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Validation Study CARES (OPSA-PK)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02282696
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : September 1, 2017
Vrije Universiteit Brussel
KU Leuven
Information provided by (Responsible Party):
Johan Hellings, 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.

Condition or disease Intervention/treatment Phase
Cancer Other: Questionnaire, focus group participation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 197 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Research on Psychosocial Aspects in the Care for Patients With Cancer: Validation Study CARES.
Actual Study Start Date : January 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Arm Intervention/treatment
Experimental: cancer patients
Questionnaire, focus group participation
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.

Primary Outcome Measures :
  1. 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)

  2. 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.

Secondary Outcome Measures :
  1. To assess the distress and care needs of cancer patients [ Time Frame: week 1 ]
    inventorization of level of distress, number and kind of difficulties and care needs experienced by cancer patients

  2. To assess patients experiences with psychosocial care [ Time Frame: week 1 ]
    Patients experiences of the approach of psychosocial wellbeing in cancer care, and their preferences in this area.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02282696

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Hasselt University
Diepenbeek, Limburg, Belgium, 3590
Sponsors and Collaborators
Hasselt University
Vrije Universiteit Brussel
KU Leuven
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Principal Investigator: Hellings Johan Hasselt University
Study Chair: Bojoura Schouten, dra. Hasselt University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Johan Hellings, prof. dr., Hasselt University Identifier: NCT02282696    
Other Study ID Numbers: OPSA-PK
First Posted: November 4, 2014    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: August 2017