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【ChiCTR2500100243】Effectiveness of a Nurse-led and Mobile Instant Message Delivered Oncofertility Psychoeducational Program Among Young Adult Women with Breast Cancer: A Pilot Randomized Controlled Trial

基本信息
登记号

ChiCTR2500100243

试验状态

尚未开始

药物名称

/

药物类型

/

规范名称

/

首次公示信息日的期

2025-04-07

临床申请受理号

/

靶点

/

适应症

Reproductive concerns

试验通俗题目

Effectiveness of a Nurse-led and Mobile Instant Message Delivered Oncofertility Psychoeducational Program Among Young Adult Women with Breast Cancer: A Pilot Randomized Controlled Trial

试验专业题目

Effectiveness of a Nurse-led and Mobile Instant Message Delivered Oncofertility Psychoeducational Program Among Young Adult Women with Breast Cancer: A Pilot Randomized Controlled Trial

申办单位信息
申请人联系人
申请人名称
联系人邮箱
联系人邮编

联系人通讯地址
临床试验信息
试验目的

/

试验分类
试验类型

随机平行对照

试验分期

其它

随机化

Participants will be randomly assigned to either the Intervention group or Control group in a 1:1 ratio (block randomisation sizes of 4 or 6) after baseline assessment. An independent researcher will generate the randomization sequence using an online computer program (http://www.randomizer.org).

盲法

Due to the nature of the intervention, blinding the intervenor and participants will not be feasible. An independent researcher who responsible for data collection will be blinded.

试验项目经费来源

Self-funded

试验范围

/

目标入组人数

15

实际入组人数

/

第一例入组时间

2025-03-20

试验终止时间

2026-06-30

是否属于一致性

/

入选标准

1.Being newly diagnosed with breast cancer; 2.Aged between 18 and 40 years (the age range is selected based on several considerations: (1)The current study focuses on adults; (2)The NCCN (National Comprehensive Cancer Network) guideline defines adolescents and young adults (AYAs) as individuals aged 15 to 39 at the time of initial cancer diagnosis; (3)Fertility preservation strategies are recommended for women with cancer up to the age of 40; 3.Having not initiated chemotherapy; 4.Reporting high levels of RCs (mean item score >= 4) on at least one domain of the Reproductive Concerns After Cancer (RCAC) scale; 5.Can read and write Chinese; 6. Being willing to participate in the study; 7. Have a smartphone and WeChat account.;

排除标准

1.Being pregnant currently; 2.With advanced breast cancer (Stage IV or with distant metastatic cancer); 3.With other cancer diagnosis; 4.Having undergone hysterectomy, oophorectomy, or tubal ligation procedures; 5.Primary or secondary infertility diagnosed prior to breast cancer; 6.Partners have been diagnosed as infertile (if married); 7. Having known psychiatric morbidity.;

研究者信息
研究负责人姓名
试验机构

The University of Hong Kong

研究负责人电话
研究负责人邮箱
研究负责人邮编

/

联系人通讯地址

The University of Hong Kong的其他临床试验

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