Reflects the Intervention (AI Chatbot) (BC-CHAT)

April 17, 2025 updated by: Mostafa Shaban

Empowering Breast Cancer Clients Through AI Chatbots: Transforming Knowledge and Attitudes for Enhanced Nursing Care

The goal of this clinical trial is to investigate the impact of an AI-powered chatbot intervention on improving knowledge, attitudes, and empowerment in breast cancer patients. The study focuses on female breast cancer patients, aged 18 years or older, who are receiving treatment at Kafr El-Sheikh University Hospital in Egypt.

The main questions it aims to answer are:

Can the AI chatbot intervention improve breast cancer knowledge compared to standard care?

Can the AI chatbot intervention positively influence attitudes toward AI in healthcare?

Does the AI chatbot intervention enhance patient empowerment in managing breast cancer?

Researchers will compare:

Intervention group (AI chatbot + standard care) to control group (standard care alone) to see if the AI chatbot intervention leads to greater improvements in knowledge, more positive attitudes towards AI, and higher perceived empowerment.

Participants will:

Engage with an AI-powered chatbot designed to provide personalized education on breast cancer, treatment options, and emotional support.

Complete pre- and post-intervention assessments to measure changes in knowledge, attitudes toward AI, and empowerment.

Receive standard care, including routine oncology consultations and nursing support, alongside the chatbot intervention (for the intervention group).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study explores the integration of AI-powered chatbots in breast cancer care to enhance patient education, self-management, and psychosocial support. Breast cancer is often accompanied by a range of psychological challenges, including anxiety and uncertainty about treatment options, side effects, and overall prognosis. Traditional healthcare systems struggle to provide continuous support, which is where AI technology can offer a solution by enabling 24/7 access to information and emotional support.

The study design employs a quasi-experimental approach, where 122 breast cancer patients were recruited from Kafr El-Sheikh University Hospital. Participants were randomly assigned to one of two groups:

Intervention Group (n=61): Participants in this group received standard care, which includes routine consultations with oncology specialists and nurses, in addition to an AI chatbot intervention. The chatbot delivered personalized educational content about breast cancer, treatment options, and self-care. It also offered emotional support by answering queries and providing motivational messages.

Control Group (n=61): Participants in this group received only standard care, which consisted of regular oncology consultations and nursing support without the chatbot.

The AI chatbot intervention is designed to:

Improve knowledge about breast cancer, treatment side effects, symptom management, and emotional well-being.

Foster positive attitudes toward AI in healthcare by providing a reliable, non-judgmental source of information.

Enhance empowerment by allowing patients to actively engage with their care information outside of regular hospital visits.

Participants' knowledge, attitudes toward AI, and empowerment were assessed at two time points:

Baseline (before the intervention)

Post-intervention (after 4 weeks of engaging with the chatbot)

The primary outcome of the study is to evaluate improvements in breast cancer-related knowledge, measured through a questionnaire that assesses knowledge in key areas such as early detection, treatment options, side effects, and AI's role in healthcare. The secondary outcomes focus on attitudes toward AI and perceived empowerment, assessed through validated Likert scales designed for this purpose.

This study will provide valuable insights into the feasibility and efficacy of AI-powered chatbots in enhancing patient care for breast cancer patients, especially in resource-limited settings. Furthermore, it aims to contribute to the growing body of evidence supporting the use of digital health technologies in oncology nursing and patient empowerment.

Study Type

Interventional

Enrollment (Estimated)

122

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 Contact

Study Locations

  • Egypt
      • Cairo, Egypt
        • Faculty of Nursing Cairo University
        • Contact:

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

Yes

Description

Inclusion Criteria:

Female participants diagnosed with breast cancer, regardless of cancer stage.

Age 18 years or older.

Ability to read and communicate in Arabic to interact with the AI chatbot.

Willingness to participate in the study and to engage with the AI chatbot for the duration of the intervention.

Ability to provide informed consent.

Exclusion Criteria:

Participants with cognitive impairments or serious mental health conditions that may hinder understanding or participation in the study.

Patients currently receiving palliative care, as they may prioritize symptom management over educational interventions.

Participants who are physically unable to engage with the study's digital tools or complete assessments (e.g., due to severe illness).

Individuals who are unable to communicate in Arabic, as the AI chatbot intervention is designed in Arabic.

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: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group (AI Chatbot + Standard Care)
Participants in this arm will receive standard oncology care in addition to interacting with an AI-powered chatbot. The chatbot will provide personalized educational content on breast cancer, treatment options, side effects, and offer emotional support. Participants will engage with the chatbot for 4 weeks, with assessments at baseline and post-interventi
Behavioral: AI Chatbot for Breast Cancer Patient Education and Empowerment
The AI Chatbot for Breast Cancer Patient Education and Empowerment is a digital health intervention that leverages artificial intelligence to provide personalized educational content and emotional support to breast cancer patients. The chatbot delivers information on breast cancer management, treatment options, side effects, and self-care practices. It is available 24/7, offering real-time answers to patient queries and tailored suggestions based on their treatment path. The aim is to increase patient knowledge, improve attitudes toward AI, and empower patients to take a more active role in their care. The chatbot intervention is provided alongside standard oncology care at Kafr El-Sheikh University Hospital.
No Intervention: Control Group (Standard Care Only)
Participants in this arm will receive standard oncology care only, including routine consultations with oncology specialists and nurses. They will not have access to the AI chatbot intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast Cancer Knowledge Improvement
Time Frame: 2 months
This outcome measures the change in breast cancer knowledge from baseline to post-intervention for participants who used the AI chatbot compared to the control group. Knowledge is assessed using the Artificial Intelligence of Breast Cancer Questionnaire, which covers topics such as treatment options, side effects, symptom management, and AI's role in healthcare.
2 months

Collaborators and Investigators

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

Sponsor

Mostafa Shaban

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 20, 2025

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 15, 2025

Study Registration Dates

First Submitted

April 17, 2025

First Submitted That Met QC Criteria

April 17, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

April 25, 2025

Last Update Submitted That Met QC Criteria

April 17, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSU-BC-AI-2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We currently do not plan to share individual participant data (IPD) outside of the research team due to concerns about participant confidentiality and the sensitive nature of the data collected. The study includes personal health information that is protected under ethical guidelines and privacy regulations. Additionally, sharing IPD may present challenges related to data security and informed consent, as participants have not explicitly consented to broader data sharing. However, the study's aggregate findings will be made publicly available through peer-reviewed publications and presentations

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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