NCT06713122

Effects of Symptom Management Education With Mobile Application in Gynecological Cancer Patients Receiving Chemotherapy

The Effect of Symptom Management Training Given to Gynaecological Cancer Patients Receiving Chemotherapy With Artificial Intelligence Supported Mobile Application on Supportive Care Needs, Symptom Severity and Psychological Well-Being

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Esra Nur Erdoğan · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. It is very important to identify the symptoms experienced, evaluate, control and provide professional health guidance. The spread of digitalisation has turned mobile learning into a kind of need or necessity rather than a preference. Increases the control of individuals over themselves and provides self-discipline. The aim of this study was to evaluate the effect of symptom management training given with an artificial intelligence supported mobile application on supportive care needs, symptom severity and psychological well-being of gynaecological cancer patients receiving chemotherapy. The study was planned as a randomised controlled trial. The population of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit for the first time to receive chemotherapy treatment for gynaecological cancer and completed the first course. The study will be conducted with a total of 70 patients, including 35 patients from the intervention group and 35 patients from the control group. Research Hypotheses: Gynaecological cancer patients receiving chemotherapyBetween the intervention group receiving symptom management training with a mobile application and the control group receiving standard care; 1. H1: There is a difference in terms of the severity of symptoms experienced. 2. H2: There is a difference in terms of supportive care needs. 3. H3: There is a difference in terms of psychological well-being levels. Data Collection Tools Descriptive Information Form, Edmonton Symptom Diagnostic Scale, Supportive Care Needs Scale, Psychological Well-Being Scale and Eastern Cooperative Oncology Group (ECOG) Performance Scale will be used as data collection tools. Modules to be included in the Mobile Application: The forms will be administered a total of three times, initially at the end of the 3rd and 5th cycle. Module 1: Introducing Module Module 2: Application Usage Instruction Module Module 3: Recognise the Disease Module Module 4: Common Symptoms and Recommendations During Chemotherapy Treatment Module Module 5: Let's Fight Symptoms Together Module Module 6: Ask Anything - Counselling Module

Detailed description

Gynaecological cancers, which have an important place among the cancers seen both in the world and in our country, are malignant tumours of the female reproductive organ. In the treatment of gynaecological cancers, many methods such as chemotherapy, radiotherapy, surgical treatment, hormone therapy are used alone or together. Chemotherapy, which is one of the most commonly used and basic methods in cancer treatment, causes many physical and psychological side effects while treating the disease. However, side effects may not occur at the same time and some may develop after discharge. Therefore, it is very important to identify the symptoms experienced, evaluate, control and provide professional health guidance. The spread of digitalisation has turned mobile learning into a kind of need or necessity rather than a preference. The use of web-based platforms in disease management leads to effective communication between the patient and the healthcare team. Thanks to the use of a web-based platform, communication between the patient and the caregiver increases, saving time and reducing costs. In addition to the benefits such as the ability of the health professional to plan the treatment planning by incorporating the patient's experiences, needs and concerns into the process and providing the benefit of access without spatial limitations, it also increases the control of individuals over themselves and provides self-discipline. The aim of this study is to evaluate the effect of symptom management training given with an artificial intelligence supported mobile application developed for gynaecological cancer patients receiving chemotherapy on supportive care needs, symptom severity and psychological well-being. The study was planned as a randomised controlled trial. Block randomisation will be used to assign patients to intervention and control groups. The population of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit for the first time to receive chemotherapy treatment for gynaecological cancer and completed the first course. The sample of the study will consist of patients who applied to Etlik City Hospital-Oncology Hospital-Day Outpatient Unit to receive chemotherapy treatment for the first time and who meet the following inclusion criteria. The study will be conducted with a total of 70 patients, including 35 patients from the intervention group and 35 patients from the control group (The sample number of the study was calculated by using the G Power programme using the data of a study in which mobile application intervention was carried out on cancer patients. Accordingly, the confidence interval was 95%; the margin of error was accepted as 5% and a total of 56 patients were found as 28 intervention and 28 control group. Considering that there may be losses during the mobile application intervention, the sample number was kept 25% higher than the calculated sample number.) Research Hypotheses: Gynaecological cancer patients receiving chemotherapyBetween the intervention group receiving symptom management training with a mobile application and the control group receiving standard care; 1. H1: There is a difference in terms of the severity of symptoms experienced. 2. H2: There is a difference in terms of supportive care needs. 3. H3: There is a difference in terms of psychological well-being levels. Data Collection Tools Descriptive Information Form, Edmonton Symptom Diagnostic Scale, Supportive Care Needs Scale, Psychological Well-Being Scale and Eastern Cooperative Oncology Group (ECOG) Performance Scale will be used as data collection tools. * Data collection tools will be sent to patients via the application and will be asked to be filled in. Modules to be included in the Mobile Application: * The application will include module, registration, login and profile creation sections. * The intervention group will be able to give feedback as they use the application. * Motivational messages will be sent. * At the end of the study, the mobile application will also be open to the control group. * The forms will be administered a total of three times, initially at the end of the 3rd and 5th cycle. * Module 1: Introducing Module * Module 2: Application Usage Instruction Module * Module 3: Recognise the Disease Module * Module 4: Common Symptoms and Recommendations During Chemotherapy Treatment Module * Module 5: Let's Fight Symptoms Together Module * Module 6: Ask Anything - Counselling Module

Conditions

• Gynaecological Cancer
• Chemotherapy
• Nursing Care

Interventions

Type	Name	Description
BEHAVIORAL	İntervention Group- Group receiving Symptom Management Training with Mobile Application	The application to be developed in the research will be both Android and IOS supported. Monitoring the active use of the patients from the interface by the researcher and receiving individual and collective notifications in line with the profile that the patients receiving chemotherapy will create in the application will increase the usability of the application. Thus, the benefit that users receive after active use can be determined. The content of the Let's fight the symptoms together module will be created by experts in the field and people will be able to actively use these methods while struggling with the symptoms they experience. Patients may not always have the opportunity to reach a nurse or health professional. In symptom management with the mobile application, artificial intelligence will be trained by the researcher and integrated into the application will help patients reach the right information without wasting time.

Timeline

• Start date: 2025-01-01
• Primary completion: 2025-09-01
• Completion: 2026-02-02
• First posted: 2024-12-03
• Last updated: 2024-12-03

Locations

1 site across 1 country: Turkey (Türkiye)