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Validation Study CARES

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02282696
Acronym
OPSA-PK
Enrollment
197
Registered
2014-11-04
Start date
2013-01-31
Completion date
2015-03-31
Last updated
2017-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

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.

Interventions

OTHERQuestionnaire, 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.

Sponsors

Vrije Universiteit Brussel
CollaboratorOTHER
KU Leuven
CollaboratorOTHER
Hasselt University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
25 Years to 60 Years
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).

Design outcomes

Primary

MeasureTime frameDescription
Validity of the CARESweek 1CARES-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 CARESweek 1Total- 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

MeasureTime frameDescription
To assess the distress and care needs of cancer patientsweek 1inventorization of level of distress, number and kind of difficulties and care needs experienced by cancer patients
To assess patients experiences with psychosocial careweek 1Patients experiences of the approach of psychosocial wellbeing in cancer care, and their preferences in this area.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026