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

January 4, 2024 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

148

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Video + Chatbot
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.
Other: Video + Paper
Other: 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.
Other: Paper + Chatbot
Other: 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.
Other: Paper + Paper
Other: Paper + Paper
Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using paper materials.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
APAIS(Amsterdam Preoperative Anxiety and Information Scale)
Time Frame: 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.
baseline, before radiation therapy, after all radiation, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
STAI-X(State-Trait Anxiety Inventory for Adults)
Time Frame: 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.
baseline, before radiation therapy, after all radiation, an average of 1 month
LASA(Linear Analog Scale Assessments)
Time Frame: 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.
baseline, before radiation therapy, after all radiation, an average of 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Yong Bae Kim, Yonsei Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2022

Primary Completion (Actual)

April 7, 2023

Study Completion (Actual)

April 18, 2023

Study Registration Dates

First Submitted

December 8, 2023

First Submitted That Met QC Criteria

January 4, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 4, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2022-0044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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