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NCT Number: NCT07766226

Online Sharing for Head & Neck Cancer Support

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Change in Anxiety Score (HADS-A)

    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.

Secondary outcomes

  1. Change in Depression Score (HADS-D)

    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.

  2. Change in Combined HADS Total Score

    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.

  3. Prevalence of Severe Psychological Distress

    Time frame: Within 7 days post-radiotherapy

    Proportion of participants with a combined HADS total score ≥ 15 at radiotherapy completion.

Other outcomes

  1. Radiotherapy Interruption Rate

    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.

  2. APP Engagement Rate

    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.

  3. Change From Baseline in EORTC QLQ-C30 Global Health Status/Quality of Life Score

    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.

  4. EORTC QLQ-H&N35 Symptom Scale and Single-Item Scores

    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.

  5. Number and Proportion of Participants With Radiotherapy-Related Adverse Events Assessed by CTCAE Version 5.0

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xingchen Peng

CONTACT

[email protected]

+86 18980606753

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

A Prospective Randomized Controlled Trial of Network Platform Sharing Intervention for Psychological Outcomes in Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Aug 14, 2026
Registry last updated
Aug 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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