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Improving Quality of Life of Children With Cancer Through Psychosocial Screening

8. oktober 2019 opdateret af: Maru Barrera, The Hospital for Sick Children

Improving Quality of Life of Children With Cancer Through Psychosocial Screening and Improved Communication in Health Care Providers

In Canada, approximately 1450 children are diagnosed with cancer annually. Diagnosis of childhood cancer and its aggressive treatment can have devastating psychosocial effects on the whole family (e.g. unpleasant feelings or emotions that impact your daily activities). It is not known whether health care providers who treat these children use and value psychosocial tools or how beneficial the use of these tools is for these families. This research team will test the benefits of using psychosocial screening on the quality of life of treated children, parents and siblings.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

In Canada approximately 1450 children are diagnosed with cancer annually. Childhood cancer diagnosis and treatment can have devastating psychosocial effects on the family. Tools to screen for psychosocial risks (PSR) in pediatric oncology are rare. Our preliminary work adapted the Psychosocial Assessment Tool (PAT) for the Canadian population, PATrevised (PATrev), and developed the Psychosocial Care Checklist (PCCL). The PATrev is completed by parents of children with cancer, and yields a summary of the psychosocial needs of the patient, parents, and siblings. The PCCL assesses HCPs knowledge of family's psychosocial needs and services. Importantly, psychosocial screening is associated with reduced parental anxiety and improved child's quality of life (QOL). Demonstration of the tool's ability to maximize patient and family psychosocial outcomes is needed. Participants will be parents of children newly diagnosed with cancer, (patients and siblings (> 8 years), if available). Design: RCT with concealed allocation to experimental group (EG) and control group (CG), with repeated measures (after diagnosis= T1, 6 months later=T2). The EG treating team will receive a summary of PATrev risk information based on parent report. No risk information will be provided in the CG. Parents in both groups will complete the PATrev, family environment questionnaire, self--report and proxy reported QoL, distress and mood measures for the patient and one sibling. Patients and siblings will self-report on QOL, distress and mood. Patient charts will be reviewed (T2) to determine treatment intensity and documented psychosocial services for each family.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

183

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
        • BC Women and Children's Hospital
    • Ontario
      • Toronto, Ontario, Canada, M5V1X8
        • The Hospital for Sick Children

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

8 år til 100 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Parents of children newly diagnosed with cancer, within 2 to 4 weeks post-diagnosis.
  • Siblings of children newly diagnosed with cancer, within 2-4 weeks post-diagnosis, between the ages of 8 years and 16 years, able to complete outcome measures, without a physical chronic condition.
  • Children with cancer, newly diagnosed, within 2 to 4 weeks post-diagnosis, between the ages of 8 and 16 years, able to complete outcome measures.

Exclusion Criteria:

  • Parents of children not diagnosed with cancer.
  • Sibling of children not diagnosed with cancer
  • Children not diagnosed with cancer.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental Group
Participants in this arm will have a summary of their family's psychosocial risk factors provided to the treatment team. This will occur twice: once shortly after diagnosis (within 2-4 weeks) and once approximately 6 months following diagnosis.
Andet: Summary of psychosocial risk factors
The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.
Aktiv komparator: Control Group
Participants in this arm will NOT have a summary of their family's psychosocial risk factors provided to the treatment team shortly after diagnosis. However, the risk factors will be distributed to the treatment team 6 months following diagnosis.
Andet: Control
The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline psychological distress at pediatric cancer diagnosis to six months later
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Measured by Hospital Anxiety and Depression Scale (HADS). A standardized measure of symptoms of anxiety and depression in adults. The HADS is suitable for all ages from 17+. The HADS consists of 14 questions, which are ranked according to a 4 point Likert type scale.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Measured by Caregiver Quality of Life Scale (CQOLC), 35 items using a five-point Likert-type scale to assess QoL in the family caregiver of cancer patients.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline distress at pediatric cancer diagnosis to six months following
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Measured by the Distress Thermometer, a standardized screening tool for measuring emotional distress in adults. Has been widely used as a screening tool of distress in adult cancer patients and caregivers.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline family climate at pediatric cancer diagnosis to six months
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Measured by Family Environment Scale (FES), a standardized measure of social climate within the family. The FES is a self-report measure which contains 27 true/false statements.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline quality of life at pediatric cancer diagnosis to six months (Self) report
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Measured by Pediatric Quality of Life (PedsQL 4.0) - Cancer Module, Standardized tool measures child/parent perceptions of a child's health-related quality of life specific to having cancer. Self report and parent proxy perception of health-related quality of life across 8 domains: pain, nausea, procedure, and treatment anxiety, worry, cognition, physical and commutation.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Change from baseline quality of life at pediatric cancer diagnosis to six months (Proxy Report)
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Measured by Pediatric Quality of Life (PedsQL 4.0) - Generic Module.The measure assesses perception for the child's general health across global, physical, emotional , social and academic domains. Parent/self report by healthy sibling
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Pediatric Distress Thermometer
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Standardized screening tool for measuring emotional distress in children. The distress thermometer adapted for pediatric population. Participants self-report on their distress on a line drawing representation of a thermometer. For this age group, distress is defined as worry, anxiety, sadness and fear on a visual analog scale from 0 (no distress) to 5 (moderate distress) to 10 (high distress). For patient with cancer and healthy sibling.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Pediatric Index of Emotional Distress (PI-ed)
Tidsramme: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
A 14-item self-report measure of emotional distress in children rated on a 4-point Likert scale (0 = not at all; 3 = always). This measure, based on the Hospital Anxiety and Depression Scale (HADS;[62]), was designed to differentiate symptoms of emotional distress from physical illness in pediatric populations. It comprises two subscales assessing depression and anxiety, which when summated, provides a global index of emotional distress. For child with Cancer and healthy sibling.
T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

The Hospital for Sick Children

Samarbejdspartnere

Provincial Health Services Authority

Efterforskere

  • Ledende efterforsker: Maru Barrera, PhD, The Hospital for Sick Children

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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 (Faktiske)

1. juni 2015

Primær færdiggørelse (Faktiske)

31. juli 2017

Studieafslutning (Faktiske)

31. juli 2017

Datoer for studieregistrering

Først indsendt

27. maj 2016

Først indsendt, der opfyldte QC-kriterier

1. juni 2016

Først opslået (Skøn)

2. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

10. oktober 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. oktober 2019

Sidst verificeret

1. oktober 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 702843

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