Practices and Organizations Related to Emerging Occupations of Care (EPOCK) Coordination in Oncology (EPOCK)

June 18, 2020 updated by: University Hospital, Bordeaux

Pilot Observational and Analytic Study of Practices and Organizations Related to Emerging Occupations of Care Coordination in Oncology: Modeling the Concept of Care Coordination in Oncology (EPOCK)

Several stakeholders are implied in cancer care pathways and there is a need for coordinating their actions. New occupations of care coordination have thus emerged. However, the conditions of their efficiency have been too few reported and included discrepancies between reports. In this context, the main objective is to propose a modeling of care coordination and associated emerging occupations (nurse-based) by comparing theoretical expected outcomes to professionals, patients and caregivers representations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Several stakeholders are implied in cancer care pathways and there is a need to coordinate their actions. New occupations of care coordination have thus emerged, such as nurse coordinator in France (IDEC: Infirmière de Coordination). However, the conditions of their efficiency are not well known. Moreover, several other complementary approaches and nurse occupations have to be identified because of their contribution to care coordination (IDE TAS, IPO, IDE AMA, IDE-CO, IDE HAD-CAD, IDE ETP)*. Finally, all together, these interventions of care coordination appeared as complex and asked for a theoretical model. Because of this high variability of the practices, without an underlying model, the impact of care coordination on patient quality of life, safety and efficiency of care is difficult to assess. In this context, the main objective is to propose a modeling of care coordination and associated emerging occupations by comparing theoretical expected outcomes to professionals, patients and caregivers representations.

The pilot observational study is based on three distinct stages: (1) the definition of care coordination in oncology using a literature review and a Delphi consensus study; (2) the description of practices, contexts, perceptions and attitudes related to care coordination occupations in oncology using a qualitative and a cross-sectional quantitative survey; (3) the comparison of the practices to the theoretical model to propose a modeling of care coordination occupations in oncology.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
960

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France
        • Institut Sainte Catherine
      • Bordeaux, France
        • Chu de Bordeaux
      • Bordeaux, France
        • Clinique Tiivoli Ducos
      • Langon, France
        • CH Sud Gironde
      • Libourne, France
        • CH de Libourne
      • Paris, France
        • Institut Curie
      • Saint-Priest, France
        • Institut de Cancerologie de La Loire
      • Talence, France
        • HAD Bagatelle
      • Toulouse, France
        • Institut Claudius Regaud
      • Toulouse, France
        • CHU de Toulouse

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Four samples :

  • Professionals of cancer care coordination
  • Cancer patients
  • Family caregivers of the selected patients
  • Professionals working with professionals of care coordination

Description

Inclusion Criteria:

  • For health institutions: public or private institutions in which nurses contributing to care coordination. Each institution will be associated with one type of coordination occupation, even if other healthcare workers contribute to care coordination in the same institution.
  • For professionals of care coordination: nurses contributing to care coordination in oncology (IDEC , IDE TAS, IPO, IDE AMA, IDE-CO, IDE HAD-CAD or IDE ETP)

  • For professionals working with professionals of care coordination:

    • Medical and non-medical healthcare professionals (oncologist, surgeon, nurses…), administrative professionals (secretary…), professionals of supportive care (psychologists, social workers…) and volunteers in patient organizations.
    • Private practitioners: general practitioner, private nurses, pharmacist
  • For the patients : adults under supervision of the selected professionals of care coordination for at least four weeks and able to express themselves
  • For the caregivers: family caregivers of the selected patients.

Exclusion Criteria:

  • For health institutions: private healthcare networks, territorial support platforms, home-based care providers, healthcare houses
  • For professionals of care coordination: coordinating medical doctors of care networks, coordinating medical doctors of hospital care at home, practitioners of regional cancer networks.
  • For the patients: <18 years old

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modeling of care coordination in Oncology in France
Time Frame: During the whole period (36 months: from Month 1 to Month 36)
Constitutive elements of modelling of care coordination in oncology in France (qualitative analysis)
During the whole period (36 months: from Month 1 to Month 36)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Care coordination profesionals quality of life
Time Frame: Quantitative cross sectional survey (from Month 10 to Month 29)
Three scores : perceived organizational support, role conflict and commitment to the organization
Quantitative cross sectional survey (from Month 10 to Month 29)
Satisfaction with care coordination for profes professionals working with professionals of care coordination
Time Frame: Quantitative cross sectional survey (from Month 10 to Month 29)
Score of satisfaction
Quantitative cross sectional survey (from Month 10 to Month 29)
Patients quality of life and satisfaction with care coordination
Time Frame: Quantitative cross sectional survey (from Month 10 to Month 29)
Score of satisfaction and score of quality of life (measured with the European Organization for Research and Treatment (EORTC) quality of life questionnaire)
Quantitative cross sectional survey (from Month 10 to Month 29)
Caregivers burden with care coordination
Time Frame: Quantitative cross sectional survey (from Month 10 to Month 29)
Score of burdean (Zarit Burden Interview) with care coordination
Quantitative cross sectional survey (from Month 10 to Month 29)
Caregivers satisfaction with care coordination
Time Frame: Quantitative cross sectional survey (from Month 10 to Month 29)
Score of satisfaction with care coordination
Quantitative cross sectional survey (from Month 10 to Month 29)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 17, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 2, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 9, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2016/31

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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