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临床试验/NCT06192862
NCT06192862已完成不适用

Effectiveness of Theory-based Outreach Using Mobile Health Technology in Colorectal Cancer Screening Uptake: a Randomized Controlled Trial

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2024年7月1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
500
试验地点
1
主要终点
CRC screening uptake rate

研究概览

简要总结

In Hong Kong, colorectal cancer (CRC) ranked second in both cancer incidence and mortality.

The fecal immunochemical test (FIT) helps reduce the incidence and mortality of CRC and is widely used for population-based CRC screening. The government-subsidized CRC screening program was launched in Hong Kong as a pilot in 2015 and fully implemented in 2020. The program was subsidized for asymptomatic Hong Kong residents, aged 50-75 years, to receive FIT screening every two years. A subsidized follow-up colonoscopy was offered for a positive FIT result. For a negative FIT result, the participant was advised to repeat the screening two years later.

Despite the subsidy and promotion, the uptake rate of the population-based colorectal cancer screening was low. Only 275,000 (~10%) underwent FIT screening under this program as of 31st December 2021.

Similar to colonoscopy screening outreach, FIT screening can be done by providing contact information with primary care physicians located in the subject's preferred district via mobile messenger-based chatbots to arrange it. Chatbots have already proven to be useful in increasing the intention to vaccinate against COVID-19.

Moreover, CRC screening uptake is highly associated with Health Belief Model (HBM) constructs and high risk perception of developing CRC is associated with higher screening uptake rate. HBM-based education and Trans-Theoretical Model (TTM)-based personalized risk assessment of CRC may increase the screening uptake rate by improving their knowledge of CRC screening (in terms of susceptivity, perceived benefits, and cues to actions) and informing subjects that they are at a relatively higher risk of developing CRC.

Therefore, we will develop a theory-based mobile messenger-initiated chatbot and conduct a randomized controlled trial to evaluate its performance in improving the CRC screening uptake when compared to standard text reminders.

详细描述

In Hong Kong, Colorectal cancer (CRC) ranked second in both cancer incidence and mortality, accounting for 16.7% of all new cancer cases and 14.6% of all cancer-related deaths in 2019. There was a staggering 2.5-fold increase in the number of newly diagnosed CRC cases from 1584 to 2019.

The fecal immunochemical test (FIT) helps reduce the incidence and mortality of CRC and is widely used for population-based CRC screening. The government-subsidized CRC screening program was launched in Hong Kong as a pilot in 2015 and fully implemented in 2020. The program was subsidized for asymptomatic Hong Kong residents, aged 50-75 years, to receive FIT screening every two years. A subsidized follow-up colonoscopy was offered for a positive FIT result. For a negative FIT result, the participant was advised to repeat the screening two years later.

Despite the subsidy and promotion, the uptake rate of the population-based colorectal cancer screening was low. Only 275,000 (~10%) underwent FIT screening under this program as of 31st December 2021. Efforts have been made to increase the rate. Outreach is the active dissemination of screening outside of the primary care setting, and it also includes mailing, texting, and calling to encourage scheduling of screening procedures.

It was technically infeasible to conduct fecal test outreach by mailing the test kits in Hong Kong because the government-subsidized colorectal cancer screening program required consultation with a primary care physician to assess the subjects' health condition, and their eligibility before distributing the fecal test kits. Similar to colonoscopy screening outreach, an alternative method is to provide contact information with primary care physicians located in the subject's preferred district via mobile messenger-based chatbots to arrange a consultation for FIT screening. Chatbots have already proven to be useful in increasing the intention to vaccinate against COVID-19.

Moreover, CRC screening uptake is highly associated with Health Belife Model (HBM) constructs and high risk perception of developing CRC is associated with higher screening uptake rate. HBM-based education and Trans-Theoretical Model (TTM)-based personalized risk assessment of CRC may increase the screening uptake rate by improving their knowledge of CRC screening (in terms of susceptivity, perceived benefits, and cues to actions) and informing subjects that they are at a relatively higher risk of developing CRC.

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

There will no masking

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 50-75 years old
  • asymptomatic and eligible to enroll in a government-subsidized colorectal cancer screening program
  • subjects themselves or their family members living in the same household with access to WhatsApp Messenger
  • able to read Chinese
  • willingness to be followed up by telephone

排除标准

  • subject without access to WhatsApp Messenger
  • unable to provide informed consent

研究组 & 干预措施

Text reminder group (control)

No Intervention

Randomized subjects to the text reminder group will be asked about their intention to undergo CRC screening in the next 6 months. For those who are at pre-contemplation and contemplation stage, a standard text message will be delivered to invite them to undergo CRC screening by informing them that they are due to CRC screening because they are aged >50 years and are yet to receive CRC screening. No HBM-based health education video or personalized risk assessment will be provided. The chatbot then asks the subject's intention to undergo CRC screening again. For those who propelled to preparation stage or those who are at preparation stage at the beginning, the website link of the government-subsidized CRC screening program which lists the names of all primary care physicians and their contact and co-payment information will be provided.

Chatbot outreach group

Experimental

Subjects in chatbot outreach group will be asked about their intention to undergo CRC screening in the next 6 months and their TTM stage will be determined according to their answers. For subjects who are at preparation stage, the chatbot will further request for the preferred district to have a consultation under the government-subsidized CRC screening.

For subjects who are at pre-contemplation stage, the chatbot will deliver an HBM-based health education video filmed by gastroenterologists and colorectal cancer survivor who has been diagnosed by screening. The subject's intention will be asked again after the video.

For those who upgrade to contemplation stage or remain at pre-contemplation stage and those who are at contemplation stage at the beginning, the chatbot will assess the personalized risk of CRC using the Asia-Pacific Colorectal Screening Score (APCS). Finally, the subject's intention to undergo screening will be asked for the last time.

干预措施: Assessment of screening intention and Transtheoretical Model stages for CRC screening (Behavioral)

结局指标

主要结局

CRC screening uptake rate

时间窗: during the study period up to six months

The primary outcome is the CRC screening uptake rate, defined as participation in and completion of the government-subsidized CRC screening program by returning valid FIT kits at three months after intervention and at six months after recruitment

CRC screening uptake rate at 3 months

时间窗: during the study period up to three months

The primary outcome is the CRC screening uptake rate, defined as participation in and completion of the government-subsidized CRC screening program by returning valid FIT kits at three months after intervention

次要结局

  • Likert scale(during the study period up to six months)
  • qualitative factors checklist associated with CRC screening(during the study period up to six months)
  • time interval(during the study period up to six months)
  • CRC screening uptake rate at 6 months(during the study period up to six months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Yuen Tung Lam

Assistant professor

Chinese University of Hong Kong

研究点 (1)

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