Hospital HM Sanchinarro
Madrid, 28050, Spain
Completed
NCT Number: NCT06745401
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.
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Conditions
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
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Usability of Caaring® for the management of oncology patients in outpatient oral treatment
Time frame: 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 outcomes
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Degree of completion of data relating to treatment adherence
Time frame: 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.
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Degree of completion of data related to the toxicity of their treatment
Time frame: 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
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Quality of the care process through impact on the patient's quality of life: WHOQOL
Time frame: 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.
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Quality of the care process through impact on the patient's quality of life: IPAQ
Time frame: 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
Time frame: Week 12
Evaluate the Patient workload through the percentage of patients who complete the study correctly by completing all questionnaires
Sponsors and collaborators
Lead sponsor
Persei Vivarium
Other
Collaborators
- Effice Servicios Para la Investigacion S.L.
Registry information
Important dates
- Study start
- 2024
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Dec 20, 2024
- Registry last updated
- Jun 5, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.