The Effect of Self-Care Insufficiency Care Model and Mobile Application Supported Care on Symptoms and Quality of Life of Gastrointestinal Cancer Patients

Study Overview
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Brief Summary
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Remarkably, the incidence of gastrointestinal cancer cases among cancer types is increasing. Gastrointestinal cancers are one of the 10 most common cancer types in the World. This increase worldwide is remarkable, especially due to the increase in urbanization, consumption of foods rich in animal fat, insufficient dietary fiber intake and lifestyle changes. Cytotoxic therapy, which is used in the treatment of malignant diseases, can cause serious complications in gastrointestinal cancer, distinguishing it from other types of cancer. In addition, patients experience symptoms such as nausea-vomiting, mucositis, diarrhea, and constipation much more severely due to the direct effects of these agents on the gastrointestinal system. For this reason, patients' compliance with the treatment process and their quality of life are seriously affected, and patients have difficulties especially in meeting their self-care needs.

Detailed Description
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Remarkably, the incidence of gastrointestinal cancer cases among cancer types is increasing. Gastrointestinal cancers are one of the 10 most common cancer types in the World. This increase worldwide is remarkable, especially due to the increase in urbanization, consumption of foods rich in animal fat, insufficient dietary fiber intake and lifestyle changes. Cytotoxic therapy, which is used in the treatment of malignant diseases, can cause serious complications in gastrointestinal cancer, distinguishing it from other types of cancer. In addition, patients experience symptoms such as nausea-vomiting, mucositis, diarrhea, and constipation much more severely due to the direct effects of these agents on the gastrointestinal system. For this reason, patients' compliance with the treatment process and their quality of life are seriously affected, and patients have difficulties especially in meeting their self-care needs. The aim of this project is to evaluate the effects of self-care deficit care model and mobile application-supported care on symptoms and quality of life of patients with gastrointestinal cancer. Material and method: The research was conducted as a experimental study. The universe of the research; Between Feb 2022 and Jan 2023, individuals who met the criteria for inclusion in the study who applied for home care to Erzurum Atatürk University Research Hospital Oncology Clinic with the diagnosis of gastrointestinal cancer. The sample size for the research was determined by power analysis. In the power analysis, it was determined that a total of 52 people should be reached in order to reach the 95% confidence level at the 0.05 significance level and 80% power at the p<0.05 significance level. Considering that there may be data losses in the study, it was decided to reach 60 people, 15% more than the sample. The patients included in the study were determined as intervention (n=30) and control (n=30). During the data collection process, 4 patients, 1 in the control group and 3 in the experimental group, died and the study was completed with the results of 29 control and 27 intervention group patients. Patient Description Form from the intervention and control group to determine the current physical and psychological self-care needs of patients with gastrointestinal cancer, Edmonton Symptom Assesment Scale physical symptoms experienced by patients, and Quality of Life Scale for psychological symptoms and the Self care ability scale for self care ability was used to collect information. Permissions for use were obtained for each of the scales. In the analysis of data; percentile distribution, chi-square, Fisher-Freeman- Halton Exact test, t-test in independent groups, Repeated Measures ANOVA Test, Friedman Test, One Way ANOVA test, Kruskall Wallis test, and post hoc analyzes (Bonferroni, Games Howell, Dunn) will be used.

Official Title
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The Effect of Self-Care Insufficiency Care Model and Mobile Application Supported Care on Symptoms and Quality of Life of Gastrointestinal Cancer Patients

Conditions
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Nursing Care for Gastrointestinal Cancer Patients

Intervention / Treatment
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* Other: routine care group
* Other: Care in accordance with Orem's theory group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Being literate Being diagnosed with gastrointestinal cancer Being receiving chemotherapy treatment and having information about the disease Getting a score of 120 or less in the Self-Care Strength Scale pre-test. Not having a physical illness or cognitive disability that prevents participation in the -research and not having a psychiatric illness diagnosis Having an Android phone and the ability to use it Not having sensory loss related to vision and hearing Being open to communication and cooperation Exclusion Criteria: Patients who did not meet the inclusion criteria and were not volunteers were not included in the sample; Asking to leave the study Worsening of general condition/Death Change of treatment protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: routine care group<br>Routine clinic nursing care in hospital, no follow-up after discharge. | Other: routine care group<br>* Firstly, informed consent was obtained from the patients in the control group, a pre-test was applied with the existing data collection methods, and routine nursing care continued. At the end of the 6-week follow-up period, the data collection process was ended with the post-test application.<br>|
| Experimental: Care in accordance with Orem's theory group<br>care in accordance with Orem's theory in the hospital process and follow-up with a mobile application designed according to Orem's theory after discharge | Other: Care in accordance with Orem's theory group<br>* Firstly, informed consent was obtained from the Intervention group, for which the pre-test was applied, and then care was given during their stay in the hospital in accordance with Orem's theory. This care was performed when the patient came to each chemotherapy cycle. After discharge, patient follow-up and care continued with the mobile application designed with Orem's theory, which will ensure the continuity of this care given in the clinic. At the end of the 6-week follow-up period, the data collection process was ended with the post-test application.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Identification Form | Personal information form prepared by the researcher in line with the relevant literature; It consists of 20 questions that include socio-demographic characteristics such as age, gender, social security, educational status, disease-related features such as drugs used and duration of the disease. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Edmonton Symptom Assesment Scale (ESAS) | ESAS was developed to evaluate nine common symptoms in cancer patients. These symptoms are; pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, well-being, shortness of breath and other problems. The severity of each symptom is assessed by numerical numbers from 0 to 10. A score of 0 indicates that there is no symptom, and a score of 10 indicates that the symptom is felt very severely, and the severity of the symptom increases from 0 to 10. | 6 weeks | 
| EORTC QLQC30 Quality of Life Scale | The EORTC-QLQ-C30 Quality of Life Scale is a scale developed by EORTC and includes three sub-headings of general well-being, functional difficulties, symptom control, and 30 questions. None: 1, Slightly: 2, Quite: 3, or A lot: 4 points. | 6 weeks | 
| SELF CARE ABILITY SCALE | The Self-Care Ability Scale is used to determine the ability of individuals to take care of themselves. A high total score from the Self-Care Scale indicates that the patients are independent and sufficient in performing their self-care. There are 35 statements in the Turkish form and each statement is evaluated with scores ranging from 0 to 4. They are listed as 0 (does not describe me at all), 1 (does not describe me very well), 2 (no idea), 3 (describes me a little), 4 (describes me a lot). Eight statements in the scale (3, 6, 9, 13, 19, 22, 26 and 31) are evaluated as negative and scoring is reversed. Evaluation is made out of a total of 140 points. Below 82 points is considered as low, 82-120 points as medium, above 120 points as high. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nursing care, mobil application, Orem's theory, self care