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Optimizing the Care Pathways of Patients Treated for Operable Breast. (OPTIsoins01)

2017년 4월 12일 업데이트: Institut Curie

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.

연구 개요

상태

완전한

정황

상세 설명

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.

연구 유형

관찰

등록 (실제)

617

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 프랑스
      • Argenteuil, 프랑스, 95100
        • Victor Dupouy Hospital
      • Clamart, 프랑스
        • Antoine Beclère Hospital
      • Colombes, 프랑스, 92700
        • Louis Mourier Hospital
      • Le Chesnay, 프랑스, 78150
        • André Mignot Hospital - Versailles
      • Paris, 프랑스, 75005
        • Institut Curie
      • Paris, 프랑스, 75018
        • Bichat Beaujon University Hospital
      • Poissy, 프랑스, 78300
        • Poissy Interegional Hospital Center
      • Pontoise, 프랑스, 95000
        • Rene Dubos Hospital
      • Saint-Cloud, 프랑스, 92210
        • Institut Curie - René Huguenin Hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 이상 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

여성

샘플링 방법

비확률 샘플

연구 인구

Previously untreated, operable breast cancer.

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 관찰 모델: 보병대
  • 시간 관점: 유망한

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Care pathways description of early breast cancer patients.
기간: 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.
Up to one year after patient registration
Overall cost measurements of the different care pathways.
기간: 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.
Up to one year after patient registration
Overall cost measurements of the different care pathways for health insurance
기간: Up to one year after patient registration
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
기간: 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).
Up to one year after patient registration

2차 결과 측정

결과 측정
측정값 설명
기간
Patient satisfaction evaluation
기간: Up to one year after patient registration.
Patient satisfaction will be assessed at different time points using the OUT-PATSAT35 questionnaire validated in French.
Up to one year after patient registration.
Supportive care needs assessement
기간: Up to one year after patient registration
The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey - Breast Cancer module (SCNS-BR8) validated in French.
Up to one year after patient registration
Supportive care needs assessement
기간: Up to one year after patient registration
The patient's needs for supportive care will be assessed using the Supportive Care Needs Survey Short Form (SCNS-SF34) validated in French.
Up to one year after patient registration
Breast cancer impact on patient's professional activity
기간: Up to one year after patient registration.
Evaluating patient return to work : Existence of an occupational reintegration or not.
Up to one year after patient registration.
Breast cancer impact on patient's professional activity
기간: Up to one year after patient registration.
Evaluating patient return to work : Date of return to work
Up to one year after patient registration.
Breast cancer impact on patient's professional activity
기간: Up to one year after patient registration.
Evaluating patient return to work : Organization of working time description
Up to one year after patient registration.
Breast cancer impact on patient's professional activity
기간: Up to one year after patient registration.
Evaluating patient return to work : Number of days out of work
Up to one year after patient registration.
Structures and organizations interactions description
기간: Up to one year after patient registration
Identification of health care actors inside and outside the hospital
Up to one year after patient registration
Structures and organizations interactions description
기간: Up to one year after patient registration
identification of the interactions between the organizations (e.g., identification, shared tools, resource sharing and nurse training).
Up to one year after patient registration
Structures and organizations interactions description
기간: Up to one year after patient registration
Regular practitioners questionnaires
Up to one year after patient registration

기타 결과 측정

결과 측정
측정값 설명
기간
Care pathways suggestion for a regional health territory.
기간: Through study completion (within one year after the last patient follow-up)
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.
Through study completion (within one year after the last patient follow-up)

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Institut Curie

수사관

  • 연구 책임자: Roman ROUZIER, Pr, Institut Curie
  • 연구 책임자: Delphine HEQUET, MD PhD, Institut Curie

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2014년 12월 1일

기본 완료 (실제)

2017년 2월 1일

연구 완료 (실제)

2017년 4월 1일

연구 등록 날짜

최초 제출

2016년 1월 6일

QC 기준을 충족하는 최초 제출

2016년 6월 21일

처음 게시됨 (추정)

2016년 6월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2017년 4월 13일

QC 기준을 충족하는 마지막 업데이트 제출

2017년 4월 12일

마지막으로 확인됨

2017년 4월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • IC 2014-11

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Papua New Guinea

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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