xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06007001</url>
    </required_header>
    <id_info>
      <org_study_id>eCAN pilots</org_study_id>
      <nct_id>NCT06007001</nct_id>
    </id_info>
    <brief_title>Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA</brief_title>
    <acronym>eCAN</acronym>
    <official_title>Telerehabilitation and Tele-psychological Support in Cancer Patients: the Pilots Projects of eCAN JA</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sciensano</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>European Commission</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Sciensano</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The integration of teleconsultation (TC) and telemonitoring (TM) in cancer patients care may&#xD;
        allow to improve person-centered care and patients' empowerment.&#xD;
  &#xD;
        The eCAN JA explores the role of telemedicine tools (i.e. TC &amp; TM) in clinical trials&#xD;
        focusing on tele-rehabilitation and tele-psychological support in different populations of&#xD;
        cancer patients in 10 European countries. The pilots will be conducted among 354 patients&#xD;
        affected by breast (BC, pilot 1a), head &amp; neck (H&amp;N, pilot 1b) and advanced (pilot 2)&#xD;
        cancers.&#xD;
  &#xD;
        The main aim is to assess the effect of TC and TM program focused on rehabilitation and&#xD;
        psychological support for cancer patients on patient reported outcomes measures (PROMs) in&#xD;
        three pilots compare to usual care.&#xD;
  &#xD;
        Patients will be randomly assigned either to the intervention or control groups using a 1:1&#xD;
        ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks&#xD;
        through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be&#xD;
        performed by a remote physiotherapist and will consist of a series of rehabilitation&#xD;
        exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist&#xD;
        and will consist of techniques for managing emotions and stress. In the intervention group,&#xD;
        patients will also have the possibility to wear a smartwatch to automatically collect&#xD;
        physical parameters. Patients in the control group will receive usual care.&#xD;
  &#xD;
        PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical&#xD;
        activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring&#xD;
        systems. A secure web platform will provide dashboard to clinicians for decision support.&#xD;
        Patients' experience and costs data will be also collected. The results of the eCAN project&#xD;
        will improve our knowledge on benefits and risks for TC and TM in cancer patients care.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 15, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change from baseline Health related quality of life measure to 8 weeks</measure>
      <time_frame>Every 2 weeks: week 0, 2, 4, 6, 8</time_frame>
      <description>EORTC QLQ-C30 questionnaire</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change from baseline Pain level to 8 weeks (for pilot 1)</measure>
      <time_frame>weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8</time_frame>
      <description>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).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change from baseline Distress level to 8 weeks (for pilot 2)</measure>
      <time_frame>weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change from baseline Physical activity to 8 weeks</measure>
      <time_frame>every day, up to 8 weeks</time_frame>
      <description>physical activity, number of steps, will be collected via wearable devices</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline sleep quality to 8 weeks</measure>
      <time_frame>every day, up to 8 weeks</time_frame>
      <description>The average sleep quality (light sleep, deep sleep, REM sleep) will be collected via wearable device (Garmin watche)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change from baseline heart rate to 8 weeks</measure>
      <time_frame>every day, up to 8 weeks</time_frame>
      <description>Daily heart rate (beats per minute) trend will be collected via wearable device (Garmin watche)</description>
    </other_outcome>
    <other_outcome>
      <measure>Patient-reported cost</measure>
      <time_frame>at week 9</time_frame>
      <description>Costs that arose for patients will be collected using a patient-reported cost questionnaire.</description>
    </other_outcome>
    <other_outcome>
      <measure>PREMS - mHealth App Usability</measure>
      <time_frame>at week 9</time_frame>
      <description>usability of the teleconsultation program and telemonitoring with mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients</description>
    </other_outcome>
    <other_outcome>
      <measure>PREMS - telehealth usability</measure>
      <time_frame>at week 9</time_frame>
      <description>usability of the teleconsultation program and telemonitoring with TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">354</enrollment>
    <condition>Cancer</condition>
    <arm_group>
      <arm_group_label>Telemedicine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Patients in the control group will receive usual care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Telemedicine</intervention_name>
      <description>Pilot 1a/b : the tele-rehabilitation intervention in BC or H&amp;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.&#xD;
  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.&#xD;
  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.</description>
      <arm_group_label>Telemedicine</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Pilot 1a: All consenting adult women, aged between 45 and 65 years old, who undergo a&#xD;
               unilateral mastectomy plus axillary dissection for newly diagnosed breast cancer in a&#xD;
               cancer center of participating European countries will be eligible for this study.&#xD;
  &#xD;
            -  Pilot 1b: All consenting adult patients, aged between 18 and 75 years old, with&#xD;
