Ignite Creation Date:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2026-01-02 @ 4:23 AM
Study NCT ID:
NCT02788604
Status:
COMPLETED
Last Update Posted:
2019-10-10
First Post:
2016-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Improving Quality of Life of Children With Cancer Through Psychosocial Screening
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
Improving Quality of Life of Children With Cancer Through Psychosocial Screening and Improved Communication in Health Care Providers
Status:
COMPLETED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: