Optimizing the Care Pathways of Patients Treated for Operable Breast.

NCT02813317 | Completed

• 1 other identifier: IC 2014-11
• Study Type: observational
• Target: 617
• Locations: 1 country
• Sites: 9

Brief 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 actors inside and outside the hospital.

Conditions

Breast Cancer; Surgery

Keywords

Surgery; Breast cancer; Quality of life; Care pathway; Economic evaluation

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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

  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).

  Up to one year after patient registration

Secondary Outcomes (10)

• Patient satisfaction evaluation

  Up to one year after patient registration.

• Supportive care needs assessement

  Up to one year after patient registration

• Supportive care needs assessement

  Up to one year after patient registration

• Breast cancer impact on patient's professional activity

  Up to one year after patient registration.

• Breast cancer impact on patient's professional activity

  Up to one year after patient registration.

Other Outcomes (1)

• Care pathways suggestion for a regional health territory.

  Through study completion (within one year after the last patient follow-up)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously untreated, operable breast cancer.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (9)

Victor Dupouy Hospital

Argenteuil, 95100, France

Location

Antoine Béclère Hospital

Clamart, France

Location

Louis Mourier Hospital

Colombes, 92700, France

Location

André Mignot Hospital - Versailles

Le Chesnay, 78150, France

Location

Institut Curie

Paris, 75005, France

Location

Bichat Beaujon University Hospital

Paris, 75018, France

Location

Poissy Interegional Hospital Center

Poissy, 78300, France

Location

René Dubos Hospital

Pontoise, 95000, France

Location

Institut Curie - René Huguenin Hospital

Saint-Cloud, 92210, France

Location

Related Publications (1)

• 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.

  PMID: 29776920 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Roman ROUZIER, Pr

  Institut Curie

  STUDY DIRECTOR

• Delphine HEQUET, MD PhD

  Institut Curie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: June 27, 2016
• Study Start: December 1, 2014
• Primary Completion: February 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 13, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)