NCT00728442

Brief Summary

The objective of the study is to evaluate how the use of OncoDoc2, a computerized guideline-based decision support system, could improve the compliance of multidisciplinary staff meeting decisions with local clinical practice guidelines in the management of non-metastatic breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
816

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 5, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

September 4, 2013

Status Verified

September 1, 2013

Enrollment Period

1.3 years

First QC Date

July 31, 2008

Last Update Submit

September 2, 2013

Conditions

Breast Cancer

Keywords

Clinical practice guidelinesGuideline adherenceClinical decision support systemsRandomized controlled trialIntervention study

Outcome Measures

Primary Outcomes (1)

  • Compliance of multidisciplinary staff meeting (MSM) decisions with OncoDoc2 guideline-based recommendations at one year : MSM decisions are recorded on a weekly basis.

    Every week

Secondary Outcomes (3)

  • Compliance of actually administered treatments with OncoDoc2 recommendations at 18 months (treatments administration may last until 8 months after the therapeutic decision has been taken by MSMs)

    at 18 months

  • typology of non-compliant reasons for both MSM decisions and treatments administration

    at 18 months

  • patient profiles associated with non-guideline-compliant therapeutic decisions.

    at 18 months

Study Arms (2)

1

EXPERIMENTAL

medical decision based on computerized guideline-based decision support system

Device: ONCODOC LOGICIEL

2

NO INTERVENTION

Interventions

ONCODOC LOGICIELDEVICE

Introduction of a computer-based decision support system in the medical decision process

1

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Non metastatic, including invasive and in situ, breast cancers as well as axillary cancer without breast tumor.
  • At least one therapeutic MSM decision.

You may not qualify if:

  • Breast disease without cancer
  • Metastatic breast cancer
  • Male breast cancer
  • Breast cancer cases when medical records are not accessible to investigators
  • Management but not therapeutic breast cancer decisions (diagnostic investigations, treatment follow-up, delayed decisions…)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de gynecologie obstetrique, Hopital Tenon

Paris, 75020, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Serge UZAN, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 5, 2008

Study Start

December 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2011

Last Updated

September 4, 2013

Record last verified: 2013-09

Locations

FR(1)