NCT03561467

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 19, 2018

Completed
10 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 29, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2018

Completed
Last Updated

June 19, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 25, 2018

Last Update Submit

June 7, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of dysfunctions

    Number of dysfunctions objectified during the 3-month follow-up period, by sub-processes of the course

    3 months

Secondary Outcomes (8)

  • Drug adherence

    3 months

  • Drug adherence

    3 months

  • Adverse events

    3 months

  • Expenses related to the use of unplanned hospital care

    3 months

  • Satisfaction of the patient

    At month 3

  • +3 more secondary outcomes

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult outpatients treated by oral chemotherapy for a cancer disease

You may qualify if:

  • 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 )

You may not qualify if:

  • \- Patient treated by oral anticancer chemotherapy for another pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caen University Hopsital

Caen, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Watchful Waiting

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Valérie CHEDRU-LEGROS, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 19, 2018

Study Start

March 29, 2018

Primary Completion

June 29, 2018

Study Completion

September 29, 2018

Last Updated

June 19, 2018

Record last verified: 2018-05

Locations