Remote Monitoring of Cancer Patients With Outpatient Treatment

NCT06745401 | Completed

• 1 other identifier: PersV.Onco.DTx01
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Degree of completion of data relating to treatment adherence

  Weekly up to 3 months

• Degree of completion of data related to the toxicity of their treatment

  Weekly up to 3 months

• Quality of the care process through impact on the patient's quality of life: WHOQOL

  Day 0 and week 12

• Quality of the care process through impact on the patient's quality of life: IPAQ

  Day 0 and week 12

• Patient workload

  Week 12

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Persei Vivarium: lead
• Effice Servicios Para la Investigacion S.L.: collaborator

Study Sites (1)

Hospital HM Sanchinarro

Madrid, Madrid, 28050, Spain

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: November 21, 2024
• Primary Completion: March 3, 2025
• Study Completion: March 3, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)