Clinical trial NCT06636188: A Chatbot to Reduce Physical and Psychological Distress of Patients With Head and Neck Cancer Undergoing Radiotherapy
Official title: Novel Artificial Intelligence Patient Navigator Chatbot to Reduce Physical and Psychological Distress of Patients With Head and Neck Cancer Undergoing Radiotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Keywords: chatbot
digital health
oncology care
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Queen Elizabeth Hospital, Hong Kong
First posted: 2024-10-10
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_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.

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

Primary outcomes:
measure: National Comprehensive Cancer Network Distress Thermometer
timeFrame: 1 week, 8 weeks, and 12 weeks
Secondary outcomes:
measure: Memorial Symptom Assessment Scale
timeFrame: 1 week, 8 weeks, and 12 weeks
measure: Functional Assessment of Cancer Therapy-Head and Neck
timeFrame: 1 week, 8 weeks, and 12 weeks
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: The University of Hong Kong
name: Tongyao Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References: