Screening for Psychosocial Risk in Flemish Families of a... | NCT03241251

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

NCT03241251

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Jul 3, 2024Actual

Enrollment

240Actual

Phase

Not provided

Conditions

Pediatric Cancer

Interventions

questionnaire

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 8, 2022Actual

Completion Date

Sep 8, 2022Actual

First Submitted Date

Jul 28, 2017

First Submission Date that Met QC Criteria

Aug 4, 2017

First Posted Date

Aug 7, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2024

Last Update Posted Date

Jul 3, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

240Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
parents children pediatric cancer		Screening questionnaire psychosocial risk factors	Other: questionnaire

Interventions

Name	Type	Description	Arm Group Labels	Other Names
questionnaire	Other	Questionnaire of psychosocial risk factors	parents children pediatric cancer

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

no knowledge of Dutch language

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jurgen Lemiere, PhD	UZ Leuven	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UZ Leuven		Leuven		3000	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

Not provided

Browse Branches

Not provided