Baek Soo Yeon, Kim Hong-Kyu, Park Seho, Yu Jong Han, Lee Min Hyuk, Youn Hyun Jo, Kim Hyun-Ah, Han Jai Hong, Choi Jung Eun, Lee Jung Ryeol, Lee Kyung-Hun, Chung Seockhoon, Chae Hee Dong, Kim Seonok, Yoo Soyoung, Hahm Sang Keun, Kim Hee Jeong
Department of Surgery, Ajou University School of Medicine, Suwon, Korea.
Department of Surgery, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
J Breast Cancer. 2023 Dec;26(6):582-592. doi: 10.4048/jbc.2023.26.e44. Epub 2023 Oct 11.
Fertility preservation (FP) is an important issue for young survivors of breast cancer. Although international guidelines recommend pre-treatment fertility counseling for women with breast cancer, there is no standardized protocol or referral system for FP in South Korea. There are also barriers to discussing FP that make patient-centered decision making difficult. This study aimed to develop a shared decision making program for FP and compare the rates of FP procedures between the usual care and shared decision making groups. We hypothesized that multidisciplinary shared decision making for FP would increase the rate of FP procedures and patient satisfaction.
The multidisciplinary shared decision making for FP in young women with breast cancer (MYBC) is a multicenter, clustered, stepped-wedge, randomized trial. A total of 1100 patients with breast cancer, aged 19-40 years, from nine hospitals in South Korea, will be enrolled. They will be randomized at the institutional level and assigned to usual care and shared decision making groups. Four institutions, each of which can recruit more than 200 patients, will each become a cluster, whereas five institutions, each of which can recruit more than 50 patients, will become one cluster, for a total of five clusters. The shared decision making groups will receive multidisciplinary programs for FP developed by the investigator. The primary outcome is the rate of FP procedures; secondary outcomes include fertility results, satisfaction, and quality of life. Outcomes will be measured at enrollment, treatment initiation, and the 1-, 3-, and 5-year follow-ups after starting breast cancer treatment.
A multidisciplinary shared decision making program for FP is expected to increase fertility rates and satisfaction among young patients with breast cancer. This study will provide the evidence to implement a multidisciplinary system for patients with breast cancer.
ClinicalTrials.gov Identifier: NCT05139641. Registered on December 1, 2021.
生育力保存（FP）对于年轻乳腺癌幸存者而言是一个重要问题。尽管国际指南建议为乳腺癌女性提供治疗前生育咨询，但韩国尚无针对FP的标准化方案或转诊系统。在讨论FP方面也存在障碍，这使得以患者为中心的决策变得困难。本研究旨在开发一个关于FP的共同决策项目，并比较常规护理组和共同决策组之间FP程序的实施率。我们假设，针对FP的多学科共同决策将提高FP程序的实施率和患者满意度。
针对年轻乳腺癌女性（MYBC）的FP多学科共同决策是一项多中心、整群、阶梯式楔形随机试验。将招募来自韩国9家医院的1100名年龄在19至40岁之间的乳腺癌患者。她们将在机构层面进行随机分组，并被分配到常规护理组和共同决策组。四个机构，每个机构可招募200多名患者，将各自成为一个集群，而五个机构，每个机构可招募50多名患者，将成为一个集群，总共五个集群。共同决策组将接受由研究者制定的关于FP的多学科项目。主要结局是FP程序的实施率；次要结局包括生育结果、满意度和生活质量。结局将在入组时、治疗开始时以及开始乳腺癌治疗后的1年、3年和5年随访时进行测量。
预计针对FP的多学科共同决策项目将提高年轻乳腺癌患者的生育率和满意度。本研究将为实施针对乳腺癌患者的多学科系统提供证据。
ClinicalTrials.gov标识符：NCT05139641。于2021年12月1日注册。
