Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

Cancer Clinical Trial

— eCAN  

Official title:

Telerehabilitation and Tele-psychological Support in Cancer Patients: the Pilots Projects of eCAN JA

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06007001
• Other study ID #: eCAN pilots
• Status: Recruiting
• Phase: N/A
• Start date: September 25, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: April 2024
• Source: Sciensano
• Contact: Andrea Pace, Dr
• Phone: +390652666153
• Email: andrea.pace[@]ifo.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 354
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Telemedicine
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.

Locations

Country	Name	City	State
Belgium	The Antwerp University Hospital (UZA)	Antwerp
Cyprus	German Oncology Center (GOC)	Agios athanasios
Cyprus	CUT	Limassol
Cyprus	The Bank of Cyprus Oncology Center (BOCOC)	Stróvolos
Greece	Aristotle University of Thessaloniki	Thessaloníki
Hungary	National Institute of Oncology	Budapest
Ireland	Dr Steevens Hospital	Dublin
Italy	The National Cancer Institute of Naples (INT Pascale)	Naples
Italy	The Regina Elena National Cancer Institute (IFO-IRE)	Roma
Lithuania	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
Portugal	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
Slovenia	The institute of Oncology Ljubljana (OIL)	Ljubljana
Spain	IDIVAL	Santander
Spain	Andalusian Health Service	Sevilla

Sponsors (2)

Lead Sponsor	Collaborator
Sciensano	European Commission

Countries where clinical trial is conducted

Belgium,  Cyprus,  Greece,  Hungary,  Ireland,  Italy,  Lithuania,  Portugal,  Slovenia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline Physical activity to 8 weeks	physical activity, number of steps, will be collected via wearable devices	every day, up to 8 weeks
Other	Change from baseline sleep quality to 8 weeks	The average sleep quality (light sleep, deep sleep, REM sleep) will be collected via wearable device (Garmin watche)	every day, up to 8 weeks
Other	Change from baseline heart rate to 8 weeks	Daily heart rate (beats per minute) trend will be collected via wearable device (Garmin watche)	every day, up to 8 weeks
Other	Patient-reported cost	Costs that arose for patients will be collected using a patient-reported cost questionnaire.	at week 9
Other	PREMS - mHealth App Usability	usability of the teleconsultation program and telemonitoring with mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients	at week 9
Other	PREMS - telehealth usability	usability of the teleconsultation program and telemonitoring with TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)	at week 9
Primary	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	Change from baseline Pain level to 8 weeks (for pilot 1)	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).	weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8
Secondary	Change from baseline Distress level to 8 weeks (for pilot 2)	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.	weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8