Clinical trial NCT06943911: Reflects the Intervention (AI Chatbot)
Official title: Empowering Breast Cancer Clients Through AI Chatbots: Transforming Knowledge and Attitudes for Enhanced Nursing Care
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
Keywords: AI Chatbot
Breast Cancer
Patient Education
Empowerment
Oncology Nursing
Attitudes Toward AI
Digital Health
Patient Support
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-04-25
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study uses a quasi-experimental, parallel group design, where one group receives an AI chatbot intervention alongside standard care, while the other group receives only standard care. The groups will be compared to measure the intervention's effectiveness on knowledge improvement, AI attitudes, and empowerment.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Breast Cancer Knowledge Improvement
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Nursing Cairo University
Study officials:
References:
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