Clinical trial NCT02726815: Developing a Symptom List for Children With Cancer
Official title: Pain and Symptoms in Children With Advanced Cancer: a Longitudinal Study to Develop a Comprehensive Symptom Inventory
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Paediatric Oncology Palliative Care
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-04-04
Enrollment: 40
Sex: ALL
Minimum age (years): 7
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any child/young person (CYP) aged 7 to 17 years and 364 days referred and accepted to the paediatric symptom care teams at the Royal Marsden will be eligible for inclusion.

Brief summary: Primary Objective

The aim of this research study is to develop a comprehensive inventory of symptoms that occur in children with advanced cancer who are receiving a specialist palliative care service.

Secondary Objectives

* To assess correlation between parent, child and nurse scores on the Memorial Symptom Assessment Scale (MSAS).
* To identify symptom prevalence in children with advanced cancer as identified by the child/young person (CYP), nurse and parent (to be analysed separately for parent, child and nurse).
* To identify whether there are any symptoms missing from the age appropriate MSAS as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To identify whether any items on the age appropriate MSAS are not relevant to the population being studied (to be analysed separately for parent, child and nurse).
* To identify which symptoms cause the most distress as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To identify degree of severity of each symptom as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To identify which symptoms occur most frequently as identified by the CYP, nurse and parent (to be analysed separately for parent, child and nurse).
* To assess the trends between phase of illness and symptom profile, severity and distress.


Eligibility criteria: Inclusion Criteria:

* Any child/young person (CYP) aged 7 to 17 years and 364 days referred and accepted to the palliative care service (PATCH team) at the Royal Marsden (RM) will be eligible for inclusion. The PATCH team is responsible for co-ordinating palliative care services for children with both malignant and non-malignant conditions in the South Thames and South East Coast areas. The team can provide home visits, local hospital and hospice visits for symptom and palliative care advice. The team are also available by telephone 24 hours a day, 365 days a year to provide symptom advice to families and health care professionals from all settings who are caring for children known to the team. Acceptance to this service is via multidisciplinary team (MDT) discussion.

Exclusion Criteria:

* Severe cognitive impairment in the parent/carer
* Lack of fluent English
* Lack of ability to read and write English
* Psychological concerns about the CYP and/or parent/carer. All potential participants will be discussed with the psychosocial team before being invited to participate.

Primary outcomes:
measure: Prevalence of all symptoms identified by child using the age appropriate Memorial Symptom Assessment Scale.
timeFrame: 18 months
measure: Prevalence of all symptoms identified by the parent using the same assessment tool as the child
timeFrame: 18 months
measure: Prevalence of all symptoms identified by the nurse
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Anna-Karenia Anderson, MbchB
role: PRINCIPAL_INVESTIGATOR
References: