Examining the Effectiveness of a Mobile App on Self-care for a Colostomy

NCT ID: NCT05072379

Last Updated: 2022-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-19

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colostomy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

1. mobile health app group
2. control group
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mobile health app group

routine care and mobile health app

Group Type EXPERIMENTAL

colostomy self-care app

Intervention Type DEVICE

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.

control group

routine care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

colostomy self-care 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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Taipei University of Nursing and Health Sciences

OTHER

Sponsor Role collaborator

Cheng-Hsin General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ya-Ling Hung, BS

Role: PRINCIPAL_INVESTIGATOR

Cheng-Hsin General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Cheng Hsin General Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ya-Ling Hung, BS

Role: CONTACT

+886920250932

Chun-Yi Tai, Ph.D

Role: CONTACT

+886-2-2822-7101 ext. 3171

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ya-Ling Hung, BS

Role: primary

+886920250932

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27046974 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29139070 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32347599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27287964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29051047 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CHGH110-(IU)03

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.