Telemedicine support for cancer patients
Telerehabilitation and Tele-psychological Support in Cancer Patients: the Pilots Projects of eCAN JA
This study is testing if telemedicine support can help cancer patients feel better during their recovery compared to regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 354 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sciensano Government |
| Locations | 18 sites (Antwerp and 17 other locations) |
| Trial ID | NCT06007001 on ClinicalTrials.gov |
What this trial studies
The eCAN JA project investigates the use of teleconsultation and telemonitoring to enhance rehabilitation and psychological support for cancer patients across 10 European countries. It involves three pilot studies focusing on breast cancer, head and neck cancer, and advanced cancers, with a total of 354 participants. Patients will be randomly assigned to either receive telemedicine interventions or standard care, with the aim of improving patient-reported outcomes. The intervention includes weekly teleconsultations for eight weeks using a secure platform.
Who should consider this trial
Good fit: Ideal candidates include adult cancer patients aged 18 to 75 who are undergoing specific surgical procedures or have advanced cancer.
Not a fit: Patients with certain conditions, such as those undergoing breast reconstruction, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of care and psychological well-being for cancer patients.
How similar studies have performed: Other studies utilizing telemedicine in cancer care have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Antwerp and 17 other locations
- The Antwerp University Hospital (UZA) — Antwerp, Belgium (Not_yet_recruiting)
- German Oncology Center (GOC) — Agios athanasios, Cyprus (Recruiting)
- Cut — Limassol, Cyprus (Recruiting)
- The Bank of Cyprus Oncology Center (BOCOC) — Stróvolos, Cyprus (Recruiting)
- Aristotle University of Thessaloniki — Thessaloníki, 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) — Lisboa, 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 — Sevilla, Spain (Recruiting)
Study contacts
- Principal investigator: Andrea Pace, Dr — Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy
- Study coordinator: Andrea Pace, Dr
- Email: andrea.pace@ifo.it
- Phone: +390652666153
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.