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

Not Applicable

Completed

• Conditions: Breast Neoplasms
• Interventions: Other: Paper + Paper; Other: Video + Chatbot; Other: Video + Paper; Other: Paper + Chatbot

• Registration Number: NCT06207474
• Lead Sponsor: Yonsei University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-04-18
• Primary Completion: 2023-04-07
• Study Completion: 2023-04-18
• Study First Submitted: 2023-12-08
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-17
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 148

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Paper + Paper	Paper + Paper	-
Video + Chatbot	Video + Chatbot	-
Video + Paper	Video + Paper	-
Paper + Chatbot	Paper + Chatbot	-

Primary Outcome Measures

Name	Time	Method
APAIS(Amsterdam Preoperative Anxiety and Information Scale)	baseline, before radiation therapy, after all radiation, an average of 1 month	The Amsterdam Preoperative Anxiety and Information Scale (APAIS): The APAIS consists of six self-reported items, primarily assessing anxiety associated with anesthesia and surgery.

Secondary Outcome Measures

Name	Time	Method
STAI-X(State-Trait Anxiety Inventory for Adults)	baseline, before radiation therapy, after all radiation, an average of 1 month	The STAI is a widely recognized self-report instrument for gauging anxiety levels.
LASA(Linear Analog Scale Assessments)	baseline, before radiation therapy, after all radiation, an average of 1 month	LASA is a tool to measure a patient's self-assessment of various aspects of their health and wellbeing.

Trial Locations

Locations (1)

Yonsei Cancer Center; 🇰🇷 Seoul, Korea, Republic of