Head and Neck CancerDigi-CoachNCT06636188
An Oncology Nurse AI Agent to Reduce Cancer Distress During Radiotherapy
A study testing Digi-Coach Chatbot in people with Head and Neck Cancer, run by The University of Hong Kong at 2 sites in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Digi-Coach Chatbot
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 2 sitesHong Kong
- Study dates
- 1 Feb 2026to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- insufficient command of Chinese
- have any other factors precluding the ability to give informed consent or comply with the protocol
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong2 sites, 1 recruiting
- Active, not recruiting
The University of Hong Kong
Hong Kong, Hong Kong, 000000
- Recruiting
Queen Mary Hospital
Hong Kong, Hong Kong
Tongyao Wang, PhD, 39102790, tongyao1@hku.hk
About this study
Official title: 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?
Read more
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.
Read the 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.
- Conditions
- Head and Neck Cancer
- Being tested
- Digi-Coach Chatbot
- Keywords
- chatbot, digital health, oncology care
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Digi-Coach Chatbot |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week, 8 weeks, and 12 weeks
Secondary outcomes (2)
Memorial Symptom Assessment Scale
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).
Measured: 1 week, 8 weeks, and 12 weeks
Functional Assessment of Cancer Therapy-Head and Neck
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.
Measured: 1 week, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2024
- Study start1 Feb 2026
- Primary completionNov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong
- Responsible party
- Principal investigator, Tongyao WANG, The University of Hong Kong
- Investigators
- Tongyao Wang, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06636188
- Sponsor's protocol ID
- KC/KE-23-0116/ER-4
- Acronym
- Digi-Coach
- Status last verified
- Mar 2026
- First submitted
- 3 Oct 2024
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Oncology Nurse Artificial Intelligence Agent to Reduce Cancer Distress of Patients Undergoing Radiotherapy: A Mixed-Methods Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06636188
- Acronym / sponsor ID
- Digi-Coach / KC/KE-23-0116/ER-4
- Conditions
- Head and Neck Cancer
- Keywords
- chatbot, digital health, oncology care
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Queen Mary Hospital, Hong Kong, Queen Elizabeth Hospital, Hong Kong
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 10 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Other: Digi-Coach ChatbotParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- insufficient command of Chinese
- have any other factors precluding the ability to give informed consent or comply with the protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digi-Coach ChatbotParticipants 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. | Other | Digi-Coach Chatbot Arm |
Primary outcome
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.
2 secondary outcomes
Memorial Symptom Assessment Scale
Time frame: 1 week, 8 weeks, and 12 weeks
Functional Assessment of Cancer Therapy-Head and Neck
Time frame: 1 week, 8 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: No. 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.
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Head and Neck Cancer (H&N)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Tongyao Wang, PhD principal investigator
The University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digi-Coach Chatbot in people with Head and Neck Cancer, run by The University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tongyao Wang, PhD (852-39102790, tongyao1@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
National Comprehensive Cancer Network Distress Thermometer (time frame: 1 week, 8 weeks, and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.