A Single-Arm Interventional Trial of Pepper- Robot Delivered Cancer Education for Adults With Intellectual Disability (Pep-SMARTID)

Pilot Single Arm Clinical Trial of Pepper, a Semi Humanoid Robot -Delivered Cancer Awareness and Education Intervention for Adults With Intellectual Disability

Individuals with Intellectual disability face numerous barriers to cancer education, awareness and screening, including communication challenges, anxiety, and a lack of accessible educational resources. Traditional methods often fail to meet their unique learning needs, contributing to lower screening rates , delayed diagnoses and poorer outcomes..

Socially assistive robots, have demonstrated effectiveness in delivering interactive, engaging, and tailored education, helping individuals with cognitive impairments better understand medical procedures and the importance of preventive care.

The study investigators propose to conduct a pilot single arm clinical trial with a semi humanoid robot to deliver cancer awareness education to adults with intellectual disability attending a disability day service in Ireland .The semi humanoid robot will be programmed to engage in 2 way communication about the cancer related educational content that is uploaded on its system.

.Approximately 25 adults with ID will receive the robot led educational intervention addressing both breast and colorectal cancer awareness and screening. This a pragmatic pilot study to inform a future larger controlled clinical trial Our overall objective is to Improve breast and colorectal cancer awareness knowledge level among adults with ID receiving a robot-delivered education intervention

Study Overview

• Status: Not yet recruiting
• Conditions: Intellectual Disabilities (F70-F79); Cancer Awareness and Prevention Education; Breast Cancer Awareness
• Intervention / Treatment: Other: Robot delivered Education

Detailed Description

Individuals with intellectual disabilities (ID) face significant barriers in accessing healthcare education, including, challenges in understanding complex medical information and communicating with healthcare providers and anxiety1 Traditional methods of education delivery often fail to meet the unique learning needs of this population. Cancer screening is particularly affected by these barriers, leading to lower participation rates and delayed diagnoses 2 Socially assistive robots have demonstrated effectiveness in delivering interactive, engaging, and tailored education, helping individuals with cognitive impairments better understand medical procedures and the importance of preventive care. The integration of robotics in cancer awareness education offers a promising solution by providing an appealing and accessible learning experiences tailored to individuals with ID.

A number of studies have been conducted to investigate the use of social robots in healthcare learning .Findings demonstrate that technology which utilises artificial intelligence, speech recognition, and interactive displays enhance learning among individuals with cognitive impairments3 .A randomised controlled trial conducted in 2021 found the physical presence of the robot played a key role in engaging adults with ID and was valuable in learning as a facilitator of communication4.

Robots can simplify cancer awareness concepts using visual aids, step-by-step explanations, and gamification techniques to improve comprehension and retention. Additionally, research has shown that robots provide a non-judgmental and anxiety-free environment, making it easier for individuals with ID to engage with health education materials5,6.They also positively influence health behaviours and encourage proactive awareness participation7 Interactive robotic assistants have been shown to improve knowledge retention and promote adherence to medical recommendations among individuals with ID 8 Additionally it has also been demonstrated that social robots increase motivation in people with ASD when participating in educational activity9 By fostering independent learning and reducing healthcare disparities, robotics-based education represents a transformative approach to promoting cancer awareness screening and early detection.

'Breaking down Barriers' report10 (2023) is an assessment of the needs of disabled people in accessing cancer awareness services in Ireland. Recommendations to enhance cancer awareness in this population include person centred training and education using materials and assistive technologies to enhance delivery.

To this end the investigators plan to conduct a pilot a clinical trial to deliver Cancer Awareness and Prevention Education using the robot 'Pepper'. The trial will be conducted in collaboration with partners at the Brothers of Charity and colleagues at University of Galway, Galway University Hospital cancer services with support from the National Breast Cancer Research Institute ( NBCRI) ensuring co-design, implementation fidelity, and translation to routine care.

Cancer awareness resources already established by the National Cancer screening service will be utilised.

