App aims to catch Quality-of-Life drops early in head and neck cancer survivors
NCT ID NCT05315570
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed trial tested a mobile app and web platform (BD4QoL) to monitor quality of life in 410 head and neck cancer survivors after curative treatment. The goal was to see if the platform could reduce or catch early declines in quality of life compared to standard follow-up. Participants used a smartphone app to report symptoms and complete questionnaires, while doctors tracked their data through a separate tool.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BD4QoL platform (mobile app and web tool for patient monitoring and quality of life questionnaires)
- What this could lead to
- If successful, this approach could help doctors detect and address quality-of-life declines earlier in head and neck cancer survivors, improving their well-being during follow-up.
- What could go wrong
- This is a completed study focused on monitoring, not a new treatment. The platform may not significantly reduce quality-of-life deterioration compared to standard care, and results may not apply to all cancer types.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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410 people
The number who actually took part.
- Started
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Mar 2022
- Finished
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Oct 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fondazione Casa Sollievo della Sofferenza
San Giovanni Rotondo, Italy
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
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University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
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