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| Name | Class |
|---|---|
| University College Dublin | OTHER |
| King's College London | OTHER |
| University of California, San Francisco | OTHER |
| University of Athens |
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Chemotherapy may cause distressing symptoms which can impact on patients' quality of life. Chemotherapy is frequently given on an outpatient basis therefore patients are often required to manage the symptoms they experience at home without direct supervision from healthcare professionals. This study aims to evaluate the impact of a mobile phone based, remote monitoring, symptom management system (ASyMS) on the delivery of care to people with nonmetastatic breast, colorectal or haematological cancer during chemotherapy and for one year following treatment. The study aims to compare a number of outcomes of patients using the ASyMS intervention with outcomes of patients who receive normal care at their hospital. For up to 6 cycles of chemotherapy treatment, once a day and any other time they feel unwell, patients allocated to the mobile phone group will enter information on the phone regarding any symptoms they are experiencing, take their temperature and enter this on the phone. The information is sent via secure connection to a computer, which assesses the information and sends an alert to their health care professional in the hospital, who will call the patient at home if the patient has reported problematic symptoms. Patients in the normal care group will receive care as normal at their hospital. Both groups of patients will be asked to complete a series of questionnaires before they start treatment, after each chemotherapy cycle (for a maximum of 6 cycles) and at 3 monthly intervals for up to one year thereafter (a subset of patients will also be asked to complete midcycle symptom assessments). The study will also evaluate the cost benefit of ASyMS, assess changes in clinical practice as a result of ASyMS and develop a predictive risk model (statistical model) for use in future care of patients receiving chemotherapy for these cancers. This multicentre study is taking place across a number of European countries.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASyMS intervention Group | Experimental | Patients in the intervention group will be instructed to use the ASyMS intervention once daily (and whenever they feel unwell) for up to 6 cycles of chemotherapy treatment. |
|
| Control Group | No Intervention | Patients in the control group will receive standard care as is currently available at their clinical site. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASyMS intervention Group | Other | ASyMS is a mobile phone-based remote-monitoring system that enables the 'real-time' monitoring of patients' symptoms through use of a patient-reported outcome measure (PROM) |
| Measure | Description | Time Frame |
|---|---|---|
| Memorial Symptom Assessment Scale (MSAS) | The MSAS is a multidimensional selfreport questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Memorial Symptom Assessment Scale (MSAS) | The MSAS is a multidimensional self-report questionnaire that evaluates 32 physical and psychological symptoms according to their frequency, severity and distress/bother to the person in the past week. | At the halfway point during each cycle of chemotherapy (each cycle can be wither 14, 21 or 28 days long) for up to a maximum of 6 cycles of chemotherapy and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. |
| Measure | Description | Time Frame |
|---|---|---|
| EuroQol 5-Dimensions combined with the Client Services Receipt Inventory | To evaluate the cost-effectiveness of the intervention for the management of chemotherapy-related symptoms | 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 and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roma Maguire | University of Strathclyde | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Vienna Comprehensive Cancer Center | Vienna | Austria | ||||
| Agioi Anargiri Cancer Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39626227 | Derived | McCann L, Lewis L, Oduntan O, Harris J, Darley A, Berg GV, Lubowitzki S, Cheevers K, Miller M, Armes J, Ream E, Fox P, Furlong EP, Gaiger A, Kotronoulas G, Patiraki E, Katsaragakis S, McCrone P, Miaskowski C, Cardone A, Orr D, Flowerday A, Skene S, Moore M, De Souza N, Donnan P, Maguire R. Patients' and Clinicians' Experiences Using a Real-Time Remote Monitoring System for Chemotherapy Symptom Management (ASyMS): Qualitative Study. J Med Internet Res. 2024 Dec 3;26:e53834. doi: 10.2196/53834. | |
