CancerNCT06481527
Seen and Be Heard: Ensuring Fair Cancer Care for All Children
An observational study of Cancer and Oncology, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cancer, Oncology, Haematological Malignancy
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Sep 2024to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Healthcare professionals involved in cancer care delivery
- UK based
- Clinical service leads
- 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)
Show all 14Show fewer
- Children and Young people receiving cancer care, with/without learning disability and or who are autistic at hospital research site
- Ages 5-15
- 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:
- Service providers of cancer care at hospital research site
Who cannot join
- Outside stated of location
- Organisational survey
- 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:
Trial locations and contacts
No sites are listed yet.
Phillip Harniess, PhD contact
About this study
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.
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.
Read more
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
- Medical subject headings
- Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Length of hospital stay
Relevant to retrospective electronic case note review
Measured: 2017-2023
Mortality
Relevant to retrospective electronic case note review
Measured: 2017-2023
Symptom management profiles: e.g. pain, constipation, nausea and vomiting
Relevant to retrospective electronic case note review
Measured: 2017-2023
Cross-sectional Organisational Survey
Purpose designed survey to explore organisational level policies, training and implementation of interventions including making reasonable adjustments.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2024
- Study start2 Sep 2024 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University College London Hospitals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06481527
- Sponsor's protocol ID
- 22CB16
- Status last verified
- Jun 2024
- First submitted
- 25 Jun 2024
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41259352
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06481527
- Acronym / sponsor ID
- 22CB16
- Conditions
- Cancer, Oncology, Haematological Malignancy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Great Ormond Street Hospital for Children NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University College London Hospitals
- Study start
- 2 Sep 2024 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 1 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (14 listed)
- Healthcare professionals involved in cancer care delivery
- UK based
- Clinical service leads
- 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.
Key exclusion criteria (7 listed)
- Outside stated of location
- Organisational survey
- Within palliative care at the time of recruitment
- Subject to child safeguarding proceedings
- Outside of stated age range
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cross-sectional Staff Survey
Time frame: 6 months
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.
Length of hospital stay
Time frame: 2017-2023
Relevant to retrospective electronic case note review
Mortality
Time frame: 2017-2023
Relevant to retrospective electronic case note review
Symptom management profiles: e.g. pain, constipation, nausea and vomiting
Time frame: 2017-2023
Relevant to retrospective electronic case note review
Cross-sectional Organisational Survey
Time frame: 6 months
Purpose designed survey to explore organisational level policies, training and implementation of interventions including making reasonable adjustments.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 41259352Oulton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Phillip Harniess, PhD contact
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Oncology, run by Great Ormond Street Hospital for Children NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kate Oulton, PhD (02074059200, kate.oulton@gosh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cross-sectional Staff Survey (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06481527, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2024.