Oral Therapies in Oncology: Cognitive Function and Compliance

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Centre Francois Baclesse
Sponsor:
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01597284
First received: May 10, 2012
Last updated: July 3, 2014
Last verified: July 2014
  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: 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 ]

Estimated Enrollment: 141
Study Start Date: February 2012
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
  Eligibility

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)

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: JOLY Florence, PhD (+33) 2 31 45 50 02 f.joly@baclesse.fr

Locations
France
Centre François Baclesse Recruiting
Caen, France, 14076
Contact: JOLY Florence, PhD    (+33) 2 31 45 50 02    f.joly@baclesse.fr   
Contact: GRELLARD Jean-Michel, CRA    (+33) 2 31 45 50 02    jm.grellard@baclesse.fr   
Principal Investigator: JOLY Florence, PhD         
Sub-Investigator: RIVIERE Alain, MD         
Sub-Investigator: GALAIS Marie-Pierre, MD         
Sub-Investigator: JACOB Jacques-Henri, MD         
Sub-Investigator: DO Pascal, MD         
Sub-Investigator: GERVAIS Radj, MD         
Sub-Investigator: LEFEBVRE Anne-Charlotte, MD         
Sub-Investigator: SEVIN Emmanuel, MD         
Sub-Investigator: DELCAMBRE Corinne, MD         
Sub-Investigator: ALLOUACHE Djelila, MD         
Sub-Investigator: FAVEYRIAL Audrey, MD         
Sub-Investigator: GUNZER Katharina, MD         
Sub-Investigator: VILQUE Jean-Pierre, MD         
Sub-Investigator: MUSAFIRI Dada, MD         
Sub-Investigator: FRUCHART Christophe, MD         
Sub-Investigator: HERON Jean-François, PHD         
Sub-Investigator: NOAL Sabine, MD         
Sub-Investigator: FLORESCU Carmen, MD         
Sub-Investigator: LEROUGE Delphine, MD         
Sub-Investigator: LHEUREUX Stéphanie, MD         
Sub-Investigator: M'VONDO Che Mabubu, MD         
Sub-Investigator: POLYCARPE-OSAER Florence, MD         
Sub-Investigator: MOISE Laura, MD         
Sub-Investigator: PARZY Aurélie, MD         
Sponsors and Collaborators
Centre Francois Baclesse
Investigators
Principal Investigator: JOLY Florence, PhD Centre François Baclesse
  More Information

No publications provided

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: July 3, 2014
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
Cancer
cognitive function
compliance

ClinicalTrials.gov processed this record on August 01, 2014