Oral Therapies in Oncology: Cognitive Function and Compliance

This study has been terminated.
(Loss of recruitment)
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
First received: May 10, 2012
Last updated: March 14, 2016
Last verified: March 2016
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

Oral Therapies
Cognitive Function

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

Resource links provided by NLM:

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01597284

Centre François Baclesse
Caen, France, 14076
Sponsors and Collaborators
Centre Francois Baclesse
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 
Study First Received: May 10, 2012
Last Updated: March 14, 2016
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Centre Francois Baclesse:
Oral therapies
cognitive function

ClinicalTrials.gov processed this record on May 24, 2016