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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT01847599 |
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Date of registration:
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05/04/2013 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
ProMETheX |
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Scientific title:
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Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib |
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Date of first enrolment:
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September 6, 2011 |
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Target sample size:
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65 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01847599 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Isabelle VAN PRAAGH, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Jean Perrin |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Age> 18 years
- histologically confirmed breast cancer or colorectal cancer
- Patient starting oral treatment : capecitabine alone or in combination with lapatinib
(can be included before the first cycle or during the first 2 cycles).
- Volunteer to participate in the study.
- ambulatory treated patient
- Able to read, write and understand French.
- Subject who accept to use MEMS monitors to automatically compile their drug dosing
histories
- Written informed consent
Exclusion Criteria:
- more than 3 metastatic chemotherapies
- any severe concomitant condition which makes it undesirable for the patient to
participate in the study or which would jeopardize adherence with trial protocol
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Colorectal Cancer
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Metastatic Breast Cancer
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Intervention(s)
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Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib
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Primary Outcome(s)
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evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib
[Time Frame: every visit during 3 cycles i.e. 9 weeks (adherent patients) and for 6 additional cycles i.e. 18 weeks during educational intervention (nonadhererent patients)]
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Secondary Outcome(s)
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safety and tolerability as determined by adverse events frequency
[Time Frame: for 3 cycles e.i. 9 weeks (adherent patients) or 9 cycles e.i. 27 weeks (nonadherent patients)]
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patient satisfaction to the educational program as determined by questionnaire
[Time Frame: at the end of the educational program i.e. approximately during the week 27]
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Secondary ID(s)
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2010-A01300-39
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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