Skip to main content
OpenTrials
Completed

NCT Number: NCT02282696

Validation Study CARES

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hasselt University

Diepenbeek, Limburg, 3590, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Questionnaire, focus group participation

Other

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.

Primary outcomes

  1. 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)

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Hasselt University

Other

Collaborators

  • KU Leuven
  • Vrije Universiteit Brussel

Registry information

Official study title

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

Acronym: OPSA-PK

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Nov 4, 2014
Registry last updated
Sep 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.