Clinical trial NCT05072379: Examining the Effectiveness of a Mobile App on Self-care for a Colostomy
Official title: Examining the Effectiveness of a Mobile App on Self-care for a Colostomy Among Colorectal Cancer Patients and Family Caregivers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colostomy
Keywords: m-Health
Colostomy
Anxiety
quality of life
Lead sponsor: Cheng-Hsin General Hospital
Sponsor class: OTHER
Collaborators: name: National Taipei University of Nursing and Health Sciences
First posted: 2021-10-08
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. mobile health app group
2. control group
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

1. At least 20 years old
2. The main caregiver for women who are diagnosed with colorectal cancer for the first time and have a stoma
3. Can use mobile phone to surf the Internet
4. Fluent in listening, speaking, reading and writing Chinese
5. Volunteer participation in this research

Exclusion Criteria:

1. Those who are unconscious or unable to communicate clearly
2. Those who have been diagnosed with mental illness

Primary outcomes:
measure: Change from the baseline score of the Stoma Care Awareness Assessment at the first and second months after discharge
timeFrame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
measure: Change from the baseline score of the General Anxiety Disorder-7(GAD-7) at the first and second months after discharge
timeFrame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
measure: Change from the baseline score of the Patient Health Questionnaire-9(PHQ-9) at the first and second months after discharge
timeFrame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
measure: Change from the baseline score of the WHO Quality of Life-BREF,WHOQOL- BREF at the first and second months after discharge
timeFrame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
Secondary outcomes:
measure: The User Version of the Mobile Application Rating Scale: uMARS
timeFrame: Data will be collected after discharge in the second month(T2).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Cheng Hsin General Hospital
Study officials:
affiliation: Cheng-Hsin General Hospital
name: Ya-Ling Hung, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dabas H, Sharma KK, Joshi P, Agarwala S. Video teaching program on management of colostomy: Evaluation of its impact on caregivers. J Indian Assoc Pediatr Surg. 2016 Apr-Jun;21(2):54-6. doi: 10.4103/0971-9261.176933.
citation: Kim H, Goldsmith JV, Sengupta S, Mahmood A, Powell MP, Bhatt J, Chang CF, Bhuyan SS. Mobile Health Application and e-Health Literacy: Opportunities and Concerns for Cancer Patients and Caregivers. J Cancer Educ. 2019 Feb;34(1):3-8. doi: 10.1007/s13187-017-1293-5.
citation: Putranto D, Rochmawati E. Mobile applications for managing symptoms of patients with cancer at home: A scoping review. Int J Nurs Pract. 2020 Aug;26(4):e12842. doi: 10.1111/ijn.12842. Epub 2020 Apr 29.
citation: Stoyanov SR, Hides L, Kavanagh DJ, Wilson H. Development and Validation of the User Version of the Mobile Application Rating Scale (uMARS). JMIR Mhealth Uhealth. 2016 Jun 10;4(2):e72. doi: 10.2196/mhealth.5849.
citation: Sun V, Ercolano E, McCorkle R, Grant M, Wendel CS, Tallman NJ, Passero F, Raza S, Cidav Z, Holcomb M, Weinstein RS, Hornbrook MC, Krouse RS. Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Contemp Clin Trials. 2018 Jan;64:167-172. doi: 10.1016/j.cct.2017.10.008. Epub 2017 Oct 16.