Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer
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.
Behavioral: telephone-based intervention
Drug: tamoxifen citrate
Other: communication analysis
Other: communication intervention
Other: counseling intervention
Other: educational intervention
Other: questionnaire administration
Other: study of socioeconomic and demographic variables
Procedure: psychosocial assessment and care
|Official Title:||A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer|
- Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM [ Designated as safety issue: No ]
- Factors hindering women from taking chemoprevention for breast cancer [ Designated as safety issue: No ]
- Reasons for the choice of raloxifene vs tamoxifen among menopausal women [ Designated as safety issue: No ]
|Study Start Date:||August 2011|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01399359
|Principal Investigator:||Christine Holmberg, PhD, MPH, MA||NSABP Foundation Inc|
|Investigator:||Angela Fagerlin, PhD||University of Michigan Cancer Center|