This pilot will assess feasibility, acceptability, and preliminary effectiveness of a robot-led education intervention to improve knowledge, reduce anxiety, and encourage participation in population-based cancer awareness programmes.

The project aligns with the Irish National Screening Service (NSS) programmes (e.g., Breast Check and Bowel Screen) and leverages accessible educational materials already established by NSS, adapted for delivery by Pepper.

Co-design workshops with adults with ID, caregivers, and Limelight staff will inform: content selection, accessible wording, imagery, session pacing, and anxiety supports. PPI contributors will review the easy-read materials and pilot the interaction flow on Pepper.

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronica McInerney, RN,PhD; Phone Number: +353 91494031; Email: veronica.mcinerney@universityofgalway.ie
• Study Contact Backup: Name: Aoife Lowery, MB,FRCS,PhD; Phone Number: +353 91 493033; Email: alowery@universityofgalway.ie

Study Locations

• Ireland
  • Galway, Ireland, H91 YR 71
    • University Hospital Galway
    • Contact: Veronica B McInerney, PhD; Phone Number: +353 91 494031; Email: veronica.mcinerney@universityofgalway.ie
    • Contact: Aoife Lowery, MB,FRCS,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Adults (≥18 years) with an intellectual disability requiring any level of support needs.
2. Able to provide informed consent, or where capacity is limited, able to assent with decision support in line
3. Attending the disability service day center.
4. Sufficient receptive/expressive communication (with supports) to participate in interactive sessions

Exclusion Criteria:

1 Severe sensory impairments that cannot be reasonably accommodated (e.g., profound hearing/vision loss without assistive solutions available for the session).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ARM A; Each participant will receive at two ( or more if required) Pepper Robot sessions approx. 10-15 minutes delivered within a 2-week window, in small groups (2-5) or individually as needed. Breast cancer awareness and breast examination training will be delivered via pepper. Participants will use the breast examination mannequin and also the breast awareness shower card to enhance learning about performing self breast -examination Colorectal cancer awareness information and red flag symptoms will also be delivered via pepper

Other: Robot delivered Education; Two Pepper Robot educational sessions , each approx. 10-15 minutes in duration delivered within a 2-week window, to small groups (2-5) or individually if needed, to people with intellectual disability Breast cancer awareness and breast examination training will be delivered via the robot pepper. Participants will use the breast examination mannequin and also the breast awareness shower card to enhance learning about performing self breast -examination Colorectal cancer awareness information and red flag symptoms will also be delivered via pepper

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in cancer awareness knowledge score range from pre- to post-intervention (immediate),	Easy-read Knowledge Questionnaire (breast & bowel awareness, 10-15 items each, pictorial supports, multiple choice/true-false.	Before enrolment and post intervention -immediately after the final education session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety level related to checking for red flag symptoms (pre/post) using a 5-point visual faces scale validated/adapted for ID populations	Visual Faces Anxiety Scale (3 -point) will measure anxiety levels	At baseline and post intervention -immediately after the final education session
Intention to check for red flag symptoms (pre/post) on a 5-point pictorial Likert scale.	Smiley face Likert scale (1-5) will measure assessment of intention to check for red flag symptoms and conduct self breast examinations (3)	At basline and post intervention -immediately after the final education session
Participant experience of the semi-humanoid robot to deliver the educational program via short structured questionnaire.	Participant Experience Smiley Face Survey will be used to assess the participants in using the semi humanoid robot Pepper to deliver cancer awareness education	At baseline and post intervention -immediately after the final education session
Participant acceptability of the semi-humanoid robot to deliver the educational program via short structured questionnaire.	Smiley Face Survey will be used to assess the participants acceptability in using the semi humanoid robot Pepper to deliver cancer awareness education.	At baseline and post intervention -immediately after the final education session
Participant reported usability of the semi-humanoid robot to deliver the educational program via short structured questionnaire.	Smiley Face Survey will be used to assess participants percieved usability of the semi humanoid robot Pepper to deliver cancer awareness education.	At baseline and post intervention -immediately after the final education session
The acceptability of using a robot assisted educational program	System Assessment for Staff and Professionals survey -6 point questionairre.	At end of study
The usability of a robot system for delivery of an educational program	System Usability Scale (SUS)	At end of study

