An Oncology Nurse AI Agent to Reduce Cancer Distress During Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Digi-Coach Chatbot.
- Who it may be relevant to
- Registry conditions: Head and Neck Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hong Kong
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
An Oncology Nurse Artificial Intelligence Agent to Reduce Cancer Distress of Patients Undergoing Radiotherapy: A Mixed-Methods Randomized Controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- National Comprehensive Cancer Network Distress Thermometer [Time frame: 1 week, 8 weeks, and 12 weeks]
Secondary outcome measures (2)
- 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]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Supportive care
Study locations
Hong Kong · 2 centers
- The University of Hong Kong — Hong Kong
- Queen Mary Hospital — Hong Kong
Identifiers
NCT: NCT06636188 · KC/KE-23-0116/ER-4