Colorectal Neoplasms, Stoma Colostomy, Stoma Ileostomy
Conditions
Keywords
Stoma, Colorectal neoplasms, Quality of life
Brief summary
This study aims to enhance the physical, psychological, and social aspects of stoma care by providing a self-management service via a smartphone application, and to evaluate the impact of this digital-based application on patients' quality of life.
Detailed description
This study will include patients who have undergone colorectal cancer surgery and received either a colostomy or ileostomy, provided they are comfortable using digital devices like smartphones. Patients will be randomly assigned to either the intervention group, receiving stoma care through a smartphone application, or the conventional group, receiving standard outpatient-based care. The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. The app provides patients with information on diet, physical activity, stoma care, emotional support, and daily living needs. Both groups will be assessed for outcomes at the time of enrollment, and at 1 and 6 months. Outcome measures include stoma-related complications such as peristomal dermatitis, dehydration, acute renal failure, readmission due to stoma-related issues, and quality of life and emotional state assessments using EQ-5D-5L and Stoma Quality of Life questionnaires.
Interventions
BEHAVIORALThe Use of a Mobile Application for Stoma Self-Care
The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. The app provides patients with information on diet, physical activity, stoma care, emotional support, and daily living needs.
Sponsors
The Korean Society of Coloproctology
Wonju Severance Christian Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The intervention group will use a mobile application where patients input their stoma condition, allowing healthcare professionals to monitor and manage their care. The control group consists of patients who received conventional outpatient-based stoma care without using the application service.
Eligibility
Sex/Gender
ALL
Age
19 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Patients aged 19 years or older * Patients who have a colostomy or ileostomy after surgery for colon cancer * Patients who do not have difficulty using a smartphone
Exclusion criteria
* Patients younger than 19 years * Patients aged 80 years or older * Patients who do not know how to use a smartphone * Patients with cognitive impairments * Patients with pre-existing psychiatric disorders * Patients who have undergone emergency surgery * Patients who already have stoma-related complications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peristomal Dermatitis | enrollment, 1 month, and 6 months. | Evaluated using the DET Score (Discoloration, Erosion, and Tissue Overgrowth) on a scale ranging from 0 to 3. |
| Wound Infection, stoma retraction, bleeding, hernia, and Acute kidney injury | enrollment, 1 month, and 6 months. | Incidence rate as a percentage of patients affected. |
| Readmission Rate | enrollment, 1 month, and 6 months. | Incidence rate as the percentage of patients readmitted due to stoma-related complications. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Anxiety and Depression | enrollment, 1 month, and 6 months. | The EuroQol-5 Dimension (EQ-5D) will be utilized to gauge the general health status. The EQ-5D-5L score consists of two components. One component is the Visual Analogue Scale (VAS), which assesses an individual's overall health status on a scale from 0 to 100. A score of 0 represents the worst imaginable health state, while a score of 100 represents the best imaginable health state. The other component assesses health status across five dimensions, each rated on a five-level scale ranging from 1 (no problems) to 5 (extreme problems). The combination of these five dimensions represents a specific health state, and a value set specific to each country is used to calculate a score based on this state. This score typically ranges from 0 to 1, with 1 indicating perfect health. |
| Evaluation of Quality of Life | enrollment, 1 month, and 6 months. | The Stoma Quality-of-Life Scale will be used to assess the quality of life specifically related to stoma management and its impacts. The Stoma-QoL questionnaire consists of 20 questions, with a total score range from 20 to 80. Higher scores indicate a better quality of lif |
Contacts
Primary ContactSanghyun An, M.D., Ph.D.
Backup ContactIk-Yong Kim, M.D., Ph.D.
Outcome results
None listed