CancerNCT05946070
Effectiveness of Mobile Based Monitoring System in the Management of Chemotherapy-Related Symptoms
A study testing ONKOSIS in people with Cancer and Chemotherapeutic Toxicity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Chemotherapeutic Toxicity, Mobile Applications
- What is being tested?
- ONKOSIS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Jun 2023to 5 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Cancer, Chemotherapeutic Toxicity, Mobile Applications
- Being tested
- ONKOSIS
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ONKOSISOther
Also called Mobile Application
ONKOSIS is a mobile phone-based monitoring system in the management of chemotherapy-related symptoms
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Admission to hospital due to chemotherapy side effects during treatment
Measured: At the end of chemotherapy, a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
Assessment of Satisfaction
App satisfaction score (0-10)
Measured: 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
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)
Measured: At the end of chemotherapy, up to a maximum of 6. cycles (each cycle can be 14, 21 or 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start23 Jun 2023
- Primary completion31 May 2024
- Study completion5 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulbeyaz Can, Istanbul University - Cerrahpasa
- Investigators
- Gülbeyaz Can, Prof, Principal investigator, Istanbul University - Cerrahpasa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05946070
- Sponsor's protocol ID
- 35621
- Status last verified
- Dec 2024
- First submitted
- 22 Jun 2023
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18953579McCann 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.
PubMed 19267731Maguire 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.
PubMed 34289996Onsuz U, Can G. Effectiveness of mobile-based monitoring system (ONKOSIS) in the management of chemotherapy-related symptoms: a randomized controlled trial. Support Care Cancer. 2026 Mar 4;34(3):278. doi: 10.1007/s00520-026-10512-5.
PubMed 41781572
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mobile Based Monitoring System in the Management of Chemotherapy-Related Symptoms
- ClinicalTrials.gov ID
- NCT05946070
- Acronym / sponsor ID
- 35621
- Conditions
- Cancer, Chemotherapeutic Toxicity, Mobile Applications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 5 Dec 2024 (actual)
- First posted
- 14 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (ONKOSIS) | Experimental | Other: ONKOSISPatients 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Being diagnosed with cancer
- Receiving first-line cytotoxic chemotherapy
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ONKOSISAlso: Mobile ApplicationONKOSIS is a mobile phone-based monitoring system in the management of chemotherapy-related symptoms | Other | Intervention Group (ONKOSIS) |
Primary outcome
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.
3 secondary outcomes
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)
Assessment of Satisfaction
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Background: PubMed 18953579Kearney 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.
- Background: PubMed 19267731McCann 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.
- Background: PubMed 34289996Maguire 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.
- Derived from this study: PubMed 41781572Onsuz U, Can G. Effectiveness of mobile-based monitoring system (ONKOSIS) in the management of chemotherapy-related symptoms: a randomized controlled trial. Support Care Cancer. 2026 Mar 4;34(3):278. doi: 10.1007/s00520-026-10512-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gülbeyaz Can, Prof principal investigator
Istanbul University - Cerrahpasa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ONKOSIS in people with Cancer and Chemotherapeutic Toxicity, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05946070, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2024.