Using mobile technology to improve quality of life for head and neck cancer survivors

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

This study is testing a smartphone app that helps head and neck cancer survivors track their daily activities and feelings to see if it can improve their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 420 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano (Academic / other)
• Drugs / interventions: radiation, chemotherapy
• Locations: 3 sites (Milano and 2 other locations)
• Trial ID: NCT05315570 on ClinicalTrials.gov

What this trial studies

This study utilizes the BD4QoL platform, which integrates mobile technology to monitor and empower patients who have been treated for head and neck cancer. Participants will use a smartphone app that collects various data through embedded sensors, including activity levels, location, and phone usage, to assess their quality of life over time. The goal is to identify behavioral and affective traits that correlate with quality of life outcomes, ultimately leading to predictive models that can enhance patient care. The platform also includes a Point of Care application for clinical investigators to manage patient data and follow-up effectively.

Who should consider this trial

Good fit: Ideal candidates are individuals who have been effectively cured of head and neck squamous cell carcinoma or non-metastatic salivary gland cancer.

Not a fit: Patients with metastatic head and neck cancers or those who have not been histologically defined as cured may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance the quality of life for head and neck cancer survivors by providing personalized insights and interventions.

How similar studies have performed: Other studies utilizing mobile health technologies for cancer survivorship have shown promising results, indicating potential for success in this novel approach.

Eligibility criteria

Inclusion Criteria:

1. 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:

   1. 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.
   2. 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.
   3. 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).
   4. 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.
2. Patients having completed treatment with curative intent (including any single modality or multimodal approach) within 10 years at the time of accrual.
3. 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.
4. Ability to fill in questionnaires as per protocol.
5. Geographical accessibility and willingness to be followed-up for up to 2 years with information-technology (IT) devices in addition to questionnaires.
6. Age ≥ 18 years.
7. Signed informed consent.
8. Willingness to use their smartphone and their Internet access for the study.
9. Smartphone having the following minimum characteristics:

   1. RAM: Minimum of 2 GB
   2. Storage: Minimum of 512 MB free storage
   3. Operating system: Android version 7 (Nougat) or upper.

Exclusion Criteria:

1. 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).
2. 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.
3. 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.
4. Participation in clinical trials with other experimental agents within 30 days of study entry or concomitant treatment with experimental drugs.
5. Patients unable to comply with the protocol, in the opinion of the investigator.
6. 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.
7. Having a smartphone operating system other than Android.

Where this trial is running

Milano and 2 other locations

• Fondazione IRCCS Istituto Nazionale dei Tumori — Milano, Italy (Recruiting)
• Fondazione Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy (Recruiting)
• University Hospitals Birmingham NHS Foundation Trust — Birmingham, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Stefano Cavalieri, MD — Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
• Study coordinator: Lisa Licitra, MD, Prof

Conditions Head and Neck Cancer; Survivorship; Quality of Life; mHealth; eHealth; remote monitoring