Remote Monitoring of Cancer Patients With Outpatient Treatment

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.

Study Overview

• Status: Completed
• Conditions: Cancer Patients With Outpatient Treatment

• Study Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28050
    • Hospital HM Sanchinarro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Cancer Patients from the Hospital HM Sanchinarro diagnosed who meet the selection criteria and sign the informed consent will be included.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability of Caaring® for the management of oncology patients in outpatient oral treatment	Percentage 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	Day 0 up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of completion of data relating to treatment adherence	The Degree of completion of therapeutic adherence by patients in Caaring application between visits is defined as the ratio between the questionnaires requested and completed.	Weekly up to 3 months
Degree of completion of data related to the toxicity of their treatment	The 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	Weekly up to 3 months
Quality of the care process through impact on the patient's quality of life: WHOQOL	Changes 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.	Day 0 and week 12
Quality of the care process through impact on the patient's quality of life: IPAQ	Changes 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	Day 0 and week 12
Patient workload	Evaluate the Patient workload through the percentage of patients who complete the study correctly by completing all questionnaires	Week 12

Collaborators and Investigators

• Sponsor: Persei Vivarium
• Collaborators: Effice Servicios Para la Investigacion S.L.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2024
• Primary Completion (Actual): March 3, 2025
• Study Completion (Actual): March 3, 2025

Study Registration Dates

• First Submitted: December 17, 2024
• First Submitted That Met QC Criteria: December 17, 2024
• First Posted (Actual): December 20, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 2, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Digital Health; PROMs; Remote patient monitoring; Cancer patients; real-world data; DTx; outpatient treatment; Caaring; patient-reported data
• Other Study ID Numbers: PersV.Onco.DTx01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No