ChiCTR2600116880 版本V1.0 版本创建时间2026/01/16 09:19:20 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：

 ChiCTR2600116880 

最近更新日期：

Date of Last Refreshed on：

 2026-01-16 09:19:04 

注册时间：

Date of Registration：

 2026-01-16 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Effect of a Health Education Program on Lung Cancer Screening among College Students Who Smoke

Public title：

Effect of a Health Education Program on Lung Cancer Screening among College Students Who Smoke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Efficacy of the Health Belief Model-Based Intervention in Enhancing Lung Cancer Screening among Smoker Collegians: A Randomized Controlled Trial

Scientific title：

Efficacy of the Health Belief Model-Based Intervention in Enhancing Lung Cancer Screening among Smoker Collegians: A 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：

Methaq Nawfal Qasim 

研究负责人：

Methaq Nawfal Qasim 

Applicant：

Methaq Nawfal Qasim 

Study leader：

Methaq Nawfal Qasim 

申请注册联系人电话：

Applicant telephone：

 +964 751 520 4787

研究负责人电话：

Study leader's
telephone：

+964 751 520 4787

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：

 mithaq.qasem2406m@conursing.uobaghdad.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

 mithaq.qasem2406m@conursing.uobaghdad.edu.iq

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：

College of Nursing, University of Baghdad, Baghdad, Iraq

研究负责人通讯地址：

College of Nursing, University of Baghdad, Baghdad, Iraq

Applicant address：

College of Nursing, University of Baghdad, Baghdad, Iraq

Study leader's address：

College of Nursing, University of Baghdad, Baghdad, Iraq

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：

University of Baghdad, College of Nursing

Applicant's institution：

University of Baghdad, College of Nursing

研究负责人所在单位：

University of Baghdad, College of Nursing

Affiliation of the Leader：

University of Baghdad, College of Nursing

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 33

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：

Research Ethical Approval Committee

Name of the ethic committee：

Research Ethical Approval Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-11-20 00:00:00

伦理委员会联系人：

Prof. Wissam J. Kassim,Ph.D.

Contact Name of the ethic committee：

Prof. Wissam J. Kassim,Ph.D.

伦理委员会联系地址：

College of Nursing/University of Baghdad Bab Al Mua’adham-Baghdad-Iraq

Contact Address of the ethic committee：

College of Nursing/University of Baghdad Bab Al Mua’adham-Baghdad-Iraq

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +964 774 285 7710

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nursing@conursing.uobaghdad.edu.iq

研究实施负责（组长）单位：

College of Nursing, University of Baghdad

Primary sponsor：

College of Nursing, University of Baghdad

研究实施负责（组长）单位地址：

College of Nursing, University of Baghdad, Bab Al-Muadham, Baghdad, Iraq

Primary sponsor's address：

College of Nursing, University of Baghdad, Bab Al-Muadham, Baghdad, Iraq

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iraq

省(直辖市)：

Nineveh Governorate

市(区县)：

Telafer

Country：

Iraq

Province：

Nineveh Governorate

City：

Telafer

单位(医院)：

College of Nursing, University of Baghdad

具体地址：

University of Telafer, Telafer District, Nineveh Governorate, Iraq

Institution
hospital：

Colleges of Education and Basic Education at the University of Telafer

Address：

University of Telafer, Telafer District, Nineveh Governorate, Iraq

经费或物资来源：

Self-funded / No external funding

Source(s) of funding：

Self-funded / No external funding

研究疾病：

Lung Cancer (Screening and Prevention)  

Target disease：

Lung Cancer (Screening and Prevention)

研究疾病代码：

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：

This study aims to examine the efficacy of Health Belief Model–based intervention in enhancing lung cancer screening among smoker collegians.  

Objectives of Study：

This study aims to examine the efficacy of Health Belief Model–based intervention in enhancing lung cancer screening among smoker collegians.

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. University students currently enrolled at the University of Telafer; 2. Current smokers; former smokers within the past 15 years; or individuals with a smoking history of one pack per day for 30 years; 3. Aged 18 years and above; 4. Able to read and understand Arabic; 5. Willing to participate and provide informed consent.

Inclusion criteria

1. University students currently enrolled at the University of Telafer; 2. Current smokers; former smokers within the past 15 years; or individuals with a smoking history of one pack per day for 30 years; 3. Aged 18 years and above; 4. Able to read and understand Arabic; 5. Willing to participate and provide informed consent.

