Validation Study CARES

Cancer Clinical Trial

— OPSA-PK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02282696
• Other study ID #: OPSA-PK
• Status: Completed
• Phase: N/A
• First received: July 16, 2014
• Last updated: August 30, 2017
• Start date: January 2013
• Est. completion date: March 2015

Study information

• Verified date: August 2017
• Source: Hasselt University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Belgium	Hasselt University	Diepenbeek	Limburg

Sponsors (3)

Lead Sponsor	Collaborator
Hasselt University	Katholieke Universiteit Leuven, Vrije Universiteit Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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