CancerNCT01058044
Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
A study testing Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System " in people with Cancer, run by Centre Jean Perrin at 1 site in France.
Trial summary
The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2009to Jan 2011
- 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 proven malignant tumor
- documented decision of treatment with i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor
- ambulatory treated subject
- Subject who accept to use MEMS monitors to automatically compile their drug dosing histories
- Written informed consent
Who cannot join
- any severe concomitant wich makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol
- patient who does not agreed to participate the program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
The purpose of this study is to describe adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. Moreover, this study is aimed at evaluating the feasibility to use a " Medication Event Monitoring System " (MEMS®) in order to assess adherence of an oral anticancer treatment delivered by dispensary pharmacy.
- Conditions
- Cancer
- Being tested
- Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "
- Keywords
- Cancer, Sunitinib, capecitabine, anastrozole, letrozole, adherence, anticancer treatment
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "Other
Evaluation of adherence using a " Medication Event Monitoring System " (MEMS®) for oral anticancer treatment delivered by dispensary pharmacy
| Study group | Role | What they receive |
|---|---|---|
| adherence assessment group | Experimental | evaluation of adherence using MEMS Receives: Other: Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System " |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor.
Measured: everey visit during 6 months
Secondary outcomes (4)
evaluation of liberal nurse satisfaction
Measured: inclusion
resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy)
Measured: during 6 months
Patient satisfaction
Measured: 6 months
drug interaction
Measured: during 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2010 (estimated)
- Study startJul 2009
- Primary completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01058044
- Sponsor's protocol ID
- AU792
- Other IDs
- RCB 2009-A00244-53
- Status last verified
- Aug 2012
- First submitted
- 27 Jan 2010
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Adherence to Oral Anticancer Treatment Using Electronic Monitoring System
- ClinicalTrials.gov ID
- NCT01058044
- Acronym / sponsor ID
- AU792
- Conditions
- Cancer
- Keywords
- Cancer, Sunitinib, capecitabine, anastrozole, letrozole, adherence, anticancer treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jan 2011 (actual)
- First posted
- 28 Jan 2010 (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 describe adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. Moreover, this study is aimed at evaluating the feasibility to use a " Medication Event Monitoring System " (MEMS®) in order to assess adherence of an oral anticancer treatment delivered by dispensary pharmacy.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adherence assessment group | Experimental | Other: Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "evaluation of adherence using MEMS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- histologically proven malignant tumor
- documented decision of treatment with i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor
- ambulatory treated subject
- Subject who accept to use MEMS monitors to automatically compile their drug dosing histories
Key exclusion criteria (2 listed)
- any severe concomitant wich makes it undesirable for the patient to participate in the study or which would jeopardize adherence with trial protocol
- patient who does not agreed to participate the program
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 |
|---|---|---|
| Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System "Evaluation of adherence using a " Medication Event Monitoring System " (MEMS®) for oral anticancer treatment delivered by dispensary pharmacy | Other | adherence assessment group |
Primary outcome
evaluation of adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor.
Time frame: everey visit during 6 months
4 secondary outcomes
evaluation of liberal nurse satisfaction
Time frame: inclusion
resort to healthcare system (oncologist, doctor, nurse, hospital pharmacy, dispensary pharmacy)
Time frame: during 6 months
Patient satisfaction
Time frame: 6 months
drug interaction
Time frame: during 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of adherence to 3 oral anticancer treatment using a " Medication Event Monitoring System " in people with 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 6 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: finished, as of the sponsor's last update on 9 Aug 2012. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 adherence to 3 oral anticancer treatment: i) a chemotherapeutic regimen with capecitabine (alone or in association with lapatinib), ii) or sunitinib an tyrosine kinase inhibitor, iii) or an non-steroidal aromatase inhibitor. (time frame: everey visit during 6 months). 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 9 Aug 2012.