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

NCT ID: NCT05139641

Last Updated: 2021-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

4100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2028-12-31

Brief Summary

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

Detailed Description

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Conditions

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Young Womenwith Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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control group

Group Type PLACEBO_COMPARATOR

Counseling to preserve fertility

Intervention Type BEHAVIORAL

Counseling to preserve fertility VS Control group

counseling theraphy

Group Type EXPERIMENTAL

Counseling to preserve fertility

Intervention Type BEHAVIORAL

Counseling to preserve fertility VS Control group

Retrospective data

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Counseling to preserve fertility

Counseling to preserve fertility VS Control group

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role collaborator

MedicalExcellence

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Medical Excellence

Seoul, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Minjung Kim

Role: CONTACT

Phone: 82-2-3482-7809

Email: [email protected]

Facility Contacts

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Minjung Kim

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37985382 (View on PubMed)

Other Identifiers

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MYBC

Identifier Type: -

Identifier Source: org_study_id