A Prospective Randomized Controlled Trial of Network Platform Sharing Intervention for Psychological Outcomes in Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in Anxiety Score (HADS-A)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- •Adequate cognitive and reading ability to complete questionnaires
- •Ability to use a smartphone or tablet device
- •Fluent in Chinese (reading and speaking)
- •Willing and able to provide signed informed consent
排除标准
- •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
- •Uncontrolled systemic disease (poorly controlled DM, NYHA III-IV HF, interstitial lung disease)
研究组 & 干预措施
Control Group
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).
干预措施: Usual Care with Psycho-educational Manual (Other)
Online Sharing Group
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.
干预措施: Social Sharing-Based Mobile Application (Other)
结局指标
主要结局
Change in Anxiety Score (HADS-A)
时间窗: 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.
次要结局
- Change in Depression Score (HADS-D)(Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy)
- Change in Combined HADS Total Score(Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy)
- Prevalence of Severe Psychological Distress(Within 7 days post-radiotherapy)
研究者
Xingchen Peng
Professor
West China Hospital