Oral Therapies in Oncology: Cognitive Function and Compliance

Cancer Clinical Trial

Official title:

Oral Therapies in Oncology: Cognitive Function and Compliance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01597284
• Other study ID #: COG-OBS
• Status: Terminated
• Phase: N/A
• First received: May 10, 2012
• Last updated: February 9, 2017
• Start date: February 2012
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 129
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Cognitive Function
• Compliance
• Oral Therapies

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment.		8 months