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Completed

NCT Number: NCT02788604

Improving Quality of Life of Children With Cancer Through Psychosocial Screening

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.

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Key information

Conditions

Cancer Neoplasms

Age range

8 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Women and Children's Hospital, Vancouver, British Columbia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Summary of psychosocial risk factors

Other

The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.

Control

Other

The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.

Primary outcomes

  1. Change from baseline psychological distress at pediatric cancer diagnosis to six months later

    Time frame: 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.

Secondary outcomes

  1. Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)

    Time frame: 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.

  2. Change from baseline distress at pediatric cancer diagnosis to six months following

    Time frame: 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.

  3. Change from baseline family climate at pediatric cancer diagnosis to six months

    Time frame: 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.

  4. Change from baseline quality of life at pediatric cancer diagnosis to six months (Self) report

    Time frame: 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.

  5. Change from baseline quality of life at pediatric cancer diagnosis to six months (Proxy Report)

    Time frame: 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

  6. Pediatric Distress Thermometer

    Time frame: 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.

  7. Pediatric Index of Emotional Distress (PI-ed)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Collaborators

  • Provincial Health Services Authority British Columbia

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2016
Registry last updated
Oct 10, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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