A Chatbot to Reduce Physical and Psychological Distress of Patients With Head and Neck Cancer Undergoing Radiotherapy
- Conditions
- Head and Neck Cancer
- Registration Number
- NCT06636188
- Lead Sponsor
- The University of Hong Kong
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 138
- 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
- insufficient command of Chinese
- have any other factors precluding the ability to give informed consent or comply with the protocol
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (1)
The University of Hong Kong
🇭🇰Hong Kong, Hong Kong
The University of Hong Kong🇭🇰Hong Kong, Hong Kong