West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
NCT Number: NCT07766226
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.
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Not applicable
Chengdu, Sichuan, 610041, China
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Participants receive standard radiotherapy care and a printed psychological adjustment manual, without access to the social sharing APP during the initial intervention phase.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Within 7 days post-radiotherapy
Proportion of participants with a combined HADS total score ≥ 15 at radiotherapy completion.
Time frame: From the first planned radiotherapy fraction through completion or early discontinuation of radiotherapy
Proportion of participants with unplanned radiotherapy delay of ≥5 days beyond the scheduled treatment period (including weekends and holidays) due to any cause.
Time frame: Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy
Proportion of participants in the intervention group with an average login frequency of >2 times per week during the active intervention period.
Time frame: Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Global Health Status/Quality of Life scale consists of two items. Raw scores will be linearly transformed to a 0-to-100 scale according to the EORTC QLQ-C30 scoring manual. Higher scores indicate better global health status and quality of life. Change from baseline will be calculated at each post-baseline assessment, with a positive change indicating improvement.
Time frame: Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy
Head and neck cancer-specific symptoms and problems will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Head and Neck Cancer Module (EORTC QLQ-H&N35). The questionnaire includes multi-item scales assessing pain, swallowing, senses, speech, social eating, social contact, and sexuality, as well as single items assessing additional head and neck cancer-related symptoms and problems. Scale and single-item scores will be linearly transformed to a 0-to-100 scale according to the EORTC scoring manual. Higher scores indicate greater symptom burden or more severe problems.
Time frame: From initiation of radiotherapy through 12 weeks after completion of radiotherapy
Radiotherapy-related adverse events will be identified and graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 5.0. For each participant, adverse events will be summarized by event type and maximum CTCAE grade. Results will be reported as the number and proportion of participants experiencing each adverse event and each severity grade. CTCAE grades are defined as Grade 1, mild; Grade 2, moderate; Grade 3, severe; Grade 4, life-threatening or disabling; and Grade 5, death related to an adverse event.
Contact information is provided by the study sponsor or research team.
West China Hospital
Other
A Prospective Randomized Controlled Trial of Network Platform Sharing Intervention for Psychological Outcomes in Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy
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