Breast CancerOPTIsoins01NCT02813317
Optimizing the Care Pathways of Patients Treated for Operable Breast.
An observational study of Breast Cancer and Surgery, run by Institut Curie at 9 sites in France.
Trial summary
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Surgery
- How many people
- 617 participants
- Where
- 9 sitesFrance
- Study dates
- Dec 2014to Apr 2017
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Previously untreated, operable breast cancer.
Who may be able to join
- Signed written informed consent.
- Patients aged ≥18 years.
- Previously untreated, operable breast cancer
- Affiliation with the social security system (or a similar coverage)
- Patient living in one of these french department : "Hauts-de-Seine (92)", "les Yvelines (78)", or "le Val d'Oise (95)".
- Female gender.
Who cannot join
- Previous history of breast cancer.
- Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC (American Joint Committee on Cancer, 7th Edition).
- Any prior treatment for primary breast cancer.
- Patient with any psychological, sociological or geographical condition potentially hampering compliance with the study follow-up schedule.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
Victor Dupouy Hospital
Argenteuil, 95100
Antoine Béclère Hospital
Clamart
Louis Mourier Hospital
Colombes, 92700
André Mignot Hospital - Versailles
Le Chesnay, 78150
Institut Curie
Paris, 75005
Bichat Beaujon University Hospital
Paris, 75018
Poissy Interegional Hospital Center
Poissy, 78300
René Dubos Hospital
Pontoise, 95000
Institut Curie - René Huguenin Hospital
Saint-Cloud, 92210
About this study
Official title: Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.
Read the detailed description
The treatment course of a breast cancer patient includes a hospital stay, home health care that requires outpatient services, supportive care and a follow-up course. Outpatient surgery and home hospitalization units are two innovative organizational technologies that are strongly recommended because of their putative positive medico-economic impact; however, these structures are poorly studied in terms of quality of care and patient satisfaction. Regional implementation of these innovations is heterogeneous, thus allowing a comparative study.
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.
This study will be conducted in academic centers, general hospitals and private centers. In the different participating centers, the implemented care steps are different and may include outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care. Outpatient surgery and home hospitalization in particular are two health technologies that are validated by the French National Authority for Health but used differently in different centers.
The primary objective is to examine the economic and financial measurements of the different care pathways of early breast cancer patients to compare the economic burden of outpatient surgery and home hospitalization with the conventional care pathway.
The secondary objectives are:
Assessing patient satisfaction and needs for supportive care. Evaluating the structures and organizations. Evaluating the tool exchanges between the actors over the treatment course.
All parameters related to the patient and to disease characteristics, determinants and management characteristics within and outside the center within one year will be collected and centralized in the study database. The patients' course of care will be divided into five stages: preadmission, hospitalization, the postoperative period (+ 1 month), adjuvant treatments and one-year follow-up. Care pathways will be identified, described and analyzed to meet the primary objective and the secondary objectives.
After analyzing these care pathways, we will propose solutions for optimizing hospital and nonhospital care, thereby building efficient connections among the hospital, home health care, district nurse networks, medical and social sectors, and occupational reintegration.
- Conditions
- Breast Cancer, Surgery
- Keywords
- Surgery, Breast cancer, Quality of life, Care pathway, Economic evaluation
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Care pathways description of early breast cancer patients.
Care pathways will be characterized by the sequence of different care steps. Care steps may include : outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care.
Measured: Up to one year after patient registration
Overall cost measurements of the different care pathways.
Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives.
Measured: Up to one year after patient registration
Overall cost measurements of the different care pathways for health insurance
Evaluating the indirect costs of health insurance
Measured: Up to one year after patient registration
Overall cost measurements of the different care pathways for the patient
Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs).
Measured: Up to one year after patient registration
Secondary outcomes (10)
Patient satisfaction evaluation
Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.
Measured: Up to one year after patient registration.
Supportive care needs assessement
The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey - Breast Cancer module (SCNS-BR8) validated in French.
Measured: Up to one year after patient registration
Supportive care needs assessement
The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey Short Form (SCNS-SF34) validated in French.
Measured: Up to one year after patient registration
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Existence of an occupational reintegration or not.
Measured: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Date of return to work
Measured: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Organization of working time description
Measured: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Evaluating patient return to work : Number of days out of work
Measured: Up to one year after patient registration.
Structures and organizations interactions description
Identification of health care actors inside and outside the hospital
Measured: Up to one year after patient registration
Structures and organizations interactions description
identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).
Measured: Up to one year after patient registration
Structures and organizations interactions description
Regular practitioners questionnaires
Measured: Up to one year after patient registration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startDec 2014
- Primary completionFeb 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 617 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roman ROUZIER, Pr, Study director, Institut CurieDelphine HEQUET, MD PhD, Study director, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813317
- Sponsor's protocol ID
- IC 2014-11
- Acronym
- OPTIsoins01
- Status last verified
- Apr 2017
- First submitted
- 6 Jan 2016
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Hequet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276.
PubMed 29776920
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
- ClinicalTrials.gov ID
- NCT02813317
- Acronym / sponsor ID
- OPTIsoins01 / IC 2014-11
- Conditions
- Breast Cancer, Surgery
- Keywords
- Surgery, Breast cancer, Quality of life, Care pathway, Economic evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 617 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 27 Jun 2016 (estimated)
- 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.
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.
