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临床试验/NCT04297384
NCT04297384已完成不适用

Breast Cancer Pathways Impact on Patient Shared Decision Making and Experience in Academic and Community Practice

Roswell Park Cancer Institute2 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2019年2月6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
174
试验地点
2
主要终点
Number of physician visits and diagnostic tests

研究概览

简要总结

This trial studies the impact of the breast cancer pathways program on the patient experience, including decision making and quality of life. Measuring how the breast cancer pathways program affects decision making and quality of life in patients may help doctors improve cancer education.

详细描述

PRIMARY OBJECTIVES:

I. Evaluate the impact of breast cancer pathways on patient experience, burden of decision making and quality of life in tertiary cancer center and community oncology practice.

II. Identify modifiable factors that affect provider adoption of breast cancer pathways in tertiary cancer center and community oncology practice.

OUTLINE: Participants are assigned to 1 of 2 groups.

GROUP I: Participants receive standard chemotherapy educational materials. Participants also complete surveys over approximately 22 minutes at the time of first chemotherapy infusion, and approximately 8 weeks after first chemotherapy infusion.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Treatment includes intravenous chemotherapy for breast cancer for primary disease as neoadjuvant or adjuvant therapy, or for recurrent and/or metastatic cancer
  • Can provide consent
  • Are able to comprehend written materials in English or Spanish
  • Will receive their chemotherapy at Roswell Park sites in Buffalo or Amherst, New York (NY), or Roswell Park Oncology primary care (PC) sites in Niagara Falls, Amherst, West Seneca, or Jamestown NY

排除标准

  • Breast cancer patients receiving oral therapy alone
  • Patients who are not able to comprehend written materials in English or Spanish
  • Patients who will not receive chemotherapy at a Roswell Park site
  • Patients who are not able to comprehend written materials will not be included in this study, as the consent document will be administered in multiple infusion centers that cannot be all staffed daily with a research associate. The study instruments used are standardized tools that have been developed as best as possible with appropriate literacy levels
  • Patients enrolled in clinical trials for their breast chemotherapy will be excluded from this study because they will require alternative educational materials that are specific to the trial drugs being administered

结局指标

主要结局

Number of physician visits and diagnostic tests

时间窗: Up to 2 years

change in Patient quality of life

时间窗: Baseline and 8 weeks

Assessed by surveys.

Change in Patient quality of decision

时间窗: Baseline and 8 weeks

Assessed by surveys

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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