Awareness Enhancing Interventions (AWEI)
2021年10月19日 更新者:MICHELLE Y MARTIN、University of Tennessee
Increasing Recruitment of Underrepresented Cancer Survivors With Awareness Enhancing Interventions
The purpose of this study is to determine if increasing awareness and, thus, enhancing positive attitudes about research, prior to recruitment attempts, will increase participation in cancer clinical research among African American (AA) cancer survivors so that recruitment efforts can focus on the most optimal and cost- effective approaches
研究概览
地位
招聘中
干预/治疗
- 其他:Navigation - Study Specific - Researcher Voice
- 其他:Navigation - Study Specific - Cancer Survivor Voice
- 其他:Navigation - Research General - Researcher Voice
- 其他:Navigation - Research General - Cancer Survivor Voice
- 其他:Brochure - Study Specific - Researcher Voice
- 其他:Brochure - Study Specific - Cancer Survivor Voice
- 其他:Brochure - Research General - Researcher Voice
- 其他:Brochure - Research General - Cancer Survivor Voice
详细说明
In this project, 2000 AA potential AMPLIFI project participants will be randomized to the awareness-enhancing intervention (AWEI) or to the comparison condition in which they do not receive AWEI intervention but only the Adapting Multiple Behavior Interventions that Effectively Improve Cancer Survivor Health (AMPLIFI) basic recruitment strategy (No AWEI).
Randomization for the AWEI Randomized Controlled Trial (RCT) will occur soon after the AMPLIFI recruitment letter is sent, and AWEI interventions will be delivered over a two-week period between the AMPLIFI recruitment invitation letter and the AMPLIFI recruitment call.
Survivors randomized to AWEI intervention will be exposed to 8 different combinations of the AWEI components according to different types of strategies and type of information reflecting the survivor voice or not.
Subsequent to the AMPLIFI recruitment call, a 20% random sample of cancer survivors will be surveyed over the phone to assess intervention fidelity.
研究类型
介入性
注册 (预期的)
2000
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Michelle Y Martin, PhD
- 电话号码:901.448.2383
- 邮箱:mmart126@uthsc.edu
研究联系人备份
- 姓名:Catherine E womack, BA
- 电话号码:9014481189
- 邮箱:ewomack5@uthsc.edu
学习地点
-
-
Alabama
-
Birmingham、Alabama、美国、35294
- 招聘中
- University of Alabama at Birmingham
-
接触:
- Maria Pisu, PhD
- 邮箱:mpisu@uabmc.edu
-
接触:
- Aquila Brown Galvan, MPH
- 邮箱:abgalvan@uabmc.edu
-
-
Tennessee
-
Memphis、Tennessee、美国、38105
- 招聘中
- University of Tennessee Health Science Center
-
接触:
- Catherine E womack, BA
- 电话号码:9014481189
- 邮箱:ewomack5@uthsc.edu
-
接触:
- Michelle Y Martin
- 电话号码:901-448-2383
- 邮箱:mmart126@uthsc.edu
-
首席研究员:
- Michelle Y Martin, PhD
-
-
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- African American/Black
- adults (age ≥50 years old)
- diagnosed with obesity/physical activity associated cancers that have a 70% or greater 5-year relative cancer-free survival rate multiple myeloma, localized kidney cancer and loco- regional cancers of the colorectum, female breast, prostate, endometrium, and ovary).
- 1-5 years post diagnosis
- reside in an area with wireless coverage
- In the AMPLIFI recruitment pool
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配: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 |
---|---|
无干预:Control Group
This group will receive no intervention before receiving the AMPLIFI Recruitment Call
|
|
其他:Navigation
After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a phone call from a Research Specialist who will discuss the importance of research participation for cancer survivors to increase research awareness and aid in recruitment.
The information will focus on the importance of research and will be delivered from the perspective of either a researcher or a cancer survivor.
|
The intervention is delivered over the telephone
The intervention is delivered over the telephone
The intervention is delivered over the telephone
The intervention is delivered over the telephone
|
其他:Brochure
After receiving recruitment letter from AMPLIFI, participant randomized to this arm will receive a brochure which will focus on the importance of research participation for cancer survivors in order to increase research awareness and aid in recruitment.
|
The invention is mailed to the participant in a brochure.
The invention is mailed to the participant in a brochure.
The invention is mailed to the participant in a brochure.
The invention is mailed to the participant in a brochure.
|
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 |
---|---|---|
recruitment yield
大体时间:within 3 months of receiving intervention
|
measured by the proportion of targeted survivors who, at the time of the recruitment call, after the screening process is complete, decide to participate in AMPLIFI.
|
within 3 months of receiving intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Interest in Participating in the AMPLIFI Study
大体时间:within 3 months of receiving intervention
|
proportion of survivors who express interest in participating and return the consent form to the AMPLIFI team.
|
within 3 months of receiving intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Michelle Y Marttin, PhD、University of Tennessee
- 首席研究员:Maria Pisu, PhD、University of Alabama at Birmingham
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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- Pisu M, Demark-Wahnefried W, Kenzik KM, Oster RA, Lin CP, Manne S, Alvarez R, Martin MY. A dance intervention for cancer survivors and their partners (RHYTHM). J Cancer Surviv. 2017 Jun;11(3):350-359. doi: 10.1007/s11764-016-0593-9. Epub 2017 Jan 9.
- Martin MY, Pollack LA, Evans MB, Smith JL, Kratt P, Prayor-Patterson H, Watson CD, Dignan M, Cheney LC, Pisu M, Liwo A, Hullett S. Tailoring cancer education and support programs for low-income, primarily African American cancer survivors. Oncol Nurs Forum. 2011 Jan;38(1):E55-9. doi: 10.1188/11.ONF.E55-E59.
- Pisu M, Martin MY, Shewchuk R, Meneses K. Dealing with the financial burden of cancer: perspectives of older breast cancer survivors. Support Care Cancer. 2014 Nov;22(11):3045-52. doi: 10.1007/s00520-014-2298-9. Epub 2014 Jun 10.
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年4月12日
初级完成 (预期的)
2022年8月1日
研究完成 (预期的)
2023年3月30日
研究注册日期
首次提交
2020年12月19日
首先提交符合 QC 标准的
2020年12月19日
首次发布 (实际的)
2020年12月24日
研究记录更新
最后更新发布 (实际的)
2021年10月25日
上次提交的符合 QC 标准的更新
2021年10月19日
最后验证
2021年10月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
是的
IPD 计划说明
We will share data which will include the AMPLIFI final disposition code (recruited versus not recruited), the impact of the AWEI interventions versus the standard recruitment approach.
IPD 共享时间框架
All data will be shared once all primary outcomes papers have been published (consonant with the NIH definition of "timely fashion") but no later than within one year of the completion of the funded study.
IPD 共享访问标准
The access to the data will be granted to investigators working in an organization with a Federal Wide Assurance (FWA).
Before access is granted, individuals must provide a copy of their Institutional Review Board (IRB) approval to use the data to answer their specific study questions.
Individuals in receipt of data must produce proof of human subjects and HIPAA training.
All datasets will conform to the "Standards for Privacy of Individually Identifiable Health Information" rule of HIPAA.
In order to maintain HIPAA compliance, we will provide a limited-use dataset (i.e., stripped of identifying information).
Requesting users will be required to sign a data-use sharing agreement.
Although not immediately precluded, data deemed to be "sensitive" will be added to limited use datasets only after careful consideration.
Resulting publications must credit the funding for this grant.
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.