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Remote Monitoring of Cancer Patients With Outpatient Treatment

Remote Monitoring of Cancer Patients With Outpatient Treatment

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06745401
Enrollment
34
Registered
2024-12-20
Start date
2024-11-21
Completion date
2025-03-03
Last updated
2025-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Patients With Outpatient Treatment

Keywords

Remote patient monitoring, Cancer patients, outpatient treatment, Caaring, real-world data, DTx, patient-reported data, Digital Health, PROMs

Brief summary

This project focuses on studying the use of digital platforms for monitoring, between medical visits, parameters such as toxicities and therapeutic adherence. The goal of this observational study is to know the degree of usability of the Caaring® digital platform in cancer patients undergoing outpatient oral treatment. This will allow in the future to design comparative studies that demonstrate the advantages of using this application in the management of these patients. Participants will fill out various questionnaires in the Caaring app related to their symptoms, adherence to treatment, quality of life and physical activity, among others.

Interventions

None listed

Sponsors

Effice Servicios Para la Investigacion S.L.
CollaboratorINDUSTRY
Persei Vivarium
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* Cancer patients with adjuvant or metastatic oncological treatment * Cancer patients with oral oncological treatment * Patients who are able to complete the study questionnaires * Patients who are able to handle the application on a smart mobile phone. * Informed consent is obtained from the patient.

Exclusion criteria

* Patients who will not be able to commit to carrying out the follow-ups or do not have adequate technological skills. * Patients with inability to give adequately the informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Usability of Caaring® for the management of oncology patients in outpatient oral treatmentDay 0 up to 3 monthsPercentage of patients with at least 80% of the data completed in the application, Percentage of patients with 100% of the data completed in the application and Percentage of completion per patient

Secondary

MeasureTime frameDescription
Degree of completion of data relating to treatment adherenceWeekly up to 3 monthsThe Degree of completion of therapeutic adherence by patients in Caaring application between visits is defined as the ratio between the questionnaires requested and completed.
Degree of completion of data related to the toxicity of their treatmentWeekly up to 3 monthsThe Degree of completion of toxicity of their treatments by patients in Caaring application between visits: Percentage of patient participation defined as data completed among requested data; Percentage of patients with at least 80% of the data completed; Percentage of patients with 100% of the data completed and Percentage of patients with at least 80% of the data completed by questionnaire
Quality of the care process through impact on the patient's quality of life: WHOQOLDay 0 and week 12Changes in patient's quality of life scale WHOQOL (World Health Organization Quality of Life) scores at the end of the study compared to baseline. Values (0-100), a higher score reflects a higher health-related quality of life.
Quality of the care process through impact on the patient's quality of life: IPAQDay 0 and week 12Changes in International Physical Activity Questionaire (IPAQ) scores at the end of the study compared to baseline. Values (46-100), a higher score reflects a higher Physical Activity
Patient workloadWeek 12Evaluate the Patient workload through the percentage of patients who complete the study correctly by completing all questionnaires

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026