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.|
|ClinicalTrials.gov Identifier: NCT02282696|
Recruitment Status : Completed
First Posted : November 4, 2014
Last Update Posted : September 1, 2017
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||197 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
- 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)
- 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.
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT02282696
|Diepenbeek, Limburg, Belgium, 3590|
|Principal Investigator:||Hellings Johan||Hasselt University|
|Study Chair:||Bojoura Schouten, dra.||Hasselt University|