Online Sharing for Head & Neck Cancer Support

NCT07766226 | Not Yet Recruiting

• 1 other identifier: 2026-734
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Change in Anxiety Score (HADS-A)

  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.

  Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy

Secondary Outcomes (3)

• 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

Other Outcomes (5)

• Radiotherapy Interruption Rate

  From the first planned radiotherapy fraction through completion or early discontinuation of radiotherapy

• APP Engagement Rate

  Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy

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

  Baseline (within 1 week pre-radiotherapy) through 12 weeks post-radiotherapy

Study Arms (2)

Online Sharing Group

EXPERIMENTAL

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: Social Sharing-Based Mobile Application

Control Group

OTHER

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).

Other: Usual Care with Psycho-educational Manual

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.

Online Sharing Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (14)

• Yang 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 BACKGROUND

• Zhang 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 BACKGROUND

• Akdogan 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 BACKGROUND

• Kangas 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 BACKGROUND

• van 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 BACKGROUND

• van 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.

  PMID: 23429740 BACKGROUND

• De Leeuw JR, De Graeff A, Ros WJ, Hordijk GJ, Blijham GH, Winnubst JA. Negative and positive influences of social support on depression in patients with head and neck cancer: a prospective study. Psychooncology. 2000 Jan-Feb;9(1):20-8. doi: 10.1002/(sici)1099-1611(200001/02)9:13.0.co;2-y.

  PMID: 10668056 BACKGROUND

• Panwar A, Lydiatt W, Osazuwa-Peters N. Genetic Depression Risk for Head and Neck Cancer Survivors-Fait Accompli? JAMA Otolaryngol Head Neck Surg. 2024 Jul 1;150(7):607-608. doi: 10.1001/jamaoto.2024.0377. No abstract available.

  PMID: 38814662 BACKGROUND

• Fenech AL, Humphris GM, Laurenceau JP, Siegel SD, Rogers SN, Ozakinci G, Crawford JR, Pring M. Anxiety, depression, and fear of cancer recurrence in head and neck cancer. Health Psychol. 2024 Nov;43(11):803-812. doi: 10.1037/hea0001397. Epub 2024 Jul 25.

  PMID: 39052377 BACKGROUND

• Barber B, Dergousoff J, Slater L, Harris J, O'Connell D, El-Hakim H, Biron VL, Mitchell N, Seikaly H. Depression and Survival in Patients With Head and Neck Cancer: A Systematic Review. JAMA Otolaryngol Head Neck Surg. 2016 Mar;142(3):284-8. doi: 10.1001/jamaoto.2015.3171.

  PMID: 26796781 BACKGROUND

• Rao WW, Yang MJ, Cao BN, You YY, Zhang YY, Liu YY, Kou C, Yu Y, Cassidy RM, Yu Q, Zhang XY. Psychological distress in cancer patients in a large Chinese cross-sectional study. J Affect Disord. 2019 Feb 15;245:950-956. doi: 10.1016/j.jad.2018.11.089. Epub 2018 Nov 13.

  PMID: 30699880 BACKGROUND

• Martinez MC, Finegersh A, Baik FM, Holsinger FC, Starmer HM, Orloff LA, Sunwoo JB, Sirjani D, Divi V, Chen MM. Comorbid Depression in Patients With Head and Neck Cancer Compared With Other Cancers. JAMA Otolaryngol Head Neck Surg. 2024 Dec 1;150(12):1097-1104. doi: 10.1001/jamaoto.2024.3233.

  PMID: 39446380 BACKGROUND

• Bjordal K, Kaasa S, Mastekaasa A. Quality of life in patients treated for head and neck cancer: a follow-up study 7 to 11 years after radiotherapy. Int J Radiat Oncol Biol Phys. 1994 Mar 1;28(4):847-56. doi: 10.1016/0360-3016(94)90104-x.

  PMID: 8138437 BACKGROUND

• Chow LQM. Head and Neck Cancer. N Engl J Med. 2020 Jan 2;382(1):60-72. doi: 10.1056/NEJMra1715715. No abstract available.

  PMID: 31893516 BACKGROUND

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Xingchen Peng

CONTACT

+86 18980606753; pxx2014@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: August 14, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: August 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)