An Oncology Nurse AI Agent to Reduce Cancer Distress During Radiotherapy (Digi-Coach)

March 5, 2026 updated by: Tongyao WANG, The University of Hong Kong

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

The goal of this clinical trial is to assess the effectiveness of the Digi-Coach chatbot for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

The main question it aims to answer is: How effective is the Digi-Coach chatbot in reducing physical and psychological distress?

Researchers will compare Digi-Coach chatbot to usual nursing care to see if Digi-Coach chatbot is effective for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

Participants will have access to the Digi-Coach chatbot during radiotherapy in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer-related concerns in the chatbot.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The goal of this clinical trial is to assess the effectiveness of the Digi-Coach chatbot for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

The main question it aims to answer is: How effective is the Digi-Coach chatbot in reducing physical and psychological distress? Researchers will compare Digi-Coach chatbot to usual nursing care to see if Digi-Coach chatbot is effective for reducing physical and psychological distress in people undergoing radiotherapy for head and neck cancer.

A single-blinded parallel randomized controlled trial (RCT allocation ratio = 1:1) will be conducted, with baseline data collection at week 1 (T0) and three follow-up timepoints at week 8 (T1), week 12 (T2) following radiotherapy commencement.

Participants in the Treatment-As-Usual group will receive routine onsite nursing care in which the nurse discussed general knowledge of self-care behaviors regarding the management of radiotherapy-related side effects.

Participants in the intervention group will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer-related concerns in the chatbot.

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Tongyao Wang, PhD
  • Phone Number: 852-39102790
  • Email: tongyao1@hku.hk

Study Locations

  • Hong Kong
    • Hong Kong
      • Hong Kong, Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
      • Hong Kong, Hong Kong, Hong Kong, 000000
        • Active, not recruiting
        • The University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Treatment-As-Usual Arm
Participants in the Treatment-As-Usual group will receive routine onsite nursing care in which the nurse discusses general knowledge of self-care behaviors regarding the management of radiotherapy-related side effects.
Experimental: Digi-Coach Chatbot Arm
Participants in Digi-Coach Chatbot Arm will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to use the chatbot.
Other: Digi-Coach Chatbot
Participants will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to navigate the chatbot and ask participants to query all their cancer related concerns in the chatbot.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
National Comprehensive Cancer Network Distress Thermometer
Time Frame: 1 week, 8 weeks, and 12 weeks
A 2-item measurement that has participants first rate their distress levels on a scale of 0 (no distress) to 10 (extreme distress) and then self-report their concerns by choosing from a given list of physical, emotional, social, practical, spiritual, or other concerns.
1 week, 8 weeks, and 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Memorial Symptom Assessment Scale
Time Frame: 1 week, 8 weeks, and 12 weeks
32-item comprehensive tool for assessing cancer-related symptom burden with three analysis domains of symptom severity (1 = slight, 4 = very severe), prevalence (1 = rarely, 4 = almost constantly), and distress (0 = not at all, 4 = very much).
1 week, 8 weeks, and 12 weeks
Functional Assessment of Cancer Therapy-Head and Neck
Time Frame: 1 week, 8 weeks, and 12 weeks
27 items on the general well-being domain (physical, social/family, emotional, and functional) and 11 items specific to head and neck cancer on a 5-point Likert scale. The total score ranges from 0 to 148; the higher the score, the better the quality of life.
1 week, 8 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Collaborators

Queen Elizabeth Hospital, Hong Kong
Queen Mary Hospital, Hong Kong

Investigators

  • Principal Investigator: Tongyao Wang, PhD, The University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 8, 2024

First Posted (Actual)

October 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 5, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KC/KE-23-0116/ER-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The de-identified individual participant data will not be shared, as the participants did not consent to their data being shared with others at the time of collection.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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