Improving Quality of Life of Children With Cancer Through Psychosocial Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Summary of psychosocial risk factors
* Other: Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>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<br>* The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.<br>|
| Active Comparator: Control Group<br>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<br>* The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.<br>|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychosocial screening, quality of life