Effectiveness of Mobile Based Monitoring System in the Management of Chemotherapy-Related Symptoms

Trial Title: Effectiveness of Mobile Based Monitoring System in the Management of Chemotherapy-Related Symptoms

NCT ID: NCT05946070

Condition: Cancer
Chemotherapeutic Toxicity
Mobile Applications

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: ONKOSIS
Description: ONKOSIS is a mobile phone-based monitoring system in the management of chemotherapy-related symptoms
Arm group label: Intervention Group (ONKOSIS)

Other name: Mobile Application

Summary: Mobile health applications open the door to a safe and effective health system. Mobile communication channels and mobile phones not only provide training paths to healthcare professionals, but also provide remote decision support using automated data analysis or the ability to engage in real-time interviews with experts(1). The prevalence of symptoms due to cancer treatment and this adversely affect the quality of life and vital functions of patients and their relatives, and the increase in non-treatment admissions to the hospital. This shows that there is a need for programs where patients can control symptoms related to oncological treatment at home. It is thought that the use of mobile applications can be cost-effective by increasing access to health services and improving diagnosis, treatment and rehabilitation (2). Our single-blind, randomized-controlled, experimental study will be carried out between April 2022 and December 2022 at Kocaeli University Oncology and Palliative Care Center Ambulatory Chemotherapy Unit. The population of the study will consist of chemotherapy patients who applied to the unit and agreed to participate in the study. Based on the calculation made, it was decided to include 212 patients. In this context, it is thought that the mobile-based monitoring system in the management of chemotherapy-related symptoms will contribute to the management of treatment-related symptoms and increase the quality of life in patients receiving chemotherapy. Expected results from the use of the mobile application; - reducing the symptom burden, - improving the quality of life, - enabling informed changes in clinical practice and care, - reducing the social and economic burdens of cancer care.

Detailed description: The oncology symptom management system will help patients undergoing cancer treatment manage their symptoms and side effects while going about their daily lives. Therefore, the main customer base consists of patients receiving cancer treatment. However, with the implementation of the application, studies will be carried out in line with the targeted work packages. It is foreseen that the results to be obtained from this will increase the market diversity by integrating the institutions from which cancer treatment patients receive service into the system. For example, improving the quality of life of cancer patients using the application, providing better symptom management in home conditions and reducing the rates of admission to the hospital will reduce the costs of private health insurance companies and increase their profit rates. In addition, if the application is used in the follow-up of patients receiving cancer treatment services from A group private hospitals, it is predicted that institutional satisfaction will increase as well as other added values. It will be possible for private health insurance companies to use the Oncology symptom management system to reduce costs by reducing non-monitoring hospital admissions. In addition, it will be possible for health institutions providing oncology case manager nursing services to use the application in order to increase patient satisfaction and provide patient follow-up. It is planned to provide access to oncology nurses by participating in professional organizations to be held and cooperating with institutions such as the Oncology Nurses Association. It is aimed to use the Oncology Symptom Management System mobile application in our country in symptom management by cancer patients, in patient follow-up by healthcare professionals, and in scientific studies by academics.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Being diagnosed with cancer 2. Receiving first-line cytotoxic chemotherapy - Have been scheduled to receive 2, 3, or 4 week chemotherapy protocols (ie, chemotherapy administered in repeated cycles of 14, 21, or 28 days, respectively) 3. To receive at least 3 cycles of chemotherapy 4. To be deemed fit to participate in the research physically/psychologically by the researcher 5. Not having a communication barrier, having the ability to understand and use the mobile application. Exclusion Criteria: 1. Receiving chemotherapy for the same type of cancer or another type of cancer before being included in the study 2. Patients with treatment protocol changes during chemotherapy will be excluded from participation. 3. Receiving simultaneous radiotherapy during chemotherapy treatment 4. To be programmed to receive a weekly chemotherapy protocol.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Ünal ÖNSÜZ

Address:
City: Kocaeli̇
Country: Turkey

Status: Recruiting

Contact:
Last name: Ünal Önsüz

Phone: 905444416990
Email: unal.onsuz@kocaeli.edu.tr

Start date: June 23, 2023

Completion date: September 2024

Lead sponsor:
Agency: Istanbul University - Cerrahpasa (IUC)
Agency class: Other

Source: Istanbul University - Cerrahpasa (IUC)

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05946070