               histopathologically proven H&amp;N cancer who are prescheduled for an en bloc resection of&#xD;
               the primary tumor, neck dissection, or reconstruction in a cancer center of&#xD;
               participating European countries will be eligible for this study.&#xD;
  &#xD;
            -  Pilot 2: All consenting adult patients, aged between 18 and 75 years old, affected by&#xD;
               advanced/recurrent cancer (including lung, prostate, colorectum, breast cancer,&#xD;
               gastric, genito-urinary) will be eligible for this study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  For both study pilot 1a &amp; 1b: Patients are ineligible to participate if they meet one&#xD;
               of the following criteria: (I) having breast reconstruction, (II) having blindness or&#xD;
               severe visual impairment, (III) having life expectancy of less than 3 months, (IV)&#xD;
               having previous upper limb injury or conditions that limit upper limb range of motion&#xD;
               (shoulder flexion (&lt; 150°) or elbow extension/flexion (&lt; 0/145°) respectively), (V)&#xD;
               unable to be assigned to tele-rehabilitation due to clinical conditions requiring&#xD;
               in-person rehabilitation, (VI) unable to sign informed consent, (VII) not having&#xD;
               access to an internet connection, (VIII) not having access to an android smartphone or&#xD;
               (IX) already involved in other telemedicine services. For pilot 1b, H&amp;N cancer&#xD;
               patients needing post-surgery radiotherapy will be excluded.&#xD;
  &#xD;
            -  For pilot 2: Patients are ineligible to participate if they meet one of the following&#xD;
               criteria: (I) unable to sign informed consent; (II) present relevant cognitive&#xD;
               deterioration; (III) performance status &gt; ECOG 2; (IV) previous diagnosis of major&#xD;
               depression, the presence of mood disorders will be assessed with Personal Health&#xD;
               Questionnaire Depression Scale (PHQ-8) (13); (V) starting antidepressant&#xD;
               pharmacological treatment in the last 4 weeks before the enrollment; (VI) taking&#xD;
               antipsychotic treatment, (VII) not having access to an internet connection (VIII) not&#xD;
               having access to an android smartphone or (IX) already involved in other telemedicine&#xD;
               services.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrea Pace, Dr</last_name>
      <role>Principal Investigator</role>
      <affiliation>Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea Pace, Dr</last_name>
      <phone>+390652666153</phone>
      <email>andrea.pace@ifo.it</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Victoria Leclercq, PhD</last_name>
      <email>victoria.leclercq@sciensano.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The Antwerp University Hospital (UZA)</name>
        <address>
          <city>Antwerp</city>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Timon Vandamme, Dr</last_name>
        <email>timon.vandamme@uantwerpen.be</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>German Oncology Center (GOC)</name>
        <address>
          <city>Agios athanasios</city>
          <country>Cyprus</country>
        </address>
      </facility>
      <contact>
        <last_name>Contantinos Zambogou</last_name>
        <email>constantinos.zamboglou@goc.com.cy</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>CUT</name>
        <address>
          <city>Limassol</city>
          <country>Cyprus</country>
        </address>
      </facility>
      <contact>
        <last_name>Angelos Kassianos, Dr</last_name>
        <email>angelos.kassianos@cut.ac.cy</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Bank of Cyprus Oncology Center (BOCOC)</name>
        <address>
          <city>Stróvolos</city>
          <country>Cyprus</country>
        </address>
      </facility>
      <contact>
        <last_name>Anastasia Constantinidou</last_name>
        <email>constantinidou.anastasia@ucy.ac.cy</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Aristotle University of Thessaloniki</name>
        <address>
          <city>Thessaloníki</city>
          <country>Greece</country>
        </address>
      </facility>
      <contact>
        <last_name>Eleni Timotheadou</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>National Institute of Oncology</name>
        <address>
          <city>Budapest</city>
          <country>Hungary</country>
        </address>
      </facility>
      <contact>
        <last_name>József Lövey, Dr</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Dr Steevens Hospital</name>
        <address>
          <city>Dublin</city>
          <country>Ireland</country>
        </address>
      </facility>
      <contact>
        <last_name>Des OToole</last_name>
        <email>Des.OToole@hse.ie</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The National Cancer Institute of Naples (INT Pascale)</name>
        <address>
          <city>Naples</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Maria C Piccirillo</last_name>
        <email>m.piccirillo@istitutotumori.na.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Regina Elena National Cancer Institute (IFO-IRE)</name>
        <address>
          <city>Roma</city>
          <country>Italy</country>
        </address>
      </facility>
      <contact>
        <last_name>Andrea Pace, Dr</last_name>
        <email>andrea.pace@ifo.it</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital of Lithuanian University of Health Sciences Kauna Klinikos (KK)</name>
        <address>
          <city>Kaunas</city>
          <country>Lithuania</country>
        </address>
      </facility>
      <contact>
        <last_name>Viktoras Rudzianskas</last_name>
        <email>Viktoras.Rudzianskas@kaunoklinikos.lt</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>National Cancer Institute (NCI)</name>
        <address>
          <city>Vilnius</city>
          <country>Lithuania</country>
        </address>
      </facility>
      <contact>
        <last_name>Jolanta Paskeviciene</last_name>
