A Study on BReast Cancer Patient Care Using chAtbot and Video Education for Radiation Therapy (BRAVE)

Breast Neoplasms Clinical Trial

Official title:

A Study on BReast Cancer Patient Care Using chAtbot and Video Education for Radiation Therapy (BRAVE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06207474
• Other study ID #: 4-2022-0044
• Status: Completed
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: April 18, 2023

Study information

• Verified date: January 2024
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized trial explored whether digital media (videos and chatbots) used for patient education could more effectively reduce anxiety in breast cancer patients during radiation therapy, compared to traditional paper-based methods. Post-surgery breast cancer patients scheduled for radiation therapy were assigned to groups receiving treatment information through different media combinations. The study aimed to assess whether these modern tools more effectively ease anxiety, thus potentially improving patient compliance and treatment experience.

Description:

This study evaluates the impact of patient management and information provision using educational videos and chatbots on patient experience, satisfaction, and patient psychology in the breast cancer radiation treatment process. The experiment is designed as (2 (with or without using chatbot) X 2 (with or without using video) to distinguish groups. There is no separate treatment intervention in addition to use chatbot and video utilization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: April 18, 2023
• Est. primary completion date: April 7, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 74 Years

Eligibility

Inclusion Criteria:

1. A breast cancer patient scheduled for radiation therapy after radical surgery.

2. Subjects must have the cognitive ability to use smartphone.

3. Age = 20 year old

Exclusion Criteria:

1. Patients with visual or auditory impairment.

2. Subjects do not consent to participate in this study.

3. Pregnancy, fetus, newborn, underage

4. Age = 75 year old

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Other:
• Video + Chatbot
Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of educational videos and interactive chatbot sessions.
• Video + Paper
Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of educational videos and paper materials.
• Paper + Chatbot
Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using a combination of paper materials and interactive chatbot sessions.
• Paper + Paper
Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using paper materials.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei Cancer Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	APAIS(Amsterdam Preoperative Anxiety and Information Scale)	The Amsterdam Preoperative Anxiety and Information Scale (APAIS): The APAIS consists of six self-reported items, primarily assessing anxiety associated with anesthesia and surgery.	baseline, before radiation therapy, after all radiation, an average of 1 month
Secondary	STAI-X(State-Trait Anxiety Inventory for Adults)	The STAI is a widely recognized self-report instrument for gauging anxiety levels.	baseline, before radiation therapy, after all radiation, an average of 1 month
Secondary	LASA(Linear Analog Scale Assessments)	LASA is a tool to measure a patient's self-assessment of various aspects of their health and wellbeing.	baseline, before radiation therapy, after all radiation, an average of 1 month