Detailed description
The treatment course of a breast cancer patient includes a hospital stay, home health care that requires outpatient services, supportive care and a follow-up course. Outpatient surgery and home hospitalization units are two innovative organizational technologies that are strongly recommended because of their putative positive medico-economic impact; however, these structures are poorly studied in terms of quality of care and patient satisfaction. Regional implementation of these innovations is heterogeneous, thus allowing a comparative study.
This prospective, multicenter, observational study aims to explore a comprehensive approach to the care of early breast cancer patients in a regional health territory (including 1.5 million women and characterized by a breast cancer incidence and mortality higher than national ranges), incorporating all healthcare actors inside and outside the hospital.
This study will be conducted in academic centers, general hospitals and private centers. In the different participating centers, the implemented care steps are different and may include outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care. Outpatient surgery and home hospitalization in particular are two health technologies that are validated by the French National Authority for Health but used differently in different centers.
The primary objective is to examine the economic and financial measurements of the different care pathways of early breast cancer patients to compare the economic burden of outpatient surgery and home hospitalization with the conventional care pathway.
The secondary objectives are:
Assessing patient satisfaction and needs for supportive care. Evaluating the structures and organizations. Evaluating the tool exchanges between the actors over the treatment course.
All parameters related to the patient and to disease characteristics, determinants and management characteristics within and outside the center within one year will be collected and centralized in the study database. The patients' course of care will be divided into five stages: preadmission, hospitalization, the postoperative period (+ 1 month), adjuvant treatments and one-year follow-up. Care pathways will be identified, described and analyzed to meet the primary objective and the secondary objectives.
After analyzing these care pathways, we will propose solutions for optimizing hospital and nonhospital care, thereby building efficient connections among the hospital, home health care, district nurse networks, medical and social sectors, and occupational reintegration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously untreated, operable breast cancer.
Key inclusion criteria (6 listed)
- Signed written informed consent.
- Patients aged ≥18 years.
- Previously untreated, operable breast cancer
- Affiliation with the social security system (or a similar coverage)
- Patient living in one of these french department : "Hauts-de-Seine (92)", "les Yvelines (78)", or "le Val d'Oise (95)".
Key exclusion criteria (4 listed)
- Previous history of breast cancer.
- Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC (American Joint Committee on Cancer, 7th Edition).
- Any prior treatment for primary breast cancer.
- Patient with any psychological, sociological or geographical condition potentially hampering compliance with the study follow-up schedule.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Care pathways description of early breast cancer patients.
Time frame: Up to one year after patient registration
Care pathways will be characterized by the sequence of different care steps. Care steps may include : outpatient surgery, home hospitalization, a one-stop breast clinic visit, care by an oncology pivot nurse and/or screening for supportive care.
Overall cost measurements of the different care pathways.
Time frame: Up to one year after patient registration
Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives.
Overall cost measurements of the different care pathways for health insurance
Time frame: Up to one year after patient registration
Evaluating the indirect costs of health insurance
Overall cost measurements of the different care pathways for the patient
Time frame: Up to one year after patient registration
Evaluating the out-of-pocket health expenses for breast cancer during the first year post diagnosis (direct and indirect costs).
10 secondary outcomes
Patient satisfaction evaluation
Time frame: Up to one year after patient registration.
Supportive care needs assessement
Time frame: Up to one year after patient registration
Supportive care needs assessement
Time frame: Up to one year after patient registration
Breast cancer impact on patient's professional activity
Time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Time frame: Up to one year after patient registration.
Breast cancer impact on patient's professional activity
Time frame: Up to one year after patient registration.
Structures and organizations interactions description
Time frame: Up to one year after patient registration
Structures and organizations interactions description
Time frame: Up to one year after patient registration
Structures and organizations interactions description
Time frame: Up to one year after patient registration
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 13 Apr 2017.
- Derived from this study: PubMed 29776920Arfi A, Baffert S, Soilly AL, Huchon C, Reyal F, Asselain B, Neffati S, Rouzier R, Hequet D. Determinants of return at work of breast cancer patients: results from the OPTISOINS01 French prospective study. BMJ Open. 2018 May 18;8(5):e020276. doi: 10.1136/bmjopen-2017-020276.
- Individual participant dataSharing planned: No
Related trials for Breast Cancer
RecruitingObservational study
Collection of CSF Samples From Participants With Metastatic Triple Negative Breast Cancer (TNBC) and HER2+ Breast Cancer With no Prior History Nor Active Radiographically Detectable Brain Metastases
Breast Cancer, Breast Carcinoma
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
Not yet recruitingPhase 2
Netupitant/Palonosetron for Prevention of Nausea and Vomiting in Breast Cancer ADC Therapy
Breast Cancer
RecruitingPhase 1
A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors
Advanced Breast Cancer, Metastatic Breast Cancer (HR+/ HER2-)
Not yet recruiting
Molecular Subtype-Guided Postoperative Radiotherapy for Phyllodes Tumor of the Breast
Radiotherapy, Adjuvant, Phyllodes Breast Tumor
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.
Roman ROUZIER, Pr study director
Institut Curie
Delphine HEQUET, MD PhD study director
Institut Curie
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Surgery, run by Institut Curie at 9 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 6 inclusion and 4 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 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Care pathways description of early breast cancer patients. (time frame: Up to one year after patient registration). The study lists 4 primary outcomes in all. 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 NCT02813317, which also lists 1 linked publication.
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 13 Apr 2017.