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Clinical Trials/NCT02323555
NCT02323555CompletedNot Applicable

Optimize the Requirements and Preparations in Outpatient Chemotherapy

Centre Francois Baclesse1 site in 1 country624 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
624
Locations
1
Primary Endpoint
Patient profile for Optima

Study Overview

Brief Summary

A prescription of injectable anticancer therapy requires the collection of medical data (interview and physical examination) and often allied (laboratory tests). This requirement is made on the day of the arrival of the patient to not prepare these treatments incorrectly.

After receiving the prescription of treatment, it will take about 1 hour to prepare for pharmacy and more in times of high activity, to provide the day hospital pockets treatment, incompressible time when the patient waits to have his treatment.

A process has been selected (Optima) to anticipate prescribing injectable cancer treatments and their manufacturing to reduce patient waiting times on the day of his coming François BaclesseCentre day hospital.

Detailed Description

Given the investigators daily activity evaluated patients received 65-70 day hospital, assessing the feasibility of the project with an internalized platform seems most relevant to completely control the process and costs.

This project will consist of anticipation paramedic telephone consultation followed by a medical prescription validation will trigger the production of chemotherapy prematurely before the coming of the patient.

The François Baclesse Center therefore supports the idea of an early day hospital, that is to say a prescription and production pockets of chemotherapy before the arrival of the patient in the service.

This project was named PROJECT OPTIMA for "Optimize requirements and preparations chemotherapy Ambulatory Medicine" with a paramedic telephone consultation.

So this ambitious project is the first experience of a French advance routine injectable anticancer therapies, all protocols combined in a Centre for the Fight against Cancer but also in a hospital reference competent oncology and chemotherapy and whose preparation process of chemotherapy administered by injection is fully internalized and centralized.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient (e) old (e) 18 or more;
  • •Patient (e) reached (e) from cancer and candidate (s) to treatment with injectable anticancer preparations in day hospital
  • •solid cancerous disease for which chemotherapy is given intravenously;
  • •Patient (e) able to communicate with the investigator or his representative;
  • •Patient (e) Affiliate (e) a social security scheme;
  • •Mastery of the French language;
  • •Consent and signed.

Exclusion Criteria

  • •Exclusive orallyanticancer treatment ;
  • •Primary brain tumors;
  • •Patient (e) dysphonic or having difficulty communicating orally;
  • •Patient (e) receiving intravenous chemotherapy as part of a research protocol;
  • •Patient (e) to receive chemotherapy whose stability is less than 24:00 (Temsirolimus)
  • •Pathologies hematologic malignancies
  • •Inability to undergo medical monitoring test for geographical, social or psychological reasons.
  • •Patient (e) under guardianship or unable to give informed consent;
  • •Patient (s) whose cognitive functions do not allow a telephone interview.
  • •Any medical or psychological condition associated that could compromise the patient's ability to participate in the study

Arms & Interventions

Paramedic telephone consultation

Experimental

Establishment of a paramedic telephone consultation to the doctor to record the "virtual" early prescription or non-injectable cancer treatment before the arrival of the patient (Feasibility Process Optima), without changing the current practice of prescribing and dispensing of these treatments on the day of the coming of the patient.

Intervention: Paramedic telephone consultation (Other)

Outcomes

Primary Outcomes

Patient profile for Optima

Time Frame: up to 21 weeks

Rate of discordance for each chemotherapy protocol between the Optima process and the current process. Define which protocols for injectable cancer treatment (chemotherapy and / or targeted therapy) and for which patient profiles, the Optima process can be used routinely.

Secondary Outcomes

  • Satisfaction(up to 21 weeks)

Investigators

Sponsor
Centre Francois Baclesse
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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