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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Chemotherapy; Nursing Care; Gynaecological Cancer
• Intervention / Treatment: Behavioral: İntervention Group- Group receiving Symptom Management Training with Mobile Application

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

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey
    • Etlik City Hospital-Oncology Hospital-Day Outpatient Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervention Group- Group receiving Symptom Management Training with Mobile Application; 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; 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.
No Intervention: Control Group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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'	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.	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.	Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: Esra Nur Erdoğan
• Investigators: Study Chair: Esra Nur Erdoğan, PhD Student, University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology; Principal Investigator: Gülten Güvenç, Prof.Dr., University of Health Sciences Gulhane Faculty of Nursing, Department of Obstetrics and Gynaecology; Study Chair: Tülay Eren, Asst. Prof., Etlik City Hospital, Medical Oncology

Publications and helpful links

General Publications

• Graetz I, Anderson JN, McKillop CN, Stepanski EJ, Paladino AJ, Tillmanns TD. Use of a web-based app to improve postoperative outcomes for patients receiving gynecological oncology care: A randomized controlled feasibility trial. Gynecol Oncol. 2018 Aug;150(2):311-317. doi: 10.1016/j.ygyno.2018.06.007. Epub 2018 Jun 11.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2025
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): February 2, 2026

Study Registration Dates

• First Submitted: November 10, 2024
• First Submitted That Met QC Criteria: December 1, 2024
• First Posted (Actual): December 3, 2024

Study Record Updates

• Last Update Posted (Actual): December 3, 2024
• Last Update Submitted That Met QC Criteria: December 1, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: chemotherapy; mobile application; psychological well-being; nursing care; supportive care needs; Gynaecological cancer
• Other Study ID Numbers: 2024-442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After the end of the study: study protocol and Clinical Study Report (CSR)
• IPD Sharing Time Frame: After the end of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No