Evidence map›Paper›PMID 36798825›Full record

ArticleFrontiers in oncology2023

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: Clinical study protocol.

Stefano Cavalieri, Claudia Vener, Marissa LeBlanc, Laura Lopez-Perez, Giuseppe Fico, Carlo Resteghini, Dario Monzani, Giulia Marton, Gabriella Pravettoni, Mauricio Moreira-Soares and 14 more

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Frontiers in oncology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05315570 (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), which is not on this map. Cited by 6 papers.

0numbers the graph read from it
0cells of the map it votes in
6citing papers in PubMed
1.6field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05315570 nacompletednot on this map

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

TypeinterventionalSponsorFondazione IRCCS Istituto Nazionale dei Tumori, MilanoRan2022 to 2025Enrolled410ConditionsHead and Neck Cancer, Survivorship, Quality of LifeArmsBD4QoL platform
3 · Its place in the literature

Who cites it

6 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. Article
  3. Balancing survival rates and quality-of-life outcomes after transoral laser microsurgery for locally advanced glottic cancer.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2025
    Article
  4. Conversational Agents to Support Pain Management: A Scoping Review.European journal of pain (London, England) · 2025
    Article
  5. Review
  6. Recent advances in head and neck surgical oncology.Journal of surgical oncology · 2024
    Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

24 authors at 14 institutions in 5 countries.

Stefano CavalieriHead and Neck Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan, Italy.
Claudia VenerDepartment of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Marissa LeBlancOslo Center for Biostatistics and Epidemiology, University of Oslo, Oslo, Norway.
Laura Lopez-PerezUniversidad Politécnica de Madrid-Life Supporting Technologies Research Group, ETSIT, Madrid, Spain.
Giuseppe FicoUniversidad Politécnica de Madrid-Life Supporting Technologies Research Group, ETSIT, Madrid, Spain.
Carlo ResteghiniHead and Neck Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan, Italy.
Dario MonzaniDepartment of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Giulia MartonDepartment of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Gabriella PravettoniDepartment of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Mauricio Moreira-SoaresOslo Center for Biostatistics and Epidemiology, University of Oslo, Oslo, Norway.
Despina Elizabeth FilippidouInformation Technology Programme Management Office, DOTSOFT, Thessaloniki, Greece.
Aitor AlmeidaInformation Technology Programme Management Office, DOTSOFT, Thessaloniki, Greece.
Aritz BilbaoDeustoTech, Faculty of Engineering, Universidad de Deusto, Bilbao, Spain.
Hisham MehannaInstitute of head and neck studies and Education, University of Birmingham, Birmingham, United Kingdom.
Susanne SingerDivision of Epidemiology and Health Care Research, JGU - Johannes Gutenberg University, Mainz, Germany.
Steve ThomasDivision of Oral and Maxillofacial Surgery - Bristol Dental Hospital, University of Bristol - Bristol Medical School, Bristol, United Kingdom.
Luca LacerenzaMaxillo-Facial Surgery, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Alfonso ManfusoMaxillo-Facial Surgery, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, Italy.
Chiara CopelliMaxillo-Facial Surgery, Interdisciplinary Department of Medicine, University of Bari "Aldo Moro", Bari, Italy.
Franco MercalliMultiMed Engineers srls, Parma, Italy.
Arnoldo FrigessiOslo Center for Biostatistics and Epidemiology, University of Oslo, Oslo, Norway.
Elena MartinelliDepartment of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.
Lisa LicitraHead and Neck Medical Oncology Department, Fondazione Istituto di Ricovero e Cura a Carattere Scientifico Istituto Nazionale dei Tumori, Milan, Italy.
BD4QoL Consortium
University of Milan · ITEuropean Institute of Oncology · ITFondazione IRCCS Istituto Nazionale dei Tumori · ITOslo University Hospital · NOUniversidad de Deusto · ESUniversidad Politécnica de Madrid · ESCasa Sollievo della Sofferenza · ITIstituti di Ricovero e Cura a Carattere Scientifico · ITJohannes Gutenberg University Mainz · DEMultiMedica · ITUniversity of Bari Aldo Moro · ITUniversity of Birmingham · GBUniversity of Bristol · GBUniversity of Oslo · NO

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Patients surviving head and neck cancer (HNC) suffer from high physical, psychological, and socioeconomic burdens. Achieving cancer-free survival with an optimal quality of life (QoL) is the primary goal for HNC patient management. So, maintaining lifelong surveillance is critical. An ambitious goal would be to carry this out through the advanced analysis of environmental, emotional, and behavioral data unobtrusively collected from mobile devices. The aim of this clinical trial is to reduce, with non-invasive tools (i.e., patients' mobile devices), the proportion of HNC survivors (i.e., having completed their curative treatment from 3 months to 10 years) experiencing a clinically relevant reduction in QoL during follow-up. The Big Data for Quality of Life (BD4QoL) study is an international, multicenter, randomized (2:1), open-label trial. The primary endpoint is a clinically relevant global health-related EORTC QLQ-C30 QoL deterioration (decrease ≥10 points) at any point during 24 months post-treatment follow-up. The target sample size is 420 patients. Patients will be randomized to be followed up using the BD4QoL platform or per standard clinical practice. The BD4QoL platform includes a set of services to allow patients monitoring and empowerment through two main tools: a mobile application installed on participants' smartphones, that includes a chatbot for e-coaching, and the Point of Care dashboard, to let the investigators manage patients data. In both arms, participants will be asked to complete QoL questionnaires at study entry and once every 6 months, and will undergo post-treatment follow up as per clinical practice. Patients randomized to the intervention arm (n=280) will receive access to the BD4QoL platform, those in the control arm (n=140) will not. Eligibility criteria include completing curative treatments for non-metastatic HNC and the use of an Android-based smartphone. Patients undergoing active treatments or with synchronous cancers are excluded. Clinical Trial Registration: ClinicalTrials.gov, identifier (NCT05315570).

Indexed as

androidBD4QoLhead and neck cancermHealthQOLsurvivorshipunobtrusive

Identifiers

PMID36798825
PMCPMC9927199
OpenAlexW4318613336

What OpenQuestion holds

Textmetadata
LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.