Improving Quality of Life of Children With Cancer Through Psychosocial Screening

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788604
• Other study ID #: 702843
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: July 31, 2017

Study information

• Verified date: October 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 183
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Summary of psychosocial risk factors
The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.
• Control
The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	BC Women and Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Provincial Health Services Authority

Country where clinical trial is conducted

Canada, 

References & Publications (10)

Barrera M, D'Agostino NM, Gibson J, Gilbert T, Weksberg R, Malkin D. Predictors and mediators of psychological adjustment in mothers of children newly diagnosed with cancer. Psychooncology. 2004 Sep;13(9):630-41. — View 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. — View Citation

Boman K, Lindahl A, Björk O. Disease-related distress in parents of children with cancer at various stages after the time of diagnosis. Acta Oncol. 2003;42(2):137-46. — View Citation

Kazak AE, Brier M, Alderfer MA, Reilly A, Fooks Parker S, Rogerwick S, Ditaranto S, Barakat LP. Screening for psychosocial risk in pediatric cancer. Pediatr Blood Cancer. 2012 Nov;59(5):822-7. doi: 10.1002/pbc.24166. Epub 2012 Apr 10. Review. — View Citation

Kazak AE, Simms S, Rourke MT. Family systems practice in pediatric psychology. J Pediatr Psychol. 2002 Mar;27(2):133-43. — View Citation

Kupst MJ, Natta MB, Richardson CC, Schulman JL, Lavigne JV, Das L. Family coping with pediatric leukemia: ten years after treatment. J Pediatr Psychol. 1995 Oct;20(5):601-17. — View Citation

Patel SK, Mullins W, Turk A, Dekel N, Kinjo C, Sato JK. Distress screening, rater agreement, and services in pediatric oncology. Psychooncology. 2011 Dec;20(12):1324-33. doi: 10.1002/pon.1859. Epub 2010 Oct 5. — View Citation

Sawyer MG, Antoniou G, Toogood I, Rice M, Baghurst PA. A prospective study of the psychological adjustment of parents and families of children with cancer. J Paediatr Child Health. 1993 Oct;29(5):352-6. — View Citation

Wijnberg-Williams BJ, Kamps WA, Klip EC, Hoekstra-Weebers JE. Psychological distress and the impact of social support on fathers and mothers of pediatric cancer patients: long-term prospective results. J Pediatr Psychol. 2006 Sep;31(8):785-92. Epub 2005 Oct 26. — View Citation

Woodgate RL, Degner LF, Yanofsky R. A different perspective to approaching cancer symptoms in children. J Pain Symptom Manage. 2003 Sep;26(3):800-17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)