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| Overall Recruitment Status: Active, currently enrolling |
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| 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)
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| Region |
Sponsors |
| California - Northern |
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| Acronym |
NCT No. |
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NCT04496739 |
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| Study Type |
Phase |
| Prospective Cohort Study with Direct Patient Contact |
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| 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. |
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| Detailed Description |
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- 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
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- 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
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- Obstetrics and Gynecology
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