- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02726815
Developing a Symptom List for Children With Cancer
29. marts 2016 opdateret af: 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.
Studieoversigt
Status
Ukendt
Betingelser
Intervention / Behandling
Undersøgelsestype
Observationel
Tilmelding (Forventet)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Surrey
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Sutton, Surrey, Det Forenede Kongerige, SM2 5PT
- Rekruttering
- Royal Marsden NHS Foundation Trust
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Kontakt:
- Anna-Karenia Anderson, MbchB
- Telefonnummer: 3625 02086426011
- E-mail: annakarenia.anderson@nhs.net
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Kontakt:
- Lucy H Coombes, MSc
- Telefonnummer: 3625 02086426011
- E-mail: lucycoombes@nhs.net
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
7 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Prevalence of all symptoms identified by child using the age appropriate Memorial Symptom Assessment Scale.
Tidsramme: 18 months
|
18 months
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Prevalence of all symptoms identified by the parent using the same assessment tool as the child
Tidsramme: 18 months
|
18 months
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Prevalence of all symptoms identified by the nurse
Tidsramme: 18 months
|
18 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Anna-Karenia Anderson, MbchB, Royal Marsden NHS Foundation Trust
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. marts 2016
Primær færdiggørelse (Forventet)
1. september 2017
Studieafslutning (Forventet)
1. september 2017
Datoer for studieregistrering
Først indsendt
22. marts 2016
Først indsendt, der opfyldte QC-kriterier
29. marts 2016
Først opslået (Skøn)
4. april 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
4. april 2016
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
29. marts 2016
Sidst verificeret
1. marts 2016
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CCR4385
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Plan to share internally at meetings as well as at conferences.
Also plan to submit for publication in a peer reviewed journal.
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .