NCT03241251

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
240

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 28, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2017

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
Last Updated

July 3, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

July 28, 2017

Last Update Submit

July 2, 2024

Conditions

Keywords

psychosocial risk

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • clinical value of questionnaire

    baseline assessment at diagnosis

Study Arms (1)

parents children pediatric cancer

Screening questionnaire psychosocial risk factors

Other: questionnaire

Interventions

Questionnaire of psychosocial risk factors

parents children pediatric cancer

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • no knowledge of Dutch language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven

Leuven, 3000, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jurgen Lemiere, PhD

    UZ Leuven

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2017

First Posted

August 7, 2017

Study Start

September 1, 2017

Primary Completion

September 8, 2022

Study Completion

September 8, 2022

Last Updated

July 3, 2024

Record last verified: 2024-07

Locations