Reflects the Intervention (AI Chatbot)

NCT06943911 | Not Yet Recruiting

• 1 other identifier: KFSU-BC-AI-2025
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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).

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

Outcome Measures

Primary Outcomes (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.

  2 months

Study Arms (2)

Intervention Group (AI Chatbot + Standard Care)

EXPERIMENTAL

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

Control Group (Standard Care Only)

NO INTERVENTION

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.

Interventions

AI Chatbot for Breast Cancer Patient Education and Empowerment BEHAVIORAL

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.

Intervention Group (AI Chatbot + Standard Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mostafa Shaban: lead

Study Sites (1)

Faculty of Nursing Cairo University

Cairo, Egypt

Location

Related Publications (7)

• 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.

  PMID: 37823708 BACKGROUND

• 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.

  PMID: 34649750 BACKGROUND

• 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.

  PMID: 39416584 BACKGROUND

• 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.

  PMID: 38349734 BACKGROUND

• 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.

  PMID: 39186509 BACKGROUND

• 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.

  PMID: 39602801 BACKGROUND

• 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.

  PMID: 40731340 DERIVED

MeSH Terms

Conditions

Breast Neoplasms; Empowerment

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Social Behavior; Behavior

Central Study Contacts

Mostafa shaban, phd

CONTACT

+966565644617; mostafa.shaban2020@cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr

Model Details: 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.

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 25, 2025
• Study Start: April 20, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 15, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

EG (1)