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临床试验/NCT01885455
NCT01885455已完成不适用

Improving Resection Rates Among African Americans With NSCLC

Wake Forest University Health Sciences20 个研究点 分布在 1 个国家目标入组 248 人开始时间: 2015年4月23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
248
试验地点
20
主要终点
Receipt of LDTCI

研究概览

简要总结

This is a randomized, interventional trial in which the navigation is the intervention. Phase is not applicable. The study is a randomized trial to evaluate the impact of a nurse-led patient navigation intervention in improving rates of receipt of lung-directed therapy with curative intent (LDTCI) among African Americans with early stage lung cancer. Study sites are cluster-randomized to either the usual care study arm or the to the navigation intervention study arm. Randomization occurred at the level of the study site rather than at the level of individual participants. There are two arms.

详细描述

The burden to participants will be minimized to enhance retention. Patients in the usual care arm receive the current "gold standard" of treatment. The patients in the intervention arm are assigned to a PN, who helps to reduce the barriers to care that could negatively impact the patients' receipt of LDTCI. The telephone-administered survey is administered to all study participants at baseline and at 3-, 6-, and 12-months post-enrollment. It takes approximately 30-40 minutes to administer. The telephone mode of survey administration was chosen to reduce the number of visits that would be required by each patient. Interviews are scheduled at the convenience of the study participants. To further reduce burden to the study participants, the interviewers offer breaks during the interview process. Patients in both arms undergo standard therapy visits. Patients in the navigation arm receive standard therapy visits plus the navigation intervention. Outside of the standard therapy visits, no additional clinic visits are required of the study participants.

Once informed consent has been obtained and the informed consent document is received, the SSC/PN will communicate to the MUSC HCC study staff the participant's contact information and that the participant is ready for baseline survey administration. All the study surveys will be administered by trained MUSC HCC study staff via telephone. A survey answer guide will be provided to the participant either in-person or via mail prior to administration of the baseline survey.

研究设计

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

入排标准

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

入选标准

  • Clinically suspicious or biopsy-proven, early stage NSCLC, and
  • Ages 21 years and older

排除标准

  • Previous history of lung cancer
  • Spread of newly diagnosed probably/proven lung cancer to other part of the body
  • Diagnosis of synchronous cancer other than non-melanoma skin cancer or lung cancer, and
  • Receipt of surgical resection or radiosurgery for lung cancer since diagnosis with probable/proven lung cancer

结局指标

主要结局

Receipt of LDTCI

时间窗: 12 Months Post-Enrollment

Receipt of lung-directed therapy with curative intent (LDTCI), Inquiry at time of follow-up survey, confirmed by medical record review

次要结局

  • Time to LDTCI (For Pts. Who Received LDTCI Only) Confirmed by Medical Record Review(Baseline, 3, 6, 9, and 12 Months Post-Enrollment)
  • Receipt of Surgical and/or Radiation Oncology Consultation Confirmed by Medical Record Review(Baseline, 3, 6, 9, and 12 Months Post-Enrollment)
  • Satisfaction with Care Received, Patient Satisfaction(REF) (28 items)(6 Months Post-Enrollment)
  • Time of Death, Follow-up Survey, Confirmed by Medical Record Review(Baseline, 3, 6, 9, and 12 Months Post-Enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (20)

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