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
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Supportive Care Needs
研究概览
简要总结
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;
- H1: There is a difference in terms of the severity of symptoms experienced.
- H2: There is a difference in terms of supportive care needs.
- 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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: İntervention Group- Group receiving Symptom Management Training with Mobile Application (Behavioral)
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.
结局指标
主要结局
Supportive Care Needs
时间窗: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
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'
Symptom Severity
时间窗: Evaluation test: will be performed after the first cycle of chemotherapy treatment and after the 3rd and 5th cycles (each cycle is 28 days)
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.
Psychological Well-Being
时间窗: 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 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.
次要结局
未报告次要终点
研究者
Esra Nur Erdoğan
Associate Investigator, PhD Student, Research Assistant
Saglik Bilimleri Universitesi