Clinical trial NCT01947296: Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
Official title: Evaluation of the Impact of a Coordinated Regional Organization to Secure Patient's Care Treated by Oral Antineoplastic Agents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Oral antineoplastic agent
Adverse Effects
Cancer Networks
Continuity of care
Coordination of patient's care
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: oncorif
First posted: 2013-09-20
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with oral antineoplastic agent introduction in the region of Ile-de-France

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of early or unforeseen recourses to hospital for adverse event.
timeFrame: within the first 6 monts after oral neoplastic agent introduction
Secondary outcomes:
measure: all deaths and deaths from AE
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: number of hospitalization for AE
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: number of consultation for AE
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: number of early or unforeseen recourses to hospital for grade 1 / 2 AE
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: disease progression
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: drug dose-intensity taken by the patient during his treatment
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: number of recourses to the health care system
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: number of AE per detection grade, AE maximal grade, AE all grade
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: quality of life
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: patient's satisfaction
timeFrame: within the first 6 monts after oral neoplastic agent introduction
measure: medical economic evaluation
timeFrame: within the first 6 monts after oral neoplastic agent introduction
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Tenon
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Jean-¨Pierre Lotz, Professor
role: PRINCIPAL_INVESTIGATOR
References: