Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments counseling session, questionnaire 1, questionnaire 2, online questionnaire
Sponsor NSABP Foundation Inc
Collaborator National Cancer Institute (NCI)
Start date August 2011
End date September 2014
Trial size 1023 participants
Trial identifier NCT01399359, NSABP-DMP-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Women participate in the counseling session, questionnaire 1, and questionnaire 2, and the online questionnaire.
counseling session
questionnaire 1
Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.
questionnaire 2
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.
online questionnaire
Women participate in the counseling session, questionnaire 1 and questionnaire 2.
counseling session
questionnaire 1
Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.
questionnaire 2
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.

Primary Outcomes

Measure
Social, environmental, and psychological influences on the decision of women at risk for breast cancer as to whether or not to take a SERM
time frame: Measured at start of study and at 3 to 6 months

Secondary Outcomes

Measure
Factors hindering women from taking chemoprevention for breast cancer
time frame: Measured at start of study and at 3 to 6 months
Reasons for the choice of raloxifene vs tamoxifen among menopausal women
time frame: Measured at start of study and at 3 to 6 months
The implications of and influences on decision-making that a diagnosis of "being at risk for breast cancer" has for women.
time frame: 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.
time frame: 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.
time frame: Measured at start of study and at 3 to 6 months

Eligibility Criteria

Female participants at least 35 years old.

Inclusion criteria - The participant must be female. - The participant must be greater than or equal to 35 years of age. - The participant must be English-speaking. - The participant must have been identified as being at increased risk for breast cancer as determined by the doctor/healthcare professional (HCP) . (Increased risk for breast cancer does not have to be based on a Gail score.) - During the participant's counseling session, breast cancer risk and the use of SERMs for breast cancer risk reduction must have been discussed, as reported by the doctor/HCP who conducted the session. Note: This criterion does not apply to participants who are asked before the counseling session to participate in the video recording component of DMP-1 at the selected NSABP sites. Exclusion criteria - Previous invasive breast cancer of any type. - Previous history of ductal carcinoma in situ (DCIS). - Previous history of lobular carcinoma in situ (LCIS) if treated with mastectomy, radiation therapy, or endocrine therapy. - Participation in any other cancer prevention study involving pharmacologic intervention(s) or osteoporosis prevention study involving pharmacologic intervention(s). - Any history of or current tamoxifen, raloxifene, or other SERM therapy for any reason. (Participants are eligible if SERM use has been discussed prior to the counseling session as long as SERMs were never used.)

Additional Information

Official title A Study to Evaluate Different Decision-Making Approaches Used by Women Known to be at Increased Risk for Breast Cancer
Principal investigator Norman Wolmark, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by NSABP Foundation Inc.