Adherence, PatientObservAGNCT03195972
Observational Study to Assess Adherence Oral Anticancer Therapies
An observational study of Adherence, Patient, run by Centre Georges Francois Leclerc at 1 site in France.
Trial summary
Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adherence, Patient
- What is being tested?
- Drug diary filling
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2016to 4 Sep 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with cancer treated with oral therapy (targeted therapy or chemotherapy) excluding hormone therapy.
Who may be able to join
- Age> 18 years
- Cancer proved histologically.
- Patient receiving an initial prescription for oral anticancer therapy, excluding hormone therapy
- Illness measurable or assessable by imaging
- Patient affiliated to a social security scheme
- Patient having been informed of the study
- Non-opposition of the patient
Who cannot join
- Contraindication to oral treatment
- Patient's refusal
- Patient under tutelage, curatorship or safeguard of justice
- Psychiatric illness and / or condition of the patient compromising understanding of information or conduct of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study to Assess Adherence of Oral Anticancer Therapies
Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. The objective of oral therapies is twofold: to remove the constraints and risks associated with infusions and to allow the patient to follow his treatment at home.
However, they have significant adverse effects that may affect patients, who are sometimes at a disadvantage compared to how they are treated, and potentially lead to non-compliance with the consequences.
Read more
This study will identify the factors associated with non-adherence and determine the impact of this non-adherence in terms of treatment efficacy and tolerance.
The aim of this routine care study is to evaluate the adherence to oral anticancer therapies during 3 months.
Read the detailed description
Primary objective
- To evaluate adherence to oral anti-cancer therapies at 3 months
Secondary objectives
- To evaluate the adherence to 3 months according to the age of the patients (less than 75 years versus 75 years and more)
- Evaluate compliance at 1 and 2 months
- Evaluate toxicity at 1, 2 and 3 months according to compliance according to criteria CTCAE 4.03.
- Evaluate response to treatment at 3 months based on adherence
- Evaluate the factors associated with adherence and describe the reasons for non-adherence.
- Conditions
- Adherence, Patient
- Being tested
- Drug diary filling
- Keywords
- Adherence, Patient, oncology, oral therapy
- Medical subject headings
- Patient Compliance, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drug diary fillingOther
patient will fill every day a drug diary
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance with treatment
Treatment adherence will be assessed by the number of treatment units taken in relation to the prescribed amount. A patient will be considered as observing if he has received at least 80% of the dose initially prescribed.
Measured: 3 months
Secondary outcomes (2)
Toxicity
The toxicity of the treatment will be assessed and graded, at each medical consultation, according to the classification NCI-CTCAE V4.03, in observing and non-observing patients.
Measured: 3 months
Response to treatment
Treatment response will be assessed according to clinical status and radiological criteria RECIST 1.1.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start23 Dec 2016
- Primary completion23 Dec 2016
- Study completion4 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence, PatientStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Centre Georges Francois Leclerc
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195972
- Sponsor's protocol ID
- ObservAG
- Acronym
- ObservAG
- Status last verified
- Nov 2019
- First submitted
- 9 Jun 2017
- Last updated
- 5 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study to Assess Adherence of Oral Anticancer Therapies
- ClinicalTrials.gov ID
- NCT03195972
- Acronym / sponsor ID
- ObservAG / ObservAG
- Conditions
- Adherence, Patient
- Keywords
- Adherence, Patient, oncology, oral therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Georges Francois LeclercUniversity, hospital or other
- Study start
- 23 Dec 2016 (actual)
- Primary completion
- 23 Dec 2016 (actual)
- Study completion
- 4 Sep 2018 (actual)
- First posted
- 22 Jun 2017 (actual)
- 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.
Oral anticancer treatments are increasingly numerous. They represent an additional alternative in the therapeutic arsenal of the clinician, and appear to satisfy patients who prefer this route of administration over intravenous treatment. The objective of oral therapies is twofold: to remove the constraints and risks associated with infusions and to allow the patient to follow his treatment at home.
However, they have significant adverse effects that may affect patients, who are sometimes at a disadvantage compared to how they are treated, and potentially lead to non-compliance with the consequences.
This study will identify the factors associated with non-adherence and determine the impact of this non-adherence in terms of treatment efficacy and tolerance.
The aim of this routine care study is to evaluate the adherence to oral anticancer therapies during 3 months.
Detailed description
Primary objective
- To evaluate adherence to oral anti-cancer therapies at 3 months
Secondary objectives
- To evaluate the adherence to 3 months according to the age of the patients (less than 75 years versus 75 years and more)
- Evaluate compliance at 1 and 2 months
- Evaluate toxicity at 1, 2 and 3 months according to compliance according to criteria CTCAE 4.03.
- Evaluate response to treatment at 3 months based on adherence
- Evaluate the factors associated with adherence and describe the reasons for non-adherence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with cancer treated with oral therapy (targeted therapy or chemotherapy) excluding hormone therapy.
Key inclusion criteria (7 listed)
- Age> 18 years
- Cancer proved histologically.
- Patient receiving an initial prescription for oral anticancer therapy, excluding hormone therapy
- Illness measurable or assessable by imaging
- Patient affiliated to a social security scheme
Key exclusion criteria (4 listed)
- Contraindication to oral treatment
- Patient's refusal
- Patient under tutelage, curatorship or safeguard of justice
- Psychiatric illness and / or condition of the patient compromising understanding of information or conduct of the study
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 |
|---|---|---|
| Drug diary fillingpatient will fill every day a drug diary | Other | – |
Primary outcome
Compliance with treatment
Time frame: 3 months
Treatment adherence will be assessed by the number of treatment units taken in relation to the prescribed amount. A patient will be considered as observing if he has received at least 80% of the dose initially prescribed.
2 secondary outcomes
Toxicity
Time frame: 3 months
Response to treatment
Time frame: 3 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 5 Nov 2019.
- Individual participant dataSharing planned: No
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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?
An observational study of Adherence, Patient, run by Centre Georges Francois Leclerc 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 7 inclusion and 4 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 5 Nov 2019. 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?
Compliance with treatment (time frame: 3 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 5 Nov 2019.