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临床试验/NCT03479645
NCT03479645已完成不适用

Can a Multimodal Approach Using SMS Reminders and an Opt-out Mailed FIT Kits Improve Participation in Colorectal Cancer Screening? A Single Center Randomized Controlled Trial

University of Pennsylvania2 个研究点 分布在 1 个国家目标入组 440 人开始时间: 2018年3月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
440
试验地点
2
主要终点
Colorectal screening rate

研究概览

简要总结

This pilot study is a 2-armed randomized controlled trial assessing the impact of a multimodal approach on colorectal cancer screening participation rates in a Federally Qualified Health Center. The trial will test serial text message reminders and opt-out mailed fecal immunochemistry test (FIT) home kits against a simple reminder text message control. Patients aged 50-74 years, who are registered at a Family Practice and Counselling Network (FPCN) clinic and are overdue for colorectal cancer screening will be recruited. The primary outcome is the rate of FIT kits being returned at 12 weeks.

详细描述

It is estimated that colorectal cancer (CRC) screening can reduce the risk of dying from bowel cancer by approximately 15%. Yet despite this, the national participation rate is only approximately 62.9%, highlighting that the national target of 70.5% set out in the Healthy People 2020 Objectives remains well out of reach. The US Preventative Task Force (USPSTF) recommends colorectal screening for adults aged 50-75 years through either annual fecal occult blood testing (FOBT), flexible sigmoidoscopy every 5 years or colonoscopy every 10 years. However, many service providers rely on the opportunistic offer of screening at existing health touch-points. This requires the patient to see their healthcare provider, usually for a different clinical reason, the provider to recognize that the patient is overdue for CRC screening and the provider to recommend and book the patient for CRC screening. This process identifies a number of barriers encountered at the system, provider and patient level, to completing a screening test regularly. Furthermore, much evidence indicates that public participation in colorectal screening is heavily influences by socioeconomic factors. Lower participation rates are seen in individuals without health insurance, without a medical home, who are more deprived and from ethnic minority groups. These individuals are more likely to present with later stage disease and experience poorer outcomes. Fecal immunochemistry testing (FIT) is a stool sample based test kit that uses antibodies to detect the human haemoglobin protein in the stool sample and can be completed in the privacy of the home. Research has showed that mailed home test kits such as FOBT or FIT kits can improve CRC participation by reducing the effort required to see a provider in order to arrange CRC screening. Evidence has also shown that text message reminders can improve participation in cancer screening. Furthermore, the message content of text messages can differentially change behavior, for example reducing the 'did not attend rate' in hospital outpatient appointments but also in the context of participation in cervical cancer screening. Therefore this trial will test a multimodal outreach approach, which uses serial SMS reminders with different word contents and mailed FIT kits on the participation rates of CRC screening.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Participant)

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least 1 clinic visit to the FPCN within the previous 12 months
  • due or overdue for colorectal screening
  • Asymptomatic for bowel cancer
  • mobile phone number available

排除标准

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and FOBT/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
  • Has a history of CRC
  • Has a history of other GI cancer
  • Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis) Irritable bowel syndrome does not exclude patients.
  • Has history of colitis other than Crohns disease or ulcerative colitis
  • Has had a colectomy
  • Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  • Has been diagnosed with Familial Adenomatous Polyposis (FAP)
  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has dementia
  • Has liver cirrhosis
  • Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study.

研究组 & 干预措施

Control

No Intervention

Control arm - usual practice. Simple SMS reminder that informs patients they are overdue for CRC screening and requests they contact the clinic.

Intervention

Experimental

Serial text messages and mailed FIT kit

干预措施: Serial text messages and mailed FIT kit (Behavioral)

结局指标

主要结局

Colorectal screening rate

时间窗: 12 weeks

The rate patients with who completed colorectal screening within the trial period

次要结局

  • Per Protocol analysis: Colorectal screening rate(12 weeks)
  • FIT kit return rate(12 weeks)
  • Per protocol analysis: FIT kit return rate(12 weeks)
  • colonoscopy completion rate(12 weeks)
  • Per protocol analysis: colonoscopy completion rate(12 weeks)
  • Colorectal screening return rate by gender(12 weeks)
  • FIT return rate by gender(12 weeks)
  • Colorectal screening rate by insurance status(12 weeks)
  • FIT kit return rate by insurance status(12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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