Clinical trial NCT06161233: Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy
Official title: Pilot Study of the eHealth Application "Cancer Patients Better Life Experience" (CAPABLE) - Italy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cell Carcinoma Metastatic
Breast Cancer
Head and Neck Cancer
Thyroid Cancer
Ovary Cancer
Lung Cancer
Stomach Cancer
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
Collaborators: name: University of Pavia
name: Policlinico di Bari Ospedale Giovanni Paolo XXIII
name: Biomeris srl
name: The Netherlands Cancer Institute NKI
name: University of Haifa
name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: IBM Research
name: Bitsens JSC
name: Poznań University of Technology
name: Deontics LTD
name: Associazione Italiana Malati di Cancro AIMAC
name: Universidad Politecnica de Madrid
First posted: 2023-12-07
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Change in health-related QoL outcomes in RCC patients
timeFrame: 6 months after the enrollment
Secondary outcomes:
measure: User experience of the CAPABLE system in RCC patients
timeFrame: 6 months after the enrollment
measure: User experience of the CAPABLE system in other cancer types patients
timeFrame: 6 months after the enrollment
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Istituti Clinici Scientifici Maugeri Spa SB
Study officials:
References: