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Health Literacy study


- candidate number24195
- NTR NumberNTR5730
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-apr-2016
- Secondary IDsMETC  15-701
- Public TitleHealth Literacy study
- Scientific TitleThe role of health literacy in patients participating in clinical trials: a prospective analyse
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedHealth promotion
- Inclusion criteria- Patients >18 years
- Patients with a end stage of cancer in good condition who consider oncology clinical trials participation
- Exclusion criteria- Patients with a primairy braintumor or sympotomatic brainmetastases
- not fluent in Dutch
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 1-dec-2015
- planned closingdate31-dec-2016
- Target number of participants0
- InterventionsN?A
- Primary outcomeHealth literacy in patients considering oncology trial participation
- Secondary outcomeInfluence of health literacy on compliance
- TimepointsBefore start trial
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMs. A.J. Biessen, van der
- CONTACT for SCIENTIFIC QUERIESMD PhD Ron H.J. Mathijssen
- Sponsor/Initiator Erasmus MC Cancer Institute, department of Medical Oncology
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Department of Medical Oncology
- Publications
- Brief summaryThe aim of this study is to gain insight into the health literacy (HL) of patients participating in early clinical trials in oncology (ECTs) in relation to protocol deviations(PDs) occurring during the first treatment cycle. HL is measured by the tool: Newest Vital Sign-Dutch (NVS-D), prior to study start.The NVS-D is a six-question tool to assess an individualís ability to find and interpret information (both text and numerical information) on an ice cream nutrition label. The number of correctly answered questions provides an indication about the level of HL. During the first cycle of study participation PDs related to patient issues are scored. PDs of interest are defined as: lack of compliance, missed scheduled visit and incorrect use of a diary or questionnaire. We correlated the occurrence of the PDs to HL.
- Main changes (audit trail)
- RECORD6-apr-2016 - 22-mei-2016


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