Impact of OncoDoc2 on Guideline Compliance in the Management of Breast Cancer (OncoDoc2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00728442
Recruitment Status : Completed
First Posted : August 5, 2008
Last Update Posted : September 4, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: ONCODOC LOGICIEL Not Applicable

Detailed Description:
In France, to promote the quality of cancer care, decisions have currently to be made according to clinical practice guidelines (CPGs) during regularly organized multidisciplinary staff meetings (MSMs). Dissemination of textual CPGs has a poor impact on clinical practice as opposed to the use of clinical decision support systems (CDSSs) known to improve compliance with CPGs. OncoDoc2 is a CDSS providing patient-specific recommendations based on CPGs for non-metastatic female breast cancer management elaborated by the CancerEst INTERMEDICAL collaboration.The main goal of the study is to evaluate the effect of the routine use of OncoDoc2 during MSMs on compliance of MSM decisions with local CPGs. Impact will be measured by the compliance rate of MSM decisions with OncoDoc2 recommendations. The design of the study relies on a cluster randomized controlled trial. Under the assumption of a baseline compliance rate of 70% without intervention, an expected compliance rate of 90% in the intervention group (α = 5%, β = 20%), an inter-cluster variability of 5%, and 59 decisions per center, the required number of centers is 3 in each group, or 177 decisions in each arm. The study will be conducted in cancer care centers (public and private) from Paris area, France.This prospective trial will be conducted in two steps. First, baseline compliance rates will be measured in each center. Then, the 6 centers will be randomized into 2 arms. In the intervention arm, OncoDoc2 will be used during MSMs at decision time. Every case of non-adherence with system recommendations will have to be justified by clinicians. In both arms and after each MSM, MSM decisions will be recorded as well as patient characteristics and OncoDoc2 will be used for each patient case to get system recommendations. In the intervention arm, OncoDoc2 recommendations obtained by MSM will also be recorded, as well as the reason for non following recommendations in case MSM decision does not comply with guidelines.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 816 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Impact of the OncoDoc2 Decision Support System on Compliance of Multidisciplinary Staff Meeting Decisions With Clinical Practice Guidelines in the Management of Non-metastatic Breast Cancer.
Study Start Date : December 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Experimental: 1
medical decision based on computerized guideline-based decision support system
Introduction of a computer-based decision support system in the medical decision process

No Intervention: 2

Primary Outcome Measures :
  1. Compliance of multidisciplinary staff meeting (MSM) decisions with OncoDoc2 guideline-based recommendations at one year : MSM decisions are recorded on a weekly basis. [ Time Frame: Every week ]

Secondary Outcome Measures :
  1. 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) [ Time Frame: at 18 months ]
  2. typology of non-compliant reasons for both MSM decisions and treatments administration [ Time Frame: at 18 months ]
  3. patient profiles associated with non-guideline-compliant therapeutic decisions. [ Time Frame: at 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • 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…)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00728442

Service de gynecologie obstetrique, Hopital Tenon
Paris, France, 75020
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Serge UZAN, MD, PhD Assistance Publique - Hôpitaux de Paris

Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00728442     History of Changes
Other Study ID Numbers: K 070603
First Posted: August 5, 2008    Key Record Dates
Last Update Posted: September 4, 2013
Last Verified: September 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Clinical practice guidelines
Guideline adherence
Clinical decision support systems
Randomized controlled trial
Intervention study

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases