Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer
MYBC
1 other identifier
interventional
4,100
1 country
1
Brief Summary
Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 17, 2021
CompletedFirst Posted
Study publicly available on registry
December 1, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
December 1, 2021
November 1, 2021
6 years
November 17, 2021
November 17, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
selection ratio of fertility preservation procedure
selection ratio of fertility preservation procedure from Baseline to six years
Secondary Outcomes (1)
The success rate of pregnancy
The success rate of pregnancy from Baseline to six years
Study Arms (3)
control group
PLACEBO COMPARATORcounseling theraphy
EXPERIMENTALRetrospective data
NO INTERVENTIONInterventions
Counseling to preserve fertility VS Control group
Eligibility Criteria
You may qualify if:
- Women aged 19 to 40 years old
- A person diagnosed with breast cancer by biopsy
- Those who don't have evidence of distant metastasis
- Eastern Cooperative Oncology Group(ECOG) performance status: 0-2 score
- Before registering for clinical trials, chemotherapy, radiation therapy, anti-hormone therapy, immunotherapy, and surgery are not performed
- A person who has fully understood and listened to the explanation of this clinical trial and then gave written consent
You may not qualify if:
- Histologically, a person diagnosed with follicular or sarcoma
- Those with a history of breast cancer (including recurrent breast cancer)
- A person diagnosed with another cancer before breast cancer
- A person diagnosed with metastatic breast cancer
- A person who has a mental illness and has a hard time understanding clinical trials
- Those who plan to conduct follow-up observation elsewhere(to change of hometowm)
- Menopausal factors without menstruation after more than a year from the last menstrual date
- A pregnant woman
- Inappropriate for participation in clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MedicalExcellencelead
- Asan Medical Centercollaborator
Study Sites (1)
Medical Excellence
Seoul, South Korea
Related Publications (1)
Baek SY, Kim HK, Park S, Yu JH, Lee MH, Youn HJ, Kim HA, Han JH, Choi JE, Lee JR, Lee KH, Chung S, Chae HD, Kim S, Yoo S, Hahm SK, Kim HJ. Multidisciplinary Shared Decision Making for Fertility Preservation in Young Women With Breast Cancer. J Breast Cancer. 2023 Dec;26(6):582-592. doi: 10.4048/jbc.2023.26.e44. Epub 2023 Oct 11.
PMID: 37985382DERIVED
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2021
First Posted
December 1, 2021
Study Start
December 1, 2021
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
December 1, 2028
Last Updated
December 1, 2021
Record last verified: 2021-11