|- candidate number||8058|
|- NTR Number||NTR2324|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-mei-2010|
|- Secondary IDs||OZ05KFA00000 VUmc, KFA|
|- Public Title||Adherence and patients’ experiences with capecitabine.|
|- Scientific Title||Adherence and patients' experiences with the use of capecitabine in cancer treatment: The exploration of factors affecting the use in daily practice.|
|- hypothesis||The present study aims to get more insight into the various aspects that govern adherence to the oral anticancer drug capecitabine in daily practice. |
|- Healt Condition(s) or Problem(s) studied||Breast cancer, Colorectal cancer, Gastric carcinoma|
|- Inclusion criteria||Cancer patients starting with capecitabine.|
|- Exclusion criteria||Younger than 18 years of age or insufficient knowledge of the Dutch language.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||9-feb-2010|
|- planned closingdate||1-jan-2011|
|- Target number of participants||66|
|- Interventions||The use of capecitabine in daily practice will be monitored for 5 cycles. Every cycle takes three weeks.|
|- Primary outcome||Adherence rate: A patient is adherent with the intake of 85% or more of the prescribed medication.|
|- Secondary outcome||1. Number and grade of side-effects;|
2. Attitude towards disease;
3. Beliefs and attitude towards medicines.
|- Timepoints||Baseline and during the second week of cycle 1, 3 and 5. |
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| L. Timmers|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J.G. Hugtenburg|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|Roche Nederland BV|
|- Brief summary||Background of the study:|
Adherence to treatment is a complex and multifaceted issue that can substantially alter the outcomes of therapy. Variation in plasma concentration may be due to variability in pharmacokinetics. Even in a clinical trial setting there is a considerable variability in efficacy and side effects of capecitabine. In a less controlled environment, like the use of capecitabine in daily practice, adherence may also play a significant role. Only few studies have focused on the use of oral anticancer drugs in daily practice and the influence of adherence to its effectiveness. Information about the reasons for non-adherence among cancer patients taking the oral anticancer drug capecitabine is essential for the development of interventions that may increase adherence.
Objectives of the study:
Primary objective: Adherence in patients starting the use of capecitabine and the influence of patients attitudes and side effects on adherence.
Secondary objective: The second part of this study contains 1) a validation study of the adherence measurements and 2) an explorative study. The relationships between the following parameters will be explored: Patient characteristics, disease characteristics, side effects, quality of life, patients beliefs and attitude towards disease and medicines, satisfaction with information, adherence, dose adjustments and plasma concentration of 5’-DFUR, 5-FU and FBAL in patients with cancer will be studied.
Prospective observational cohort study in which 66 patients starting with treatment with capecitabine will be followed up until five cycles of three weeks. Cancer patients of 18 years or older under treatment in one of the participating hospitals in the Netherlands starting with capecitabine can be included. Before the start of therapy with capecitabine and during the second week of cycle 1, 3 and 5 patients will be asked to fill in a questionnaire. Before the start of therapy with capecitabine baseline blood samples are collected. Furthermore in the second week of cycle 1, 3 and 5 blood samples are collected, which will be analysed for plasma concentration of 5’-DFUR, 5-FU and FBAL.
|- Main changes (audit trail)|
|- RECORD||11-mei-2010 - 23-mei-2013|