Developing a Symptom List for Children With Cancer

NCT02726815 | Unknown

• 1 other identifier: CCR4385
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Paediatric Oncology Palliative Care

Outcome Measures

Primary Outcomes (3)

• Prevalence of all symptoms identified by child using the age appropriate Memorial Symptom Assessment Scale.

  18 months

• Prevalence of all symptoms identified by the parent using the same assessment tool as the child

  18 months

• Prevalence of all symptoms identified by the nurse

  18 months

Interventions

Questionnaire OTHER

Questionnaire based study using a symptom assessment tool

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anna-Karenia Anderson, MbchB

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lucy H Coombes, MSc

CONTACT

0208 642 6011; lucycoombes@nhs.net

Study Design

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

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: April 4, 2016
• Study Start: March 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: April 4, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will share

Locations

GB (1)