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

Istituti Clinici Scientifici Maugeri SpA

Status

Completed

Conditions

Ovary Cancer

Breast Cancer

Renal Cell Carcinoma Metastatic

Lung Cancer

Thyroid Cancer

Head and Neck Cancer

Stomach Cancer

Treatments

Device: CAPABLE cohort

Study type

Interventional

Funder types

Other

Identifiers

NCT06161233

CAPABLE-IT

Details and patient eligibility

About

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

Full 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).

Enrollment

56 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.