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Brief Title: Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA
Official Title: Telerehabilitation and Tele-psychological Support in Cancer Patients: the Pilots Projects of eCAN JA
Study ID: NCT06007001
Brief Summary: 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.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
The Antwerp University Hospital (UZA), Antwerp, , Belgium
German Oncology Center (GOC), Agios athanasios, , Cyprus
CUT, Limassol, , Cyprus
The Bank of Cyprus Oncology Center (BOCOC), Stróvolos, , Cyprus
Aristotle University of Thessaloniki, Thessaloníki, , Greece
National Institute of Oncology, Budapest, , Hungary
Dr Steevens Hospital, Dublin, , Ireland
The National Cancer Institute of Naples (INT Pascale), Naples, , Italy
The Regina Elena National Cancer Institute (IFO-IRE), Roma, , Italy
Hospital of Lithuanian University of Health Sciences Kauna Klinikos (KK), Kaunas, , Lithuania
National Cancer Institute (NCI), Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos VULSK, Vilnius, , Lithuania
Portuguese Institute of Cancer of Coimbra (IPO), Coimbra, , Portugal
Portuguese Institute of Cancer of Lisbon (IPO), Lisboa, , Portugal
Portuguese Institute of Cancer of Porto (IPO), Porto, , Portugal
The institute of Oncology Ljubljana (OIL), Ljubljana, , Slovenia
IDIVAL, Santander, , Spain
Andalusian Health Service, Sevilla, , Spain
Name: Andrea Pace, Dr
Affiliation: Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy
Role: PRINCIPAL_INVESTIGATOR