BD4QoL
Research type
Research Study
Full title
BD4QoL: Big Data for Quality of Life: A multicenter randomized trial for quality of life evaluation by non-invasive intelligent tools during post-curative treatment follow-up for head and neck cancer
IRAS ID
308702
Contact name
Hisham Mehanna
Contact email
Sponsor organisation
The University of Birmingham
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 7 months, 4 days
Research summary
Head and Neck Cancer (HNC) imposes an extremely high socioeconomic burden on patients during and after cancer compared to other tumours, including costs from treatment-induced illnesses, loss of work, and short-term disability. Patients’ quality of life (QoL) is often impaired. It is known that QoL can be used to estimate the chance of recovery or the chance of the disease coming back because it is related to overall survival in cancer patients and to loco-regional control in HNC patients.
Predictive factors for identifying which HNC patients are at higher risk of suffering long-term poor QoL have not yet been identified. To date, the only way to determine if someone has poor long-term QoL is to administer repeated QoL questionnaires during follow-up. Avoiding worsening QoL, even if temporary, is an important clinical need. The combination of big-data analysis techniques and innovative use of information technology tools (e.g. smartphones) may allow targeted interventions to improve QoL.
The main aim of the BD4QoL study is to reduce and to anticipate, with the use of the non-invasive Big Data for Quality of Life (BD4QoL) platform, the number of HNC survivors experiencing a clinically meaningful reduction in QoL. It will do this with the use of the BD4QoL platform through a web-form tool for QoL questionnaires and continuous monitoring by a mobile application (App) installed on the participant's mobile phone (intervention arm) compared to those without the BD4QoL platform (control arm).
This is an international, multi-centre, randomised (2:1 ratio) study, involving at least three sites in two countries (Italy and United Kingdom). The UK Sponsor is The University of Birmingham. The overarching study is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori di Milano in Italy. Funding is provided by the European Commission Horizon 2020 (proposal number 875192).
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
22/NW/0145
Date of REC Opinion
20 May 2022
REC opinion
Favourable Opinion