Collaborators and Investigators

• Sponsor: National University of Ireland, Galway, Ireland
• Collaborators: University College Hospital Galway; Brothers of Charity Services Galway Ireland
• Investigators: Principal Investigator: Veronica McInerney, RN,PhD, University of Galway; Principal Investigator: Aoife Lowery, MB,FRCS,PhD, University of Galway

Publications and helpful links

General Publications

• 11. Ortigosa Quiles JM, Garcia-Banda García G, Chellew K, Ponsell Vicens E, Riquelme Marín A, Nicolás Carrasco MP. Identification of degrees of anxiety in children with three- andfive-face facial scales. Psicothema 2013;25:446-51
• 10. Cithambara k, Corby, D., & Hartnett, L ., Healy S., Joyce, D (2023). Breaking Down Barriers: An Assessment of the Needs of Disabled People in Accessing Population-Based Awareness Services in Ireland. 10.13140/RG.2.2.26735.82085.
• 9. Desideri, L., Negrini, M., Malavasi, M. et al. Using a Humanoid Robot as a Complement to Interventions for Children with Autism Spectrum Disorder: a Pilot Study. Adv Neurodev Disord 2, 273-285 (2018). https://doi.org/10.1007/s41252-018
• 8. Feil-Seifer, D., & Matarić, M. J. (2011). Socially assistive robotics. IEEE Transactions on Autonomous Mental Development, 3(1), 88-103.
• 7. Papadopoulos, C., Koulouglioti, C., Ali, S., & Manthorpe, J. (2020). Promoting cancer awareness uptake for people with intellectual disabilities. BMC Public Health, 20(1), 1425
• 6. Jordan A. Mann, Bruce A. MacDonald, I.-Han Kuo, Xingyan Li, Elizabeth Broadbent,People respond better to robots than computer tablets delivering healthcare instructions, Computers in Human Behavior, Volume 43,2015,Pages 112-117,ISSN 0747-5632,https://doi.org/10.1016/j.chb.2014.10.029
• 5. Moyle, W., Jones, C., Cooke, M., O'Dwyer, S., Sung, B., & Drummond, S. (2017). Social robots helping people with dementia. Journal of Clinical Nursing, 26(23-24), 4765-4776
• 4. Mitchell, A., Sitbon, L., Balasuriya, S.S., Koplick, S., Beaumont, C. (2021). Social Robots in Learning Experiences of Adults with Intellectual Disability: An Exploratory Study. In: Ardito, C., et al. Human-Computer Interaction - INTERACT 2021. INTERACT 2021. Lecture Notes in Computer Science(), vol 12932. Springer, Cham. https://doi.org/10.1007/978-3-030-85623-6_17
• 3. Scassellati, B., Admoni, H., & Matarić, M. (2018). Robots for use in autism research. Annual Review of Biomedical Engineering, 20, 275-294
• 2. Flynn, S., Hulbert-Williams, N. J., Bramwell, R., & Stevens-Gill, D. (2015). Beliefs about cancer and health behaviors among individuals with intellectual disabilities. Journal of Applied Research in Intellectual Disabilities, 28(1), 36-45.
• 1. Tuffrey-Wijne, I., Curfs, L., Finlay, I., Hollins, S., & Bernal, J. (2018). Cancer care for people with intellectual disabilities. European Journal of Oncology Nursing, 35, 25-30.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: March 13, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 17, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: robotics; breast self examination; cancer awareness and prevention education; intellectual disablity
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Health Behavior; Self-Examination; Intellectual Disability; Breast Self-Examination
• Other Study ID Numbers: Galway01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Raw Anonymized Datasets: Coded data with Personal Health Information (PHI) removed will be shared.
• IPD Sharing Time Frame: Unending beginning after data analysis
• IPD Sharing Access Criteria: data repository
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No