Care Coordination in OncologyEPOCKNCT03350776
Practices and Organizations Related to Emerging Occupations of Care (EPOCK) Coordination in Oncology
An observational study of Care Coordination in Oncology, run by University Hospital, Bordeaux at 10 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Care Coordination in Oncology
- What is being tested?
- Care coordination
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 960 participants
- Where
- 10 sitesFrance
- Study dates
- 17 Apr 2018to 30 Oct 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Four samples : * Professionals of cancer care coordination * Cancer patients * Family caregivers of the selected patients * Professionals working with professionals of care coordination
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Institut Sainte Catherine
Avignon
CHU de Bordeaux
Bordeaux
Clinique Tiivoli Ducos
Bordeaux
CH Sud Gironde
Langon
CH de Libourne
Libourne
Institut Curie
Paris
Institut de Cancérologie de la Loire
Saint-Priest
HAD Bagatelle
Talence
CHU de Toulouse
Toulouse
Institut Claudius Regaud
Toulouse
About this study
Official title: 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.
Read the 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.
- Conditions
- Care Coordination in Oncology
- Being tested
- Care coordination
- Keywords
- Neoplasm, Chronic disease, Complex cases, Care coordination, Oncologic nursing, Theoretical model
- Medical subject headings
- Neoplasms, Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care coordinationBehavioural
Care coordination and associated emerging occupations by comparing theoretical expected outcomes to professionals, patients and caregivers representations
What is being measured
The primary outcome is the main question the study is designed to answer.
Modeling of care coordination in Oncology in France
Constitutive elements of modelling of care coordination in oncology in France (qualitative analysis)
Measured: During the whole period (36 months: from Month 1 to Month 36)
Secondary outcomes (5)
Care coordination profesionals quality of life
Three scores : perceived organizational support, role conflict and commitment to the organization
Measured: Quantitative cross sectional survey (from Month 10 to Month 29)
Satisfaction with care coordination for profes professionals working with professionals of care coordination
Score of satisfaction
Measured: Quantitative cross sectional survey (from Month 10 to Month 29)
Patients quality of life and satisfaction with care coordination
Score of satisfaction and score of quality of life (measured with the European Organization for Research and Treatment (EORTC) quality of life questionnaire)
Measured: Quantitative cross sectional survey (from Month 10 to Month 29)
Caregivers burden with care coordination
Score of burdean (Zarit Burden Interview) with care coordination
Measured: Quantitative cross sectional survey (from Month 10 to Month 29)
Caregivers satisfaction with care coordination
Score of satisfaction with care coordination
Measured: Quantitative cross sectional survey (from Month 10 to Month 29)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start17 Apr 2018
- Primary completion2 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Care Coordination in OncologyStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 960 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350776
- Sponsor's protocol ID
- CHUBX 2016/31
- Acronym
- EPOCK
- Status last verified
- Jun 2020
- First submitted
- 9 Nov 2017
- Last updated
- 19 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Colombani F, Calcagni N, Sibe M, Kret M, Fournier H, Ravaud A, Quintard B, Saillour-Glenisson F. Evidence-based modelling and taxonomy of hospital-based cancer care coordination nurses' roles and boundaries: an iterative multiphase convergent mixed study. BMJ Oncol. 2025 Nov 18;4(1):e000771. doi: 10.1136/bmjonc-2025-000771. eCollection 2025.
PubMed 41323425Colombani F, Sibe M, Kret M, Quintard B, Ravaud A, Saillour-Glenisson F. EPOCK study protocol: a mixed-methods research program evaluating cancer care coordination nursing occupations in France as a complex intervention. BMC Health Serv Res. 2019 Jul 12;19(1):483. doi: 10.1186/s12913-019-4307-7.
PubMed 31299966
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT03350776
- Acronym / sponsor ID
- EPOCK / CHUBX 2016/31
- Conditions
- Care Coordination in Oncology
- Keywords
- Neoplasm, Chronic disease, Complex cases, Care coordination, Oncologic nursing, Theoretical model
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 960 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 17 Apr 2018 (actual)
- Primary completion
- 2 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Four samples : * Professionals of cancer care coordination * Cancer patients * Family caregivers of the selected patients * Professionals working with professionals of care coordination
Key inclusion criteria (7 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care coordinationCare coordination and associated emerging occupations by comparing theoretical expected outcomes to professionals, patients and caregivers representations | Behavioural | – |
Primary outcome
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)
5 secondary outcomes
Care coordination profesionals quality of life
Time frame: 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)
Patients quality of life and satisfaction with care coordination
Time frame: 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)
Caregivers satisfaction with care coordination
Time frame: Quantitative cross sectional survey (from Month 10 to Month 29)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2020.
- Derived from this study: PubMed 41323425Colombani F, Calcagni N, Sibe M, Kret M, Fournier H, Ravaud A, Quintard B, Saillour-Glenisson F. Evidence-based modelling and taxonomy of hospital-based cancer care coordination nurses' roles and boundaries: an iterative multiphase convergent mixed study. BMJ Oncol. 2025 Nov 18;4(1):e000771. doi: 10.1136/bmjonc-2025-000771. eCollection 2025.
- Derived from this study: PubMed 31299966Colombani F, Sibe M, Kret M, Quintard B, Ravaud A, Saillour-Glenisson F. EPOCK study protocol: a mixed-methods research program evaluating cancer care coordination nursing occupations in France as a complex intervention. BMC Health Serv Res. 2019 Jul 12;19(1):483. doi: 10.1186/s12913-019-4307-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Care Coordination in Oncology, run by University Hospital, Bordeaux at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modeling of care coordination in Oncology in France (time frame: During the whole period (36 months: from Month 1 to Month 36)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350776, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2020.