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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nursing Care for Gastrointestinal Cancer Patients
• Intervention / Treatment: Other: routine care group; Other: Care in accordance with Orem's theory group

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" and "Self-Care Strength Scale" for physical symptoms experienced by patients, and "Quality of Life Scale" for psychological symptoms. and the "Short Symptom Inventory" 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.

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Yakutiye
    • Erzurum, Yakutiye, Turkey, (545) 743-1007
      • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: routine care group; Routine clinic nursing care in hospital, no follow-up after discharge.	Other: routine care group; 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.
Experimental: Care in accordance with Orem's theory group; 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; 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.

What is the study measuring?

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
Brief Symptom Inventory (BSI);	The Brief Symptom Inventory (BSI) is a likert-type self-assessment inventory developed on the need for short but valid and reliable scales to assess general psychopathology. BSI consists of 53 items in total. In the Turkish version of the scale, the BSI is organized into five subsections as "Anxiety", "Depression", "Negative 20 Self", "Somatization" and "Hostility". The items in the inventory were graded between 0-4 values corresponding to the expressions "not at all" and "too much". The minimum score that can be obtained from each question (None) is "0" and the maximum score (There is a lot) is "4". In anxiety, one of the BSI subscales; minimum "0", maximum "52", depressed; minimum "0", maximum "48" in negative self; minimum "0", maximum "48", in somatization; minimum " 0", maximum "36" and in hostility; minimum "0", maximum "28" points can be obtained. Higher total scores from subscales indicate that the individual's psychological symptoms increase.	6 weeks

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Actual): May 30, 2022
• Study Completion (Anticipated): April 30, 2023

Study Registration Dates

• First Submitted: January 11, 2023
• First Submitted That Met QC Criteria: January 11, 2023
• First Posted (Actual): January 20, 2023

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 11, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: self care; nursing care; mobil application; Orem's theory
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: AtaturkU-NRS-YCY-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No