Developing a Symptom List for Children With Cancer | NCT02726815

Studies
Developing a Symptom List for Children With Cancer

NCT02726815

Sponsor

Royal Marsden NHS Foundation Trust

Status

Unknown status

Last Update Posted

Apr 4, 2016Estimated

Enrollment

40Estimated

Phase

Not provided

Conditions

Paediatric Oncology Palliative Care

Interventions

Questionnaire

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Sep 2017Estimated

Completion Date

Sep 2017Estimated

First Submitted Date

Mar 22, 2016

First Submission Date that Met QC Criteria

Mar 29, 2016

First Posted Date

Apr 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 29, 2016

Last Update Posted Date

Apr 4, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Name	Type	Description	Arm Group Labels	Other Names
Questionnaire	Other	Questionnaire based study using a symptom assessment tool

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lucy H Coombes, MSc	Contact	0208 642 6011	3625	lucycoombes@nhs.net

Overall Officials

Name	Affiliation	Role
Anna-Karenia Anderson, MbchB	Royal Marsden NHS Foundation Trust	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Royal Marsden NHS Foundation Trust	Recruiting	Sutton	Surrey	SM2 5PT	United Kingdom

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided