ColostomyNCT05072379
Examining the Effectiveness of a Mobile App on Self-care for a Colostomy
A study testing colostomy self-care app in people with Colostomy, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colostomy
- What is being tested?
- colostomy self-care app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Mar 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 20 years old
- The main caregiver for women who are diagnosed with colorectal cancer for the first time and have a stoma
- Can use mobile phone to surf the Internet
- Fluent in listening, speaking, reading and writing Chinese
- Volunteer participation in this research
Who cannot join
- Those who are unconscious or unable to communicate clearly
- Those who have been diagnosed with mental illness
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Cheng Hsin General Hospital
Taipei
Ya-Ling Hung, BS, +886920250932, enso680710@yahoo.com.tw
About this study
Official title: Examining the Effectiveness of a Mobile App on Self-care for a Colostomy Among Colorectal Cancer Patients and Family Caregivers
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.
Read the 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.
- Conditions
- Colostomy
- Being tested
- colostomy self-care app
- Keywords
- m-Health, Colostomy, Anxiety, quality of life
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colostomy self-care appDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Mobile health app group | Experimental | routine care and mobile health app Receives: Device: colostomy self-care app |
| control group | No intervention | routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from the baseline score of the Stoma Care Awareness Assessment at the first and second months after discharge
The knowledge of self-care for their colostomy The Stoma Care Cognition Assessment Form is developed by researchers based on related literature on stoma care. There are 10 items, including normal/abnormal judgments of stoma, replacement of stoma, nutrition, and activities, all of which are single-choice questions. Each question is counted with 10 points, and the total score is 100 points. The higher the score, the better the respondent's awareness of stoma care.
Measured: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
Change from the baseline score of the General Anxiety Disorder-7(GAD-7) at the first and second months after discharge
The GAD-7 (Spitzer et al., 2006) is a one-dimensional instrument designed to detect generalized anxiety disorder symptoms as defined in the DSM-IV. The item scores range from 0 (not at all) to 3 (nearly every day), resulting in a sum score range from 0 to 21. The higher scores reflect greater anxiety severity.
Measured: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
Change from the baseline score of the Patient Health Questionnaire-9(PHQ-9) at the first and second months after discharge
The nine items of the PHQ-9 are designed to capture the nine Diagnostic and Statistical Manual of Mental Disorders (DSM) symptom criteria for a major depressive episode. Response options on the items range from "not at all" (0 points) to "nearly every day"(3 points). As a severity measure, the PHQ-9 score can range from 0 to 27.
Measured: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
Change from the baseline score of the WHO Quality of Life-BREF,WHOQOL- BREF at the first and second months after discharge
The Taiwan version of the WHOQOL-BREF questionnaire is based on the WHOQOL-BREF. The 26 questions of the WHOQOL-BREF are kept and translated into Chinese. In addition, two local questions are added to make a total of 28 questions. Divided into four categories, one is the physiological category (including physiology and independence), with a total of 7 questions; the second is the psychological category (including psychology, soul, religion, and personal beliefs), with a total of 6 questions; the third is the social relationship category, with a total of 4 questions; The fourth is the environmental project, a total of 9 questions; the other 2 questions are the overall assessment questions. Each question in the questionnaire is scored using Likert's five-point scale. The higher the score, the better the quality of life.
Measured: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
Secondary outcomes (1)
The User Version of the Mobile Application Rating Scale: uMARS
The mobile app score scale is a tool developed by Stoyanov et al. (2015) to classify and evaluate the quality of health-related mobile device apps. The scale has 23 questions and uses a 5-point scoring method (1-no Adequate, 2-Poor, 3-Acceptable, 4-Good, 5-Excellent). In addition, in order to adapt to the different situations of each mobile device application, there is also an option of "not applicable" for each question. Divided into four objective quality dimensions-participation (5 questions), functionality (4 questions), aesthetics (3 questions) and information quality (7 questions), and a subjective quality dimension (4 questions) contains to will it be recommended, frequency of use in the future, willingness to pay for it, and overall rating. The score calculation method is based on the average of the scores of each quality dimension and the total scale, the highest is 5 points, and the lowest is 1 point. The higher the average score, the better the quality.
Measured: Data will be collected after discharge in the second month(T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start19 Mar 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for ColostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. mobile health app group 2. control group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cheng-Hsin General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Responsible party
- Sponsor
- Investigators
- Ya-Ling Hung, BS, Principal investigator, Cheng-Hsin General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05072379
- Sponsor's protocol ID
- CHGH110-(IU)03
- Status last verified
- Feb 2022
- First submitted
- 29 Aug 2021
- Last updated
- 23 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27046974Kim 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.
