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Study of Barriers to Beginning and Finishing Treatment for Patients With Breast Cancer

2015年6月3日 更新者:City of Hope Medical Center

Patient Navigation in Breast Cancer Care; Addressing Barriers to Treatment Initiation, Completion, and Follow Up

RATIONALE: Gathering information about barriers to receiving breast cancer treatment may help doctors learn more about improving the treatment process and improve patients' quality of life.

PURPOSE: This clinical trial is studying barriers to beginning and finishing treatment for patients with breast cancer.

研究概览

详细说明

OBJECTIVES:

  • Identify barriers of receiving primary breast cancer treatment for older patients with either Medi-Cal insurance or who are 65 years of age and older.
  • Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these patients.
  • Identify barriers of receiving primary breast cancer treatment for patients who are Hispanic with either Medi-Cal insurance or aged 65 years and older.
  • Describe steps and processes involved in resolution of barriers to receiving primary breast cancer treatment for these Hispanic patients.
  • Describe breast cancer participants' perceptions of Patient Navigation.
  • Demonstrate the significant role of a Patient Navigator in identifying and resolving barriers to treatment.
  • Increase opportunities for participation of breast cancer patients with either Medi-Cal insurance or who are 65 years of age and older, or who are Hispanic, to breast cancer clinical trials.
  • Integrate a patient navigation program within City of Hope designed to support underserved patients during primary treatment for breast cancer.

OUTLINE: For the first 3 months of the study, medical charts are reviewed.

Beginning in month 4, patients are introduced to the Patient Navigator who provides them with telephone and e-mail contact on an Appointment Reminder Card, and develops a plan for eliminating identified barriers and/or addressing immediate concerns. Patients' plans may include contacting others on behalf of the patient, coaching the patient on how to solve a problem, referring to resources within City of Hope (COH) or in the community, and investigating possible solutions. Patients are also oriented to COH's services, open clinical trials, and resources. Navigation of care includes assistance during initial and ongoing evaluations by all cancer specialists, during initiation and completion of all primary treatment, and through the first post-treatment follow up. Patients are contacted weekly for 8 weeks of the study and at least once a month for 9 months.

The Patient Navigator will track identified barriers, processes to resolution, and time required to resolve barriers.

Patients complete questionnaires at baseline, and periodically during study, on socio-demographic, quality of life, resource-use satisfaction, and satisfaction with care and Patient Navigator.

After completion of study intervention, patients continue to receive Patient Navigator support for up to 30 days.

研究类型

介入性

注册 (实际的)

52

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Duarte、California、美国、91010-3000
        • City of Hope Comprehensive Cancer Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

50年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

DISEASE CHARACTERISTICS:

  • Histologically confirmed newly diagnosed breast cancer

    • Stage 0-III disease
    • No metastasis or recurrent disease
  • Insured with Medi-Cal OR ≥ 65 years old
  • Hormone receptor status not specified

PATIENT CHARACTERISTICS:

  • Menopausal status not specified
  • English or Spanish-speaking
  • Intending to receive all primary breast cancer treatment at City of Hope

PRIOR CONCURRENT THERAPY:

  • No prior therapy for breast cancer

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Barrier resolution (information, transportation, appointments, and communication) and time to resolution
大体时间:Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Weekly during the first 8 weeks of the study and thereafter a minimum of monthly through the 9th month of the study.
Quality of life (psychological, physical, social, and spiritual well-being)
大体时间:Prior to starting treatment and 3, 6 and 9 months after starting the study.
Prior to starting treatment and 3, 6 and 9 months after starting the study.
Navigation and care (patient's satisfaction and value, provider's perception of barriers)
大体时间:3, 6 and 9 months after starting the study.
3, 6 and 9 months after starting the study.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Rebecca Crane-Okada, PhD、City of Hope Comprehensive Cancer Center

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2008年11月1日

初级完成 (实际的)

2011年5月1日

研究完成 (实际的)

2011年5月1日

研究注册日期

首次提交

2009年7月10日

首先提交符合 QC 标准的

2009年7月10日

首次发布 (估计)

2009年7月13日

研究记录更新

最后更新发布 (估计)

2015年6月8日

上次提交的符合 QC 标准的更新

2015年6月3日

最后验证

2015年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • 08092
  • P30CA033572 (美国 NIH 拨款/合同)
  • CHNMC-08092
  • CDR0000629952 (注册表标识符:NCI PDQ)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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