An interventional study of İntervention Group- Group receiving Symptom Management Training with Mobile Application in Gynaecological Cancer, Chemotherapy and Nursing Care, sponsored by Esra Nur Erdoğan. Enrolling by invitation at 1 site in Turkey. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Esra Nur Erdoğan · Not applicable, Interventional, and Supportive care
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;
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
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;
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:
This is the only study on the registry with Esra Nur Erdoğan as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Mobile application intervention will be applied to the intervention group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles.
Behavioral: İntervention Group- Group receiving Symptom Management Training with Mobile Application
No intervention will be applied to the control group. The evaluation tests will be repeated after the first cycle of chemotherapy treatment, at the 3rd and 5th cycles.
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.
Supportive Care Needs
Supportive Care Needs Scale:Each question in the scale is numbered from 1 to 5 and 1 point corresponds to 'I did not experience this situation' and 5 points correspond to 'I needed a lot of support'
Time frame: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Symptom Severity
Edmonton Symptom Diagnostic Scale: The severity of each symptom is assessed with numerical numbers from 0 to 10. A score of 0 indicates that the symptom is absent and a score of 10 indicates that the symptom is felt very severely.
Time frame: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Psychological Well-Being
Psychological Well-Being Scale: The items of the Psychological Well-Being Scale are answered between 1-7 in the form of strongly disagree (1) and strongly agree (7). Scores vary between 8 and 56. A high score indicates that the person has many psychological resources and strengths.
Time frame: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — After the end of the study: study protocol and Clinical Study Report (CSR)
Supporting information: Study protocol, Csr
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