Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Digi-Coach oncology nurse AI to reduce distress during head and neck radiotherapy

Official title: An Oncology Nurse Artificial Intelligence Agent to Reduce Cancer Distress of Patients Undergoing Radiotherapy: A Mixed-Methods Randomized Controlled Trial

Run by The University of Hong Kong · NCT06636188 · Data updated 2026-11-12

This project will test whether the Digi-Coach chatbot helps people with head and neck cancer feel less physical and emotional distress during radiotherapy.

More Head and Neck Cancer trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment138 (estimated)
SponsorThe University of Hong Kong
Academic / other
Drugs / interventionschemotherapy
Locations2 sites (Hong Kong, Hong Kong and 1 other locations)
StatusRecruiting
StartedFebruary 1, 2026
Main results expectedNovember 2027
Study endsNovember 2028
Registry record updatedMarch 9, 2026
Trial IDNCT06636188 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18) with a new primary head and neck or laryngeal cancer scheduled for curative-intent external beam radiotherapy (with or without chemotherapy), fluent in Cantonese or Mandarin, with Karnofsky score ≥70 and distress ≥3 on the NCCN thermometer are ideal candidates.

Probably not a fit

Patients who do not speak Cantonese or Mandarin, are not receiving radiotherapy, have low distress, poor performance status, cognitive impairment, or other barriers to informed consent or using the chatbot are unlikely to benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-blinded, parallel randomized controlled trial comparing the Digi-Coach chatbot plus usual nursing care to usual nursing care alone for people receiving curative-intent external beam radiotherapy for head and neck cancer. Participants are randomized 1:1 with baseline data at week 1 and follow-ups at week 8 and week 12 after treatment start. The intervention group receives training from a research nurse and is asked to use the chatbot to report and manage cancer-related concerns; the control group receives routine onsite nursing self-care education. Primary outcomes focus on physical and psychological distress measured over the radiotherapy course and early follow-up.

Why it matters

Potential benefit: If successful, the chatbot could reduce patients' physical symptoms and emotional distress during radiotherapy and improve symptom self-management.

How similar studies have gone: Digital health and chatbot interventions in oncology have shown some promise for symptom support and distress reduction in prior studies, but high-quality randomized evidence in head and neck radiotherapy is limited and this application is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* aged 18 and above
* are able to read and speak Cantonese or Mandarin fluently
* have a new, primary diagnosis of head and neck/laryngeal cancer
* are waiting to receive a full course of curative-intent, external beam radiotherapy with or without chemotherapy
* have a Karnofsky performance score ≥70
* have distress scored 3 or above on the NCCN distress thermometer

Exclusion Criteria:

* insufficient command of Chinese
* have any other factors precluding the ability to give informed consent or comply with the protocol

Where it's running

  • Queen Mary Hospital
    Hong Kong, Hong Kong, Hong Kong
    Recruiting
  • The University of Hong Kong
    Hong Kong, Hong Kong, Hong Kong
    Active not recruiting

Study contacts

  • Principal investigator: Tongyao Wang, PhD — The University of Hong Kong
  • Study coordinator: Tongyao Wang, PhD
  • Email: tongyao1@hku.hk
  • Phone: 852-39102790

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.