Clinical trial · Observational
Optimizing the Care Pathways of Patients Treated for Operable Breast.
Optimizing the Care Pathways of Patients Treated for Operable Breast Cancer
NCT02813317CI-TRIAL-00026969OPTIsoins01completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Care pathways description of early breast cancer patients.
- timeFrame
- Up to one year after patient registration
- description
- 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.
- measure
- Overall cost measurements of the different care pathways.
- timeFrame
- Up to one year after patient registration
- description
- Evaluating the overall costs of the pathway care (health care and supportive care consumption) at one year for the different perspectives.
- measure
- Overall cost measurements of the different care pathways for health insurance
- timeFrame
- Up to one year after patient registration
- description
- Evaluating the indirect costs of health insurance
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent. 2. Patients aged ≥18 years. 3. Previously untreated, operable breast cancer 4. Affiliation with the social security system (or a similar coverage) 5. Patient living in one of these french department : "Hauts-de-Seine (92)", "les Yvelines (78)", or "le Val d'Oise (95)". 6. Female gender. Exclusion Criteria: 1. Previous history of breast cancer. 2. Metastatic, locally advanced, or inflammatory breast cancer, as defined by the AJCC (American Joint Committee on Cancer, 7th Edition). 3. Any prior treatment for primary breast cancer. 4. Patient with any psychological, sociological or geographical condition potentially hampering compliance with the study follow-up schedule.
References
Publications (1)
- DERIVEDArfi 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. PMID 29776920