Status:
RECRUITING
Determining the Effectiveness of Remote Monitoring of Cancer Patients With Oral Cancer Treatment Using Caaring® Software
Lead Sponsor:
Persei Vivarium
Collaborating Sponsors:
Effice Servicios Para la Investigacion S.L.
Conditions:
Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial investigation with device is to determinate the efficacy of the remote monitoring in cancer patients with a software called Caaring® a través del cumplimento terapéutic...
Detailed Description
This is a longitudinal, comparative non-inferiority, multicenter, with 2 arms Medical Device Clinical Trial. The protocol and informed consent documents have been reviewed and approved by the hospita...
Eligibility Criteria
Inclusion
- Patients who provide informed consent.
- Age ≥18 years.
- Oncology patients undergoing active outpatient oral therapy with: capecitabine, cyclin inhibitors, hormonal therapies, TKI inhibitors, monotherapy with or without intravenous therapy.
- Oncology patients undergoing active outpatient oral oncology treatment expected within 12 weeks of inclusion.
- Patients who must demonstrate sufficient technological skills to operate a smartphone through the "technological skills questionnaire."
- Patients who do not meet the exclusion criteria.
Exclusion
- Patients with cognitive or sensory difficulties or insufficient command of Spanish language that, in the opinion of the healthcare professional conducting the recruitment, makes it difficult to understand the questions posed in the surveys, scales, or instruments used in the study, provided they do not have a legal representative capable of participating in the study.
- Patients for whom it is anticipated that follow-up will not be possible due to a change of residence.
- Patients who are participating in any other clinical trial or experimental study at the time of recruitment. Participation in observational studies will not be an exclusion criteria.
- Patients whose primary diagnosis is a mental illness or another poorly controlled medical condition.
- Terminally ill patients and/or those receiving palliative care according to the criteria of SECPAL (Spanish Society of Palliative Care).
- Institutionalized patients.
- Patients who, according to the recruiting professional's assessment, are not considered eligible for inclusion because they are undergoing specific follow-up care in other units (hemodialysis, transplants, etc.) requiring mandatory hospital visits less frequently than once every two months.
- Patients who do not demonstrate sufficient technological skills to use a smartphone through the "technological skills questionnaire."
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2025
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT06998888
Start Date
April 11 2025
End Date
August 1 2025
Last Update
May 31 2025
Active Locations (3)
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1
Hospital Universitario HM Monteprincipe
Boadilla del Monte, Madrid, Spain, 28660
2
Hospital Universitario HM Sanchinarro
Hortaleza, Madrid, Spain, 28050
3
Hospital Universitario HM Puerta del Sur
Móstoles, Madrid, Spain, 28938