Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents

Cancer Clinical Trial

— CHIMORAL  

Official title:

Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947296
• Other study ID #: NI 12019
• Secondary ID: C1204
• Status: Completed
• Phase: N/A
• First received: September 2, 2013
• Last updated: February 20, 2017
• Start date: October 2013
• Est. completion date: June 2016

Study information

• Verified date: February 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose is to estimate evolution of patients treated by oral neoplastic agents, in term of early or unforeseen recourse to the hospital for adverse events.

Description:

Introduction :

Oral antineoplastic agents know a full development in particular targeted therapies. Their adverse events (AE) lately detected can lead to non compliance or treatment discontinuation which can be at the origin of disease progression. They can also lead to hospitalization or recourse to emergency department associating to cost for the society.

Hypothesis :

A coordinated intervention of cancer network in relation with primary healthcare professionals, would improve safety of care's patient treated with oral antineoplastic agent by preventing serious AEs through rapid detection.

Primary objective :

The primary objective is to estimate the effect of coordinated intervention of cancer network, in terms of number of early or unforeseen recourses to hospital for AE, within the first 6 months after oral neoplastic agent introduction.

Secondary objectives :

The secondary objective is to estimate the effect of coordinated intervention of cancer network, within the first 6 months after oral neoplastic agent introduction, in terms of number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, number of AE per detection grade, AE maximal grade, AE all grade, disease progression, the global survival (death for any causes and for AE), drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, quality of life, patient's satisfaction, medical economic evaluation

Primary outcome :

The main outcome is the number of early or unforeseen recourses to hospital for AE.

Secondary outcomes :

The secondary outcomes are all deaths and deaths from AE, number of hospitalization for AE, number of consultation for AE, number of early or unforeseen recourses to hospital for grade 1 / 2 AE, disease progression, drug dose-intensity taken by the patient during his treatment, number of recourses to the health care system, number of AE per detection grade, AE maximal grade, AE all grade, quality of life, patient's satisfaction, medical economic evaluationMethodology, design :

A comparative, controlled, not randomized, multicenter, prospective, "quasi-experimental" study, allows estimating evolution of patients according to the existence of a cancer network in their residence place.

Number of needed subjects: 440 patients.

Total duration of the study: 27 months. Inclusion Period: 21 months. length of participation period for one patient: 6 months. Number of participating centers: 21. Average number of inclusions a month by center: 4.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: June 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients affected by cancer (breast, colorectal, liver, lung, kidney, gastrointestinal stromal tumor, pancreas)

• treated by capecitabine, erlotinib, gefitinib, imatinib, lapatinib, sorafenib, sunitinib, vinorelbine, Evérolimus, Pazopanib, Etoposide, Topotécan

• 18 years old or more

Exclusion Criteria:

• refusal to participate

• lack proficiency in French ,

• having a Performance Status > 2,

• home based care,

• patient enrolled in clinical trials

• patient enrolled in therapeutic education program

• patient under administrative supervision or legal guardianship

• not affiliated with Patient Social Security or CMU (recipient or beneficiary)

Related Conditions & MeSH terms

• Cancer

Locations

Country	Name	City	State
France	Hôpital Tenon	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	oncorif

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of early or unforeseen recourses to hospital for adverse event.		within the first 6 monts after oral neoplastic agent introduction
Secondary	all deaths and deaths from AE		within the first 6 monts after oral neoplastic agent introduction
Secondary	number of hospitalization for AE		within the first 6 monts after oral neoplastic agent introduction
Secondary	number of consultation for AE		within the first 6 monts after oral neoplastic agent introduction
Secondary	number of early or unforeseen recourses to hospital for grade 1 / 2 AE		within the first 6 monts after oral neoplastic agent introduction
Secondary	disease progression		within the first 6 monts after oral neoplastic agent introduction
Secondary	drug dose-intensity taken by the patient during his treatment		within the first 6 monts after oral neoplastic agent introduction
Secondary	number of recourses to the health care system		within the first 6 monts after oral neoplastic agent introduction
Secondary	number of AE per detection grade, AE maximal grade, AE all grade		within the first 6 monts after oral neoplastic agent introduction
Secondary	quality of life		within the first 6 monts after oral neoplastic agent introduction
Secondary	patient's satisfaction	patient's satisfaction will be characterized with a questionnaire	within the first 6 monts after oral neoplastic agent introduction
Secondary	medical economic evaluation	Medical economic evaluation use The incremental cost-effectiveness ratio (ICER. This is an equation used commonly in health economics to provide a practical approach to decision making regarding health interventions.	within the first 6 monts after oral neoplastic agent introduction