Oral Therapies in Oncology: Cognitive Function and Compliance

Terminated

• Conditions: Compliance; Cancer; Cognitive Function; Oral Therapies

• Registration Number: NCT01597284
• Lead Sponsor: Centre Francois Baclesse

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-14
• Status Verified: 2016-03
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Last Update Submitted: 2017-02-09
• Last Update Posted: 2017-02-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 129

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment.	8 months

Trial Locations

Locations (1)

Centre François Baclesse; 🇫🇷 Caen, France