ClinicalTrials.gg
RecruitingNCT07766226Updated Sep 2, 2026

Online Sharing for Head & Neck Cancer Support

An interventional study of Social Sharing-Based Mobile Application and Usual Care with Psycho-educational Manual in Head and Neck Squamous Cell Carcinoma, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-02.

Sponsored by West China Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Started Aug 2026; still recruiting 2 months later.

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 21 studies in Squamous Cell Carcinoma of Head and Neck by West China Hospital — 11 open to participants now, 12 under way, none of them phase 3. Squamous Cell Carcinoma of Head and Neck · West China Hospital.

Planned enrollment
3rd of 20
120 · median 14
Started
2026
with 8 others
No phase
Only one
of the 21
Primary completion
2027-08
later than 9 of 11 live
Registered
21st of 21
by date

Among the 21 studies in Squamous Cell Carcinoma of Head and Neck by West China Hospital, this one is the 3rd largest by planned enrollment of the 20 interventional ones that give a count, is one of 9 that started in 2026, is the only one with no phase, reaches primary completion later than 9 of the 11 other live ones, and was the 21st registered.

Squamous Cell Carcinoma of Head and Neck

2,019 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 573 are open to participants now.

Browse Squamous Cell Carcinoma of Head and Neck studies →

Open to participants now

11 of the 21 studies in Squamous Cell Carcinoma of Head and Neck by West China Hospital are open now, in 1 country. Recruiting first, the newest first:

5 more — sign in →

By country, each count listing its studies:

All 11 open studies →

Where they have run

Who these studies take

Of the 435 Squamous Cell Carcinoma of Head and Neck studies recruiting now, 311 (71%) set no upper age limit and 87 (20%) stop at 75 or younger; 5 take children under 18; 13 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 21 studies in Squamous Cell Carcinoma of Head and Neck by West China Hospital, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Head and Neck Squamous Cell Carcinoma
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 18 - 75 years, male or female
  2. ≥ 6 months
  3. Histopathologically confirmed head and neck squamous cell carcinoma (including nasopharyngeal carcinoma) without distant
  4. Planned to receive curative radiotherapy or postoperative radiotherapy
  5. (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

Exclusion criteria

Exclusion Criteria:

  1. Other (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 to head and neck radiotherapy
  5. Uncontrolled systemic disease (poorly controlled DM, III-IV HF, interstitial lung disease)
Terms in these criteria, in plain language(8)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Adjuvant and neoadjuvant

Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Care provider, Outcomes assessor)
Enrollment
120 participants (estimated)

Study 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: Social Sharing-Based Mobile Application

  • 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).

    Other: Usual Care with Psycho-educational Manual

Interventions

  • OtherSocial Sharing-Based Mobile Application

    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.

  • OtherUsual Care with Psycho-educational Manual

    Participants receive standard radiotherapy care and a printed psychological adjustment manual, without access to the social sharing APP during the initial intervention phase.

06

What researchers measure

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.

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

Secondary outcomes

  1. Change in Depression Score (HADS-D)

    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

  2. Change in Combined HADS Total Score

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

  3. Prevalence of Severe Psychological Distress

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

    Time frame: Within 7 days post-radiotherapy

Other outcomes

  1. Radiotherapy Interruption Rate

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

  2. APP Engagement Rate

    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

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

    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

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

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

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

    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.

    Time frame: From initiation of radiotherapy through 12 weeks after completion of radiotherapy

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • 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. PubMed 34896258 ↗
  • 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. PubMed 39615074 ↗
  • 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. PubMed 40215593 ↗
  • 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. PubMed 23042612 ↗
  • 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. PubMed 24280999 ↗
  • 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. PubMed 23429740 ↗
  • 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. PubMed 10668056 ↗
  • 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. PubMed 38814662 ↗
  • 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. PubMed 39052377 ↗
  • 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. PubMed 26796781 ↗
  • 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. PubMed 30699880 ↗
  • 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. PubMed 39446380 ↗
  • 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. PubMed 8138437 ↗
  • Chow LQM. Head and Neck Cancer. N Engl J Med. 2020 Jan 2;382(1):60-72. doi: 10.1056/NEJMra1715715. No abstract available. PubMed 31893516 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Aug 2027, 11 months after the start.

Of 115 non-industry interventional studies with no phase under Squamous Cell Carcinoma of Head and Neck, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 90. This study's planned 11 months is below that.

Counting every sponsor, half of 126 studies reached it within 59 months; a quarter within 34 and three quarters within 90.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 7, 2026
First posted
Aug 14, 2026
StartActual
Aug 28, 2026
Primary completionEst.
Aug 1, 2027
CompletionEst.
Feb 1, 2028
Last update
Sep 2, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 2, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07766226
Responsible party
Xingchen Peng (Professor, West China Hospital) — Principal investigator
First posted
Aug 14, 2026
Start date
Aug 28, 2026
Primary completion
Aug 1, 2027 (estimated)
Completion
Feb 1, 2028 (estimated)
Last update
Sep 2, 2026

Study contacts

Xingchen Peng
Contact
pxx2014@163.com
+86 18980606753

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion