Menu
Not yet recruiting NCT07477938

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

No phase Interventional Cancer Awareness and Prevention Education Breast Cancer Awareness Intellectual Disabilities (F70-F79)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robot delivered Education.
Who it may be relevant to
Registry conditions: Cancer Awareness and Prevention Education, Breast Cancer Awareness, Intellectual Disabilities (F70-F79). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ireland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Interventions

  • 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

Primary outcome measures

  • Change in cancer awareness knowledge score range from pre- to post-intervention (immediate), [Time frame: Before enrolment and post intervention -immediately after the final education session]
Secondary outcome measures (7)
  • Anxiety level related to checking for red flag symptoms (pre/post) using a 5-point visual faces scale validated/adapted for ID populations [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: At baseline and post intervention -immediately after the final education session]
  • The acceptability of using a robot assisted educational program [Time frame: At end of study]
  • The usability of a robot system for delivery of an educational program [Time frame: At end of study]

Eligibility criteria

Inclusion criteria

  • Adults (≥18 years) with an intellectual disability requiring any level of support needs.
  • Able to provide informed consent, or where capacity is limited, able to assent with decision support in line
  • Attending the disability service day center.
  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Ireland · 1 center
  • University Hospital Galway — Galway

Publications

  • Ortigosa Quiles JM, Garcia-Banda Garcia G, Chellew K, Ponsell Vicens E, Riquelme Marin A, Nicolas Carrasco MP. Identification of degrees of anxiety in children with three- and five-face facial scales. Psicothema. 2013;25(4):446-51. doi: 10.7334/psicothema2012.287. PMID 24124776
  • 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

Identifiers

NCT: NCT07477938 · Galway01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