Multidisciplinary Shared Decision Making of Fertility Preservation in Young Women With Breast Cancer

Not Applicable

Not yet recruiting

• Conditions: Young Womenwith Breast Cancer
• Interventions: Behavioral: Counseling to preserve fertility

• Registration Number: NCT05139641
• Lead Sponsor: MedicalExcellence

Brief Summary

Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-11
• Study First Submitted: 2021-11-17
• Study First Submitted QC: 2021-11-17
• Last Update Submitted: 2021-11-17
• Study Start: 2021-12
• Study First Posted: 2021-12-01
• Last Update Posted: 2021-12-01
• Primary Completion: 2027-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 4100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
counseling theraphy	Counseling to preserve fertility	-
control group	Counseling to preserve fertility	-

Primary Outcome Measures

Name	Time	Method
selection ratio of fertility preservation procedure	selection ratio of fertility preservation procedure from Baseline to six years

Secondary Outcome Measures

Name	Time	Method
The success rate of pregnancy	The success rate of pregnancy from Baseline to six years

Trial Locations

Locations (1)

Medical Excellence; 🇰🇷 Seoul, Korea, Republic of