Clinical trial NCT06481527: Seen and Be Heard: Ensuring Fair Cancer Care for All Children
Official title: The Seen and Be Heard Study: Identifying the Barriers and Facilitators to Ensuring Equitable Cancer Care for Children With and Without a Learning Disability and/or Autism Spectrum Condition.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Cancer
Oncology
Haematological Malignancy
Lead sponsor: Great Ormond Street Hospital for Children NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University College London Hospitals
First posted: 2024-07-01
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Work package 1

A) National staff survey

Inclusion criteria:

* Healthcare professionals involved in cancer care delivery
* UK based

Exclusion criteria:

Outside stated of location

B) Organisational survey

Inclusion criteria:

- Clinical service leads

C) Anonymised retrospective electronic case note review

Inclusion criteria:

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)

Inclusion criteria

* Children and Young people receiving cancer care, with/without learning disability and or who are autistic at hospital research site
* Ages 5-15

Exclusion criteria

* 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:

Inclusion

* Of children receiving cancer care in hospital research site
* If included for interview only, child's age may be aged 0-16
* Conversational English

Exclusion - Has mental health difficulties that would impair ability to participate effectively or create an unmanageable risk e.g. psychosis

Healthcare professionals:

Inclusion

- Service providers of cancer care at hospital research site

Primary outcomes:
measure: Cross-sectional Staff Survey
timeFrame: 6 months
measure: Length of hospital stay
timeFrame: 2017-2023
measure: Mortality
timeFrame: 2017-2023
measure: Symptom management profiles: e.g. pain, constipation, nausea and vomiting
timeFrame: 2017-2023
measure: Cross-sectional Organisational Survey
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: