跳至主要内容
临床试验/NCT03007641
NCT03007641已完成不适用

Improving the Approach to and Management of the Older Metastatic Breast Cancer Patient Via a Provider Didactic Intervention

Fox Chase Cancer Center10 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
10
主要终点
Number of geriatric abnormalities detected

研究概览

简要总结

The purpose of this study is to enhance the care of older metastatic breast cancer (MBC) patients by increasing awareness among oncology providers as to the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic breast cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include three phases.

详细描述

Older oncology patients pose a significant treatment challenge due to poor chemotherapy tolerance as a result of underlying co-morbidities, lack of social support, and diminished functional reserve. Oncologists are faced with the challenge of differentiating between patients that can and cannot tolerate chemotherapy, and tailoring therapy to the patient's biologic rather than chronologic age.

A significant challenge that surrounds the treatment of the older metastatic breast cancer (MBC) patient in particular, lies in the lack of evidence based clinical data to guide the oncologist in determination of a treatment plan. This is a result of under representation of older patients in clinical trials. Due to these challenges a thorough evaluation of the older patient is recommended prior to initiation of anti-cancer therapy.

The purpose of this research study is to enhance the care of the older MBC patient by increasing awareness among oncology providers as to the unique aspects of care required for older patients. The goal of the study is to educate providers on the utility of geriatric assessment in guiding therapy of older metastatic breast cancer patients. The investigators will also assess the feasibility and benefit of incorporating geriatric self-assessments into clinical practice. The study will include three phases:

  1. Needs assessments - to understand the population of older metastatic breast cancer patients seen in routine practice at community centers, and assess their treatment approach.
  2. Educational programming about management of older metastatic breast cancer patients, and geriatric assessment of these patients.
  3. Active testing of the use of geriatric assessment in clinical practice.

The ultimate goal is to develop an educational curriculum that could be implemented at other community oncology sites beyond the participants on this study. This type of educational intervention can be applied to other disease sites in the future. During the study period we will identify the specific gaps that exist in each practice and develop an educational intervention to match these gaps. Our hope is that all involved practices will benefit from incorporating a geriatric assessment into their practice and will find it feasible to use the tools provided. These data are of high importance to the oncologic community and would be hypothesis-generating for future clinical trials.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
70 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Evidence of metastatic breast cancer (MBC)
  • Ongoing active therapy for MBC
  • Ability to sign informed consent, and complete a self-assessment evaluation.
  • Life expectancy >3 months

排除标准

  • No evidence of MBC
  • Inability to read and understand English
  • Not on active therapy

结局指标

主要结局

Number of geriatric abnormalities detected

时间窗: 18 months

Investigators will test the proportions of patients having at least one abnormality detected by the Comprehensive Geriatric Assessment that was missed in the standard clinical assessment compared to a null-hypothesis rate of 5%.

Percentage of treatment plan changes

时间窗: 18 months

Investigators will assess the percentage of physician reported cases whose treatment plan was modified due to responses on the Comprehensive Geriatric Assessment.

次要结局

  • Provider perception(18 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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