Clinical trial · Interventional
Online Sharing for Head & Neck Cancer Support
A Prospective Randomized Controlled Trial of Network Platform Sharing Intervention for Psychological Outcomes in Patients With Head and Neck Squamous Cell Carcinoma Undergoing Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Squamous Cell Carcinoma | Head and Neck Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Social Sharing-Based Mobile Application | Other | — | UNRESOLVED |
| Usual Care with Psycho-educational Manual | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Online Sharing Group
- description
- 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.
- interventionNames
- Other: Social Sharing-Based Mobile Application
- type
- OTHER
- label
- Control Group
- description
- 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).
- interventionNames
- Other: Usual Care with Psycho-educational Manual
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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)
References
Publications (14)
- BACKGROUNDYang M, Zhang Z, Nice EC, Wang C, Zhang W, Huang C. Psychological intervention to treat distress: An emerging frontier in cancer prevention and therapy. Biochim Biophys Acta Rev Cancer. 2022 Jan;1877(1):188665. doi: 10.1016/j.bbcan.2021.188665. Epub 2021 Dec 9. PMID 34896258
- BACKGROUNDZhang T, Ren Z, Wakefield CE, Hui BPH, Akechi T, Shi C, Du X, Chen W, Lai L, Zhao C, Li Y, Zhou Y. Are digital psychological interventions for psychological distress and quality of life in cancer patients effective? A systematic review and network meta-analysis. Clin Psychol Rev. 2025 Feb;115:102520. doi: 10.1016/j.cpr.2024.102520. Epub 2024 Nov 26. PMID 39615074
- BACKGROUNDAkdogan O, Uyar GC, Yesilbas E, Baskurt K, Malkoc NA, Ozdemir N, Yazici O, Oksuzoglu B, Uner A, Ozet A, Sutcuoglu O. Effect of a ChatGPT-based digital counseling intervention on anxiety and depression in patients with cancer: A prospective, randomized trial. Eur J Cancer. 2025 May 15;221:115408. doi: 10.1016/j.ejca.2025.115408. Epub 2025 Apr 3. PMID 40215593
- BACKGROUNDKangas M, Milross C, Taylor A, Bryant RA. A pilot randomized controlled trial of a brief early intervention for reducing posttraumatic stress disorder, anxiety and depressive symptoms in newly diagnosed head and neck cancer patients. Psychooncology. 2013 Jul;22(7):1665-73. doi: 10.1002/pon.3208. Epub 2012 Oct 8. PMID 23042612
- BACKGROUNDvan der Meulen IC, May AM, de Leeuw JR, Koole R, Oosterom M, Hordijk GJ, Ros WJ. Long-term effect of a nurse-led psychosocial intervention on health-related quality of life in patients with head and neck cancer: a randomised controlled trial. Br J Cancer. 2014 Feb 4;110(3):593-601. doi: 10.1038/bjc.2013.733. Epub 2013 Nov 26. PMID 24280999
- BACKGROUNDvan der Meulen IC, May AM, Ros WJ, Oosterom M, Hordijk GJ, Koole R, de Leeuw JR. One-year effect of a nurse-led psychosocial intervention on depressive symptoms in patients with head and neck cancer: a randomized controlled trial. Oncologist. 2013;18(3):336-44. doi: 10.1634/theoncologist.2012-0299. Epub 2013 Feb 21.