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

NCT05692284 | Completed

• 1 other identifier: AtaturkU-NRS-YCY-01
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Nursing Care for Gastrointestinal Cancer Patients

Keywords

nursing care; mobil application; Orem's theory; self care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Edmonton Symptom Assesment Scale (ESAS)

  6 weeks

• EORTC QLQC30 Quality of Life Scale

  6 weeks

• SELF CARE ABILITY SCALE

  6 weeks

Study Arms (2)

routine care group

OTHER

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

Other: routine care group

Care in accordance with Orem's theory group

EXPERIMENTAL

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

Interventions

routine care group OTHER

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.

routine care group

Care in accordance with Orem's theory group OTHER

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.

Care in accordance with Orem's theory group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Asking to leave the study
• Worsening of general condition/Death
• Change of treatment protocol

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, Yakutiye, (545) 743-1007, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: In the study, 60 individuals, including 1 experimental and 1 control group, were included in the study.

Study Record Dates

• First Submitted: January 11, 2023
• First Posted: January 20, 2023
• Study Start: February 2, 2022
• Primary Completion: January 30, 2023
• Study Completion: May 30, 2023
• Last Updated: September 27, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)