Improving Quality of Life of Children With Cancer Through Psychosocial Screening

The Hospital for Sick Children

Status: Completed

Conditions: Cancer

Treatments: Other: Summary of psychosocial risk factors; Other: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT02788604

702843

Details and patient eligibility

About

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.

Full 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.

Enrollment: 183 patients

Sex: All

Ages: 8 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 2 patient groups

Experimental Group

Experimental group

Description:

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.

Treatment:

Other: Summary of psychosocial risk factors

Control Group

Active Comparator group

Description:

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.

Treatment:

Other: Control