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Validation Study CARES

NCT02282696 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 197

Last updated 2017-09-01

No results posted yet for this study

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.

Conditions

Interventions

OTHER

Questionnaire, focus group participation

participants of the quantitative part of the study are asked to fill in a questionnaire, participants of the qualitative part are asked to participate in a focus group interview.

Sponsors & Collaborators

  • Vrije Universiteit Brussel

    collaborator OTHER

  • KU Leuven

    collaborator OTHER

  • Hasselt University

    lead OTHER

Principal Investigators

  • Hellings Johan · Hasselt University

  • Bojoura Schouten, dra. · Hasselt University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02282696 on ClinicalTrials.gov