Oral Therapies in Oncology: Cognitive Function and Compliance

NCT ID: NCT01597284

Last Updated: 2017-02-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

129 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2016-03-31

Brief Summary

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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

Detailed Description

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Conditions

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Oral Therapies Cancer Cognitive Function Compliance

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Francois Baclesse

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JOLY Florence, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre François Baclesse

Locations

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Centre François Baclesse

Caen, , France

Site Status

Countries

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France

Other Identifiers

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COG-OBS

Identifier Type: -

Identifier Source: org_study_id

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