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

November 17, 2021 updated by: MedicalExcellence
Multidisciplinary shared decision making of fertility preservation in Young womenwith Breast Cancer (MYBC): A Pragmatic stepped wedge cluster randomised trial

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

4100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: control group
Behavioral: Counseling to preserve fertility
Counseling to preserve fertility VS Control group
Experimental: counseling theraphy
Behavioral: Counseling to preserve fertility
Counseling to preserve fertility VS Control group
No Intervention: Retrospective data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
selection ratio of fertility preservation procedure
Time Frame: selection ratio of fertility preservation procedure from Baseline to six years
selection ratio of fertility preservation procedure from Baseline to six years

Secondary Outcome Measures

Outcome Measure
Time Frame
The success rate of pregnancy
Time Frame: The success rate of pregnancy from Baseline to six years
The success rate of pregnancy from Baseline to six years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MedicalExcellence

Collaborators

Asan Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2021

Primary Completion (Anticipated)

December 1, 2027

Study Completion (Anticipated)

December 1, 2028

Study Registration Dates

First Submitted

November 17, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

December 1, 2021

Last Update Submitted That Met QC Criteria

November 17, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MYBC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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