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

NCT01947296 | Completed

• 2 other identifiers: NI 12019C1204
• Study Type: observational
• Target: 284
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Oral antineoplastic agent; Adverse Effects; Cancer Networks; Continuity of care; Coordination of patient's care

Outcome Measures

Primary Outcomes (1)

• Number of early or unforeseen recourses to hospital for adverse event.

  within the first 6 monts after oral neoplastic agent introduction

Secondary Outcomes (11)

• all deaths and deaths from AE

  within the first 6 monts after oral neoplastic agent introduction

• number of hospitalization for AE

  within the first 6 monts after oral neoplastic agent introduction

• number of consultation for AE

  within the first 6 monts after oral neoplastic agent introduction

• number of early or unforeseen recourses to hospital for grade 1 / 2 AE

  within the first 6 monts after oral neoplastic agent introduction

• disease progression

  within the first 6 monts after oral neoplastic agent introduction

Study Arms (2)

Group " coordinated care"

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

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"

Eligibility Criteria

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

Study Population

Patients with oral antineoplastic agent introduction in the region of Ile-de-France

You may qualify if:

• 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
• years old or more

You may not qualify if:

• 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)

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• oncorif: collaborator

Study Sites (1)

Hôpital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jean-¨Pierre Lotz, Professor

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2013
• First Posted: September 20, 2013
• Study Start: October 1, 2013
• Primary Completion: February 1, 2016
• Study Completion: June 1, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Locations

FR (1)