A Prospective Randomized Controlled Trial of Network Platform Sharing Intervention for Psychological Outcomes in Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy
| Registry | NCT07766226 |
|---|---|
| Status | Recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 120 (Estimated) |
| Sponsor | West China Hospital (Other) |
| Conditions | Head and Neck Squamous Cell Carcinoma |
| Interventions | Social Sharing-Based Mobile Application, Usual Care with Psycho-educational Manual (Other) |
| Dates | start 2026-08-28, primary completion 2027-08-01 (estimated), completion 2028-02-01 (estimated), first posted 2026-08-14, last updated 2026-09-02 |
| Locations | 1 site in China |
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All trials for Head and Neck Squamous Cell Carcinoma All trials of Social Sharing-Based Mobile Application All trials of Usual Care with Psycho-educational Manual
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Online Sharing Group | Experimental | Other: Social Sharing-Based Mobile Application | Participants receive immediate access to the social sharing-based mobile app intervention. The active intervention phase begins at radiotherapy initiation and lasts for 8 weeks, through 4 weeks post-radiotherapy, during which participants are encouraged to post at least 2 shares and complete at least 3 interactions per week. App access remains open thereafter for voluntary use through 12 weeks post-radiotherapy. |
| Control Group | Other | Other: Usual Care with Psycho-educational Manual | Participants receive a printed psychoeducational booklet during the initial phase and will gain access to the same app intervention after the primary endpoint assessment (radiotherapy completion). |
Sex: All, ages: 18 Years to 75 Years
Inclusion Criteria: 1. Age 18 - 75 years, male or female 2. Life expectancy ≥ 6 months 3. Histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) without distant metastasis 4. Planned to receive curative radiotherapy or postoperative adjuvant radiotherapy 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 6. Adequate cognitive and reading ability to complete questionnaires 7. Ability to use a smartphone or tablet device 8. Fluent in Chinese (reading and speaking) 9. Willing and able to provide signed informed consent Exclusion Criteria: 1. Other malignancies (except treated basal cell skin cancer or cervical CIS) 2. Prior head and neck radiotherapy 3. History of psychiatric disorder or psychotropic medication use 4. Absolute contraindication to head and neck radiotherapy 5. Uncontrolled systemic disease (poorly controlled DM, NYHA III-IV HF, interstitial lung disease)
| Facility | City | Country | Status |
|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu, Sichuan | China | Recruiting |