跳至主要内容
临床试验/NCT00400699
NCT00400699已完成不适用

UPMC McKeesport/ROCOG Radiation Oncology Minorities Outreach Program

University of Pittsburgh4 个研究点 分布在 1 个国家目标入组 3,150 人开始时间: 2004年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
3,150
试验地点
4
主要终点
Total radiation dosage per patient (curative and palliative endpoints)

研究概览

简要总结

RATIONALE: An outreach program may help minority or low-income cancer patients overcome problems that keep them from receiving quality care.

PURPOSE: This clinical trial is studying how well a radiation therapy outreach program works in minority or low-income patients with newly diagnosed cancer.

详细描述

OBJECTIVES:

  • Develop, over five years, and implement a shared infrastructure that will permit participating community cancer centers to participate in radiation oncology clinical research and dramatically increase their rate of trial accrual above historical patterns.
  • Increase access to radiation oncology services and clinical trials for underserved minority and/or low-income patients in the target areas, through community and professional education and outreach activities.
  • Assess and ensure the quality of radiation oncology services at participating facilities through the use of a new integrated radiation oncology outcomes database and a quality assurance program, benchmarking daily practice patterns to clinical practice protocol.
  • Compare treatment approaches and outcomes for cervical, colorectal, lung, prostate, breast, and head and neck cancers across racial and socioeconomic status groups.
  • Conduct community intervention pilot programs that advance the understanding of factors that lead to health disparities.
  • Develop and implement clinical treatment studies that attempt to reduce or eliminate health disparities through novel treatment approaches.
  • Develop and refine a model program that can be sustained by the community treatment facilities long after study completion, and that the National Cancer Institute or other similarly motivated funders can replicate within other regions.

OUTLINE: This is a multicenter study.

Patients are enrolled in the Patient Navigator program, an initiative to promote equal access and quality of cancer care. Patients undergo an interview with the Patient Navigator, who is an oncology health professional, over approximately 1 hour to identify specific needs, in terms of receiving cancer care. The interview serves as a basis for developing a plan to assist patients through treatment and follow up. The Patient Navigator meets the patient, in person or over the phone, at various times during treatment to help the patient overcome barriers to completion of cancer therapy. The Patient Navigator then provides yearly follow up to facilitate continued medical follow up. Patients complete surveys before and after program participation.

Patients are followed periodically to determine their current status in cancer therapy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
盲法
None

入排标准

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

入选标准

  • •DISEASE CHARACTERISTICS:
  • •Newly diagnosed cancer
  • •Receiving radiation therapy and/or chemotherapy
  • •Minority and/or economically disadvantaged population
  • •PATIENT CHARACTERISTICS:
  • •Within any of the following service areas of 5 different hospitals in western Pennsylvania:
  • •New Castle
  • •Pittsburgh Metro
  • •Mckeesport
  • •Johnstown
  • •Any race, ethnicity, gender, or HIV status allowed
  • •HIV serostatus is not evaluated specifically for study participation
  • •PRIOR CONCURRENT THERAPY:
  • •See Disease Characteristics

排除标准

  • 未提供

研究组 & 干预措施

REview

Other

干预措施: counseling intervention (Other)

REview

Other

干预措施: study of socioeconomic and demographic variables (Other)

REview

Other

干预措施: psychosocial assessment and care (Procedure)

结局指标

主要结局

Total radiation dosage per patient (curative and palliative endpoints)

时间窗: Observation

Rate of treatment completion

时间窗: Observation

Clinical stage at time of presentation (indicator of early access to system)

时间窗: Observation

Date and nature of post-diagnosis surgery or biopsy

时间窗: Observation

Proportion of patients compliant with treatment plan

时间窗: Observation

Supportive services provided to patients

时间窗: Observation

Accrual for clinical research protocols

时间窗: Observation

Retention in clinical research protocols

时间窗: Observation

Barriers to treatment (perceived and real)

时间窗: Observation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dwight Heron

MD, FACRO, FACR

University of Pittsburgh

研究点 (4)

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