Clinical trial NCT02788604: Improving Quality of Life of Children With Cancer Through Psychosocial Screening
Official title: Improving Quality of Life of Children With Cancer Through Psychosocial Screening and Improved Communication in Health Care Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: psychosocial screening, quality of life
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Provincial Health Services Authority
First posted: 2016-06-02
Enrollment: 183
Sex: ALL
Minimum age (years): 8
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline psychological distress at pediatric cancer diagnosis to six months later
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Secondary outcomes:
measure: Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
measure: Change from baseline distress at pediatric cancer diagnosis to six months following
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
measure: Change from baseline family climate at pediatric cancer diagnosis to six months
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
measure: Change from baseline quality of life at pediatric cancer diagnosis to six months (Self) report
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
measure: Change from baseline quality of life at pediatric cancer diagnosis to six months (Proxy Report)
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
measure: Pediatric Distress Thermometer
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
measure: Pediatric Index of Emotional Distress (PI-ed)
timeFrame: T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: BC Women and Children's Hospital
state: British Columbia
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Maru Barrera, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: 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.
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citation: 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.
citation: 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.
citation: 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.