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Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care (MiChoice)
Overall Recruitment Status: Active, currently enrolling
 
Official Title
Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women With Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention Into Care (MiChoice)
 
Region Sponsors
California - Northern
SWOG Cancer Research Network
 
Acronym KP IRB No.
S65
 
Study Type Phase
Prospective Cohort Study with Direct Patient Contact
 
Study Population Description
 
Purpose
This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.
 
Detailed Description
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Patients must have histologically-confirmed atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) documented by breast pathology report at any time in the past. Patients with borderline breast lesions and pleomorphic LCIS are also eligible Patients must be women at least 35 and no more than 74 years of age at registration, since the Breast Cancer Surveillance Consortium (BCSC) risk calculator is valid only for this age range Both pre/perimenopausal and postmenopausal women are eligible Patients must be able to read and write in English or Spanish since study questionnaires and educational materials are only available in English and Spanish Baseline questionnaires must be completed prior to patient registration
 
Exclusion Criteria
  • atients must not have a history of invasive breast cancer or ductal carcinoma in situ Patients must not have prior or current use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) NOTE: The following are approved SERMS and AIs, however, the study is not limited to these. SERMs: tamoxifen, raloxifene AIs: anastrozole, exemestane, letrozole Patients must not be currently taking hormone replacement therapy Patients must not have a history of bilateral mastectomies or breast implants since the risk calculator is not applicable to these women Patients must not be pregnant or lactating

 
Keywords and/or Specific Medical Conditions
  • Obstetrics and Gynecology
  • Oncology (Adult)
 
KP Clinical Facility
  • All Kaiser Permanente Northern California Medical Centers
 
Clinical Area
  • Obstetrics and Gynecology
  • Oncology (Adult)


Principal Investigator:
Samantha Seaward
Contact Information:
- Desiree Goldstein
-ctpcollaborate@kp.org
-All Kaiser Permanente Northern California Medical Centers


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