Remote Screening and Navigation to Increase Trial Enrollment, INVITE Trial (INVITE)
INVITE: Remote ScreenIng & NaVigation to Increase Trial Enrollment
This clinical trial studies the feasibility, acceptability, appropriateness, and effectiveness of a remote screening and navigation program in increasing clinical trial enrollment among patients with prostate and bladder cancer receiving cancer care in the community setting. Genitourinary (GU) cancers, including prostate and bladder cancer, are among the most common affecting patients in the United States. In spite of recent advances, there are still only a few broad categories of treatments effective in both prostate and bladder cancer, and investigating new therapies in clinical trials is essential. In Washington State, the majority of patients with prostate and bladder cancer are treated at local community oncology sites. Patients are referred to Fred Hutch (FH) GU oncologists for clinical trials, but often this referral occurs once a patient has exhausted all standard of care options for treatment. This remote screening and navigation study involves approaching patients at community oncology and urology clinics in the Washington State area and pre-screening them for eligibility in open clinical trials at FH. Interested eligible patients will then be referred to our patient navigation program to be seen by a GU medical oncologist at Fred Hutch Cancer Center. This program may help increase access to clinical trials for patients with prostate and bladder cancer, as well as strengthen collaboration between community oncology providers and GU oncology specialists at FH.
研究概览
地位
详细说明
OUTLINE:
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center. Patients NOT eligible for a clinical trial are assigned to Group I. Patients who are immediately eligible for a clinical trial are assigned to Group II. Patients who are eligible for a clinical trial in the future upon disease progression or change in status are assigned to Group III.
GROUP I: Patients are notified and receive no further contact.
GROUP II: Patients who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are NOT interested receive no further contact. These patients may have the option for future pre-screening.
GROUP III: Patients who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are interested in pursuing the clinical trial(s) upon eligibility, but do not wish to proceed to a GU appointment have the option to reach out at time of eligibility for re-screening and appointment. Patients who are NOT interested in the clinical trial(s) they are eligible for and/or not interested in participation receive no further contact. These patients may have the option for future pre-screening.
After completion of study, patients are followed for 12 months.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Hiba M. Khan, MD
- 电话号码：206-606-2524
- 邮箱：hibakhan@uw.edu
学习地点
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-
Washington
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Seattle、Washington、美国、98109
- Fred Hutch/University of Washington Cancer Consortium
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接触：
- Hiba M. Khan, MD
- 电话号码：206-606-2524
- 邮箱：hibakhan@uw.edu
-
首席研究员：
- Hiba M. Khan, MD
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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Age ≥ 18
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Ability to understand English or Spanish
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Records must be available to review on Epic CareEverywhere
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Ability to understand and willingness to sign a written informed consent document. Legally authorized representatives (LAR) may sign and give informed consent on behalf of study participants
- For participants utilizing LAR, participant must assent or otherwise be capable of completing patient-reported surveys
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Receiving care for prostate or bladder cancer at participating community sites
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Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-3
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Not enrolled in hospice
学习计划
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：非随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group I (pre-screening)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients NOT eligible for a clinical trial are notified and receive no further contact. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
其他名称：
|
|
实验性的：Group II (pre-screening, GU appointment)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients who are immediately eligible for a clinical trial who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are immediately eligible for a clinical trial who are NOT interested receive no further contact. These patients may have the option for future pre-screening. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
其他名称：
Attend appointment with GU medical oncologist
其他名称：
|
|
实验性的：Group III (pre-screening, GU appointment, re-screening)
Patients have their medical records reviewed by the research nursing team and are pre-screened for open clinical trials at Fred Hutch Cancer Center for 9 months. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are interested in learning more about the clinical trial(s) are contacted and scheduled for an appointment with a GU medical oncologist to discuss further. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are interested in pursuing the clinical trial(s) upon eligibility, but do not wish to proceed to a GU appointment have the option to reach out at time of eligibility for re-screening and appointment. Patients who are eligible for a clinical trial in the future upon disease progression or change in status who are NOT interested in the clinical trial(s) they are eligible for and/or not interested in participation receive no further contact. |
Ancillary studies Undergo medical record review Undergo clinical trial eligibility pre-screening
其他名称：
Attend appointment with GU medical oncologist
其他名称：
Undergo re-screening
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Percentage of patients who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
大体时间：After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
|
Percentage of community providers who "agree" or "completely agree" in the Feasibility of Intervention Measure (Feasibility)
大体时间：After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
|
Percentage of patients who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
大体时间：After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
|
Percentage of community providers who "agree" or "completely agree" in the Acceptability of Intervention Measure (Acceptability)
大体时间：After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
|
Percentage of patients who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
大体时间：After pre-screening for clinical trials is complete (Up to 9 months)
|
After pre-screening for clinical trials is complete (Up to 9 months)
|
|
|
Percentage of community providers who "agree" or "completely agree" in the Intervention Appropriateness Measure (Appropriateness)
大体时间：After enrollment is complete at the end of study period (Up to 24 months)
|
After enrollment is complete at the end of study period (Up to 24 months)
|
|
|
Percentage of remotely screened patients that are identified as eligible for a prostate or bladder cancer clinical trial at Fred Hutch (FH) and enroll in that clinical trial
大体时间：Up to 9 months
|
Analysis of these percentages will be taken into context with the reported barriers that our patient population describes. Will provide rationale for a larger clinical trial, in which barriers can be directly addressed if possible, to assess improvement in clinical trial interest/participation among patients receiving care in the community. |
Up to 9 months
|
|
Percentage of remotely screened patients that are identified as eligible or potentially eligible for a prostate or bladder cancer clinical trial at FH, and express interest in participating
大体时间：Up to 9 months
|
Analysis of these percentages will be taken into context with the reported barriers that our patient population describes. Will provide rationale for a larger clinical trial, in which barriers can be directly addressed if possible, to assess improvement in clinical trial interest/participation among patients receiving care in the community. |
Up to 9 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Perceived barriers to participation in clinical trials
大体时间：Baseline up to 9 months
|
Free-text survey data from patients and qualitative interview data from referring providers will be analyzed using Braun & Clarke's inductive thematic analysis framework. |
Baseline up to 9 months
|
|
Distribution of participants by race and ethnicity among remotely pre-screened patients who enroll or indicate intent to enroll in a clinical trial
大体时间：Up to 9 months
|
Free-text survey data from patients and qualitative interview data from referring providers will be analyzed using Braun & Clarke's inductive thematic analysis framework. |
Up to 9 months
|
合作者和调查者
调查人员
- 首席研究员：Hiba M. Khan, MD、Fred Hutch/University of Washington Cancer Consortium
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- RG1126822
- P30CA015704 (美国 NIH 拨款/合同)
- NCI-2026-07173 (注册表标识符：CTRP (Clinical Trial Reporting Program))
- STUDY00025270 (其他标识符：Fred Hutch/University of Washington Cancer Consortium)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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研究美国 FDA 监管的设备产品
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