Observational Study to Assess Adherence Oral Anticancer Therapies (ObservAG)
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|ClinicalTrials.gov Identifier: NCT03195972|
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : November 5, 2019
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.
|Condition or disease||Intervention/treatment|
|Adherence, Patient||Other: Drug diary filling|
- To evaluate adherence to oral anti-cancer therapies at 3 months
- 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 Type :||Observational [Patient Registry]|
|Actual Enrollment :||200 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Observational Study to Assess Adherence of Oral Anticancer Therapies|
|Actual Study Start Date :||December 23, 2016|
|Actual Primary Completion Date :||December 23, 2016|
|Actual Study Completion Date :||September 4, 2018|
- Other: Drug diary filling
patient will fill every day a drug diary
- 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.
- Toxicity [ Time Frame: 3 months ]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.
- Response to treatment [ Time Frame: 3 months ]Treatment response will be assessed according to clinical status and radiological criteria RECIST 1.1.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195972
|Dijon, France, 21079|