Metastatic Breast CancerProMETheXNCT01847599
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
A study testing Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib in people with Metastatic Breast Cancer and Colorectal Cancer, run by Centre Jean Perrin at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Colorectal Cancer
- What is being tested?
- Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteFrance
- Study dates
- 6 Sep 2011to 2 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib
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.
Read the 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.
- Conditions
- Metastatic Breast Cancer, Colorectal Cancer
- Being tested
- Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib
- Keywords
- educational intervention, adherence, capecitabine, lapatinib
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- LapatinibOther
| Study group | Role | What they receive |
|---|---|---|
| capecitabine | Other | patients treated by capecitabine alone (n=100) Receives: Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib |
| capecitabine + lapatinib | Other | patients treated by capecitabine and lapatinib (n=100) Receives: Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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 outcomes (2)
patient satisfaction to the educational program as determined by questionnaire
Measured: at the end of the educational program i.e. approximately during the week 27
safety and tolerability as determined by adverse events frequency
Measured: for 3 cycles e.i. 9 weeks (adherent patients) or 9 cycles e.i. 27 weeks (nonadherent patients)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study start6 Sep 2011
- Primary completion13 Oct 2016
- Study completion2 Jul 2017
Why it stopped: interim analysis : discontinuation for efficacy of the intervention
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle VAN PRAAGH, MD, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01847599
- Sponsor's protocol ID
- 2010-A01300-39
- Acronym
- ProMETheX
- Status last verified
- Jul 2017
- First submitted
- 5 Apr 2013
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of a Therapeutic Educational Program Applicated to Adherence of Patients Treated by Capecitabine Alone or in Combination With Lapatinib
- ClinicalTrials.gov ID
- NCT01847599
- Acronym / sponsor ID
- ProMETheX / 2010-A01300-39
- Conditions
- Metastatic Breast Cancer, Colorectal Cancer
- Keywords
- educational intervention, adherence, capecitabine, lapatinib
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: interim analysis : discontinuation for efficacy of the intervention
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 6 Sep 2011 (actual)
- Primary completion
- 13 Oct 2016 (actual)
- Study completion
- 2 Jul 2017 (actual)
- First posted
- 7 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| capecitabine | Other | Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinibpatients treated by capecitabine alone (n=100) |
| capecitabine + lapatinib | Other | Other: Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinibpatients treated by capecitabine and lapatinib (n=100) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib | Other | capecitabine, capecitabine + lapatinib |
Primary outcome
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)
the efficacy of the implementation of an educational program will be evaluated by adherence assessment using electronic monitoring system
2 secondary outcomes
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
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)
Results and safety
The study was stopped early (reason given: interim analysis : discontinuation for efficacy of the intervention). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle VAN PRAAGH, MD principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib in people with Metastatic Breast Cancer and Colorectal Cancer, run by Centre Jean Perrin at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: interim analysis : discontinuation for efficacy of the intervention). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.