| 38901021 |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| OTHER |
| Medical University of Vienna | OTHER |
| University of Dundee | OTHER |
| European Cancer Patient Coalition (ECPC) | UNKNOWN |
| Docobo Ltd. | INDUSTRY |
| University of Surrey | OTHER |
| Sykehuset Innlandet HF | OTHER |
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| Functional Assessment of Cancer Therapy General (FACT-G) | during active chemotherapy and/or at the 1 year follow-up | 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 and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. |
| Supportive Care Needs Survey Short Form | The 34-item instrument measures supportive care needs in five domains: health system and information, psychological needs, physical and daily living, patient care and support, and sexual-related. | 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 and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. |
| State-Trait Anxiety Inventory-Revised | The STAI-R is a 40-item measure of two types of anxiety - state anxiety (anxiety about an event), and trait anxiety (anxiety level as a personal characteristic). The State Anxiety scale assesses intensity of current feelings "at this moment". The Trait Anxiety scale assesses frequency of feelings 'in general'. | 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 and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. |
| Communication and Attitudinal Self-Efficacy scale for cancer | A 12-item measure of cancer patients' confidence and ability to engage in their self-care (i.e. self-efficacy) contributing to 3 dimensions (maintaining a positive attitude, understanding and participating in care, seeking and obtaining information). | 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 and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. |
| Work Limitations Questionnaire | A 25-item measure corresponding to 4 dimensions: time management; physical; mental/interpersonal; output demands). This was only completed by those individuals who were working. | 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 and/or at 3 monthly intervals for up to one year following a maximum of 6 cycles of chemotherapy. |
| Changes in clinical practice as a result of the intervention | Exploring experiences of an anticipatory and preventative model of care | Baseline and immediately after the intervention |
| Predictive Risk Models (PRMs) to predict patients' chemotherapy-related symptoms by combining demographic, clinical, social and health service data collected from previous studies, as well as the current study, to inform the predictions made. | To move beyond traditional approaches to manage symptoms in oncology patients receiving chemotherapy to more tailored and anticipatory approaches. | Daily throughout 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. |
| Athens |
| Greece |
| Air Force General Hospital | Athens | Greece |
| Metropolitan Hospital | Athens | Greece |
| St James's Hospital | Dublin | Ireland |
| St Vincent's Healthcare Group | Dublin | Ireland |
| Innlandet Hospital Trust | Lillehammer | Norway |
| Guy's and St Thomas' NHS Foundation Trust | London | United Kingdom |
| St George's Healthcare Trust | London | United Kingdom |
| University College London | London | United Kingdom |
| Mount Vernon Cancer Centre | Northwood | United Kingdom |
| Derived |
| Miller M, McCann L, Lewis L, Miaskowski C, Ream E, Darley A, Harris J, Kotronoulas G, V Berg G, Lubowitzki S, Armes J, Patiraki E, Furlong E, Fox P, Gaiger A, Cardone A, Orr D, Flowerday A, Katsaragakis S, Skene S, Moore M, McCrone P, De Souza N, Donnan PT, Maguire R. Patients' and Clinicians' Perceptions of the Clinical Utility of Predictive Risk Models for Chemotherapy-Related Symptom Management: Qualitative Exploration Using Focus Groups and Interviews. J Med Internet Res. 2024 Jun 20;26:e49309. doi: 10.2196/49309. |
| 34289996 | Derived | 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. |
| 28592577 | Derived | Maguire R, Fox PA, McCann L, Miaskowski C, Kotronoulas G, Miller M, Furlong E, Ream E, Armes J, Patiraki E, Gaiger A, Berg GV, Flowerday A, Donnan P, McCrone P, Apostolidis K, Harris J, Katsaragakis S, Buick AR, Kearney N. The eSMART study protocol: a randomised controlled trial to evaluate electronic symptom management using the advanced symptom management system (ASyMS) remote technology for patients with cancer. BMJ Open. 2017 Jun 6;7(5):e015016. doi: 10.1136/bmjopen-2016-015016. |