Head and Neck Squamous Cell Carcinoma
Conditions
Brief summary
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.
Interventions
OTHERSocial Sharing-Based Mobile Application
Mobile app with five modules: daily sharing, anonymous peer interaction, psychoeducational resources, task reminders, and professional support. Participants post ≥2 shares and interact ≥3 times weekly for 8 weeks. Content moderated by research assistants.
OTHERUsual Care with Psycho-educational Manual
Participants receive standard radiotherapy care and a printed psychological adjustment manual, without access to the social sharing APP during the initial intervention phase.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Anxiety Score (HADS-A) | Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy | Change in the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A) score from baseline to completion of radiotherapy. HADS-A consists of 7 items, each scored 0-3, with total score ranging from 0 to 21. Higher scores indicate more severe anxiety symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Depression Score (HADS-D) | Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy | Change in the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D) score from baseline to completion of radiotherapy. HADS-D consists of 7 items, each scored 0-3, with total score ranging from 0 to 21. Higher scores indicate more severe depressive symptoms. |
| Change in Combined HADS Total Score | Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy | Change in the combined Hospital Anxiety and Depression Scale total score (HADS-A + HADS-D, range 0-42) from baseline to completion of radiotherapy. Higher scores indicate greater overall psychological distress. |
| Prevalence of Severe Psychological Distress | Within 7 days post-radiotherapy | Proportion of participants with a combined HADS total score ≥ 15 at radiotherapy completion. |
Countries
China
Contacts
CONTACTXingchen Peng
Outcome results
None listed