Clinical trial NCT02282696: Validation Study CARES
Official title: Research on Psychosocial Aspects in the Care for Patients With Cancer: Validation Study CARES.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Hasselt University
Sponsor class: OTHER
Collaborators: name: Vrije Universiteit Brussel
name: KU Leuven
First posted: 2014-11-04
Enrollment: 197
Sex: ALL
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Validity of the CARES
timeFrame: week 1
measure: Convergent validity of the CARES
timeFrame: week 1
Secondary outcomes:
measure: To assess the distress and care needs of cancer patients
timeFrame: week 1
measure: To assess patients experiences with psychosocial care
timeFrame: week 1
Other outcomes:
Locations:
city: Diepenbeek
country: Belgium
facility: Hasselt University
state: Limburg
Study officials:
affiliation: Hasselt University
name: Hellings Johan
role: PRINCIPAL_INVESTIGATOR
affiliation: Hasselt University
name: Bojoura Schouten, dra.
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.