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

NCT06713122 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2024-12-03

No results posted yet for this study

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

Conditions

  • Gynaecological Cancer
  • Chemotherapy
  • Nursing Care

Interventions

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.

Sponsors & Collaborators

  • Esra Nur Erdoğan

    lead OTHER

Principal Investigators

  • Esra Nur Erdoğan, PhD Student · University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology

  • Gülten Güvenç, Prof.Dr. · University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology

  • Tülay Eren, Asst. Prof. · Etlik City Hospital, Medical Oncology

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-01
Primary Completion
2025-09-01
Completion
2026-02-02

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06713122 on ClinicalTrials.gov