary

- To describe the influence of social, environmental, and psychological factors
(sociality of medication intake, life-events, understanding of prevention, clinical
situation) on the decision of women at risk for breast cancer as to whether or not to
take chemoprevention agents.

Secondary

- To determine the implications of and influences on decision-making that a diagnosis of
"being at risk for breast cancer" has for women.

- To determine what factors hinder women from taking chemoprevention for breast cancer.

- To field test a questionnaire that identifies the factors that influence the
decision-making process of women at increased risk of breast cancer for whom
chemoprevention is a medically indicated option.

- To describe the influence of social, environmental, and psychological factors on the
decision of women at risk for breast cancer as to whether or not to take
chemoprevention agents by menopausal status.

- For postmenopausal women who decide to take a selective estrogen-receptor modulator
(SERM) for breast cancer prevention, to assess reasons for the choice of raloxifene
versus tamoxifen.

OUTLINE: This is a multicenter study.

Participants undergo a counseling session about their increased risk for breast cancer and
the use of a selective estrogen-receptor modulator (SERM), tamoxifen citrate or raloxifene,
to reduce breast cancer risk. Some participants may have their counseling session
video-recorded. They are also asked to review the video with their interviewers and to be
contacted for a brief follow-up telephone interview.

Participants then complete an initial questionnaire to assess recall and understanding of
risk information given to them during the counseling session. This first questionnaire is
completed preferably on the same day of counseling before leaving the clinic or office.
Participants also have the option to take the questionnaire home and return it to the study
site within 2 weeks. Participants who return the first questionnaire complete a second one
before leaving the clinic or office, or receive it by mail with a returned self-addressed
stamped envelope. Participants who indicate on the second questionnaire that they do not
want to take a SERM are asked to complete an online questionnaire. Participants who have not
made a decision about SERM use within 3 months after counseling are contacted by telephone.
They also receive the second questionnaire by mail 3 months after the telephone contact.

Interviewers, doctors, or other health-care professionals also complete questionnaires that
indicate what was discussed during counseling sessions.