Improving Quality of Life of Children With Cancer Through Psychosocial Screening

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Other: Summary of psychosocial risk factors; Other: Control

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 183
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 100 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Summary of psychosocial risk factors; The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.
Active Comparator: 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.	Other: Control; The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline psychological distress at pediatric cancer diagnosis to six months later	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)	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	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	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	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)	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	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)	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)

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Collaborators: Provincial Health Services Authority
• Investigators: Principal Investigator: Maru Barrera, PhD, The Hospital for Sick Children

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2015
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: May 27, 2016
• First Submitted That Met QC Criteria: June 1, 2016
• First Posted (Estimate): June 2, 2016

Study Record Updates

• Last Update Posted (Actual): October 10, 2019
• Last Update Submitted That Met QC Criteria: October 8, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: psychosocial screening, quality of life
• Other Study ID Numbers: 702843

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No