Developing a Symptom List for Children With Cancer

March 29, 2016 updated by: Royal Marsden NHS Foundation Trust

Pain and Symptoms in Children With Advanced Cancer: a Longitudinal Study to Develop a Comprehensive Symptom Inventory

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of all symptoms identified by child using the age appropriate Memorial Symptom Assessment Scale.
Time Frame: 18 months
18 months
Prevalence of all symptoms identified by the parent using the same assessment tool as the child
Time Frame: 18 months
18 months
Prevalence of all symptoms identified by the nurse
Time Frame: 18 months
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Investigators

  • Principal Investigator: Anna-Karenia Anderson, MbchB, Royal Marsden NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

March 22, 2016

First Submitted That Met QC Criteria

March 29, 2016

First Posted (Estimate)

April 4, 2016

Study Record Updates

Last Update Posted (Estimate)

April 4, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR4385

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share internally at meetings as well as at conferences. Also plan to submit for publication in a peer reviewed journal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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