Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Behavioral: Counseling sessionOther: Questionnaire 1Other: Questionnaire 2Other: online questionnaire
- Registration Number
- NCT01399359
- Lead Sponsor
- NSABP Foundation Inc
- Brief 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1023
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Women who decide not to take a SERM Questionnaire 1 Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire. Women who decide not to take a SERM online questionnaire Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire. Women who decide to take a SERM Questionnaire 2 Women participate in the counseling session, questionnaire 1 and questionnaire 2. Women who decide to take a SERM Questionnaire 1 Women participate in the counseling session, questionnaire 1 and questionnaire 2. Women who decide not to take a SERM Counseling session Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire. Women who decide not to take a SERM Questionnaire 2 Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire. Women who decide to take a SERM Counseling session Women participate in the counseling session, questionnaire 1 and questionnaire 2.
- Primary Outcome Measures
Name Time Method Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM Measured at start of study and at 3 to 6 months
- Secondary Outcome Measures
Name Time Method The implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women. Measured at start of study and at 3 to 6 months Factors hindering women from taking chemoprevention for breast cancer Measured at start of study and at 3 to 6 months Reasons for the choice of raloxifene vs tamoxifen among menopausal women Measured at start of study and at 3 to 6 months 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. Measured at start of study and at 3 to 6 months To 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. Measured at start of study and at 3 to 6 months
Trial Locations
- Locations (1)
MD Anderson Cancer Center
🇺🇸Houston, Texas, United States