        <email>jolanta.paskeviciene@nvi.lt</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Vilnius University Hospital Santaros Klinikos VULSK</name>
        <address>
          <city>Vilnius</city>
          <country>Lithuania</country>
        </address>
      </facility>
      <contact>
        <last_name>Marija Turlinksienė</last_name>
        <email>Marija.turlinskiene@santa.lt</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Portuguese Institute of Cancer of Coimbra (IPO)</name>
        <address>
          <city>Coimbra</city>
          <country>Portugal</country>
        </address>
      </facility>
      <contact>
        <last_name>Rui Soares</last_name>
        <email>ruisoares@ipocoimbra.min-saude.pt</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Portuguese Institute of Cancer of Lisbon (IPO)</name>
        <address>
          <city>Lisboa</city>
          <country>Portugal</country>
        </address>
      </facility>
      <contact>
        <last_name>Joana Dias</last_name>
        <email>jpsequeira@ipolisboa.min-saude.pt</email>
      </contact>
      <contact_backup>
        <last_name>Maria Moura</last_name>
        <email>mjmoura@ipolisboa.min-saude.pt</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>Portuguese Institute of Cancer of Porto (IPO)</name>
        <address>
          <city>Porto</city>
          <country>Portugal</country>
        </address>
      </facility>
      <contact>
        <last_name>Otilia Romano</last_name>
        <email>otilia.romano@ipoporto.min-saude.pt</email>
      </contact>
      <contact_backup>
        <last_name>Eunice Silva</last_name>
        <email>esilva@ipoporto.min-saude.pt</email>
      </contact_backup>
    </location>
    <location>
      <facility>
        <name>The institute of Oncology Ljubljana (OIL)</name>
        <address>
          <city>Ljubljana</city>
          <country>Slovenia</country>
        </address>
      </facility>
      <contact>
        <last_name>Cvetka Grašič Kuhar</last_name>
        <email>CGrasic@onko-i.si</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>IDIVAL</name>
        <address>
          <city>Santander</city>
          <country>Spain</country>
        </address>
      </facility>
      <contact>
        <last_name>Ignacio Durán</last_name>
        <email>ignaciojose.duran@scsalud.es</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Andalusian Health Service</name>
        <address>
          <city>Sevilla</city>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Belgium</country>
      <country>Cyprus</country>
      <country>Greece</country>
      <country>Hungary</country>
      <country>Ireland</country>
      <country>Italy</country>
      <country>Lithuania</country>
      <country>Portugal</country>
      <country>Slovenia</country>
      <country>Spain</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 23, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 17, 2023</last_update_submitted>
    <last_update_submitted_qc>August 17, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Cancer</keyword>
    <keyword>telemedicine</keyword>
    <keyword>teleconsultation</keyword>
    <keyword>telemonitoring</keyword>
    <keyword>PROM</keyword>
    <keyword>PREM</keyword>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06007001
  org study id: eCAN pilots
  nct id: NCT06007001
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Change from baseline Health related quality of life measure to 8 weeks
  time frame: Every 2 weeks: week 0, 2, 4, 6, 8
  description: EORTC QLQ-C30 questionnaire
  measure: Change from baseline Pain level to 8 weeks (for pilot 1)
  time frame: weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8
  description: 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).
  measure: Change from baseline Distress level to 8 weeks (for pilot 2)
  time frame: weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8
  description: 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.
  measure: Change from baseline Physical activity to 8 weeks
  time frame: every day, up to 8 weeks
  description: physical activity, number of steps, will be collected via wearable devices
  measure: Change from baseline sleep quality to 8 weeks
  time frame: every day, up to 8 weeks
  description: The average sleep quality (light sleep, deep sleep, REM sleep) will be collected via wearable device (Garmin watche)
  measure: Change from baseline heart rate to 8 weeks
  time frame: every day, up to 8 weeks
  description: Daily heart rate (beats per minute) trend will be collected via wearable device (Garmin watche)
  measure: Patient-reported cost
  time frame: at week 9
  description: Costs that arose for patients will be collected using a patient-reported cost questionnaire.
  measure: PREMS - mHealth App Usability
  time frame: at week 9
  description: usability of the teleconsultation program and telemonitoring with mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
  measure: PREMS - telehealth usability
  time frame: at week 9
  description: usability of the teleconsultation program and telemonitoring with TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)
  arm group label: Telemedicine
  arm group type: Experimental
  description: 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.
  arm group label: Usual care
  arm group type: No Intervention
  description: Patients in the control group will receive usual care.
  intervention type: Device
  intervention name: Telemedicine
  description: 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.
  arm group label: Telemedicine
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Andrea Pace, Dr
  role: Principal Investigator
  affiliation: Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy
  last name: Andrea Pace, Dr
  phone: +390652666153
  email: andrea.pace@ifo.it
  last name: Victoria Leclercq, PhD
  email: victoria.leclercq@sciensano.be
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  country: Belgium
  country: Cyprus
  country: Greece
  country: Hungary
  country: Ireland
  country: Italy
  country: Lithuania
  country: Portugal
  country: Slovenia
  country: Spain
  responsible party type: Sponsor
  sharing ipd: No