Oral Therapies in Oncology: Cognitive Function and Compliance
This study is currently recruiting participants.
Verified March 2013 by Centre Francois Baclesse
Sponsor:
Centre Francois Baclesse
Information provided by (Responsible Party):
Centre Francois Baclesse
ClinicalTrials.gov Identifier:
NCT01597284
First received: May 10, 2012
Last updated: March 14, 2013
Last verified: March 2013
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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 2014 |
| Estimated Primary Completion Date: | April 2014 (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
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: | March 14, 2013 |
| 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 May 16, 2013