Screening for Psychosocial Risk in Flemish Families of a Child With Cancer

The Psychosocial Assessment Tool (PAT) is an international used instrument for the screening for psychosocial risk factors in families of a child with cancer. This study want to investigate the validation and evaluation of the clinical value of the Flemish translation of the psychosocial assessment tool

Study Overview

• Status: Unknown
• Conditions: Pediatric Cancer
• Intervention / Treatment: Other: questionnaire

Detailed Description

Psychosocial support of children having a diagnosis of cancer and their families is a crucial aspect of a qualitative treatment. Assessment of psychosocial needs is a first step in order to provide better and preventive psychosocial support. In Flanders, no instrument for screening of psychosocial needs is available. The Psychosocial Assessment Tool (PAT) is an international used instrument for the screening for psychosocial risk factors in families of a child with cancer. This study want to investigate the validation and evaluation of the clinical value of the Flemish translation of the PAT. Two large Flemish pediatric oncology centers will participate: University hospital Ghent (UZGent) and the University hospital in Leuven (UZLeuven). During a time period of 2.5 years families in which a child received a new diagnosis of a pediatric cancer will be invited to participate in this study. All subscales of the PAT will be validated by the use of standardized parent questionnaires measuring similar constructs: Inventory Social Reliance, Strengths and Difficulties Questionnaire, Hospital Anxiety and Depression Scale, Parenting Stress Index-short version and illness cognitions questionnaire, parent version. The usability of the PAT will be evaluated with the PAT-Netherlands Usability questionnaire. The clinical value will be evaluated by comparing the clinical judgment of psychosocial risk by the psychosocial team members of both centers with the scores on the PAT.

The proposed project is an important step to ameliorate psychosocial support in families with a child with a diagnosis of cancer in Flemish pediatric oncological centers.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Jurgen Lemiere, PhD; Phone Number: 0032 16 34 22 35; Email: jurgen.lemiere@uzleuven.be
• Study Contact Backup: Name: Trui Vercruysse, MSc; Phone Number: 0032 16 34 02 66; Email: trui.vercruysse@uzleuven.be

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Recruiting
    • UZ Leuven
    • Contact: Jurgen Lemiere, PhD; Phone Number: 35 +32 16 34 22; Email: jurgen.lemiere@uzleuven.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

parents of all children and adolescents from 0-18 years that are diagnosed with cancer

Description

Inclusion Criteria:

• parents of all children and adolescents from 0-18 years that are diagnosed with cancer

Exclusion Criteria:

• no knowledge of Dutch language

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
parents children pediatric cancer; Screening questionnaire psychosocial risk factors	Other: questionnaire; Questionnaire of psychosocial risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
validation of PAT questionnaire	The PAT validation will be performed by correlating PAT scores with validated questionnaires measuring similar constructs as the PAT. These questionnaires are Inventory social reliance, strengths and difficulties questionnaire , hospital anxiety and depression scale, parenting stress index -short version and illness cognition questionnaire parent version.	baseline assessment at diagnosis

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical value of questionnaire	a risk estimation of psychosocial risk by psychosocial team after diagnosis, but blinded to PAT scores, will be compared with PAT scores	baseline assessment at diagnosis

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Study Director: Jurgen Lemiere, PhD, UZ Leuven

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2017
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: July 28, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 7, 2017

Study Record Updates

• Last Update Posted (Actual): November 19, 2018
• Last Update Submitted That Met QC Criteria: November 15, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Keywords: psychosocial risk
• Other Study ID Numbers: S60600

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No