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

March 7, 2024 updated by: Istituti Clinici Scientifici Maugeri SpA
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Istituti Clinici Scientifici Maugeri Spa SB

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAPABLE cohort
Group that receives the CAPABLE mobile application and a smartwatch during treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after the enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
User experience of the CAPABLE system in RCC patients
Time Frame: 6 months after the enrollment
This study will gather qualitative and quantitative information to quantify usefulness, easiness, acceptability and feasibility of the end users' solutions. The patient app will be assessed also in terms of perceived impact and support derived from the digital technologies. The health professional web application will be evaluated to understand to what extent this can be integrated and adopted in the clinical practice
6 months after the enrollment
User experience of the CAPABLE system in other cancer types patients
Time Frame: 6 months after the enrollment
To evaluate the generalizability of the system on other cancer types, the user experience study is performed also on patients with cancer types different from RCC (e.g Breast, Ovary, Head&Neck cancer). The patient app will be assessed also in terms of perceived impact and support derived from the digital technologies. The health professional web application will be evaluated to understand to what extent this can be integrated and adopted in the clinical practice
6 months after the enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Collaborators

University of Pavia
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Universidad Politecnica de Madrid
University of Haifa
IBM Research
Bitsens JSC
Poznań University of Technology
Deontics LTD
Policlinico di Bari Ospedale Giovanni Paolo XXIII
Biomeris srl
The Netherlands Cancer Institute NKI
Associazione Italiana Malati di Cancro AIMAC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

November 30, 2023

First Submitted That Met QC Criteria

November 30, 2023

First Posted (Actual)

December 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPABLE-IT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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