Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636188
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
A Chatbot to Reduce Physical and Psychological Distress of Patients With Head and Neck Cancer Undergoing Radiotherapy
Sponsor:
None
Organization:
None
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None