Improving Quality of Life of Children With Cancer Through Psychosocial Screening
8 oktober 2019 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
183
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
British Columbia
-
Vancouver, British Columbia, Kanada
- BC Women and Children's Hospital
-
-
Ontario
-
Toronto, Ontario, Kanada, M5V1X8
- The Hospital for Sick Children
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
8 år till 100 år (Barn, Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline psychological distress at pediatric cancer diagnosis to six months later
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Maru Barrera, PhD, The Hospital for Sick Children
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Barrera M, D'Agostino NM, Gibson J, Gilbert T, Weksberg R, Malkin D. Predictors and mediators of psychological adjustment in mothers of children newly diagnosed with cancer. Psychooncology. 2004 Sep;13(9):630-41. doi: 10.1002/pon.765.
- Boman K, Lindahl A, Bjork O. Disease-related distress in parents of children with cancer at various stages after the time of diagnosis. Acta Oncol. 2003;42(2):137-46. doi: 10.1080/02841860310004995.
- Kazak AE, Simms S, Rourke MT. Family systems practice in pediatric psychology. J Pediatr Psychol. 2002 Mar;27(2):133-43. doi: 10.1093/jpepsy/27.2.133.
- Sawyer MG, Antoniou G, Toogood I, Rice M, Baghurst PA. A prospective study of the psychological adjustment of parents and families of children with cancer. J Paediatr Child Health. 1993 Oct;29(5):352-6. doi: 10.1111/j.1440-1754.1993.tb00533.x.
- Wijnberg-Williams BJ, Kamps WA, Klip EC, Hoekstra-Weebers JE. Psychological distress and the impact of social support on fathers and mothers of pediatric cancer patients: long-term prospective results. J Pediatr Psychol. 2006 Sep;31(8):785-92. doi: 10.1093/jpepsy/jsj087. Epub 2005 Oct 26.
- Woodgate RL, Degner LF, Yanofsky R. A different perspective to approaching cancer symptoms in children. J Pain Symptom Manage. 2003 Sep;26(3):800-17. doi: 10.1016/s0885-3924(03)00285-9.
- Kupst MJ, Natta MB, Richardson CC, Schulman JL, Lavigne JV, Das L. Family coping with pediatric leukemia: ten years after treatment. J Pediatr Psychol. 1995 Oct;20(5):601-17. doi: 10.1093/jpepsy/20.5.601.
- Kazak AE, Brier M, Alderfer MA, Reilly A, Fooks Parker S, Rogerwick S, Ditaranto S, Barakat LP. Screening for psychosocial risk in pediatric cancer. Pediatr Blood Cancer. 2012 Nov;59(5):822-7. doi: 10.1002/pbc.24166. Epub 2012 Apr 10.
- Barrera M, Hancock K, Rokeach A, Cataudella D, Atenafu E, Johnston D, Punnett A, Nathan PC, Bartels U, Silva M, Cassidy M, Jansen P, Shama W, Greenberg C. External validity and reliability of the Psychosocial Assessment Tool (PAT) among Canadian parents of children newly diagnosed with cancer. Pediatr Blood Cancer. 2014 Jan;61(1):165-70. doi: 10.1002/pbc.24774. Epub 2013 Sep 17.
- Patel SK, Mullins W, Turk A, Dekel N, Kinjo C, Sato JK. Distress screening, rater agreement, and services in pediatric oncology. Psychooncology. 2011 Dec;20(12):1324-33. doi: 10.1002/pon.1859. Epub 2010 Oct 5.
- Barrera M, Young MA, Hancock K, Chung J. Early trajectory of psychosocial risk in families of children and adolescents newly diagnosed with cancer. Support Care Cancer. 2022 Feb;30(2):1815-1822. doi: 10.1007/s00520-021-06581-3. Epub 2021 Oct 4.
- Barrera M, Alexander S, Atenafu EG, Chung J, Hancock K, Solomon A, Desjardins L, Shama W, Mills D. Psychosocial screening and mental health in pediatric cancer: A randomized controlled trial. Health Psychol. 2020 May;39(5):381-390. doi: 10.1037/hea0000825. Epub 2020 Jan 23.
- Barrera M, Hancock K, Atenafu E, Alexander S, Solomon A, Desjardins L, Shama W, Chung J, Mills D. Quality of life in pediatric oncology patients, caregivers and siblings after psychosocial screening: a randomized controlled trial. Support Care Cancer. 2020 Aug;28(8):3659-3668. doi: 10.1007/s00520-019-05160-x. Epub 2019 Dec 6.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 juni 2015
Primärt slutförande (Faktisk)
31 juli 2017
Avslutad studie (Faktisk)
31 juli 2017
Studieregistreringsdatum
Först inskickad
27 maj 2016
Först inskickad som uppfyllde QC-kriterierna
1 juni 2016
Första postat (Uppskatta)
2 juni 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
10 oktober 2019
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 oktober 2019
Senast verifierad
1 oktober 2019
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 702843
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .