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| Name | Class |
|---|---|
| European Commission | OTHER |
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The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may allow to improve person-centered care and patients' empowerment.
The eCAN JA explores the role of telemedicine tools (i.e. TC & TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head & neck (H&N, pilot 1b) and advanced (pilot 2) cancers.
The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care.
Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care.
PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemedicine | Experimental | Patients in the intervention group will receive weekly teleconsultation of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. |
|
| Usual care | No Intervention | Patients in the control group will receive usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Telemedicine | Device | Pilot 1a/b : the tele-rehabilitation intervention in BC or H&N operated patients will consist of a series of exercises. The physiotherapist during teleconsultation rehabilitation program will explain to the patient how to perform the movements and regulate breathing. Practical advice on correct and incorrect habits will also be dispensed by the physiotherapist during the teleconsultation. Pilot 2: the tele-rehabilitation intervention will consist of tele psychological support performed by a trained psychologist in each participating center It will consist of the learning of techniques for managing negative emotions, for relaxation and for implementing effective behavioural and coping strategies. For each group, the TC will be scheduled every week for 8 weeks. The session will be available on a secure platform (Edumeet). Moreover, if they agree to, patients will also wear a smart watch to monitor physical parameters such as physical activity, sleeping and heart rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Health related quality of life measure to 8 weeks | EORTC QLQ-C30 questionnaire | Every 2 weeks: week 0, 2, 4, 6, 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Pain level to 8 weeks (for pilot 1) | Visual Analogical Scale (VAS). The ends are defined as the extreme limits of the parameter to be measured (orientated from the left (0 the worst) to the right (100 the best). | weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8 |
| Change from baseline Distress level to 8 weeks (for pilot 2) |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline Physical activity to 8 weeks | physical activity, number of steps, will be collected via wearable devices | every day, up to 8 weeks |
| Change from baseline sleep quality to 8 weeks | The average sleep quality (light sleep, deep sleep, REM sleep) will be collected via wearable device (Garmin watche) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Andrea Pace, Dr | Contact | +390652666153 | andrea.pace@ifo.it | |
| Victoria Leclercq, PhD | Contact | victoria.leclercq@sciensano.be |
| Name | Affiliation | Role |
|---|---|---|
| Andrea Pace, Dr | Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Antwerp University Hospital (UZA) | Not yet recruiting | Antwerp | Belgium |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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NCCN Distress thermometer.Distress is an unpleasant experience of a mental, physical, social, or spiritual nature. It can affect the way you think, feel, or act. Distress may make it harder to cope with having cancer, its symptoms, or its treatment. Please circle the number (0-10) that best describes how much distress you have been experiencing in the past week, including today. |
| weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8 |
| every day, up to 8 weeks |
| Change from baseline heart rate to 8 weeks | Daily heart rate (beats per minute) trend will be collected via wearable device (Garmin watche) | every day, up to 8 weeks |
| Patient-reported cost | Costs that arose for patients will be collected using a patient-reported cost questionnaire. | at week 9 |
| PREMS - mHealth App Usability | usability of the teleconsultation program and telemonitoring with mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients | at week 9 |
| PREMS - telehealth usability | usability of the teleconsultation program and telemonitoring with TELEHEALTH USABILITY QUESTIONNAIRE (TUQ) | at week 9 |
| German Oncology Center (GOC) | Recruiting | Ágios Athanásios | Cyprus |
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| CUT | Recruiting | Limassol | Cyprus |
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| The Bank of Cyprus Oncology Center (BOCOC) | Recruiting | Stróvolos | Cyprus |
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| Aristotle University of Thessaloniki | Recruiting | Thessaloniki | Greece |
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| National Institute of Oncology | Recruiting | Budapest | Hungary |
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| Dr Steevens Hospital | Not yet recruiting | Dublin | Ireland |
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| The National Cancer Institute of Naples (INT Pascale) | Not yet recruiting | Naples | Italy |
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| The Regina Elena National Cancer Institute (IFO-IRE) | Recruiting | Roma | Italy |
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| Hospital of Lithuanian University of Health Sciences Kauna Klinikos (KK) | Not yet recruiting | Kaunas | Lithuania |
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| National Cancer Institute (NCI) | Not yet recruiting | Vilnius | Lithuania |
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| Vilnius University Hospital Santaros Klinikos VULSK | Not yet recruiting | Vilnius | Lithuania |
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| Portuguese Institute of Cancer of Coimbra (IPO) | Recruiting | Coimbra | Portugal |
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| Portuguese Institute of Cancer of Lisbon (IPO) | Not yet recruiting | Lisbon | Portugal |
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| Portuguese Institute of Cancer of Porto (IPO) | Recruiting | Porto | Portugal |
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| The institute of Oncology Ljubljana (OIL) | Recruiting | Ljubljana | Slovenia |
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| IDIVAL | Recruiting | Santander | Spain |
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| Andalusian Health Service | Recruiting | Seville | Spain |
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