Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05692284
Status:
COMPLETED
Last Update Posted:
2023-01-31
First Post:
2023-01-11
Brief Title:
The Effect of Self-Care Insufficiency Care Model and Mobile Application Supported Care on Symptoms and Quality of Life of Gastrointestinal Cancer Patients
Sponsor:
Ataturk University
Organization:
Ataturk University
Study Overview
Official Title:
The Effect of Self-Care Insufficiency Care Model and Mobile Application Supported Care on Symptoms and Quality of Life of Gastrointestinal Cancer Patients
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 patients39 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:
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 patients39 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 005 significance level and 80 power at the plt005 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 n30 and control n30 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 were used
In the intervention group symptoms on the ESAS improved significantly The EORTC QLQC30 functionality and symptom sub-dimensions improved significantly In the control group the severity of symptoms increased and quality of life decreased compared to baseline measurements While self-care competence increased significantly in the experimental group there was no change in the control group The need to develop 34common language common care34 practices in oncology clinics accompanied by an evidence-based guide is also a priority in patient care The results of this study showed that mobile app-supported Orems care can effective on patients39 symptoms and self care ability
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 005 significance level and 80 power at the plt005 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 n30 and control n30 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 were used
In the intervention group symptoms on the ESAS improved significantly The EORTC QLQC30 functionality and symptom sub-dimensions improved significantly In the control group the severity of symptoms increased and quality of life decreased compared to baseline measurements While self-care competence increased significantly in the experimental group there was no change in the control group The need to develop 34common language common care34 practices in oncology clinics accompanied by an evidence-based guide is also a priority in patient care The results of this study showed that mobile app-supported Orems care can effective on patients39 symptoms and self care ability
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None