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Evaluating Biobanking Educational Tools

2021年9月17日 更新者：H. Lee Moffitt Cancer Center and Research Institute

The purpose of this study is to evaluate English and Spanish language educational materials that inform the community about a type of cancer research that involves the collection, storage, and processing of biospecimens. Part A of this study involved creating surveys about biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to evaluate education materials about biospecimen donation and research.

Phase II consists of two independent randomized controlled trials. Each trial is being conducted independently to test English and Spanish language materials (75 subjects each).

研究概览

地位

完全的

条件

干预/治疗

详细说明

The project addresses gaps in information by developing and validating English and Spanish language instruments to measure knowledge of and attitudes towards biospecimen donation and banking, as well as intention to donate biospecimens to a biobank (Part A). Once developed, the instruments will be used to evaluate biobanking educational priming tools by conducting two independent RCTs. Wherein English educational materials will be tested with 75 participants recruited from an urban clinic, and Spanish educational materials will be tested with 75 participant recruited form a rural community health center network. For each RCT following baseline assessment, participants will be randomized to either: 1) educational priming tools (DVD and booklet) developed by the Tampa Bay Community Cancer Network (TBCCN); or 2) an NCI-developed brochure entitled "Providing Your Tissue for Research: What You Need to Know." Seven to 28 days later participants will be given a telephone follow up interview.

研究类型

介入性

注册 (实际的)

339

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。

学习地点

  • 美国
    • Florida
      • Tampa、Florida、美国、33612
        • H. Lee Moffitt Cancer Center and Research Institute

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

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

English Language RCT Inclusion Criteria:

  • scheduled for an appointment at Lifetime Cancer Screening (LCS)
  • able to read and speak English
  • able to provide informed consent

Spanish Language RCT Inclusion Criteria:

  • receiving care at a participating clinic from the Suncoast Community Health Centers network
  • able to read and speak Spanish
  • able to provide informed consent

Exclusion Criteria:

  • previously diagnosed with cancer
  • previously participated in a biobank
  • participated in another TBCCN-related study entitled "community perceptions on biobanking"

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
实验性的：TBCCN-developed educational materials
Biobanking educational DVD and booklet kit developed by the Tampa Bay Community Network (TBCCN) Center. English kit is entitled "Biobanking Hope for a Cancer Cure", and Spanish kit is entitled "Biobanco: Una esperanza de cura para el cancer."
其他：TBCCN-developed educational materials
Participants will be asked to view the educational materials developed by TBCCN, in either English or Spanish depending on the RCT in which they are enrolled. These materials include a DVD and a booklet that were developed to enhance community members' understanding and awareness of biospecimen collection and biobanking from healthy individuals.
其他：Control Group
Biobanking educational Brochure developed by the National Cancer Institute. English brochure is entitled "Providing your Tissue for Research: What you need to Know", Spanish brochure is entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."
其他：NCI-developed educational materials
Participants will be asked to view the English biobanking educational Brochure entitled "Providing your Tissue for Research: What you need to Know", or Spanish brochure entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."

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
BANKS-Knowledge Scale
大体时间：Average of 28 days
Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 16-item questionnaire measuring knowledge about biobanking.
Average of 28 days
BANKS-Attitudes Scale
大体时间：Average of 28 days
Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 15-item questionnaire measuring attitudes toward biobanking.
Average of 28 days
BANKS-Self-Efficacy Scale
大体时间：Average of 28 days
Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 12-item questionnaire measuring self-efficacy in regards to donating a biospecimen to a biobank.
Average of 28 days
BANKS-Intentions
大体时间：Average of 28 days
Administered at baseline. Description: A single item measuring intentions to donate a biospecimen to a biobank.
Average of 28 days
Decisional Self-Efficacy
大体时间：Average of 28 days
Administered at follow-up (between 7 and 28 days after enrollment). Description: A validated 11-item questionnaire measuring participant's confidence in making a decision about donating a biospecimen (O'Connor M.A. Decision Self-efficacy Scale. 1995; www.ohri.ca/decisionaid).
Average of 28 days

次要结果测量

结果测量
措施说明
大体时间
BANKS-Trust Scale
大体时间：Average of 28 days
Administered at baseline and between 7 and 28 days after enrollment. Description: A validated 10-item questionnaire measuring trust related to organizations, facilities, and people that may be involved in research.
Average of 28 days

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。

赞助

H. Lee Moffitt Cancer Center and Research Institute

调查人员

  • 首席研究员：Clement Gwede, PhD, MPH, RN、H. Lee Moffitt Cancer Center and Research Institute

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。

有用的网址

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)

2010年9月27日

初级完成 (实际的)

2016年8月31日

研究完成 (实际的)

2021年9月17日

研究注册日期

首次提交

2012年8月22日

首先提交符合 QC 标准的

2012年8月22日

首次发布 (估计)

2012年8月27日

研究记录更新

最后更新发布 (实际的)

2021年9月21日

上次提交的符合 QC 标准的更新

2021年9月17日

最后验证

2021年9月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • MCC-16448

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.

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