Head and Neck Cancer
Conditions
Keywords
chatbot, digital health, oncology care
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.
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
OTHERDigi-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.
Sponsors
The University of Hong Kong
Queen Mary Hospital, Hong Kong
Queen Elizabeth Hospital, Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Comprehensive Cancer Network Distress Thermometer | 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
| Measure | Time frame | Description |
|---|---|---|
| Memorial Symptom Assessment Scale | 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). |
| Functional Assessment of Cancer Therapy-Head and Neck | 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. |
Countries
Hong Kong
Contacts
CONTACTTongyao Wang, PhD
PRINCIPAL_INVESTIGATORTongyao Wang, PhD
The University of Hong Kong
Outcome results
None listed