Validation Study CARES

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Questionnaire, focus group participation

• Registration Number: NCT02282696
• Lead Sponsor: Hasselt University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2014-07-16
• Study First Submitted QC: 2014-10-31
• Study First Posted: 2014-11-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-30
• Last Update Posted: 2017-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 197

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cancer patients	Questionnaire, focus group participation	Questionnaire, focus group participation

Primary Outcome Measures

Name	Time	Method
Validity of the CARES	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	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.

Secondary Outcome Measures

Name	Time	Method
To assess patients experiences with psychosocial care	week 1	Patients experiences of the approach of psychosocial wellbeing in cancer care, and their preferences in this area.
To assess the distress and care needs of cancer patients	week 1	inventorization of level of distress, number and kind of difficulties and care needs experienced by cancer patients

Trial Locations

Locations (1)

Hasselt University; 🇧🇪 Diepenbeek, Limburg, Belgium