Digi-Coach oncology nurse AI to reduce distress during head and neck radiotherapy
An Oncology Nurse Artificial Intelligence Agent to Reduce Cancer Distress of Patients Undergoing Radiotherapy: A Mixed-Methods Randomized Controlled Trial
This project will test whether the Digi-Coach chatbot helps people with head and neck cancer feel less physical and emotional distress during radiotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 2 sites (Hong Kong, Hong Kong and 1 other locations) |
| Trial ID | NCT06636188 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hong Kong, Hong Kong and 1 other locations
- The University of Hong Kong — Hong Kong, Hong Kong, Hong Kong (Active_not_recruiting)
- Queen Mary Hospital — Hong Kong, Hong Kong, Hong Kong (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.