NCT06161233

Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 56 (actual)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the CAPABLE study is to compare health-related quality of life in renal cell carcinoma patients who use or do not use a mobile-based application to monitor adverse events for cancer treatment at home. As secondary objectives, the study investigates the usability of the system and its generalizability to other cancer types

Detailed description

The study is designed as a prospectively enrolling, quasi-experimental cohort study in cancer patients, eligible for systemic treatment. The CAPABLE cohort will receive the smartphone application and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months after enrollment. If, after 6 months, a patient wants to keep using the system, he will be allowed to do so, until the end of the study. Questionnaires on health-related quality of life will be administered to the patients on baseline (T0) and every three months (T1 and T2). Lost to follow-up data will be included in intention-to-treat analysis. Qualitative and quantitative user experience studies will be done at enrollment, after 3 months and at the end of the follow-up period with the CAPABLE system. Results of this interventional study will be compared with a control cohort consisting of renal cell carcinoma patients, recruited in 2021 with the same inclusion criteria as this study population, but receiving standard care (ICSM CE number 2546, dated 13/04/2021 and amended on 09/02/2022).

Conditions

• Renal Cell Carcinoma Metastatic
• Breast Cancer
• Head and Neck Cancer
• Thyroid Cancer
• Ovary Cancer
• Lung Cancer
• Stomach Cancer

Interventions

Type	Name	Description
DEVICE	CAPABLE cohort	The CAPABLE cohort receives the mobileapplication and a multi-sensorial smartwatch (ASUS VivoWatch 5 HC-B05). Patients will be asked to use the system for at least 6 months. The CAPABLE app serves three main functionalities for the patient: symptom monitoring, information needs fulfilment and interventions to improve mental- and physical wellbeing

Timeline

• Start date: 2023-05-16
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2023-12-07
• Last updated: 2024-03-08

Locations

1 site across 1 country: Italy