Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

NCT06007001 | Recruiting

• 1 other identifier: eCAN pilots
• Study Type: interventional
• Target: 354
• Locations: 10 countries
• Sites: 18

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.

Conditions

Cancer

Keywords

Cancer; telemedicine; teleconsultation; telemonitoring; PROM; PREM

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Change from baseline Pain level to 8 weeks (for pilot 1)

  weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8

• Change from baseline Distress level to 8 weeks (for pilot 2)

  weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8

Other Outcomes (6)

• Change from baseline Physical activity to 8 weeks

  every day, up to 8 weeks

• Change from baseline sleep quality to 8 weeks

  every day, up to 8 weeks

• Change from baseline heart rate to 8 weeks

  every day, up to 8 weeks

Study Arms (2)

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.

Device: Telemedicine

Usual care

NO INTERVENTION

Patients in the control group will receive usual care.

Interventions

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.

Telemedicine

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sciensano: lead
• European Commission: collaborator

Study Sites (18)

The Antwerp University Hospital (UZA)

Antwerp, Belgium

NOT YET RECRUITING

German Oncology Center (GOC)

Ágios Athanásios, Cyprus

RECRUITING

CUT

Limassol, Cyprus

RECRUITING

The Bank of Cyprus Oncology Center (BOCOC)

Stróvolos, Cyprus

RECRUITING

Aristotle University of Thessaloniki

Thessaloniki, Greece

RECRUITING

National Institute of Oncology

Budapest, Hungary

RECRUITING

Dr Steevens Hospital

Dublin, Ireland

NOT YET RECRUITING

The National Cancer Institute of Naples (INT Pascale)

Naples, Italy

NOT YET RECRUITING

The Regina Elena National Cancer Institute (IFO-IRE)

Roma, Italy

RECRUITING

Hospital of Lithuanian University of Health Sciences Kauna Klinikos (KK)

Kaunas, Lithuania

NOT YET RECRUITING

National Cancer Institute (NCI)

Vilnius, Lithuania

NOT YET RECRUITING

Vilnius University Hospital Santaros Klinikos VULSK

Vilnius, Lithuania

NOT YET RECRUITING

Portuguese Institute of Cancer of Coimbra (IPO)

Coimbra, Portugal

RECRUITING

Portuguese Institute of Cancer of Lisbon (IPO)

Lisbon, Portugal

NOT YET RECRUITING

Portuguese Institute of Cancer of Porto (IPO)

Porto, Portugal

RECRUITING

The institute of Oncology Ljubljana (OIL)

Ljubljana, Slovenia

RECRUITING

IDIVAL

Santander, Spain

RECRUITING

Andalusian Health Service

Seville, Spain

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Andrea Pace, Dr

  Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrea Pace, Dr

CONTACT

+390652666153; andrea.pace@ifo.it

Victoria Leclercq, PhD

CONTACT

victoria.leclercq@sciensano.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: August 23, 2023
• Study Start: September 25, 2023
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CY (3); HU (1); GR (1); IT (2); PT (3); LI (3); BE (1); IE (1); SL (1); ES (2)