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

NCT06161233 | Completed

• 1 other identifier: CAPABLE-IT
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Conditions

Renal Cell Carcinoma Metastatic; Breast Cancer; Head and Neck Cancer; Thyroid Cancer; Ovary Cancer; Lung Cancer; Stomach Cancer

Outcome Measures

Primary Outcomes (1)

• Change in health-related QoL outcomes in RCC patients

  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 Outcomes (2)

• User experience of the CAPABLE system in RCC patients

  6 months after the enrollment

• User experience of the CAPABLE system in other cancer types patients

  6 months after the enrollment

Study Arms (1)

CAPABLE cohort

EXPERIMENTAL

Group that receives the CAPABLE mobile application and a smartwatch during treatment

Device: CAPABLE cohort

Interventions

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

CAPABLE cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Recruitment and consent denial
• Not able of understanding and complying with the protocol requirements (including basic technological abilities)

Sponsors & Collaborators

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

Study Sites (1)

Istituti Clinici Scientifici Maugeri Spa SB

Pavia, 27100, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms; Head and Neck Neoplasms; Thyroid Neoplasms; Ovarian Neoplasms; Lung Neoplasms; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Endocrine Gland Neoplasms; Endocrine System Diseases; Thyroid Diseases; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2023
• First Posted: December 7, 2023
• Study Start: May 16, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)