Observational Study to Assess Adherence Oral Anticancer Therapies

Adherence, Patient Clinical Trial

— ObservAG  

Official title:

Observational Study to Assess Adherence of Oral Anticancer Therapies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03195972
• Other study ID #: ObservAG
• Status: Completed
• Start date: December 23, 2016
• Est. completion date: September 4, 2018

Study information

• Verified date: November 2019
• Source: Centre Georges Francois Leclerc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 4, 2018
• Est. primary completion date: December 23, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adherence, Patient

Intervention

Other:
• Drug diary filling
patient will fill every day a drug diary

Locations

Country	Name	City	State
France	CGFL	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Georges Francois Leclerc

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	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.	3 months
Secondary	Response to treatment	Treatment response will be assessed according to clinical status and radiological criteria RECIST 1.1.	3 months