ChiCTR2500100243 版本V1.0 版本创建时间2025/04/07 09:28:33 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500100243 

最近更新日期：

Date of Last Refreshed on：

2025-04-07 09:28:20 

注册时间：

Date of Registration：

2025-04-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

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

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Hu Li 

研究负责人：

Hu Li 

Applicant：

Hu Li 

Study leader：

Hu Li 

申请注册联系人电话：

Applicant telephone：

+86 137 6515 6895

研究负责人电话：

Study leader's telephone：

+86 137 6515 6895

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

13765156895@163.com

研究负责人电子邮件：

Study leader's E-mail：

13765156895@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

研究负责人通讯地址：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

Applicant address：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

Study leader's address：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Applicant's institution：

School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong

研究负责人所在单位：

School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong

Affiliation of the Leader：

School of Nursing, Li Ka Shing Faculty of Medicine, The University of Hong Kong

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

UW-25-048

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster

Name of the ethic committee：

Institutional Review Board of the University of Hong Kong / Hospital Authority Hong Kong West Cluster

伦理委员会批准日期：

Date of approved by ethic committee：

2025-02-20 00:00:00

伦理委员会联系人：

Emily TSE

Contact Name of the ethic committee：

Emily TSE

伦理委员会联系地址：

Rm 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

Contact Address of the ethic committee：

Rm 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 2255 4086

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

The University of Hong Kong

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

Primary sponsor's address：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

The University of Hong Kong

具体地址：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

Institution
hospital：

The University of Hong Kong

Address：

School of Nursing, The University of Hong Kong, 3 Sassoon Road, Pokfulam, Hong Kong, China

经费或物资来源：

Self-funded

Source(s) of funding：

Self-funded

Target disease：

Reproductive concerns

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

 

Objectives of Study：

(1) design an evidence-based oncofertility psychoeducational intervention program (OFPEI) aimed at mitigating reproductive concerns; (2) test the feasibility, acceptability, and appropriateness of the OFPEI,; (3) evaluate the preliminary effectiveness of the OFPEI on reproductive concerns, oncofertility support, coping, oncofertility care service utilization, and health-related outcomes (depression, anxiety, and quality of life) among young adult women with breast cancer

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

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.

Inclusion criteria

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.

Exclusion criteria：

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.

研究实施时间：

Study execute time：

从 From 2025-03-20 00:00:00至 To 2026-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-04-21 00:00:00 至 To 2026-02-28 00:00:00  

干预措施：

Interventions：

组别：

Intervention group

样本量：

15

Group：

Intervention group

Sample size：

干预措施：

Oncofertility psychoeducational intervention (WeChat article based fertility information support, WeChat based interactions (audio calls and counseling), and fertility information handbook)

干预措施代码：

Intervention：

Oncofertility psychoeducational intervention (WeChat article based fertility information support, WeChat based interactions (audio calls and counseling), and fertility information handbook)

Intervention code：

组别：

Attention control group

样本量：

15

Group：

Attention control group

Sample size：

干预措施：

General education (WeChat article based general information support, WeChat based audio calls)

干预措施代码：

Intervention：

General education (WeChat article based general information support, WeChat based audio calls)

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Guizhou 

市(区县)：

 Guiyang 

Country：

China  

Province：

Guizhou 

City：

Guiyang 

单位(医院)：

The Affiliated Hospital of Guizhou Medical University 

单位级别：

Tertiary A 

Institution
hospital：

The Affiliated Hospital of Guizhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Acceptability and feasibility of the oncofertility psychoeducational intervention program

指标类型：

主要指标

Outcome：

Acceptability and feasibility of the oncofertility psychoeducational intervention program

Type：

Primary indicator

测量时间点：

Immediately after intervention

测量方法：

Measure time point of outcome：

Immediately after intervention

Measure method：

指标中文名：

Reproductive concerns

指标类型：

主要指标

Outcome：

Reproductive concerns

Type：

Primary indicator

测量时间点：

Baseline and Immediately after intervention

测量方法：

Measure time point of outcome：

Baseline and Immediately after intervention

Measure method：

指标中文名：

Oncofertility support

指标类型：

次要指标

Outcome：

Oncofertility support

Type：

Secondary indicator

测量时间点：

Baseline and Immediately after intervention

测量方法：

Measure time point of outcome：

Baseline and Immediately after intervention

Measure method：

指标中文名：

Oncofertility care service utilization

指标类型：

次要指标

Outcome：

Oncofertility care service utilization

Type：

Secondary indicator

测量时间点：

Baseline and Immediately after intervention

测量方法：

Measure time point of outcome：

Baseline and Immediately after intervention

Measure method：

指标中文名：

Coping

指标类型：

次要指标

Outcome：

Coping

Type：

Secondary indicator

测量时间点：

Baseline and Immediately after intervention

测量方法：

Measure time point of outcome：

Baseline and Immediately after intervention

Measure method：

指标中文名：

Depression symptoms

指标类型：

次要指标

Outcome：

Depression symptoms

Type：

Secondary indicator

测量时间点：

Baseline and Immediately after intervention

测量方法：

Measure time point of outcome：

Baseline and Immediately after intervention

Measure method：

指标中文名：

Anxiety symptoms

指标类型：

次要指标

Outcome：

Anxiety symptoms

Type：

Secondary indicator

测量时间点：

Baseline and Immediately after intervention

测量方法：

Measure time point of outcome：

Baseline and Immediately after intervention

Measure method：

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 40 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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 (https://www.randomizer.org).

Randomization Procedure (please state who generates the random number sequence and by what method)：

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 (https://www.randomizer.org).

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

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.

Blinding：

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.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

None

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

None

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

All outcomes in the study will be self-reported by participants. Upon receiving the online questionnaires, the data will be promptly verified to ensure completeness and accuracy. All original data will be entered after removing identifying information, and each record will be assigned a unique code known only to the researchers. Data security will be maintained through password-protected computer. Both personal and study-related data will be retained for 5 years following the study's completion.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

All outcomes in the study will be self-reported by participants. Upon receiving the online questionnaires, the data will be promptly verified to ensure completeness and accuracy. All original data will be entered after removing identifying information, and each record will be assigned a unique code known only to the researchers. Data security will be maintained through password-protected computer. Both personal and study-related data will be retained for 5 years following the study's completion.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2025-04-07 09:28:20