Online Sharing for Head & Neck Cancer Support

Sponsor
West China Hospital
Study ID
NCT07766226
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Social Sharing-Based Mobile Application — OTHER
    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.
  • Usual Care with Psycho-educational Manual — OTHER
    Participants receive standard radiotherapy care and a printed psychological adjustment manual, without access to the social sharing APP during the initial intervention phase.

Study Details

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.

Key Dates

First listed
Aug 14, 2026
Start date
Aug 28, 2026
Status verified
Aug 2026
Primary completion
Aug 1, 2027
Completion
Feb 1, 2028

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: 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.
  • Other: 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).

Primary Outcome Measure

Change in Anxiety Score (HADS-A) [ Time Frame: Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy ]

Central Contacts

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