Oral Chemotherapy and Quality of Care | NCT03561467

Studies
Oral Chemotherapy and Quality of Care

NCT03561467

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Jun 19, 2018Actual

Enrollment

60Estimated

Phase

Not provided

Conditions

Cancer

Interventions

Observational

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 29, 2018Actual

Primary Completion Date

Jun 29, 2018Estimated

Completion Date

Sep 29, 2018Estimated

First Submitted Date

May 25, 2018

First Submission Date that Met QC Criteria

Jun 7, 2018

First Posted Date

Jun 19, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 7, 2018

Last Update Posted Date

Jun 19, 2018Actual

Name	Class
MSD France	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Observational	Other	Evaluation of dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of dysfunctions	Number of dysfunctions objectified during the 3-month follow-up period, by sub-processes of the course	3 months

Secondary Outcomes

Measure	Description	Time Frame
Drug adherence	measured by Morisky-Green's questionnaire to the patient	3 months
Drug adherence	measured by Data on the refill of prescriptions with the National Health Insurance, and evaluated according to the Drug Possession Ratio

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult outpatients treated by oral chemotherapy for a cancer disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Valérie CHEDRU-LEGROS, PhD	Contact	+332 31 06 46 66		chedru-v@chu-caen.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hopsital	Recruiting	Caen			France

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D057832	Watchful Waiting

Ancestor Terms

ID	Term
D017063	Outcome Assessment, Health Care
D010043	Outcome and Process Assessment, Health Care
D011787	Quality of Health Care
D006298	Health Services Administration

Browse Leaves

Not provided

Browse Branches

Not provided