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

NCT05946070 | Completed

• 1 other identifier: 35621
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; Chemotherapeutic Toxicity; Mobile Applications

Outcome Measures

Primary Outcomes (1)

• Changes in quality of life as a result of the intervention

  The Nightingale Symptom Rating Scale will be used to evaluate the quality of life of patients using the mobile application compared to the control group. The Nightingale Symptom Rating Scale is a Likert-type quality of life scale used to evaluate the severity of treatment-related symptoms in cancer patients. It includes 38 symptoms frequently reported by cancer patients. The severity of symptoms experienced by patients is measured using five possible numerical responses; where 0 = not at all, 1 = a little, 2 = a little, 3 = quite a lot, and 4 = a lot. High scores indicate that patients' general quality of life or well-being regarding related sub-dimensions is poor.

  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 (3)

• Evaluation of application to hospital out of monitoring

  At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)

• Assessment of Satisfaction

  At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)

• Evaluation of suggested interventions in symptom management

  At the end of chemotherapy, up to a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)

Study Arms (2)

Intervention Group (ONKOSIS)

EXPERIMENTAL

Patients in the intervention group will be instructed to use the mobile application. Patients in the experimental group will be able to access the application contents without restrictions and will be able to use the in-app messaging module as well as the risk factors, symptom findings, and intervention suggestions for symptom management.

Other: ONKOSIS

Control group

NO INTERVENTION

Patients in the control group will receive standard care as is currently available at their clinical site. They will use demo version of the mobile application only for assessing symptom severity. In the demo version used by the control group patients, there is no in-app messaging module as well as information such as risk factors, symptoms and intervention recommendations for symptom management.

Interventions

ONKOSIS OTHER

ONKOSIS is a mobile phone-based monitoring system in the management of chemotherapy-related symptoms

Also known as: Mobile Application

Intervention Group (ONKOSIS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Being diagnosed with cancer
• 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)
• To receive at least 3 cycles of chemotherapy
• To be deemed fit to participate in the research physically/psychologically by the researcher
• Not having a communication barrier, having the ability to understand and use the mobile application.

You may not qualify if:

• Receiving chemotherapy for the same type of cancer or another type of cancer before being included in the study
• Patients with treatment protocol changes during chemotherapy will be excluded from participation.
• Receiving simultaneous radiotherapy during chemotherapy treatment
• To be programmed to receive a weekly chemotherapy protocol.

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Ünal ÖNSÜZ

Kocaeli, Kartepe, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 18953579 BACKGROUND

• 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.

  PMID: 19267731 BACKGROUND

• 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.

  PMID: 34289996 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Gülbeyaz Can, Prof

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 14, 2023
• Study Start: June 23, 2023
• Primary Completion: May 31, 2024
• Study Completion: December 5, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)