NCT02788604

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
183

participants targeted

Target at P50-P75 for not_applicable cancer

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

October 10, 2019

Status Verified

October 1, 2019

Enrollment Period

2.2 years

First QC Date

May 27, 2016

Last Update Submit

October 8, 2019

Conditions

Cancer

Keywords

psychosocial screening, quality of life

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Change from baseline quality of life at pediatric cancer diagnosis to six months (Parent Self-Report)

    T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

  • Change from baseline distress at pediatric cancer diagnosis to six months following

    T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

  • Change from baseline family climate at pediatric cancer diagnosis to six months

    T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

  • Change from baseline quality of life at pediatric cancer diagnosis to six months (Self) report

    T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

  • Change from baseline quality of life at pediatric cancer diagnosis to six months (Proxy Report)

    T1 (2-4 weeks following pediatric cancer diagnosis); T2 (6 months following diagnosis)

  • +2 more secondary outcomes

Study Arms (2)

Experimental Group

EXPERIMENTAL

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.

Other: Summary of psychosocial risk factors

Control Group

ACTIVE COMPARATOR

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.

Other: Control

Interventions

Summary of psychosocial risk factorsOTHER

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

Experimental Group
ControlOTHER

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

Control Group

Eligibility Criteria

Age8 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Parents of children not diagnosed with cancer.
  • Sibling of children not diagnosed with cancer
  • Children not diagnosed with cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

BC Women and Children's Hospital

Vancouver, British Columbia, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5V1X8, Canada

Location

Related Publications (13)

  • 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.

    PMID: 12801132BACKGROUND

  • 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.

    PMID: 11821497BACKGROUND

  • 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.

    PMID: 8240863BACKGROUND

  • 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.

    PMID: 16251479BACKGROUND

  • 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.

    PMID: 12967729BACKGROUND

  • 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.

    PMID: 7500233BACKGROUND

  • 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.

    PMID: 15334531BACKGROUND

  • 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.

    PMID: 22492662BACKGROUND

  • 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.

    PMID: 24106172BACKGROUND

  • 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.

    PMID: 20925136BACKGROUND

  • 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.

    PMID: 34608532DERIVED

  • 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.

    PMID: 31971403DERIVED

  • 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.

    PMID: 31811485DERIVED

MeSH Terms

Conditions

Neoplasms

Study Officials

  • Maru Barrera, PhD

    The Hospital for Sick Children

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

May 27, 2016

First Posted

June 2, 2016

Study Start

June 1, 2015

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

October 10, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)