Trial Title:
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA
NCT ID:
NCT06007001
Condition:
Cancer
Conditions: Keywords:
Cancer
telemedicine
teleconsultation
telemonitoring
PROM
PREM
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
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
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Pilot 1a: All consenting adult women, aged between 45 and 65 years old, who undergo
a unilateral mastectomy plus axillary dissection for newly diagnosed breast cancer
in a cancer center of participating European countries will be eligible for this
study.
- Pilot 1b: All consenting adult patients, aged between 18 and 75 years old, with
histopathologically proven H&N cancer who are prescheduled for an en bloc resection
of the primary tumor, neck dissection, or reconstruction in a cancer center of
participating European countries will be eligible for this study.
- Pilot 2: All consenting adult patients, aged between 18 and 75 years old, affected
by advanced/recurrent cancer (including lung, prostate, colorectum, breast cancer,
gastric, genito-urinary) will be eligible for this study.
Exclusion Criteria:
- For both study pilot 1a & 1b: Patients are ineligible to participate if they meet
one of the following criteria: (I) having breast reconstruction, (II) having
blindness or severe visual impairment, (III) having life expectancy of less than 3
months, (IV) having previous upper limb injury or conditions that limit upper limb
range of motion (shoulder flexion (< 150°) or elbow extension/flexion (< 0/145°)
respectively), (V) unable to be assigned to tele-rehabilitation due to clinical
conditions requiring in-person rehabilitation, (VI) unable to sign informed consent,
(VII) not having access to an internet connection, (VIII) not having access to an
android smartphone or (IX) already involved in other telemedicine services. For
pilot 1b, H&N cancer patients needing post-surgery radiotherapy will be excluded.
- For pilot 2: Patients are ineligible to participate if they meet one of the
following criteria: (I) unable to sign informed consent; (II) present relevant
cognitive deterioration; (III) performance status > ECOG 2; (IV) previous diagnosis
of major depression, the presence of mood disorders will be assessed with Personal
Health Questionnaire Depression Scale (PHQ-8) (13); (V) starting antidepressant
pharmacological treatment in the last 4 weeks before the enrollment; (VI) taking
antipsychotic treatment, (VII) not having access to an internet connection (VIII)
not having access to an android smartphone or (IX) already involved in other
telemedicine services.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The Antwerp University Hospital (UZA)
Address:
City:
Antwerp
Country:
Belgium
Status:
Not yet recruiting
Contact:
Last name:
Timon Vandamme, Dr
Email:
timon.vandamme@uantwerpen.be
Facility:
Name:
German Oncology Center (GOC)
Address:
City:
Agios athanasios
Country:
Cyprus
Status:
Recruiting
Contact:
Last name:
Contantinos Zambogou
Email:
constantinos.zamboglou@goc.com.cy
Facility:
Name:
CUT
Address:
City:
Limassol
Country:
Cyprus
Status:
Recruiting
Contact:
Last name:
Angelos Kassianos, Dr
Email:
angelos.kassianos@cut.ac.cy
Facility:
Name:
The Bank of Cyprus Oncology Center (BOCOC)
Address:
City:
Stróvolos
Country:
Cyprus
Status:
Recruiting
Contact:
Last name:
Anastasia Constantinidou
Email:
constantinidou.anastasia@ucy.ac.cy
Facility:
Name:
Aristotle University of Thessaloniki
Address:
City:
Thessaloníki
Country:
Greece
Status:
Recruiting
Contact:
Last name:
Eleni Timotheadou
Facility:
Name:
National Institute of Oncology
Address:
City:
Budapest
Country:
Hungary
Status:
Recruiting
Contact:
Last name:
József Lövey, Dr
Facility:
Name:
Dr Steevens Hospital
Address:
City:
Dublin
Country:
Ireland
Status:
Not yet recruiting
Contact:
Last name:
Des OToole
Email:
Des.OToole@hse.ie
Facility:
Name:
The National Cancer Institute of Naples (INT Pascale)
Address:
City:
Naples
Country:
Italy
Status:
Not yet recruiting
Contact:
Last name:
Maria C Piccirillo
Email:
m.piccirillo@istitutotumori.na.it
Facility:
Name:
The Regina Elena National Cancer Institute (IFO-IRE)
Address:
City:
Roma
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Andrea Pace, Dr
Email:
andrea.pace@ifo.it
Facility:
Name:
Hospital of Lithuanian University of Health Sciences Kauna Klinikos (KK)
Address:
City:
Kaunas
Country:
Lithuania
Status:
Not yet recruiting
Contact:
Last name:
Viktoras Rudzianskas
Email:
Viktoras.Rudzianskas@kaunoklinikos.lt
Facility:
Name:
National Cancer Institute (NCI)
Address:
City:
Vilnius
Country:
Lithuania
Status:
Not yet recruiting
Contact:
Last name:
Jolanta Paskeviciene
Email:
jolanta.paskeviciene@nvi.lt
Facility:
Name:
Vilnius University Hospital Santaros Klinikos VULSK
Address:
City:
Vilnius
Country:
Lithuania
Status:
Not yet recruiting
Contact:
Last name:
Marija Turlinksienė
Email:
Marija.turlinskiene@santa.lt
Facility:
Name:
Portuguese Institute of Cancer of Coimbra (IPO)
Address:
City:
Coimbra
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Rui Soares
Email:
ruisoares@ipocoimbra.min-saude.pt
Facility:
Name:
Portuguese Institute of Cancer of Lisbon (IPO)
Address:
City:
Lisboa
Country:
Portugal
Status:
Not yet recruiting
Contact:
Last name:
Joana Dias
Email:
jpsequeira@ipolisboa.min-saude.pt
Contact backup:
Last name:
Maria Moura
Email:
mjmoura@ipolisboa.min-saude.pt
Facility:
Name:
Portuguese Institute of Cancer of Porto (IPO)
Address:
City:
Porto
Country:
Portugal
Status:
Recruiting
Contact:
Last name:
Otilia Romano
Email:
otilia.romano@ipoporto.min-saude.pt
Contact backup:
Last name:
Eunice Silva
Email:
esilva@ipoporto.min-saude.pt
Facility:
Name:
The institute of Oncology Ljubljana (OIL)
Address:
City:
Ljubljana
Country:
Slovenia
Status:
Recruiting
Contact:
Last name:
Cvetka Grašič Kuhar
Email:
CGrasic@onko-i.si
Facility:
Name:
IDIVAL
Address:
City:
Santander
Country:
Spain
Status:
Recruiting
Contact:
Last name:
Ignacio Durán
Email:
ignaciojose.duran@scsalud.es
Facility:
Name:
Andalusian Health Service
Address:
City:
Sevilla
Country:
Spain
Status:
Recruiting
Contact:
Last name:
David Vicente
Email:
david.vicente.sspa@juntadeandalucia.es
Start date:
September 25, 2023
Completion date:
September 1, 2024
Lead sponsor:
Agency:
Sciensano
Agency class:
Other
Collaborator:
Agency:
European Commission
Agency class:
Other
Source:
Sciensano
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06007001
