Clinical trial · Interventional
Validation Study CARES
Research on Psychosocial Aspects in the Care for Patients With Cancer: Validation Study CARES.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire, focus group participation | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- cancer patients
- description
- Questionnaire, focus group participation
- interventionNames
- Other: Questionnaire, focus group participation
Primary outcomes (2)
- measure
- Validity of the CARES
- timeFrame
- week 1
- description
- 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)
- measure
- Convergent validity of the CARES
- timeFrame
- week 1
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 25 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (2)
- DERIVEDSchouten 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. PMID 27576341
- DERIVEDSchouten 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. PMID 26969509