NCT06636188

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
138

participants targeted

Target at P75+ for not_applicable head-and-neck-cancer

Timeline
27mo left

Started Feb 2026

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Nov 2028

First Submitted

Initial submission to the registry

October 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
1.3 years until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2028

Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

1.7 years

First QC Date

October 3, 2024

Last Update Submit

March 5, 2026

Conditions

Head and Neck Cancer

Keywords

chatbotdigital healthoncology care

Outcome Measures

Primary Outcomes (1)

  • National Comprehensive Cancer Network Distress Thermometer

    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 Outcomes (2)

  • Memorial Symptom Assessment Scale

    1 week, 8 weeks, and 12 weeks

  • Functional Assessment of Cancer Therapy-Head and Neck

    1 week, 8 weeks, and 12 weeks

Study Arms (2)

Treatment-As-Usual Arm

NO INTERVENTION

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.

Digi-Coach Chatbot Arm

EXPERIMENTAL

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

Interventions

Digi-Coach ChatbotOTHER

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.

Digi-Coach Chatbot Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The University of Hong Kong

Hong Kong, Hong Kong, 000000, Hong Kong

ACTIVE NOT RECRUITING

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Tongyao Wang, PhD

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tongyao Wang, PhD

CONTACT

852-39102790tongyao1@hku.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assitant Professor

Study Record Dates

First Submitted

October 3, 2024

First Posted

October 10, 2024

Study Start

February 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2028

Last Updated

March 9, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations

HK(2)