排除标准：

1. Students diagnosed with lung cancer or any other chronic disease; 2. Non-smokers; 3. Students who have previously participated in an educational program related to lung cancer or had undergone lung cancer screening using a low-dose CT scan.

Exclusion criteria：

1. Students diagnosed with lung cancer or any other chronic disease; 2. Non-smokers; 3. Students who have previously participated in an educational program related to lung cancer or had undergone lung cancer screening using a low-dose CT scan.

研究实施时间：

Study execute time：

从 From 2025-10-01 00:00:00至 To 2025-11-26 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-11-16 00:00:00 至 To 2025-11-24 00:00:00

干预措施：

Interventions：

组别：

Intervention group (Education group)

样本量：

 72

Group：

Intervention group (Education group)

Sample size：

干预措施：

Health Belief Model (HBM)-based health education program focusing on perceived susceptibility, perceived benefits, perceived barriers, and self-efficacy related to lung cancer screening.

干预措施代码：

Intervention：

Health Belief Model (HBM)-based health education program focusing on perceived susceptibility, perceived benefits, perceived barriers, and self-efficacy related to lung cancer screening.

Intervention code：

组别：

Control group (Non-education group)

样本量：

 72

Group：

Control group (Non-education group)

Sample size：

干预措施：

No educational intervention; participants receive only routine health information.

干预措施代码：

Intervention：

No educational intervention; participants receive only routine health information.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Nineveh Governorate 

市(区县)：

 Telafer 

Country：

Iraq

Province：

Nineveh Governorate

City：

Telafer

单位(医院)：

 University of Telafer 

单位级别：

 University 

Institution
hospital：

University of Telafer

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Lung Cancer Knowledge

指标类型：

主要指标

Outcome：

Lung Cancer Knowledge

Type：

Primary indicator

测量时间点：

Baseline, Post-intervention

测量方法：

Measure time point of outcome：

Baseline, Post-intervention

Measure method：

指标中文名：

Perceived Risk, Perceived benefit, Perceived barriers, Perceived self-efficacy

指标类型：

次要指标

Outcome：

Perceived Risk, Perceived benefit, Perceived barriers, Perceived self-efficacy

Type：

Secondary indicator

测量时间点：

Baseline, Post-intervention

测量方法：

Measure time point of outcome：

Baseline, Post-intervention

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 30 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）：

Randomization Procedure: Once the final sample had been confirmed, the 144 students who agreed to take part in the study were assigned to a study group (intervention group) and a control group (non-intervention group) using a simple random assignment procedure. All participants’ names were written on identical pieces of paper and placed in a container, which was mixed well. One student then drew the papers one by one; the first name was placed in the study group, the next in the control group, and this process continued alternately until all 144 participants had been assigned. Sign the informed consent: All participants provided written informed consent in Arabic. Length of follow-up (include time point of outcome measure): 14 days (from baseline to post-intervention measurement)

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

Randomization Procedure: Once the final sample had been confirmed, the 144 students who agreed to take part in the study were assigned to a study group (intervention group) and a control group (non-intervention group) using a simple random assignment procedure. All participants’ names were written on identical pieces of paper and placed in a container, which was mixed well. One student then drew the papers one by one; the first name was placed in the study group, the next in the control group, and this process continued alternately until all 144 participants had been assigned. Sign the informed consent: All participants provided written informed consent in Arabic. Length of follow-up (include time point of outcome measure): 14 days (from baseline to post-intervention measurement)

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：

Participants and educators were aware of group assignments due to the nature of the educational intervention; outcome assessors were blinded where possible.

Blinding：

Participants and educators were aware of group assignments due to the nature of the educational intervention; outcome assessors were blinded where possible.

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

否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）：

Individual participant data (IPD) will not be publicly shared. However, de-identified data may be made available upon reasonable request to the corresponding author after publication of the study, and only for academic purposes, in accordance with ethical approval

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

Individual participant data (IPD) will not be publicly shared. However, de-identified data may be made available upon reasonable request to the corresponding author after publication of the study, and only for academic purposes, in accordance with ethical approval

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：

Data will be collected and managed confidentially in accordance with the ethical approvals obtained from the College of Nursing, University of Baghdad. All data will be securely stored and will not be placed in a public database.

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

Data will be collected and managed confidentially in accordance with the ethical approvals obtained from the College of Nursing, University of Baghdad. All data will be securely stored and will not be placed in a public database.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-16 09:19:04