Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation
2015年11月2日 更新者：Washington University School of Medicine
A Mixed Methods Study to Reduce Disparities in Cancer Clinical Trials by Adapting a Health Literacy Intervention for Informed Consent and Comparing it to Usual Care in a Randomized Experiment
This study will update an existing health literacy intervention (decision aid) for informed consent procedures and then conduct a randomized experiment implementing the health literacy intervention at Siteman Cancer Center and evaluate its effectiveness compared to usual care.
Our hypothesis is that implementing the targeted, web-based decision aid (DA) in addition to usual care will increase knowledge about cancer clinical trials.
Secondary outcomes include patients' ability to communicate with health care providers about trials, willingness to participate in trials, and enrollment rates for minority participants.
研究概览
详细说明
A previously developed and pilot tested web-based decision aid (DA) based on best practices in health literacy that is well received by minority participants and significantly improved knowledge about cancer clinical trials and decision self-efficacy will be used. This study will expand the reach of the DA and test it in a larger study in a different geographic region and center (Siteman Cancer Center). An additional benefit of conducting this work at Siteman Cancer Center is that Siteman and the Program for the Elimination of Cancer Disparities (PECaD) already institute structural changes at the system level to improve minority participation in trials. This study will activate and educate patients and will complement the system-level interventions.
By random 1:1 assignment, 180 participants will either receive:
*Targeted, web-based decision aid (DA) about participating in cancer clinical trials.
or
*Usual care/control-Access to the Siteman Cancer Center website about clinical trials.
Outcomes from the DA group will be compared to outcomes in a usual care/control group.
研究类型
介入性
注册 (实际的)
201
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
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Missouri
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St. Louis、Missouri、美国、63110
- Siteman Cancer Center
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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
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Diagnosed with cancer in the past 6 months
- English speaking
- At least 18 years old
Exclusion Criteria:
- Past participation in a clinical trial for treatment
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：支持治疗
- 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 |
|---|---|
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实验性的：Decision Aid (DA)
The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.
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Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
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无干预：Control
Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.
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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 |
|---|---|---|
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Knowledge About Cancer Clinical Trials
大体时间：1 day (Immediately following either showing the participant the experimental or control information (same day)
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A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials.
The questionnaire will include eleven knowledge items such as "Only very sick patients are asked to take part in a cancer research study" and "Cancer research studies almost never involve the use of a placebo or sugar pill alone".
Participants will indicate each item as "True", "False", or "I don't know".
An overall knowledge composite score will be created with the average percentage of items participants in each condition correctly answer.
Participation in study concludes upon completion of questionnaire.
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1 day (Immediately following either showing the participant the experimental or control information (same day)
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Clarity of Values
大体时间：1 day (Immediately following either showing the participant the experimental or control information (same day)
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A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials.
The questionnaire will include the Values Clarity Subscale to evaluate decisional conflict.
The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories.
The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall "values clarity" score from 0 to 100.
Higher values represent less clarity.
Participation in study concludes upon completion of questionnaire.
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1 day (Immediately following either showing the participant the experimental or control information (same day)
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Uncertainty in Choice
大体时间：1 day Immediately following either showing the participant the experimental or control information (same day)
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A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials.
The questionnaire will include the Uncertainty Subscale to evaluate decisional conflict.
The subscale includes two items from the ten-item Low Literacy Decisional Conflict Scale, each with three response categories.
The combined score on the two items will be divided by 2 and multiplied by 25 to produce an overall "uncertainty" score from 0 to 100.
Higher values represent more uncertainty.
Participation in study concludes upon completion of questionnaire.
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1 day Immediately following either showing the participant the experimental or control information (same day)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Self-efficacy for Communicating About Cancer Clinical Trials
大体时间：1 day (Immediately following either showing the participant the experimental or control information (same day)
|
A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials.
The questionnaire will include an item in which participants rank their self-efficacy for finding information about cancer clinical trials on a 5-point scale with higher numbers indicating greater self-efficacy.
Participation in study concludes upon completion of questionnaire.
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1 day (Immediately following either showing the participant the experimental or control information (same day)
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Attitudes About Cancer Clinical Trials
大体时间：1 day (Immediately following either showing the participant the experimental or control information (same day)
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A questionnaire will be administered to assess outcomes of interest immediately after showing the participant either the decision aid (DA) about clinical trials or the Siteman Cancer Center website about clinical trials.
The questionnaire will include two items in which participants rank their intent to participate in a cancer clinical trial and their intent to encourage others to participate in a cancer clinical trial on a 5-point scale with higher numbers indicating greater intent.
Participation in study concludes upon completion of questionnaire.
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1 day (Immediately following either showing the participant the experimental or control information (same day)
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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：Mary C Politi, PhD、Washington University School of Medicine
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。
一般刊物
- Silverman H, Hull SC, Sugarman J. Variability among institutional review boards' decisions within the context of a multicenter trial. Crit Care Med. 2001 Feb;29(2):235-41. doi: 10.1097/00003246-200102000-00002.
- Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004 Jun 9;291(22):2720-6. doi: 10.1001/jama.291.22.2720.
- Janet Yang Z, McComas K, Gay G, Leonard JP, Dannenberg AJ, Dillon H. From information processing to behavioral intentions: exploring cancer patients' motivations for clinical trial enrollment. Patient Educ Couns. 2010 May;79(2):231-8. doi: 10.1016/j.pec.2009.08.010. Epub 2009 Sep 11.
- Institute of Medicine (US) Committee on Assessing the System for Protecting Human Research Participants; Federman DD, Hanna KE, Rodriguez LL, editors. Responsible Research: A Systems Approach to Protecting Research Participants. Washington (DC): National Academies Press (US); 2002. Available from http://www.ncbi.nlm.nih.gov/books/NBK43563/
- McNutt LA, Waltermaurer E, Bednarczyk RA, Carlson BE, Kotval J, McCauley J, Campbell JC, Ford DE. Are We Misjudging How Well Informed Consent Forms are Read? J Empir Res Hum Res Ethics. 2008 Mar;3(1):89-97. doi: 10.1525/jer.2008.3.1.89.
- Grossman SA, Piantadosi S, Covahey C. Are informed consent forms that describe clinical oncology research protocols readable by most patients and their families? J Clin Oncol. 1994 Oct;12(10):2211-5. doi: 10.1200/JCO.1994.12.10.2211.
- Corbie-Smith G, Thomas SB, Williams MV, Moody-Ayers S. Attitudes and beliefs of African Americans toward participation in medical research. J Gen Intern Med. 1999 Sep;14(9):537-46. doi: 10.1046/j.1525-1497.1999.07048.x.
- Featherstone K, Donovan JL. Random allocation or allocation at random? Patients' perspectives of participation in a randomised controlled trial. BMJ. 1998 Oct 31;317(7167):1177-80. doi: 10.1136/bmj.317.7167.1177.
- Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC. Quality of informed consent in cancer clinical trials: a cross-sectional survey. Lancet. 2001 Nov 24;358(9295):1772-7. doi: 10.1016/S0140-6736(01)06805-2.
- Dresden GM, Levitt MA. Modifying a standard industry clinical trial consent form improves patient information retention as part of the informed consent process. Acad Emerg Med. 2001 Mar;8(3):246-52. doi: 10.1111/j.1553-2712.2001.tb01300.x.
- Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB. 1990 May-Jun;12(3):1-5. No abstract available.
- Krumholz HM. Informed consent to promote patient-centered care. JAMA. 2010 Mar 24;303(12):1190-1. doi: 10.1001/jama.2010.309. No abstract available.
- Coyne CA, Xu R, Raich P, Plomer K, Dignan M, Wenzel LB, Fairclough D, Habermann T, Schnell L, Quella S, Cella D; Eastern Cooperative Oncology Group. Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol. 2003 Mar 1;21(5):836-42. doi: 10.1200/JCO.2003.07.022.
- Davis TC, Holcombe RF, Berkel HJ, Pramanik S, Divers SG. Informed consent for clinical trials: a comparative study of standard versus simplified forms. J Natl Cancer Inst. 1998 May 6;90(9):668-74. doi: 10.1093/jnci/90.9.668.
- Flory J, Emanuel E. Interventions to improve research participants' understanding in informed consent for research: a systematic review. JAMA. 2004 Oct 6;292(13):1593-601. doi: 10.1001/jama.292.13.1593.
- Entwistle V. Supporting participation in clinical research: decision aids for trial recruitment? Health Expect. 2008 Sep;11(3):205-7. doi: 10.1111/j.1369-7625.2008.00519.x. No abstract available.
- Brehaut JC, Lott A, Fergusson DA, Shojania KG, Kimmelman J, Saginur R. Can patient decision aids help people make good decisions about participating in clinical trials? A study protocol. Implement Sci. 2008 Jul 23;3:38. doi: 10.1186/1748-5908-3-38.
- Byrne MM, Tannenbaum SL, Gluck S, Hurley J, Antoni M. Participation in cancer clinical trials: why are patients not participating? Med Decis Making. 2014 Jan;34(1):116-26. doi: 10.1177/0272989X13497264. Epub 2013 Jul 29.
- Sutherland HJ, da Cunha R, Lockwood GA, Till JE. What attitudes and beliefs underlie patients' decisions about participating in chemotherapy trials? Med Decis Making. 1998 Jan-Mar;18(1):61-9. doi: 10.1177/0272989X9801800113.
- Office of Human Research Protections (OHRP): Compliance Determination Letters. US Department of Health and Human Services. Washington, DC: 2002.
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
2014年5月1日
初级完成 (实际的)
2015年5月1日
研究完成 (实际的)
2015年7月1日
研究注册日期
首次提交
2013年10月7日
首先提交符合 QC 标准的
2013年10月16日
首次发布 (估计)
2013年10月17日
研究记录更新
最后更新发布 (估计)
2015年12月7日
上次提交的符合 QC 标准的更新
2015年11月2日
最后验证
2015年11月1日
更多信息
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.