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

NCT ID: NCT01947296

Last Updated: 2017-02-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 284 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2016-06-30

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.

Conditions

Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group " coordinated care"

Patient living in place covered by cancer network participating to the study is in the group "coordinated care"

No interventions assigned to this group

Group " usual care "

Patient living in place covered by cancer network non participating to the study or without cancer network is in the group "usual care"

No interventions assigned to this group

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

oncorif

UNKNOWN

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-¨Pierre Lotz, Professor

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Hôpital Tenon

Paris, , France

Countries

France

Other Identifiers

C1204

Identifier Type: OTHER

Identifier Source: secondary_id

NI 12019

Identifier Type: -

Identifier Source: org_study_id