Clinical trial NCT06007001: 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cancer
Keywords: Cancer
telemedicine
teleconsultation
telemonitoring
PROM
PREM
Lead sponsor: Sciensano
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
First posted: 2023-08-23
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Change from baseline Health related quality of life measure to 8 weeks
timeFrame: Every 2 weeks: week 0, 2, 4, 6, 8
Secondary outcomes:
measure: Change from baseline Pain level to 8 weeks (for pilot 1)
timeFrame: weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8
measure: Change from baseline Distress level to 8 weeks (for pilot 2)
timeFrame: weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8
Other outcomes:
measure: Change from baseline Physical activity to 8 weeks
timeFrame: every day, up to 8 weeks
measure: Change from baseline sleep quality to 8 weeks
timeFrame: every day, up to 8 weeks
measure: Change from baseline heart rate to 8 weeks
timeFrame: every day, up to 8 weeks
measure: Patient-reported cost
timeFrame: at week 9
measure: PREMS - mHealth App Usability
timeFrame: at week 9
measure: PREMS - telehealth usability
timeFrame: at week 9
Locations:
city: Antwerp
country: Belgium
facility: The Antwerp University Hospital (UZA)
city: Agios athanasios
country: Cyprus
facility: German Oncology Center (GOC)
city: Limassol
country: Cyprus
facility: CUT
city: Stróvolos
country: Cyprus
facility: The Bank of Cyprus Oncology Center (BOCOC)
city: Thessaloníki
country: Greece
facility: Aristotle University of Thessaloniki
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Dublin
country: Ireland
facility: Dr Steevens Hospital
city: Naples
country: Italy
facility: The National Cancer Institute of Naples (INT Pascale)
city: Roma
country: Italy
facility: The Regina Elena National Cancer Institute (IFO-IRE)
city: Kaunas
country: Lithuania
facility: Hospital of Lithuanian University of Health Sciences Kauna Klinikos (KK)
city: Vilnius
country: Lithuania
facility: National Cancer Institute (NCI)
city: Vilnius
country: Lithuania
facility: Vilnius University Hospital Santaros Klinikos VULSK
city: Coimbra
country: Portugal
facility: Portuguese Institute of Cancer of Coimbra (IPO)
city: Lisboa
country: Portugal
facility: Portuguese Institute of Cancer of Lisbon (IPO)
city: Porto
country: Portugal
facility: Portuguese Institute of Cancer of Porto (IPO)
city: Ljubljana
country: Slovenia
facility: The institute of Oncology Ljubljana (OIL)
city: Santander
country: Spain
facility: IDIVAL
city: Sevilla
country: Spain
facility: Andalusian Health Service
Study officials:
affiliation: Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy
name: Andrea Pace, Dr
role: PRINCIPAL_INVESTIGATOR
References: