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Trial Title:
A Chatbot to Reduce Physical and Psychological Distress of Patients With Head and Neck Cancer Undergoing Radiotherapy
NCT ID:
NCT06636188
Condition:
Head and Neck Cancer
Conditions: Official terms:
Head and Neck Neoplasms
Conditions: Keywords:
chatbot
digital health
oncology care
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Digi-Coach Chatbot
Description:
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.
Arm group label:
Digi-Coach Chatbot Arm
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The University of Hong Kong
Address:
City:
Hong Kong
Zip:
000000
Country:
Hong Kong
Start date:
March 30, 2024
Completion date:
November 2028
Lead sponsor:
Agency:
The University of Hong Kong
Agency class:
Other
Collaborator:
Agency:
Queen Mary Hospital, Hong Kong
Agency class:
Other
Collaborator:
Agency:
Queen Elizabeth Hospital, Hong Kong
Agency class:
Other
Source:
The University of Hong Kong
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636188
