Oral Therapies in Oncology: Cognitive Function and Compliance

NCT01597284 | Terminated

• 1 other identifier: COG-OBS
• Study Type: observational
• Target: 129
• Locations: 1 country
• Sites: 1

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

Conditions

Oral Therapies; Cancer; Cognitive Function; Compliance

Keywords

Oral therapies; Cancer; cognitive function; compliance

Outcome Measures

Primary Outcomes (1)

• Assess the relationship between cognitive function at baseline oral anti-cancer treatment and adherence to treatment.

  8 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient treated for cancer by a first prescription of exclusive oral therapy (chemotherapy and / or targeted therapy)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (1)

Centre François Baclesse

Caen, 14076, France

Location

MeSH Terms

Conditions

Neoplasms; Patient Compliance

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• JOLY Florence, PhD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2012
• First Posted: May 14, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2016-03

Locations

FR (1)