A Chatbot to Reduce Physical and Psychological Distress of Patients With Head and Neck Cancer Undergoing Radiotherapy

The University of Hong Kong (HKU)

Status: Active, not recruiting

Conditions: Head and Neck Cancer

Treatments: Other: Digi-Coach Chatbot

Study type: Interventional

Funder types: Other

Identifiers

NCT06636188

KC/KE-23-0116/ER-4

Details and patient eligibility

About

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.

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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138 participants in 2 patient groups

Treatment-As-Usual Arm

No Intervention group

Description:

Participants in the Treatment-As-Usual group will receive routine onsite nursing care in which the nurse discusses general knowledge of self-care behaviors regarding the management of radiotherapy-related side effects.

Digi-Coach Chatbot Arm

Experimental group

Description:

Participants in Digi-Coach Chatbot Arm will have access to the Digi-Coach chatbot in addition to usual care. The research nurse will provide training on how to use the chatbot.

Treatment:

Other: Digi-Coach Chatbot