Status:
COMPLETED
Factors Influencing Decision-Making About the Use of Chemoprevention in Women at Increased Risk for Breast Cancer
Lead Sponsor:
NSABP Foundation Inc
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
FEMALE
35-120 years
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 ca...
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 ...
Eligibility Criteria
Inclusion
- 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.)
Exclusion
Key Trial Info
Start Date :
August 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
1023 Patients enrolled
Trial Details
Trial ID
NCT01399359
Start Date
August 1 2011
End Date
October 1 2014
Last Update
October 5 2021
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77030