Seen and Be Heard: Ensuring Fair Cancer Care for All Children

NCT06481527 | Not Yet Recruiting

• 1 other identifier: 22CB16
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Introduction: Research has routinely been conducted into the experiences and well-being of children and young people with cancer and their families. However, there is little research that directly involves those with learning disabilities (LD) and or who are autistic. This is despite some cancers being more far more prevalent in some syndromes associated with learning disabilities, for example Downs Syndrome. More generally paediatric hospital care, recent research has highlighted inequity for children with LD, compared with children and young people without LD. Staff often feel less capable and confident to deliver care to those with learning disabilities, as well as having less capacity. Still less is known about cancer care for autistic children and young people, for example relating to symptom management. We aim to explore how inequity might present in cancer care for children and young people aged 5-15 years with and without LD and or who are autistic to see what inequities exist, for whom, why and in what circumstances. Methods and analysis: A transformative mixed methods design will be used, comprising an individual staff and organisational level survey, retrospective case note review, ethnographic observations of clinical care, family and staff interviews, and participatory workshops. The ethnographer will follow and observe individual children and their families. A 'toolbox' of creative participatory methods will be employed, including providing a co-designed research data collection journal to support elicitation of the child's perspective. Ethics and Dissemination: The study will run from September 2024 to January 2026. Health Research Authority approval is granted (REC Reference no. 24/LO/0410 \| IRAS Project ID: 335623) for work package 2 and 3 involving the ethnography, with interviews and workshops.

Conditions

Cancer; Oncology; Haematological Malignancy

Outcome Measures

Primary Outcomes (5)

• Cross-sectional Staff Survey

  Purpose designed survey to provide staff perspectives around capacity, capability and confidence in delivering cancer care to children and young people with and without learning disabilities and or who are autistic.

  6 months

• Length of hospital stay

  Relevant to retrospective electronic case note review

  2017-2023

• Mortality

  Relevant to retrospective electronic case note review

  2017-2023

• Symptom management profiles: e.g. pain, constipation, nausea and vomiting

  Relevant to retrospective electronic case note review

  2017-2023

• Cross-sectional Organisational Survey

  Purpose designed survey to explore organisational level policies, training and implementation of interventions including making reasonable adjustments.

  6 months

Study Arms (3)

Children and young people

Children and young people aged 5-15 with or without learning disabilities or autism that are receiving cancer care.

Parents

Parents of eligible children and young people aged 5-15 with or without learning disabilities or autism that are receiving cancer care.

Healthcare Staff

Healthcare staff that provide cancer care services to children and young people.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The aim of this study is to recruit approximately up to 50 participants across the different groups within the ethnography work package with approximately equal healthcare professionals to parents / children and young people. Many participants will be involved only in interviews. For every child without LD/ASC, two children with LD/ASC will be recruited. Healthcare professionals that provide cancer care will make up approximately half of this sample and it will be ensured that they do not outnumber family participants. It is estimated up to 12-16 (6-8 with learning disability and or who are autistic and 4-6 without LD or autism) participants in the ethnography will be required, with a further 10 in-depth parent interviews. Staff interviews will be conducted with up to 25 staff members. This number will allow breadth of exploration while remaining feasible for this work package.

You may qualify if:

• Healthcare professionals involved in cancer care delivery
• UK based

You may not qualify if:

• Outside stated of location
• B) Organisational survey
• \- Clinical service leads
• C) Anonymised retrospective electronic case note review
• Children and Young aged 0-16 with Cancer diagnosis between April 2017 - present, within one large children's hospital site.
• Work Package 2 - Ethnography study (including interviews)
• Children and Young people receiving cancer care, with/without learning disability and or who are autistic at hospital research site
• Ages 5-15
• Within palliative care at the time of recruitment
• Subject to child safeguarding proceedings
• Outside of stated age range
• Children who have not been disclosed their cancer diagnosis and where their family would prefer to maintain a complete non-disclosure approach
• Parents:
• Of children receiving cancer care in hospital research site
• If included for interview only, child's age may be aged 0-16

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• University College London Hospitals: collaborator

Related Publications (1)

• Oulton K, Wray J, Foo-Caballero M, Flynn S, Harniess P, Rao A, Gibson F. The seen and be heard study: A national mixed methods study to identify the barriers and facilitators to ensuring equitable cancer care for children with and without learning disabilities and/or who are autistic - Protocol Paper. PLoS One. 2025 Nov 19;20(11):e0333020. doi: 10.1371/journal.pone.0333020. eCollection 2025.

  PMID: 41259352 DERIVED

MeSH Terms

Conditions

Neoplasms; Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Kate Oulton, PhD

CONTACT

02074059200; kate.oulton@gosh.nhs.uk

Phillip Harniess, PhD

CONTACT

phillip.harniess@gosh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: FAMILY BASED
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2024
• First Posted: July 1, 2024
• Study Start: September 2, 2024
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06