Research on Psychosocial Aspects in the Care for Patients With Cancer: Validation Study CARES.

Hasselt University1 site in 1 country197 target enrollmentJanuary 2013

ConditionsCancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cancer
Sponsor: Hasselt University
Enrollment: 197
Locations: 1
Primary Endpoint: Validity of the CARES
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to validate the CARES, a needs assessment instrument which can be used to inventorize cancer patients biopsychosocial distress and care needs.

QUANTITATIVE PART OF THE STUDY: Patients need to fill in a questionnaire package containing questions about social-demographic and medical data, the CARES and convergent measures: Karnofsky Performance Scale (KPS), Hospital Anxiety Depression Scale (HADS), Social Support List (SSL), Maudsley Marital Questionnaire (MMQ), European Organisation for Research and Treatment of Cancer Quality Of Life Core 30 (EORTC-QOL-C30), Distress Thermometer (DT) and a Care Needs Questionnaire. One week after the first questionnaire package participants have to fill in the CARES a second time and answer some questions to evaluate the feasibility of the CARES.
QUALITATIVE PART OF THE STUDY: Participants from the quantitative part of the study and other (ex-) cancer patients who not have to fulfill the criteria of age and cancer stage can participate in a focus group interview. In these focus groups the content validity and preferences on psychosocial screening in care are discussed.

Registry

clinicaltrials.gov

Start Date

January 2013

End Date

March 2015

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Hasselt University

Responsible Party

Principal Investigator

Johan Hellings

prof. dr.

Hasselt University

Eligibility Criteria

Inclusion Criteria

•Primary cancer diagnosis stage I, II, III
•All types of cancer

Exclusion Criteria

•Having had or premorbid neurological problems or cognitive dysfunctions.
•The lack of proficiency in Dutch (Flemish).

Outcomes

Primary Outcomes

Validity of the CARES

Time Frame: week 1

CARES-total and subscale scores. Computation of internal consistency of summary scales (for reliability), intra-class correlation between test and retest scores (for reliability), confirmatory factor analysis (for construct-validity)

Convergent validity of the CARES

Time Frame: week 1

Total- and subscale scores of convergent instruments (KPS, HADS,SSL, MMQ, EORTC-QOL-C30, DT). Computation of correlation between CARES-scores and scores of convergent instruments.