Observational Study to Assess Adherence Oral Anticancer Therapies

NCT ID: NCT03195972

Last Updated: 2019-11-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-12-23
• Study Completion Date: 2018-09-04

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.

Conditions

Adherence, Patient

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Drug diary filling

patient will fill every day a drug diary

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Georges Francois Leclerc

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

CGFL

Dijon, , France

Countries

France

Other Identifiers

ObservAG

Identifier Type: -

Identifier Source: org_study_id