Oral Chemotherapy and Quality of Care

Cancer Clinical Trial

— PARCOURS  

Official title:

Community and Hospital Experiences for Patients Treated by Oral Chemotherapy at the University Hospital of Caen: Analysis of the Process and Its Dysfunctions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03561467
• Other study ID #: 17-134
• Status: Recruiting
• Start date: March 29, 2018
• Est. completion date: September 29, 2018

Study information

• Verified date: May 2018
• Source: University Hospital, Caen
• Contact: Valérie CHEDRU-LEGROS, PhD
• Phone: +332 31 06 46 66
• Email: chedru-v[@]chu-caen.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PARCOURS is a non-interventional research study evaluating dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy (60 patients followed for 3 months).

References used are the National Cancer Institute recommendations for the oral chemotherapy treated outpatients.

Parameters found are : information exchanged, ambulatory and hospital monitoring in case of adverse event and adherence to treatment. The study includes also a medico-economic evaluation (hospitalization and transport spending in case of dysfunction in the patient's journey). Deviations will be analyzed.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 29, 2018
• Est. primary completion date: June 29, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old

• Suffering from cancer (hematological malignancies, digestive tumors, thoracic tumors or cutaneous tumors)

• With an oral anticancer chemotherapy initial prescription written by an oncologist or hematologist from the University Hospital of Caen, whatever the place of the drug dispensing (Community pharmacy or hospital pharmacy )

Exclusion Criteria:

• Patient treated by oral anticancer chemotherapy for another pathology

Related Conditions & MeSH terms

• Cancer

Intervention

Other:
• Observational
Evaluation of dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy

Locations

Country	Name	City	State
France	Caen University Hopsital	Caen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Caen	MSD France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dysfunctions	Number of dysfunctions objectified during the 3-month follow-up period, by sub-processes of the course	3 months
Secondary	Drug adherence	measured by Morisky-Green's questionnaire to the patient	3 months
Secondary	Drug adherence	measured by Data on the refill of prescriptions with the National Health Insurance, and evaluated according to the Drug Possession Ratio	3 months
Secondary	Adverse events	number	3 months
Secondary	Expenses related to the use of unplanned hospital care	Expenses related to the use of unplanned hospital care during the follow-up period: number of oncologist consultations, transport spending, emergency rehospitalizations and additional examinations.	3 months
Secondary	Satisfaction of the patient	RESOCAN questionnaire	At month 3
Secondary	Satisfaction of the caregiver	RESOCAN questionnaire	At month 3
Secondary	Satisfaction of the local professionals	RESOCAN questionnaire	At month 3
Secondary	Quality of life of patients	QLQC 30	At month 3