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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

Primary Purpose

Nursing Care for Gastrointestinal Cancer Patients

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
routine care group
Care in accordance with Orem's theory group
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Nursing Care for Gastrointestinal Cancer Patients focused on measuring nursing care, mobil application, Orem's theory, self care

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

routine care group

Care in accordance with Orem's theory group

Arm Description

Routine clinic nursing care in hospital, no follow-up after discharge.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
January 11, 2023
Last Updated
January 30, 2023
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT05692284
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
May 30, 2022 (Actual)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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, 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nursing Care for Gastrointestinal Cancer Patients
Keywords
nursing care, mobil application, Orem's theory, self care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.
Masking
Participant
Masking Description
The patients in the control and intervention groups did not know which group they belonged to, only the researcher knew who was in which group, and the study was continued single-blindly by providing blinding in this way.
Allocation
Non-Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
routine care group
Arm Type
Other
Arm Description
Routine clinic nursing care in hospital, no follow-up after discharge.
Arm Title
Care in accordance with Orem's theory group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
routine care group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Care in accordance with Orem's theory group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Identification Form
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Edmonton Symptom Assesment Scale (ESAS)
Description
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.
Time Frame
6 weeks
Title
EORTC QLQC30 Quality of Life Scale
Description
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.
Time Frame
6 weeks
Title
SELF CARE ABILITY SCALE
Description
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.
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ataturk University
City
Erzurum
State/Province
Yakutiye
ZIP/Postal Code
(545) 743-1007
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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