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
Trial ID: NCT06713122
Status: ENROLLING_BY_INVITATION
Study type: INTERVENTIONAL
Phase: NA
Start date: 2025-01-01
Completion date: 2026-02-02
Sponsor: Esra Nur Erdoğan
Conditions: Gynaecological Cancer; Chemotherapy; Nursing Care
Interventions: İntervention Group- Group receiving Symptom Management Training with Mobile Application
Locations: Etlik City Hospital-Oncology Hospital-Day Outpatient Unit
Countries: Turkey (Türkiye)
Enrollment: 70
Age range: 18 Years - None
Sex: FEMALE

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

Eligibility criteria:
Inclusion Criteria:

* Receiving chemotherapy for the first time due to gynaecological cancer and completing the first chemotherapy course
* At least 18 years old
* Not previously diagnosed with cancer, diagnosed with gynaecological cancer for the first time and only
* Literate
* Who agreed to participate in the research
* 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:

* The investigator discontinued the treatment
* Chemotherapy treatment discontinued after the start of the study
* Not actively using the mobile application
* Not filling in the forms during the use of the Mobile Application
* The occurrence of another cancer during the research

Outcomes:
Supportive Care Needs; Symptom Severity; Psychological Well-Being