Improving Quality of Life of Children With Cancer Through Psychosocial Screening

NCT ID: NCT02788604

Last Updated: 2019-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

183 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-01

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental Group

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.

Group Type EXPERIMENTAL

Summary of psychosocial risk factors

Intervention Type OTHER

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

Control Group

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.

Group Type ACTIVE_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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Summary of psychosocial risk factors

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

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

8 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Provincial Health Services Authority

OTHER

Sponsor Role collaborator

The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Maru Barrera

Psychologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maru Barrera, PhD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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BC Women and Children's Hospital

Vancouver, British Columbia, Canada

Site Status

The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

References

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Boman K, Lindahl A, Bjork 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. doi: 10.1080/02841860310004995.

Reference Type BACKGROUND
PMID: 12801132 (View on PubMed)

Kazak AE, Simms S, Rourke MT. Family systems practice in pediatric psychology. J Pediatr Psychol. 2002 Mar;27(2):133-43. doi: 10.1093/jpepsy/27.2.133.

Reference Type BACKGROUND
PMID: 11821497 (View on PubMed)

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. doi: 10.1111/j.1440-1754.1993.tb00533.x.

Reference Type BACKGROUND
PMID: 8240863 (View on PubMed)

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. doi: 10.1093/jpepsy/jsj087. Epub 2005 Oct 26.

Reference Type BACKGROUND
PMID: 16251479 (View on PubMed)

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. doi: 10.1016/s0885-3924(03)00285-9.

Reference Type BACKGROUND
PMID: 12967729 (View on PubMed)

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. doi: 10.1093/jpepsy/20.5.601.

Reference Type BACKGROUND
PMID: 7500233 (View on PubMed)

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. doi: 10.1002/pon.765.

Reference Type BACKGROUND
PMID: 15334531 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22492662 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24106172 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20925136 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34608532 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31971403 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31811485 (View on PubMed)

Other Identifiers

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702843

Identifier Type: -

Identifier Source: org_study_id

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