Validation Study CARES

Study Overview
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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.

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

Conditions
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Cancer

Intervention / Treatment
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* Other: Questionnaire, focus group participation


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cancer patients<br>Questionnaire, focus group participation | Other: Questionnaire, focus group participation<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity of the CARES | 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) | week 1 | 
| Convergent validity of the CARES | 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. | week 1 | 

Secondary Outcome Measures

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