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
Phase: NA
Conditions: Gynaecological Cancer, Chemotherapy, Nursing Care
Sponsor: Esra Nur Erdoğan

 
Official Title: 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 
NCT number:  NCT ID not yet assigned 
ID: 2024-442  
Document Date:10.09.2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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. 
Inclusion Criteria 
Women who have received chemotherapy for the first time due to gynecological cancer and 
have completed their first chemotherapy course 
At least 18 years old 
No previous cancer diagnosis, First AND ONLY gynecological cancer diagnosis 
Literate 
Agree to participate in the study 
No communication barrier 
Eastern Cooperative Oncology Group (ECOG) Performance Scale score below 3 
No diagnosed psychiatric illness 
Women who have an Android or IOS smartphone and can access the internet 
Exclusion Criteria 
Researcher leaving treatment unfinished 
Treatment treatment ended after the study started 

Not actively using the mobile application 
Not filling out the forms during the use of the mobile application 
Another cancer developing during the study period 
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. 
o Data collection tools will be sent to patients via the application and will be asked 
to be filled in. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
STUDY PROTOCOL 
                                                                           
 
The research was planned as a randomised controlled study. 
All participants will fill in the Introductory Information Form. 
 
                                                                   Randomisation 
    
Intervention Group 
Control Group 
   
 
The mobile application will be downloaded to all groups and the patients will be Pre-tested 
after the first course of chemotherapy (Edmonton Symptom 
Assessment Scale (ESAS), Supportive Care Needs Survey, Psychological Well-Being Scale and 
Eastern Cooperative Oncology Group (ECOG) Performance Scale). 
 
 
Intervention Group  
2 months mobile application intervention 
will be applied. 
Control Group  
The control group will continue with standard 
care. 
 
                                   
Kemoterapi 3. kür sonrası testler 
tekrarlanacaktır. 
(Edmonton Symptom 
Assessment Scale (ESAS), Supportive Care 
Needs Survey, Psychological Well-Being Scale 
and Eastern Cooperative Oncology Group 
(ECOG) Performance Scale) 
Kemoterapi 3. kür sonrası testler 
tekrarlanacaktır. 
(Edmonton Symptom 
Assessment Scale (ESAS), Supportive Care 
Needs Survey, Psychological Well-Being Scale 
and Eastern Cooperative Oncology Group 
(ECOG) Performance Scale) 
 
 
 

Intervention Group  
Mobile application intervention will be 
applied for 2 more months. 
Control Group  
The control group will continue with standard 
care. 
 
 
 
After the 5th cycle of chemotherapy, 
patients will be given the last test. 
(Edmonton Symptom 
Assessment Scale (ESAS), Supportive Care 
Needs Survey, Psychological Well-Being Scale 
and Eastern Cooperative Oncology Group 
(ECOG) Performance Scale) 
After the 5th cycle of chemotherapy, patients 
will be given the last test. 
 (Edmonton Symptom 
Assessment Scale (ESAS), Supportive Care 
Needs Survey, Psychological Well-Being Scale 
and Eastern Cooperative Oncology Group 
(ECOG) Performance Scale) 
 
 
Data will be analysed, findings and research report will be written.