Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Renal Cell Carcinoma Metastatic
- Sponsor
- Istituti Clinici Scientifici Maugeri SpA
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Change in health-related QoL outcomes in RCC patients
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adults (age \>=18 years)
- •Sufficient understanding of the Italian language
- •Patients or their caregiver (upon patient's consent) can use a smartphone
- •Histologically or cytologically confirmed diagnosis of RCC, lung, breast, thyroid o head and neck cancer
- •Candidate to systemic treatment (targeted agents, immune checkpoint inhibitors, or a combination of the two)
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at the start of the treatment.
Exclusion Criteria
- •Recruitment and consent denial
- •Not able of understanding and complying with the protocol requirements (including basic technological abilities)
- •Given the fact that each subject involved in the clinical study must be able to understand and sign the informed consent presented by the researcher, lack of this capability represents a specific exclusion criterion in the study protocol.
Outcomes
Primary Outcomes
Change in health-related QoL outcomes in RCC patients
Time Frame: 6 months after the enrollment
The primary objective of this study is to investigate whether HRQoL of RCC patients eligible for systemic treatment can be improved by a patient-centred mobile coaching- and monitoring system
Secondary Outcomes
- User experience of the CAPABLE system in other cancer types patients(6 months after the enrollment)
- User experience of the CAPABLE system in RCC patients(6 months after the enrollment)