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Effectiveness of SMS Invitation on Colorectal Cancer Screening Among 45-49-Year-Olds in Yingge District, New Taipei City, Taiwan

Not Applicable
Not yet recruiting
Conditions
No Condition
No Conditions, Aged 45-49
Registration Number
NCT07112729
Lead Sponsor
Chang Gung University
Brief Summary

The goal of this study is to learn if sending text message invitations increases participation in colorectal cancer screening among 45-49 year olds in Yingge District, New Taipei City. It will also assess the effectiveness of this method. The main questions it aims to answer are:

* Does sending text message invitations increase the number of residents who obtain a fecal occult blood test (FOBT) kit?

* Does sending text message invitations increase the number of residents who complete fecal occult blood test (FOBT)? This study will compare a group receiving text message invitations to a control group receiving standard notifications to see if text messages are an effective way to increase screening rates.

Participants will:

* Be randomly assigned to either receive text message invitations or standard notifications.

* The intervention group will receive an initial text and a reminder text one week later.

* The control group will receive standard notifications, and after one month will receive the same text message.

* The study will track who obtains a FOBT kit and who completes the test within a three-month period.

Detailed Description

This study is a randomized controlled trial designed to evaluate the effectiveness of active SMS (Short Message Service) invitations for increasing participation in colorectal cancer screening among residents aged 45-49 in Yingge District, New Taipei City.

Background: Colorectal cancer is a significant public health concern, and early detection through screening is crucial for improving outcomes. This study aims to explore a simple and cost-effective method to increase screening rates in a specific population group (45-49 years old) where screening just initiated.

Objectives: The primary objective is to assess whether sending active SMS invitations increases the rate of fecal occult blood test (FOBT) completion among the target population. Secondary objectives include determining whether SMS invitations increase the rate at which individuals obtain FOBT kits.

Study Design: The study employs a randomized controlled trial design.

Eligible participants will be randomly assigned to one of two groups:

* Intervention Group (Active SMS Invitation): Participants in this group will receive a text message inviting them to participate in the free FOBT program. The SMS message will include a brief explanation of the program, instructions on how to obtain a screening kit, and a contact number for inquiries. A reminder SMS message will be sent one week after the initial message.

* Control Group (Standard Notification): Participants in this group will receive the standard notification procedures typically used to inform residents about the FOBT program. After one month of the first SMS sent to the Intervention Group, the Control group will receive the same SMS message as the intervention group.

Participants:

* Inclusion Criteria: Residents aged 45-49 in Yingge District, New Taipei City, with registered mobile phone numbers.

* Exclusion Criteria: Residents aged 45-49 in Yingge District, New Taipei City, without registered mobile phone numbers.

* Recruitment: Participants will be identified through the health department's information system, which contains records of residents eligible for the national colorectal cancer screening program and their mobile phone numbers. There is no separate recruitment or enrollment procedure.

* Sample Size: A total of 6,708 eligible residents will be randomly assigned to the intervention and control groups. The sample size is calculated based on previous research, which indicates that approximately 13.1% of individuals in this age group participate in FOBT screening without active intervention. The study aims to increase participation by 5%, reaching an 18% participation rate with SMS invitations.

Timeline: The study will be conducted over a three-month period, from August 5, 2025, to October 31, 2025.

Data Collection and Management:

* The health department will provide a de-identified list of eligible residents, including a random code, gender, age, and mobile phone number. This information will be used for random assignment and statistical analysis.

* Random assignment will be performed using computer-generated random numbers.

* The SMS messages will be sent by a contracted SMS provider. The health department will provide the SMS provider with a secure file containing the random code and mobile phone number for each participant.

* The SMS provider will provide data on message delivery status. The health department staff will record whether participants obtain the screening kit and whether they return a completed test kit. This information will be provided to the principal investigator (PI) for analysis.

Outcome Measures:

* Primary Endpoint: Completion of fecal occult blood test (defined as the return of a completed test kit).

* Secondary Endpoint: Whether participants obtain the fecal occult blood test kit (either by visiting the health center or calling to inquire).

Data Analysis: The primary analysis will be conducted using an intention-to-treat (ITT) approach, where all participants will be included in the analysis based on their assigned group, regardless of whether they actually received the intervention or completed the screening. On the other hand, this study will conduct per-protocol (PP) approach to evaluate those who successfully sent SMS subjects for evaluation. Statistical methods, including chi-square tests and logistic regression, will be used to compare the outcomes between the intervention and control groups.

Ethical Considerations: The study has been designed to protect the privacy and confidentiality of participants. Data will be de-identified and stored securely. All personal data will be protected through anonymized coding and data encryption. SMS dissemination will be handled by a third-party vendor under confidentiality agreements, and no personally identifiable information will be shared beyond phone number use for message delivery. The project is funded through existing administrative cancer screening budgets, without external sponsorship. The study will comply with all relevant ethical guidelines and regulations.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
6708
Inclusion Criteria
  • Residents aged 45-49 in Yingge District, New Taipei City, with registered mobile phone numbers.
Exclusion Criteria
  • Residents aged 45-49 in Yingge District, New Taipei City, without registered mobile phone numbers.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Primary OutcomeFrom first SMS to 31 days

Completion of fecal occult blood test (defined as the return of a completed test kit).

Secondary Outcome Measures
NameTimeMethod
Secondary outcomeFrom first SMS to 31 days

Whether participants obtain the fecal occult blood test kit (either by visiting the health center or calling to inquire).

Trial Locations

Locations (1)

Yingge District Public Health Center, New Taipei City

🇨🇳

New Taipei City, Taiwan

Yingge District Public Health Center, New Taipei City
🇨🇳New Taipei City, Taiwan

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