Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: Learning about how patients make decisions about using chemoprevention may help
      doctors plan treatment in which more patients are willing to choose chemoprevention to reduce
      their breast cancer risk.

      PURPOSE: This clinical trial studies factors influencing decision-making about the use of
      chemoprevention in women at increased risk for breast cancer.
    

Detailed description: 
      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.
    

Intervention name(s): Counseling session; Questionnaire 1; Questionnaire 2; online questionnaire
Intervention type(s): Behavioral; Other; Other; Other
Intervention description(s): Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.; Questionnaire 2 focuses on what factors, other thana the numerical risk-benefit analysis of SERM intake, are important in the decision-making process of women at increased risk for breast cancer.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women at increased risk for breast cancer.
      
Keywords: breast cancer