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Search / Trial NCT06007001

Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA

Launched by SCIENSANO · Aug 17, 2023

Trial Information

Current as of August 20, 2025

Recruiting

Keywords

Cancer Telemedicine Teleconsultation Telemonitoring Prom Prem

ClinConnect Summary

The eCAN JA trial is studying how telemedicine tools, like online consultations and monitoring, can help improve care for cancer patients. The goal is to see if using these tools for rehabilitation and psychological support can enhance the quality of life and overall well-being of patients compared to standard care. The trial involves 354 patients across 10 European countries who have different types of cancer, including breast and head & neck cancers, as well as advanced cancers.

To participate, patients need to meet certain criteria. For example, women aged 45 to 65 who have recently had breast surgery, and adults aged 18 to 75 with specific types of cancer may be eligible. Participants in the study will be randomly assigned to either receive tele-support (which includes weekly online sessions with a physiotherapist or psychologist) or the usual care they would receive without the telemedicine option. They may also wear a smartwatch to track their physical activity and health data. Throughout the study, researchers will gather information on patients' experiences, quality of life, and any changes in their health. This trial aims to better understand the benefits and challenges of using telehealth in cancer care.

Gender

ALL

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.

About Sciensano

Sciensano is a Belgian public research institute dedicated to advancing public health through scientific research and innovation. As a leading sponsor of clinical trials, it focuses on epidemiology, health promotion, and disease prevention, leveraging multidisciplinary expertise to address pressing health challenges. With a commitment to high ethical standards and regulatory compliance, Sciensano collaborates with various stakeholders, including academic institutions, healthcare providers, and industry partners, to facilitate groundbreaking research that informs policy and enhances population health outcomes.

Locations

Budapest, , Hungary

Thessaloníki, , Greece

Antwerp, , Belgium

Agios Athanasios, , Cyprus

Limassol, , Cyprus

Stróvolos, , Cyprus

Dublin, , Ireland

Naples, , Italy

Roma, , Italy

Kaunas, , Lithuania

Vilnius, , Lithuania

Vilnius, , Lithuania

Coimbra, , Portugal

Lisboa, , Portugal

Porto, , Portugal

Ljubljana, , Slovenia

Santander, , Spain

Sevilla, , Spain

Patients applied

0 patients applied

Trial Officials

Andrea Pace, Dr

Principal Investigator

Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported