Reflects the Intervention (AI Chatbot)

Not Applicable

Not yet recruiting

• Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)

• Registration Number: NCT06943911
• Lead Sponsor: Mostafa Shaban

Brief Summary

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).

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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-17
• Study First Submitted QC: 2025-04-17
• Last Update Submitted: 2025-04-17
• Study Start: 2025-04-20
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25
• Primary Completion: 2025-07-01
• Study Completion: 2025-07-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 122

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Breast Cancer Knowledge Improvement	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.

Trial Locations

Locations (1)

Faculty of Nursing Cairo University; 🇪🇬 Cairo, Egypt