Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06161233
Status:
COMPLETED
Last Update Posted:
2024-03-08
First Post:
2023-11-30
Brief Title:
Pilot Study of the eHealth Application Cancer Patients Better Life Experience CAPABLE - Italy
Sponsor:
Istituti Clinici Scientifici Maugeri SpA
Organization:
Istituti Clinici Scientifici Maugeri SpA
Study Overview
Official Title:
Pilot Study of the eHealth Application Cancer Patients Better Life Experience CAPABLE - Italy
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CAPABLE-IT
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 13042021 and amended on 09022022
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 13042021 and amended on 09022022
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None