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Completed

NCT Number: NCT06161233

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

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

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Key information

Conditions

Renal Cell Carcinoma Metastatic Adnexal Diseases Breast Cancer Breast Diseases Breast Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Ovarian Diseases Ovarian Neoplasms Ovary Cancer Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Cancer Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Thyroid Cancer Thyroid Diseases Thyroid Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istituti Clinici Scientifici Maugeri Spa SB

Pavia, 27100, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CAPABLE cohort

Device

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

Primary outcomes

  1. 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

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Istituti Clinici Scientifici Maugeri SpA

Other

Collaborators

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

Registry information

Acronym: CAPABLE-IT

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2023
Registry last updated
Mar 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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