NCT06207474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
148

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 18, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2023

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 8, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 17, 2024

Completed
Last Updated

January 17, 2024

Status Verified

January 1, 2024

Enrollment Period

12 months

First QC Date

December 8, 2023

Last Update Submit

January 4, 2024

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • STAI-X(State-Trait Anxiety Inventory for Adults)

    baseline, before radiation therapy, after all radiation, an average of 1 month

  • LASA(Linear Analog Scale Assessments)

    baseline, before radiation therapy, after all radiation, an average of 1 month

Study Arms (4)

Video + Chatbot

OTHER
Other: Video + Chatbot

Video + Paper

OTHER
Other: Video + Paper

Paper + Chatbot

OTHER
Other: Paper + Chatbot

Paper + Paper

OTHER
Other: Paper + Paper

Interventions

Video + ChatbotOTHER

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 + Chatbot
Video + PaperOTHER

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.

Video + Paper
Paper + ChatbotOTHER

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 + Chatbot
Paper + PaperOTHER

Participants will receive detailed information about the radiation therapy process, potential side effects, frequently asked questions, and aftercare instructions using paper materials.

Paper + Paper

Eligibility Criteria

Age20 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A breast cancer patient scheduled for radiation therapy after radical surgery.
  • Subjects must have the cognitive ability to use smartphone.
  • Age ≥ 20 year old

You may not qualify if:

  • Patients with visual or auditory impairment.
  • Subjects do not consent to participate in this study.
  • Pregnancy, fetus, newborn, underage
  • Age ≥ 75 year old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yonsei Cancer Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Videotape RecordingPaper

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevisionManufactured Materials

Study Officials

  • Yong Bae Kim

    Yonsei Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2023

First Posted

January 17, 2024

Study Start

April 18, 2022

Primary Completion

April 7, 2023

Study Completion

April 18, 2023

Last Updated

January 17, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)