Remote Monitoring of Cancer Patients with Outpatient Treatment

Recruiting

• Conditions: Cancer Patients with Outpatient Treatment

• Registration Number: NCT06745401
• Lead Sponsor: Persei Vivarium

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-21
• Study First Submitted: 2024-12-17
• Study First Submitted QC: 2024-12-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-27
• Primary Completion: 2025-04
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Usability of Caaring® for the management of oncology patients in outpatient oral treatment	Day 0 up to 3 months	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

Secondary Outcome Measures

Name	Time	Method
Quality of the care process through impact on the patient's quality of life: IPAQ	Day 0 and week 12	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
Patient workload	Week 12	Evaluate the Patient workload through the percentage of patients who complete the study correctly by completing all questionnaires
Degree of completion of data relating to treatment adherence	Weekly up to 3 months	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.
Degree of completion of data related to the toxicity of their treatment	Weekly up to 3 months	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
Quality of the care process through impact on the patient's quality of life: WHOQOL	Day 0 and week 12	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.

Trial Locations

Locations (1)

Hospital HM Sanchinarro; 🇪🇸 Madrid, Spain