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

M

MedicalExcellence

Status

Not yet enrolling

Conditions

Young Womenwith Breast Cancer

Treatments

Behavioral: Counseling to preserve fertility

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

4,100 estimated patients

Sex

Female

Ages

19 to 40 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

4,100 participants in 3 patient groups, including a placebo group

control group
Placebo Comparator group
Treatment:
Behavioral: Counseling to preserve fertility
counseling theraphy
Experimental group
Treatment:
Behavioral: Counseling to preserve fertility
Retrospective data
No Intervention group

Trial contacts and locations

1

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Central trial contact

Minjung Kim

Data sourced from clinicaltrials.gov

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