Back to resultsEducational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib (ProMETheX)
Primary Purpose
Metastatic Breast Cancer, Colorectal Cancer
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring educational intervention, adherence, capecitabine, lapatinib
Eligibility Criteria
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
Sites / Locations
- Centre Jean Perrin
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
capecitabine
capecitabine + lapatinib
Arm Description
patients treated by capecitabine alone (n=100)
patients treated by capecitabine and lapatinib (n=100)
Outcomes
Primary Outcome Measures
evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib
the efficacy of the implementation of an educational program will be evaluated by adherence assessment using electronic monitoring system
Secondary Outcome Measures
patient satisfaction to the educational program as determined by questionnaire
safety and tolerability as determined by adverse events frequency
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01847599
Brief Title
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
Acronym
ProMETheX
Official Title
Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
interim analysis : discontinuation for efficacy of the intervention
Study Start Date
September 6, 2011 (Actual)
Primary Completion Date
October 13, 2016 (Actual)
Study Completion Date
July 2, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Jean Perrin
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib.
Detailed Description
200 subjects who meet the inclusion/exclusion criteria treated by capecitabine +/- lapatinib, will be enrolled into the study. Adherence to treatment of all subjects will be assessed during a first adherence evaluation period of 3 cycles in order to identify patients who need educational intervention(non adherent patients). Only nonadherent patients (adherence rate < 80%) will receive an education intervention. During the educational program, the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib will be evaluated for the 6 subsequent cycles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer, Colorectal Cancer
Keywords
educational intervention, adherence, capecitabine, lapatinib
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
capecitabine
Arm Type
Other
Arm Description
patients treated by capecitabine alone (n=100)
Arm Title
capecitabine + lapatinib
Arm Type
Other
Arm Description
patients treated by capecitabine and lapatinib (n=100)
Intervention Type
Other
Intervention Name(s)
Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib
Primary Outcome Measure Information:
Title
evaluation of the efficacy of the implementation of an educational program on adherence to capecitabine alone or in combination to lapatinib
Description
the efficacy of the implementation of an educational program will be evaluated by adherence assessment using electronic monitoring system
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)
Secondary Outcome Measure Information:
Title
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
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Isabelle VAN PRAAGH, MD
Organizational Affiliation
Centre Jean Perrin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Jean Perrin
City
Clermont Ferrand
ZIP/Postal Code
63011
Country
France
12. IPD Sharing Statement
Learn more about this trial
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
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