PubMed 29139070Putranto 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.
PubMed 32347599Stoyanov 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.
PubMed 27287964Sun 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.
PubMed 29051047
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effectiveness of a Mobile App on Self-care for a Colostomy Among Colorectal Cancer Patients and Family Caregivers
- ClinicalTrials.gov ID
- NCT05072379
- Acronym / sponsor ID
- CHGH110-(IU)03
- Conditions
- Colostomy
- Keywords
- m-Health, Colostomy, Anxiety, quality of life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Cheng-Hsin General HospitalUniversity, hospital or other
- Collaborators
- National Taipei University of Nursing and Health Sciences
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 8 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 1. mobile health app group 2. control group
| Arm | Type | Receives |
|---|---|---|
| Mobile health app group | Experimental | Device: colostomy self-care approutine care and mobile health app |
| control group | No intervention | –routine care |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- At least 20 years old
- The main caregiver for women who are diagnosed with colorectal cancer for the first time and have a stoma
- Can use mobile phone to surf the Internet
- Fluent in listening, speaking, reading and writing Chinese
- Volunteer participation in this research
Key exclusion criteria (2 listed)
- Those who are unconscious or unable to communicate clearly
- Those who have been diagnosed with mental illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colostomy self-care appThe 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. | Device | Mobile health app group |
Primary outcome
Change from the baseline score of the Stoma Care Awareness Assessment at the first and second months after discharge
Time frame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
The knowledge of self-care for their colostomy The Stoma Care Cognition Assessment Form is developed by researchers based on related literature on stoma care. There are 10 items, including normal/abnormal judgments of stoma, replacement of stoma, nutrition, and activities, all of which are single-choice questions. Each question is counted with 10 points, and the total score is 100 points. The higher the score, the better the respondent's awareness of stoma care.
Change from the baseline score of the General Anxiety Disorder-7(GAD-7) at the first and second months after discharge
Time frame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
The GAD-7 (Spitzer et al., 2006) is a one-dimensional instrument designed to detect generalized anxiety disorder symptoms as defined in the DSM-IV. The item scores range from 0 (not at all) to 3 (nearly every day), resulting in a sum score range from 0 to 21. The higher scores reflect greater anxiety severity.
Change from the baseline score of the Patient Health Questionnaire-9(PHQ-9) at the first and second months after discharge
Time frame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
The nine items of the PHQ-9 are designed to capture the nine Diagnostic and Statistical Manual of Mental Disorders (DSM) symptom criteria for a major depressive episode. Response options on the items range from "not at all" (0 points) to "nearly every day"(3 points). As a severity measure, the PHQ-9 score can range from 0 to 27.
Change from the baseline score of the WHO Quality of Life-BREF,WHOQOL- BREF at the first and second months after discharge
Time frame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.
The Taiwan version of the WHOQOL-BREF questionnaire is based on the WHOQOL-BREF. The 26 questions of the WHOQOL-BREF are kept and translated into Chinese. In addition, two local questions are added to make a total of 28 questions. Divided into four categories, one is the physiological category (including physiology and independence), with a total of 7 questions; the second is the psychological category (including psychology, soul, religion, and personal beliefs), with a total of 6 questions; the third is the social relationship category, with a total of 4 questions; The fourth is the environmental project, a total of 9 questions; the other 2 questions are the overall assessment questions. Each question in the questionnaire is scored using Likert's five-point scale. The higher the score, the better the quality of life.
1 secondary outcome
The User Version of the Mobile Application Rating Scale: uMARS
Time frame: Data will be collected after discharge in the second month(T2).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2022.
- Background: PubMed 27046974Dabas 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.
- Background: PubMed 29139070Kim 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.
- Background: PubMed 32347599Putranto 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.
- Background: PubMed 27287964Stoyanov 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.
- Background: PubMed 29051047Sun 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya-Ling Hung, BS principal investigator
Cheng-Hsin General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing colostomy self-care app in people with Colostomy, run by Cheng-Hsin General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ya-Ling Hung, BS (+886920250932, enso680710@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from the baseline score of the Stoma Care Awareness Assessment at the first and second months after discharge (time frame: Data will be collected before discharge(baseline-T0), after discharge in the first(T1) and second(T2) months.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05072379, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2022.