The effect of a community-based participatory intervention on colorectal cancer health literacy in Middle-Aged Population

Intervention 1: Intervention group: The components of the intervention program include; Survey of the participants - Organizing group meetings with the participation of ordinary people, health center personnel and health liaisons to determine educational and support programs - Designing individual and telephone counseling programs for each participant specifically - Holding five group training sessions as a workshop for 45 minutes in cultural center, health center or neighborhood mosque - preparation and distribution of educational materials and pamphlets - face-to-face follow-up through home visits by health liaisons and friendly meetings and asking about the condition and telephone follow-up and referral of participants to take the test Screening will be to health centers. The intervention has a triangulation mode and its three sides include; a) health centers b) mosques, cultural centers and c) members of the research team,. Intervention 2: Control group: They will not receive any intervention and only at the end of the study, in order to comply with the ethical standards, educational materials will be provided to them in the form of pamphlets.
Primary outcome(s): Colorectal cancer health literacy. Timepoint: before the start of the intervention, immediately after the intervention and one month after the intervention. Method of measurement: It will be controlled based on the European Health Literacy Questionnaire HLS-EU.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, a simple and individual randomization method is used, at first we will have access to people by using the electronic file of people in the comprehensive middle-aged program of the health center, then according to the criteria of entry and non-entry, people will be called and after completing Questionnaires will be assigned to intervention and control groups by simple and individual randomization method using statistical software. The method of using Sequentially numbered, sealed, opaque envelopes (SNOSE) is also used for concealment. For this, a statistical consultant will be used so that the project implementers are not involved in this issue, Blinding description: In this case, the people participating in the study who are assigned to the intervention or control group are kept blind. Also, due to the use of a statistica

干预1：干预组：本干预方案的组成内容如下：① 针对参与者的调研——组织普通民众、基层医疗机构人员与健康联络员共同开展团体会议，以明确健康教育与支持方案；② 为每位参与者定制个体化电话咨询方案；③ 在文化中心、基层医疗机构或社区清真寺开展5次工作坊式团体培训，每次时长45分钟；④ 编制并发放教育材料与宣传手册；⑤ 通过健康联络员上门随访、开展友好座谈了解参与者状况、进行电话跟进，并将需筛查的参与者转诊至基层医疗机构接受检测。本干预采用三角验证模式，三大实施主体分别为：a) 基层医疗机构；b) 清真寺与文化中心；c) 研究团队成员。

干预2：对照组：对照组不接受任何干预措施，仅在研究结束阶段，为符合伦理规范要求，向其发放宣传册形式的教育材料。

主要结局指标：结直肠癌健康素养。
测量时间点：干预开始前、干预结束即刻及干预结束后1个月。
测量方法：采用欧洲健康素养问卷（HLS-EU）进行评估。

研究设计：
随机化方式：随机分组；设盲方式：双盲；安慰剂设置：未使用安慰剂；分组模式：平行分组；研究目的：疾病预防。
随机化说明：本研究采用简单个体随机化方法。首先通过基层医疗机构综合中年人群项目的电子档案招募受试者，随后根据入排标准筛选受试者，在完成问卷调研后，借助统计软件采用简单个体随机化方法将其分配至干预组与对照组。同时采用顺序编号密封不透光信封（SNOSE）进行随机隐藏，此项工作将由统计顾问完成，以避免项目实施者参与相关流程。
设盲说明：本研究中，被分配至干预组或对照组的受试者将保持盲态。此外，因使用了统计[原文未完整表述]