Big Data for Quality of Life in Head and Neck Cancer

NCT05315570 | Completed

• 1 other identifier: INT 267-21
• Study Type: interventional
• Target: 410
• Locations: 2 countries
• Sites: 3

Brief 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

Keywords

mHealth; eHealth; remote monitoring

Outcome Measures

Primary Outcomes (1)

• Clinically meaningful deterioration of global QoL between at least 2 visits during post-treatment follow-up

  Proportion of HNC survivors experiencing a clinically meaningful global health-related EORTC QLQ-C30 QoL deterioration (decrease ≥10 points)

  6-24 months

Secondary Outcomes (4)

• Time to the first clinically meaningful deterioration of global QoL between at least 2 visits during post-treatment follow-up

  6-24 months

• Clinically meaningful deterioration of pre-specified EORTC-QLQ-C30 scales QoL between at least 2 visits during post-treatment follow-up

  6-24 months

• Clinically meaningful deterioration of pre-specified EORTC-QLQ-HN43 scales QoL between at least 2 visits during post-treatment follow-up

  6-24 months

• Clinically meaningful deterioration of pre-specified EQ-5D-5L domains between at least 2 visits during post-treatment follow-up

  6-24 months

Other Outcomes (12)

• Association of clinically relevant variations in QoL with disease recurrence and survival

  24 months

• Correlation of time-dependent variations in QoL with disease-free survival (DFS)

  24 months

• Correlation of time-dependent variations in QoL with event-free survival (EFS)

  24 months

Study Arms (2)

Intervention arm

EXPERIMENTAL

Study participants will be followed up as per clinical practice and will receive the investigational electronic platform, including an Android-based app. Study subjects will be asked to fill in questionnaires at study entry and during follow-up.

Other: BD4QoL platform

Control arm

NO INTERVENTION

No specific mobile apps will be provided to study participants, who will be followed as per clinical practice. Study subjects will be asked to fill in questionnaires at study entry and during follow-up.

Interventions

BD4QoL platform OTHER

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.

Intervention arm

Eligibility Criteria

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

You may qualify if:

• Effectively cured histologically defined head and neck squamous cell carcinoma (HNSCC) from one of these subsites: oral cavity, nasopharynx, hypopharynx, larynx, Human Papillomavirus (HPV)-positive or negative oropharynx, nasal cavity, paranasal sinuses (ICD codes in Annex 12). Non-metastatic salivary gland cancer (SGC) of any histological type can be included only if curative or postoperative radiotherapy included the neck:
• For p16-negative or p16-unknown HNSCC (including nasal cavity and paranasal sinuses), stage I, II, III, IVa or IVb (no IVc) according to UICC/AJCC 8th edition22. Regional neck metastases from squamous cell carcinoma from unknown primary head and neck sites are allowed.
• For nasopharyngeal cancer (NPC), stage I, II, III, IVa (no IVb) according to UICC/AJCC 8th edition22. Regional neck metastases from EBV-positive carcinoma from unknown primary head and neck sites are allowed.
• For SGCs, stage III, IVa or IVb according to UICC/AJCC 8th edition22 treated with radiotherapy that included the neck (either post-operative radiation or radical treatment in case of unresectable disease).
• For p16-positive oropharyngeal squamous cell carcinoma, stage I, II or III according to UICC/AJCC 8th edition22. Regional neck metastases from p16-positive and/or HPV-positive squamous cell carcinoma from unknown primary head and neck sites are allowed.
• Patients having completed treatment with curative intent (including any single modality or multimodal approach) within 10 years at the time of accrual.
• Patients being disease-free at the time of accrual. Patients will be deemed in complete remission if the clinical examination is negative for recurrence; clinical examination should be preferably, but not mandatorily, integrated with unequivocal radiological imaging that shows the absence of disease (in case of doubt, further radiological imaging should be performed or integrated with cyto/histological samples of the area with suspected disease persistence and the exams will have to be consistently negative) after at least three months following treatment completion.
• Ability to fill in questionnaires as per protocol.
• Geographical accessibility and willingness to be followed-up for up to 2 years with information-technology (IT) devices in addition to questionnaires.
• Age ≥ 18 years.
• Signed informed consent.
• Willingness to use their smartphone and their Internet access for the study.
• Smartphone having the following minimum characteristics:
• RAM: Minimum of 2 GB
• Storage: Minimum of 512 MB free storage

You may not qualify if:

• Distant metastases (the following populations are excluded: stage IVc HPV-negative HNSCC and SGC, stage IV p16-positive oropharyngeal squamous cell carcinoma, stage IVb NPC).
• Thyroid cancers, non-melanoma skin cancers (e.g. squamous cell carcinoma of the skin, skin basal cell carcinoma, skin adnexal carcinoma), and non-carcinoma of the head and neck area (e.g. melanoma, sarcoma, etc.) are excluded.
• Subjects with previous malignancies (except localized non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, esophageal, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least 5 years prior to study entry AND no additional therapy is required during the study period. Premalignant lesions (e.g. leukoplakia, erythroplakia, lichen etc.) are allowed.
• Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with experimental drugs.
• Patients unable to comply with the protocol, in the opinion of the investigator.
• Any known or underlying medical conditions that, in the opinion of the investigator, could adversely affect the ability of the participating subject to comply with the study.
• Having a smartphone operating system other than Android.

Sponsors & Collaborators

• University of Birmingham: collaborator
• University Hospital Birmingham NHS Foundation Trust: collaborator
• Dotsoft Olokliromenes Efarmoges Diadiktioy kai Vaseon Dedomenon AE: collaborator
• IBM Ireland limited: collaborator
• Multimed Engineers srl: collaborator
• Regione Lombardia: collaborator
• Universidad de la Iglesia de Deusto Entidad Religiosa: collaborator
• Universidad Politecnica de Madrid: collaborator
• University of Milan: collaborator
• University of Oslo: collaborator
• Johannes Gutenberg University Mainz: collaborator
• Aria S.p.A.: collaborator
• University of Bristol: collaborator
• Casa Sollievo della Sofferenza IRCCS: collaborator
• Fondazione IRCCS Istituto Nazionale dei Tumori, Milano: lead
• INETUM: collaborator

Study Sites (3)

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

Location

Fondazione Casa Sollievo della Sofferenza

San Giovanni Rotondo, Italy

Location

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

Location

Related Publications (1)

• Cavalieri S, Vener C, LeBlanc M, Lopez-Perez L, Fico G, Resteghini C, Monzani D, Marton G, Pravettoni G, Moreira-Soares M, Filippidou DE, Almeida A, Bilbao A, Mehanna H, Singer S, Thomas S, Lacerenza L, Manfuso A, Copelli C, Mercalli F, Frigessi A, Martinelli E, Licitra L; BD4QoL Consortium. 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. Front Oncol. 2023 Jan 31;13:1048593. doi: 10.3389/fonc.2023.1048593. eCollection 2023.

  PMID: 36798825 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Stefano Cavalieri, MD

  Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

  PRINCIPAL INVESTIGATOR

• Luca Lacerenza, MD

  Fondazione Casa Sollievo della Sofferenza

  PRINCIPAL INVESTIGATOR

• Paul Nankivell, MD

  University Hospital Birmingham NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, international, randomized (2:1 ratio), open-label, superiority trial

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: April 7, 2022
• Study Start: March 28, 2022
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

GB (1); IT (2)