Status:
RECRUITING
Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA
Lead Sponsor:
Sciensano
Collaborating Sponsors:
European Commission
Conditions:
Cancer
Eligibility:
All Genders
18-75 years
Phase:
NA
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 telemedi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 25 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
354 Patients enrolled
Trial Details
Trial ID
NCT06007001
Start Date
September 25 2023
End Date
September 1 2024
Last Update
April 19 2024
Active Locations (18)
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1
The Antwerp University Hospital (UZA)
Antwerp, Belgium
2
German Oncology Center (GOC)
Ágios Athanásios, Cyprus
3
CUT
Limassol, Cyprus
4
The Bank of Cyprus Oncology Center (BOCOC)
Stróvolos, Cyprus