Oral Therapies in Oncology: Cognitive Function and Compliance

February 9, 2017 updated by: Centre Francois Baclesse
The investigators propose to evaluate the compliance of oral cancer therapies, particularly the possible link between this observance and cognitive function of patients at initiation of treatment. To our knowledge, this study will be among the first conducted on the issue in France and is an innovative approach in the management of cancer patients. The inclusion of cognitive dysfunction is part of a comprehensive approach to improving the quality of life and fully meets the objectives of both plans cancer, including those of the axis "Living during and after cancer" highlighted in the Cancer Plan

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

129

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
      • Caen, France, 14076
        • Centre François Baclesse

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

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient treated for cancer by a first prescription of exclusive oral therapy (chemotherapy and / or targeted therapy)

Description

Inclusion Criteria:

  • Age over 18 years,
  • Patients treated with a first prescription of exclusive oral therapy (chemotherapy and/or targeted therapy) as part of a cancer,
  • Patients who begin treatment with ZYTIGA ® (abiraterone acetate) are incluables,
  • Patients with asymptomatic brain metastases are incluables,
  • Lack of personality disorders and psychiatric illness scalable,
  • Knowledge of spoken and written French,
  • Having signed the informed consent of study participation.

Exclusion Criteria:

  • Pathology psychiatric
  • Refusal to participate,
  • Patient unable to respond to cognitive tests, - Documented use of drugs,
  • Heavy drinking, - Cancer primitive central nervous system, - Participation in a clinical trial.

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
Time Frame
Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment.
Time Frame: 8 months
8 months

Collaborators and Investigators

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

Sponsor

Centre Francois Baclesse

Investigators

  • Principal Investigator: JOLY Florence, PhD, Centre François Baclesse

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

February 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

May 10, 2012

First Submitted That Met QC Criteria

May 11, 2012

First Posted (Estimate)

May 14, 2012

Study Record Updates

Last Update Posted (Actual)

February 10, 2017

Last Update Submitted That Met QC Criteria

February 9, 2017

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • COG-OBS

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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