Not yet recruiting NCT05139641
Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Counseling to preserve fertility.
- Who it may be relevant to
- Registry conditions: Young Womenwith Breast Cancer. Basic parameters: 19 years — 40 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial
Interventions
- Behavioral Counseling to preserve fertility
Counseling to preserve fertility VS Control group
Primary outcome measures
- selection ratio of fertility preservation procedure [Time frame: selection ratio of fertility preservation procedure from Baseline to six years]
Secondary outcome measures (1)
- The success rate of pregnancy [Time frame: The success rate of pregnancy from Baseline to six years]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
South Korea · 1 center
- Medical Excellence — Seoul
Publications
- 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 37985382
Identifiers
NCT: NCT05139641 · MYBC