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

Pediatric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03241251
• Other study ID #: S60600
• Status: Recruiting
• Start date: September 1, 2017
• Est. completion date: December 2020

Study information

• Verified date: November 2018
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Jurgen Lemiere, PhD
• Phone: 0032 16 34 22 35
• Email: jurgen.lemiere[@]uzleuven.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• no knowledge of Dutch language

Related Conditions & MeSH terms

• Pediatric Cancer

Intervention

Other:
• questionnaire
Questionnaire of psychosocial risk factors

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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