|- candidate number||9423|
|- NTR Number||NTR2891|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-mei-2011|
|- Secondary IDs||2010/277 METC VUmc|
|- Public Title||Adherence and patientsí experiences with oral anticancer agents.|
|- Scientific Title||Adherence and patientsí experiences with oral anticancer agents.|
|- hypothesis||The present study aims to get more insight into the use of oral anticancer agents in daily practice.|
|- Healt Condition(s) or Problem(s) studied||Cancer|
|- Inclusion criteria||Patients with cancer of 18 years and older who have filled at least one prescription for an oral anticancer agent in the past period of three months.|
|- Exclusion criteria||1. Patients younger than 18 years;|
2. Treatment in the (neo)adjuvant setting;
3. Not eligible according to the doctor;
4. Unable to fill out questionnaires;
5. Insufficient knowledge of the Dutch language;
6. No signed informed consent.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||10-nov-2010|
|- planned closingdate||31-dec-2011|
|- Target number of participants||200|
|- Interventions||Adherence will be determined using the Patientís files-Pharmacy records-Pill count method (using data of the patientís medical file, pharmacy dispensions, and a pill count). Patients are asked to fill out two questionnaires.|
|- Primary outcome||Adherence rate.|
|- Secondary outcome||1. Nature and grade of side effects as perceived by the patient;|
2. Attitude towards disease;
3. Beliefs and attitude towards medication;
4. Information received about the medication;
5. Quality of life;
6. Adherence by means of Medication Adherence Rating Scale (MARS);
7. Dose adjustment;
11. Partner status;
12. Socio-economic status;
13. Disease stage.
|- Timepoints||Patients are contacted ones by phone. The two questionnaires will be send afterwards.|
|- Trial web site||N/A|
|- status||stopped: trial finished|
|- CONTACT FOR PUBLIC QUERIES|| L. Timmers|
|- CONTACT for SCIENTIFIC QUERIES|| L. Timmers|
|- Sponsor/Initiator ||VU University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief summary||Background:|
Cytotoxic therapies given IV have always been the most important drugs for treatment of cancer. However, in the past decade both the availability and use of oral anticancer agents have increased. Suboptimal adherence to oral (cancer)therapies can have multiple consequences. Only few studies have focused on the use of oral anticancer agents in daily practice and the factors governing adherence. Information about the reasons for non-adherence among cancer patients taking oral anticancer agents is essential for the development of interventions that may increase adherence and positively alter therapy outcomes.
Primary: Determination of the adherence in patients using an oral anticancer agent.
Secondary: Determination of the influence of side effects and patientsí attitudes towards disease and medication on adherence and other factors that may influence adherence to oral anticancer agents in daily practice.
Observational multicenter study in which patients who filled a prescription for an oral anticancer agent in the past period of three months, will be extracted from the pharmacy databases and inquired for participation. The following drugs will be included: lenalidomide, thalidomide, dasatinib, imatinib, nilotinib, erlotinib, gefitinib, sorafenib, sunitinib, everolimus, capecitabine, lapatinib, temozolomide. Patients will be asked to sign informed consent.
Adherence rate will be determined using the Patientís files-Pharmacy records-Pill count method (PPP-method): Patients will be contacted by the researcher by phone to count their remaining pills at that moment. The pharmacy records and data on drug prescription in the medical file of the patient will be assessed. Patients will be asked whether they had returned pills at the pharmacy or disposed pills at any other way. The actual used number of tablets will be calculated from this obtained information (dispensions minus pill count) and compared to the prescribed number of tablets, as registered in the patientís medical file.
Data of the prescribed dose, dose adjustment and information concerning the disease will be retrieved from the patientís medical file.
Data of patient and treatment related factors will be collected by means of two questionnaires. These factors include date of birth, gender, partner status, socio-economic status, adherence by means of Medication Adherence Rating Scale (MARS), nature and grade of side effects as perceived by the patient, quality of life (EORTC QLQ-C30), attitude towards disease (Brief IPQ) and medication (BMQ), the information received about the medication (SIMS), and discontinuation.
|- Main changes (audit trail)|
|- RECORD||10-mei-2011 - 23-mei-2013|