Adherence, Patient
Conditions
Keywords
Adherence, Patient, oncology, oral therapy
Brief 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. 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.
Interventions
OTHERDrug diary filling
patient will fill every day a drug diary
Sponsors
Centre Georges Francois Leclerc
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance with treatment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Toxicity | 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 | 3 months | Treatment response will be assessed according to clinical status and radiological criteria RECIST 1.1. |
Countries
France
Outcome results
None listed