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Oral Therapies in Oncology: Cognitive Function and Compliance

This study has been terminated.
(Loss of recruitment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01597284
First Posted: May 14, 2012
Last Update Posted: February 10, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Francois Baclesse
  Purpose
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

Condition
Oral Therapies Cancer Cognitive Function Compliance

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
Official Title: Oral Therapies in Oncology: Cognitive Function and Compliance

Further study details as provided by Centre Francois Baclesse:

Primary Outcome Measures:
  • Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment. [ Time Frame: 8 months ]

Enrollment: 129
Study Start Date: February 2012
Study Completion Date: March 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient treated for cancer by a first prescription of exclusive oral therapy (chemotherapy and / or targeted therapy)
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597284


Locations
France
Centre François Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: JOLY Florence, PhD Centre François Baclesse
  More Information

Responsible Party: Centre Francois Baclesse
ClinicalTrials.gov Identifier: NCT01597284     History of Changes
Other Study ID Numbers: COG-OBS
First Submitted: May 10, 2012
First Posted: May 14, 2012
Last Update Posted: February 10, 2017
Last Verified: March 2016

Keywords provided by Centre Francois Baclesse:
Oral therapies
Cancer
cognitive function
compliance