Big Data for Quality of Life in Head and Neck Cancer

Launched by FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI, MILANO · Mar 29, 2022

Keywords

ClinConnect Summary

This clinical trial, called "Big Data for Quality of Life in Head and Neck Cancer," is exploring how to improve the quality of life for survivors of head and neck cancer. Many patients experience ongoing challenges even after their cancer treatment, which may include surgery, radiation, or chemotherapy. The study aims to use a new platform that collects data through smartphones to understand and predict changes in quality of life over time. By doing this, researchers hope to identify ways to help survivors avoid significant declines in their well-being.

To participate in this study, individuals must have been diagnosed with specific types of head and neck cancer and completed their treatment within the last 10 years. They should be in good health and free of any signs of cancer at the time of enrollment. Participants will need to fill out questionnaires and use their smartphones to share information for up to two years. This innovative approach promises to make the process less burdensome while providing valuable insights into how to support cancer survivors better.

Gender

ALL

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.