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Improving Quality of Life of Children With Cancer Through Psychosocial Screening

8 ottobre 2019 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

183

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 8 anni a 100 anni (Bambino, Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Quadruplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: Summary of psychosocial risk factors
The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.
Comparatore attivo: 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.
Altro: Control
The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline psychological distress at pediatric cancer diagnosis to six months later
Lasso di tempo: 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)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Hospital for Sick Children

Collaboratori

Provincial Health Services Authority

Investigatori

  • Investigatore principale: Maru Barrera, PhD, The Hospital for Sick Children

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 giugno 2015

Completamento primario (Effettivo)

31 luglio 2017

Completamento dello studio (Effettivo)

31 luglio 2017

Date di iscrizione allo studio

Primo inviato

27 maggio 2016

Primo inviato che soddisfa i criteri di controllo qualità

1 giugno 2016

Primo Inserito (Stima)

2 giugno 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

10 ottobre 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

8 ottobre 2019

Ultimo verificato

1 ottobre 2019

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 702843

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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