Gastroesophageal Reflux Symptoms and Help-seeking Behavior, Medication Use and Esophageal Cancer Awareness: Dutch Population-based Survey
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 4,719
- 试验地点
- 1
- 主要终点
- Level of awareness of esophageal cancer risk factors and alarm symptoms
研究概览
简要总结
Rationale: Screening for esophageal adenocarcinoma (EAC) precursors and treating them may help to decrease mortality of this malignancy. To understand the size of the target population for potential EAC screening, insight in the prevalence of registered and unregistered individuals with gastro-esophageal reflux disease (GERD) symptoms is needed. Insight in public awareness of EAC will provide additional useful information for public communication strategies.
Objective: The aims of this study are to assess the prevalence of GERD symptoms and related help-seeking behavior, registered and unregistered medication use and awareness of esophageal cancer in the general Dutch population.
Study design: Cross-sectional population-based survey.
Study population: Dutch citizens aged 18-75 years.
Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.
Main study parameters/endpoints: The outcome variables are presence of current GERD symptoms, number of GERD patients that consulted a doctor, number of GERD patients using prescribed and/or over the counter (OTC) antacids, histamine-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs), and awareness and beliefs about esophageal cancer. The association between socio-demographic background and outcome variables will also be evaluated.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study.
Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 75 years
排除标准
- •Unable to provide informed consent for any reason;
- •Unable to fill out the digital survey for any reason.
结局指标
主要结局
Level of awareness of esophageal cancer risk factors and alarm symptoms
时间窗: Baseline
The awareness and beliefs about cancer (ABC) measure was adapted for this outcome. The alarm symptom module measures whether participants think dysphagia, change in stool pattern, change in appearance of a mole, weightloss and palpable lesions are alarm symptoms of cancer (yes/no/don't know). The risk factor module measures whether participants think alcohol, smoking, obesity, male sex, GERD symptoms, age\>50y, familial esophageal cancer, hot drinks and radiation are risk factors for esophageal cancer on a 4 point scale (strongly disagree - strongly agree).
Prevalence of GERD symptoms (heartburn, regurgitation and/or dyspepsia)
时间窗: 7 days
The Dutch translation of the validated Reflux Disease Questionnaire will be used to measure this outcome.
次要结局
- Number of individuals with GERD that used antacids, H2RAs and PPI's (over-the-counter)(6 months)
- Beliefs about esophageal cancer(Baseline)
- Number of individuals that sought help for GERD (general practitioner/referral)(20 years)
- Number of individuals with GERD that used antacids, H2RAs and PPI's (prescribed)(6 months)