NCT07477938

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
May 2026Sep 2026

First Submitted

Initial submission to the registry

February 26, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 17, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

March 17, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

February 26, 2026

Last Update Submit

March 13, 2026

Conditions

Keywords

cancer awareness and prevention educationintellectual disablityroboticsbreast self examination

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Anxiety level related to checking for red flag symptoms (pre/post) using a 5-point visual faces scale validated/adapted for ID populations

    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.

    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.

    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.

    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.

    At baseline and post intervention -immediately after the final education session

  • +2 more secondary outcomes

Study Arms (1)

ARM A

EXPERIMENTAL

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

Interventions

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

ARM A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Galway

Galway, H91 YR 71, Ireland

Location

Related Publications (11)

  • 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

    BACKGROUND
  • 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.

    BACKGROUND
  • 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

    BACKGROUND
  • 8. Feil-Seifer, D., & Matarić, M. J. (2011). Socially assistive robotics. IEEE Transactions on Autonomous Mental Development, 3(1), 88-103.

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 3. Scassellati, B., Admoni, H., & Matarić, M. (2018). Robots for use in autism research. Annual Review of Biomedical Engineering, 20, 275-294

    BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Intellectual DisabilityBreast Self-Examination

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodevelopmental DisordersMental DisordersSelf-ExaminationHealth BehaviorBehavior

Study Officials

  • Veronica McInerney, RN,PhD

    University of Galway

    PRINCIPAL INVESTIGATOR
  • Aoife Lowery, MB,FRCS,PhD

    University of Galway

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aoife Lowery, MB,FRCS,PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a single-arm, open-label, non-randomized pilot feasibility trial conducted at a single community site with support from Galway University Hospital Cancer Services and University of Galway Research team. Approximately 25 adults with ID will receive the robot ' Pepper'-led education intervention addressing both breast and colorectal cancer awareness. This a pragmatic pilot study to inform a future larger controlled clinical trial.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

February 26, 2026

First Posted

March 17, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

March 17, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Raw Anonymized Datasets: Coded data with Personal Health Information (PHI) removed will be shared.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Unending beginning after data analysis
Access Criteria
data repository
More information

Locations