Big Data for Quality of Life in Head and Neck Cancer

Summary

Depending on disease stage, head and neck cancer (HNC) can be cured either with a single modality or with multimodal treatments, consisting of various combinations of surgery, radiotherapy, and chemotherapy. Despite treatment with curative intent, loco-regional recurrences and/or distant relapses are frequent. Moreover, these therapeutic approaches result in significant acute toxicities and late sequelae. Therefore, quality of life (QoL) is often impaired in these survivors. It is known that QoL is a prognostic factor because it is related to overall survival in cancer patients and to loco-regional control in HNC patients.

The adoption of mobile technologies of common use (i.e. embedded into standard mobile phones) for behavior reconstruction and linkage of behavior modifications to quality of life indicators, and the realization of predictive models for quality of life modifications will allow seamless and unobtrusive data capture over time, making the execution of clinical investigations more precise and less burdensome as compared to standard (manual) data capture.

The main aim of the present study is to reduce and to anticipate, with the use of the non-invasive Big data for quality of life (BD4QoL) platform, the proportion of HNC survivors experiencing a clinically meaningful reduction in QoL.

Conditions

• Head and Neck Cancer
• Survivorship
• Quality of Life

Interventions

OTHER

BD4QoL platform

The BD4QoL platform consists of a set of services to allow patient monitoring and empowerment, through two main tools: Point of Care application to manage all patients data and follow-up by clinical investigators, and a mobile application (App) installed on participating subject's smartphone. Also, a web-form tool is delivered to allow the QoL questionnaire completion.

Sponsors & Collaborators

• University of Birmingham

  collaborator OTHER

• University Hospital Birmingham NHS Foundation Trust

  collaborator OTHER

• Dotsoft Olokliromenes Efarmoges Diadiktioy kai Vaseon Dedomenon AE

  collaborator UNKNOWN

• IBM Ireland limited

  collaborator UNKNOWN

• INETUM

  collaborator UNKNOWN

• Multimed Engineers srl

  collaborator UNKNOWN

• Regione Lombardia

  collaborator OTHER

• Universidad de la Iglesia de Deusto Entidad Religiosa

  collaborator UNKNOWN

• Universidad Politecnica de Madrid

  collaborator OTHER

• University of Milan

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• Johannes Gutenberg University Mainz

  collaborator OTHER

• Aria S.p.A.

  collaborator UNKNOWN

• University of Bristol

  collaborator OTHER

• Casa Sollievo della Sofferenza IRCCS

  collaborator OTHER

• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

  lead OTHER

Principal Investigators

• Stefano Cavalieri, MD · Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

• Luca Lacerenza, MD · Fondazione Casa Sollievo della Sofferenza

• Paul Nankivell, MD · University Hospital Birmingham NHS Foundation Trust

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-28

Primary Completion

2025-10-31

Completion

2025-10-31

Countries

• Italy
• United Kingdom

Study Locations