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Breast Cancer Early Stage Breast Cancer (Stage 1-3)BC-CHATNCT06943911

Reflects the Intervention (AI Chatbot)

A study testing AI Chatbot for Breast Cancer Patient Education and Empowerment in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Mostafa Shaban at 1 site in Egypt.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
AI Chatbot for Breast Cancer Patient Education and Empowerment
Could I receive a placebo?
No, everyone receives an active treatment
How many people
122 participants
Where
1 siteEgypt
Study dates
20 Apr 2025to 15 Jul 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Egypt1 site
  • Faculty of Nursing Cairo University

    Cairo

    marwa mamdouh, phd, 00201067612255, marwa.mamdouh@cu.edu.eg

Other trials in Egypt

About this study

Official title: 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:

Read more

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).

Read the 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.

Being tested
AI Chatbot for Breast Cancer Patient Education and Empowerment
Keywords
AI Chatbot, Breast Cancer, Patient Education, Empowerment, Oncology Nursing, Attitudes Toward AI, Digital Health, Patient Support
Medical subject headings
Breast Neoplasms, Empowerment

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AI Chatbot for Breast Cancer Patient Education and EmpowermentBehavioural

    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.

Study groups in NCT06943911
Study groupRoleWhat they receive
Intervention Group (AI Chatbot + Standard Care)ExperimentalParticipants 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
Receives: Behavioral: AI Chatbot for Breast Cancer Patient Education and Empowerment
Control Group (Standard Care Only)No interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Breast Cancer Knowledge Improvement

    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.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2025
  2. Study start20 Apr 2025 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion15 Jul 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
122 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06943911
Sponsor's protocol ID
KFSU-BC-AI-2025
Acronym
BC-CHAT
Status last verified
Apr 2025
First submitted
17 Apr 2025
Last updated
25 Apr 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • Janopaul-Naylor JR, Koo A, Qian DC, McCall NS, Liu Y, Patel SA. Physician Assessment of ChatGPT and Bing Answers to American Cancer Society's Questions to Ask About Your Cancer. Am J Clin Oncol. 2024 Jan 1;47(1):17-21. doi: 10.1097/COC.0000000000001050. Epub 2023 Oct 12.

    PubMed 37823708
  • Siglen E, Vetti HH, Lunde ABF, Hatlebrekke TA, Stromsvik N, Hamang A, Hovland ST, Rettberg JW, Steen VM, Bjorvatn C. Ask Rosa - The making of a digital genetic conversation tool, a chatbot, about hereditary breast and ovarian cancer. Patient Educ Couns. 2022 Jun;105(6):1488-1494. doi: 10.1016/j.pec.2021.09.027. Epub 2021 Oct 6.

    PubMed 34649750
  • Agrawal A. Fairness in AI-Driven Oncology: Investigating Racial and Gender Biases in Large Language Models. Cureus. 2024 Sep 16;16(9):e69541. doi: 10.7759/cureus.69541. eCollection 2024 Sep.

    PubMed 39416584
  • Ma Y, Achiche S, Pomey MP, Paquette J, Adjtoutah N, Vicente S, Engler K; MARVIN chatbots Patient Expert Committee; Laymouna M, Lessard D, Lemire B, Asselah J, Therrien R, Osmanlliu E, Zawati MH, Joly Y, Lebouche B. Adapting and Evaluating an AI-Based Chatbot Through Patient and Stakeholder Engagement to Provide Information for Different Health Conditions: Master Protocol for an Adaptive Platform Trial (the MARVIN Chatbots Study). JMIR Res Protoc. 2024 Feb 13;13:e54668. doi: 10.2196/54668.

    PubMed 38349734
  • Chang YC, Wu CH, Lupo R, Botti S, Conte L, Vitone M, Massafra R, De Nunzio G, Vitale E. Generative Artificial Intelligence (AI) to Uncover Insights From Breast Cancer Patients' Perceptions to Mindfulness-Based Stress Reduction (MBSR) Interventions. Holist Nurs Pract. 2025 Sep-Oct 01;39(5):317-325. doi: 10.1097/HNP.0000000000000677. Epub 2025 Aug 13.

    PubMed 39186509
  • Sato A, Haneda E, Hiroshima Y, Narimatsu H. Preliminary Screening for Hereditary Breast and Ovarian Cancer Using an AI Chatbot as a Genetic Counselor: Clinical Study. J Med Internet Res. 2024 Nov 27;26:e48914. doi: 10.2196/48914.

    PubMed 39602801
  • Shaban M, Osman YM, Mohamed NA, Shaban MM. Empowering breast cancer clients through AI chatbots: transforming knowledge and attitudes for enhanced nursing care. BMC Nurs. 2025 Jul 29;24(1):994. doi: 10.1186/s12912-025-03585-w.

    PubMed 40731340

Questions about this trial

What is this clinical trial studying?

A study testing AI Chatbot for Breast Cancer Patient Education and Empowerment in people with Breast Cancer Early Stage Breast Cancer (Stage 1-3), run by Mostafa Shaban at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mostafa shaban, phd (+966565644617, mostafa.shaban2020@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Breast Cancer Knowledge Improvement (time frame: 2 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06943911, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.

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