Impact of SMS Notifications on the Colorectal Cancer Screening Program
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,084
- 试验地点
- 1
- 主要终点
- Participation rate
研究概览
简要总结
Colorectal cancer is a leading cause of mortality in Catalonia. Although early detection programs using the fecal immunochemical test (FIT) are effective in reducing both incidence and mortality, their success relies on high population participation. Currently, in the Vallès Occidental region, the participation rate stands at 42%, which is below the 65% minimum recommended by European health authorities. The objective of this randomized controlled trial is to evaluate whether sending a reminder text message (SMS) is an effective tool to increase participation in the screening program. The study will include 10,084 participants aged between 50 and 69 years. Half of the participants will receive a reminder SMS five weeks after their initial invitation, while the other half will follow the standard of care involving postal letters. Researchers anticipate that this strategy will not only increase the number of individuals undergoing screening but also shorten the response time and reduce the need for sending postal reminders
详细描述
This study is a pragmatic, randomized, parallel-group clinical trial with a 1:1 allocation ratio, conducted within the framework of the Colorectal Cancer Early Detection Program (PDPCCR) in the Vallès Occidental region. The trial is coordinated by the Cancer Screening Unit of the Consorci Corporació Sanitària Parc Taulí.
Operational Flow and Randomization: The study follows a sequential recruitment process. At Week 0, the entire target population receives a standard invitation letter according to the program's usual standard of care. For individuals who have not participated by Week 5, a computer-generated randomization sequence (Microsoft Excel) is applied weekly to assign them to either the intervention or control group. This weekly approach ensures the intervention is timely and integrated into the program's existing administrative workflow.
Intervention Logistics: The Intervention Group receives a one-way SMS reminder sent via the 'Alhora' platform, the secure institutional messaging system used by the screening program. The content of the SMS was previously optimized and validated through a qualitative pilot study involving semi-structured interviews to ensure high readability and cultural acceptability among the target population. Non-participants in both groups receive the standard postal reminder letter at Week 6.
Statistical Analysis Plan: The analysis will be conducted on both an intent-to-treat (ITT) and per-protocol basis. Descriptive statistics will report frequencies and medians with interquartile ranges (25th-75th percentiles). Bivariate analysis will utilize Chi-square tests for participation rates and the Mann-Whitney U test for response time differences. To estimate the effect size, Relative Risks (RR) with 95% confidence intervals will be calculated. Furthermore, a multivariate binary logistic regression will be performed using Jamovi software to adjust for potential confounders such as sex, age, geographic area, and history of previous participation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
Due to the nature of the behavioral intervention (sending an SMS reminder), masking of participants and investigators is not possible. However, to minimize bias, the primary outcome measure (participation) is objective, as it is automatically determined by the screening program's information system when the participant's sample is analyzed in the laboratory. Furthermore, statistical analysis will be performed on an anonymized database where the analyst will use unique identification codes dissociated from personal data.
入排标准
- 年龄范围
- 50 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women and men aged 50 to 69 years.
- •Residents of the Vallès Occidental area.
- •Individuals invited to the Colorectal Cancer Screening Program (PDPCCR) who have not participated within 5 weeks of the initial invitation.
排除标准
- •Personal history of colorectal cancer.
- •Inflammatory bowel disease (IBD)
- •Colorectal polyps requiring specific clinical follow-up.
- •Hereditary polyposis syndromes.
- •High-risk family history of colorectal cancer: a first-degree relative diagnosed before age 50, or two or more first-degree relatives at any age.
- •Severe morbidity that precludes the performance of a colonoscopy in the event of a positive test result.
研究组 & 干预措施
Control Group: Standard Care
Participants in this group follow the screening program's standard operating procedure. This consists of an initial invitation letter sent at week 0 and, in the event of non-participation, a postal reminder letter sent at week 6.
干预措施: Standard invitation and postal reminder letters (Behavioral)
Intervention Group: SMS + Standard Care
Participants receive the initial invitation letter at week 0. If they have not participated by week 5, an SMS text message reminder is sent. If they remain non-participants following the SMS, they receive the standard postal reminder letter at week 6.
干预措施: Text Messaging (Behavioral)
Intervention Group: SMS + Standard Care
Participants receive the initial invitation letter at week 0. If they have not participated by week 5, an SMS text message reminder is sent. If they remain non-participants following the SMS, they receive the standard postal reminder letter at week 6.
干预措施: Standard invitation and postal reminder letters (Behavioral)
结局指标
主要结局
Participation rate
时间窗: 3 months after the initial invitation
Proportion of individuals who complete a valid fecal immunochemical test (FIT) relative to the total number of individuals invited. This variable will be objectively obtained through the screening program's information system
次要结局
- Time to participation(3 months after the initial invitation (at the conclusion of the study follow-up).)
- Number of reminder letters sent(3 months after the initial invitation.)
研究者
Anna Selva
Researcher
Corporacion Parc Tauli