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NCT Number: NCT06636188

An Oncology Nurse AI Agent to Reduce Cancer Distress During Radiotherapy

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.

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen Mary Hospital, Hong Kong

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digi-Coach Chatbot

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Tongyao Wang, PhD

CONTACT

[email protected]

852-39102790

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

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

Registry information

Official study title

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

Acronym: Digi-Coach

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Oct 10, 2024
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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