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Clinical Trial Summary

Colorectal cancer has been one of the most common cancers in Taiwan. Using m-Health Apps to improve accessibility of personal health management has received greater attention and recognition. The purpose of this study is to develop a mobile App and understand its effects on improving colorectal cancer participants and their family caregivers' knowledge of colostomy care, anxiety, and quality of life as well as their satisfaction of the App. The study will use mixed methods as the study design in which content analysis will be used to identify the content suited for the App based on interviews with participants. A systematic research and development process will be utilized to design the text, videos, and images in the App's simulations to provide accurate, consistent, and complete knowledge of the skills needed for colostomy self-care and contending with any potential emergency. The results of this study not only will help colorectal participants and their family caregivers increase their knowledge of self-care for their colostomy, reduce anxiety, and improve quality of life, but it will also help the hospital to provide a high-quality and innovative technology for colorectal cancer participant and their family caregivers. Through this App, the quality of interaction and the rapport developed between healthcare professionals and participants will be enhanced, facilitating participant and family caregivers' responses to emergent situations and their endorsements toward the hospital. Ultimately, participants and their families will increase their satisfaction with the care.


Clinical Trial Description

In the first stage, a total of 10 pairs of colorectal cancer participants and their main caregivers will be recruited in the hospital to conduct individual interviews to understand the care and learning needs of colorectal cancer participants and their main caregivers, and then use content analysis to analyze the interviews. The result is used as the connotation of a smartphone application to help participants with colorectal cancer stoma and their main caregivers prepare the knowledge and skills needed during care and respond to emergencies that may occur. In the second stage, patients with colorectal cancer stoma and their main caregivers who have received individual interviews will be invited to trial and provide qualitative feedback after use to facilitate modification and completion of the surface validity test. In the third stage, 30 pairs of colorectal cancer stoma participants and main caregivers will be recruited in the experimental group and the control group in a randomized controlled design, and the effectiveness of this mobile application will be evaluated by a questionnaire survey before and after the test. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05072379
Study type Interventional
Source Cheng-Hsin General Hospital
Contact Ya-Ling Hung, BS
Phone +886920250932
Email enso680710@yahoo.com.tw
Status Recruiting
Phase N/A
Start date March 19, 2021
Completion date December 31, 2022

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