Validation Study CARES

NCT ID: NCT02282696

Last Updated: 2017-09-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2015-03-31

Brief Summary

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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

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Conditions

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Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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cancer patients

Questionnaire, focus group participation

Group Type EXPERIMENTAL

Questionnaire, focus group participation

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vrije Universiteit Brussel

OTHER

Sponsor Role collaborator

KU Leuven

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Johan Hellings

prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hellings Johan

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Bojoura Schouten, dra.

Role: STUDY_CHAIR

Hasselt University

Locations

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Hasselt University

Diepenbeek, Limburg, Belgium

Site Status

Countries

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Belgium

References

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Schouten B, Hellings J, Van Hoof E, Vankrunkelsven P, Bulens P, Buntinx F, Mebis J, Vandijck D, Schrooten W. Validation of the flemish CARES, a quality of life and needs assessment tool for cancer care. BMC Cancer. 2016 Aug 30;16(1):696. doi: 10.1186/s12885-016-2728-9.

Reference Type DERIVED
PMID: 27576341 (View on PubMed)

Schouten B, Van Hoof E, Vankrunkelsven P, Schrooten W, Bulens P, Buntinx F, Mebis J, Vandijck D, Cleemput I, Hellings J. Assessing cancer patients' quality of life and supportive care needs: Translation-revalidation of the CARES in Flemish and exhaustive evaluation of concurrent validity. BMC Health Serv Res. 2016 Mar 11;16:86. doi: 10.1186/s12913-016-1335-4.

Reference Type DERIVED
PMID: 26969509 (View on PubMed)

Other Identifiers

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OPSA-PK

Identifier Type: -

Identifier Source: org_study_id

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