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OpenTrials
Completed

NCT Number: NCT03241251

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

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven

Leuven, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • no knowledge of Dutch language

Treatment and study plan

Questionnaire

Other

Questionnaire of psychosocial risk factors

Primary outcomes

  1. validation of PAT questionnaire

    Time frame: baseline assessment at diagnosis

    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.

Secondary outcomes

  1. clinical value of questionnaire

    Time frame: baseline assessment at diagnosis

    a risk estimation of psychosocial risk by psychosocial team after diagnosis, but blinded to PAT scores, will be compared with PAT scores

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2017
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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