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

March 4, 2024 updated by: Gulbeyaz Can, Istanbul University - Cerrahpasa (IUC)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (ONKOSIS)
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
ONKOSIS is a mobile phone-based monitoring system in the management of chemotherapy-related symptoms
Other Names:
  • Mobile Application
No Intervention: Control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in quality of life as a result of the intervention
Time Frame: 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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of application to hospital out of monitoring
Time Frame: At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
Admission to hospital due to chemotherapy side effects during treatment
At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
Assessment of Satisfaction
Time Frame: At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
App satisfaction score (0-10)
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
Time Frame: At the end of chemotherapy, up to a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
It is aimed to evaluate the effectiveness of the interventions recommended by the patients to manage the symptoms in oncology patients receiving chemotherapy. Efficiency score of the proposed interventions in coping with chemotherapy side effects (0-10)
At the end of chemotherapy, up to a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University - Cerrahpasa (IUC)

Investigators

  • Principal Investigator: Gülbeyaz Can, Prof, Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 23, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 22, 2023

First Submitted That Met QC Criteria

July 6, 2023

First Posted (Actual)

July 14, 2023

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 35621

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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