Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA (eCAN)

April 16, 2024 updated by: Sciensano

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

354

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Telemedicine
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

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.
No Intervention: Usual care
Patients in the control group will receive usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Health related quality of life measure to 8 weeks
Time Frame: Every 2 weeks: week 0, 2, 4, 6, 8
EORTC QLQ-C30 questionnaire
Every 2 weeks: week 0, 2, 4, 6, 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Pain level to 8 weeks (for pilot 1)
Time Frame: weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8
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
Change from baseline Distress level to 8 weeks (for pilot 2)
Time Frame: weekly: week 0, 1, 2, 3, 4, 5, 6, 7, 8
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline Physical activity to 8 weeks
Time Frame: every day, up to 8 weeks
physical activity, number of steps, will be collected via wearable devices
every day, up to 8 weeks
Change from baseline sleep quality to 8 weeks
Time Frame: every day, up 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
Change from baseline heart rate to 8 weeks
Time Frame: every day, up to 8 weeks
Daily heart rate (beats per minute) trend will be collected via wearable device (Garmin watche)
every day, up to 8 weeks
Patient-reported cost
Time Frame: at week 9
Costs that arose for patients will be collected using a patient-reported cost questionnaire.
at week 9
PREMS - mHealth App Usability
Time Frame: at week 9
usability of the teleconsultation program and telemonitoring with mHealth App Usability Questionnaire (MAUQ) for Standalone mHealth Apps Used by Patients
at week 9
PREMS - telehealth usability
Time Frame: at week 9
usability of the teleconsultation program and telemonitoring with TELEHEALTH USABILITY QUESTIONNAIRE (TUQ)
at week 9

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sciensano

Collaborators

European Commission

Investigators

  • Principal Investigator: Andrea Pace, Dr, Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 25, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

June 23, 2023

First Submitted That Met QC Criteria

August 17, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • eCAN pilots

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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