Clinical trial NCT05946070: Effectiveness of Mobile Based Monitoring System in the Management of Chemotherapy-Related Symptoms
Official title: Effectiveness of Mobile Based Monitoring System in the Management of Chemotherapy-Related Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Chemotherapeutic Toxicity
Mobile Applications
Lead sponsor: Istanbul University - Cerrahpasa
Sponsor class: OTHER
First posted: 2023-07-14
Enrollment: 199
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Changes in quality of life as a result of the intervention
timeFrame: At the end of each cycle of chemotherapy (each cycle can be either 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy.
Secondary outcomes:
measure: Evaluation of application to hospital out of monitoring
timeFrame: At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
measure: Assessment of Satisfaction
timeFrame: At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
measure: Evaluation of suggested interventions in symptom management
timeFrame: At the end of chemotherapy, up to a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
Other outcomes:
Locations:
city: Kocaeli̇
country: Turkey
facility: Ünal ÖNSÜZ
state: Kartepe
Study officials:
affiliation: Istanbul University - Cerrahpasa
name: Gülbeyaz Can, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kearney N, McCann L, Norrie J, Taylor L, Gray P, McGee-Lennon M, Sage M, Miller M, Maguire R. Evaluation of a mobile phone-based, advanced symptom management system (ASyMS) in the management of chemotherapy-related toxicity. Support Care Cancer. 2009 Apr;17(4):437-44. doi: 10.1007/s00520-008-0515-0. Epub 2008 Oct 25.
citation: McCann L, Maguire R, Miller M, Kearney N. Patients' perceptions and experiences of using a mobile phone-based advanced symptom management system (ASyMS) to monitor and manage chemotherapy related toxicity. Eur J Cancer Care (Engl). 2009 Mar;18(2):156-64. doi: 10.1111/j.1365-2354.2008.00938.x.
citation: Maguire R, McCann L, Kotronoulas G, Kearney N, Ream E, Armes J, Patiraki E, Furlong E, Fox P, Gaiger A, McCrone P, Berg G, Miaskowski C, Cardone A, Orr D, Flowerday A, Katsaragakis S, Darley A, Lubowitzki S, Harris J, Skene S, Miller M, Moore M, Lewis L, DeSouza N, Donnan PT. Real time remote symptom monitoring during chemotherapy for cancer: European multicentre randomised controlled trial (eSMART). BMJ. 2021 Jul 21;374:n1647. doi: 10.1136/bmj.n1647.