Observational Study to Assess Adherence Oral Anticancer Therapies (ObservAG)

November 4, 2019 updated by: Centre Georges Francois Leclerc

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • CGFL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient with cancer treated with oral therapy (targeted therapy or chemotherapy) excluding hormone therapy.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months
Response to treatment
Time Frame: 3 months
Treatment response will be assessed according to clinical status and radiological criteria RECIST 1.1.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Georges Francois Leclerc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2016

Primary Completion (Actual)

December 23, 2016

Study Completion (Actual)

September 4, 2018

Study Registration Dates

First Submitted

June 9, 2017

First Submitted That Met QC Criteria

June 20, 2017

First Posted (Actual)

June 22, 2017

Study Record Updates

Last Update Posted (Actual)

November 5, 2019

Last Update Submitted That Met QC Criteria

November 4, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ObservAG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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