About this trial
Head and neck cancer patients often experience significant anxiety and depression during radiation therapy, which can affect their quality of life and treatment adherence. However, traditional psychological support is limited by resource constraints and accessibility. This study aims to evaluate whether a mobile application based on social sharing and peer interaction can improve psychological distress in patients with head and neck squamous cell carcinoma (HNSCC) undergoing radiotherapy.
This is a prospective, randomized, parallel-group, open-label trial. A total of 120 participants will be randomly assigned in a 1:1 ratio to either the immediate intervention group or a waitlist control group. Participants in the intervention group will use a dedicated app featuring daily sharing, peer interaction (anonymous comments, likes, private messaging), psychoeducational resources, and reminders. The control group will receive a printed psychoeducational booklet during the initial phase and will gain access to the app after the primary endpoint assessment.
The primary outcome is the change in anxiety score (HADS-A) from baseline to completion of radiotherapy. Secondary outcomes include depression scores (HADS-D), radiotherapy interruption rate, app engagement, and severe psychological distress prevalence. Exploratory outcomes include quality of life (EORTC QLQ-C30, H\&N35), readmission rate, adverse event severity (CTCAE v5.0), and biological markers (e.g., cortisol, IL-6, CRP).
The study is expected to run from April 2026 to August 2027. Findings may inform scalable digital psychosocial interventions for cancer patients.
Eligibility criteria
Qualifiers
Age 18 - 75 years, male or female
Life expectancy ≥ 6 months
Histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) without distant metastasis
Planned to receive curative radiotherapy or postoperative adjuvant radiotherapy
Disqualifiers
Other malignancies (except treated basal cell skin cancer or cervical CIS)
Prior head and neck radiotherapy
History of psychiatric disorder or psychotropic medication use
Absolute contraindication to head and neck radiotherapy
Trial design
Treatments tested in this trial
- Social Sharing-Based Mobile Application
- Usual Care with Psycho-educational Manual