Optimize the Requirements and Preparations in Outpatient Chemotherapy

NCT02323555 | Completed

• 1 other identifier: OPTIMA
• Study Type: interventional
• Target: 624
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer; IV Anticancer Therapy

Keywords

Cancer; chemotherapy; Targeted therapy; Day Hospital

Outcome Measures

Primary Outcomes (1)

• Patient profile for Optima

  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.

  up to 21 weeks

Secondary Outcomes (1)

• Satisfaction

  up to 21 weeks

Study Arms (1)

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.

Other: Paramedic telephone consultation

Interventions

Paramedic telephone consultation OTHER

Paramedic telephone consultation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead
• Roche Pharma AG: collaborator

Study Sites (1)

Centre François Baclese

Caen, 14076, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Audrey FAVEYRIAL, MD

  Centre François Baclesse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2014
• First Posted: December 23, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: September 1, 2016
• Last Updated: February 10, 2017

Record last verified: 2016-08

Locations

FR (1)