Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation

Study Description

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Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Cancer	Behavioral: Decision Aid (DA)	Not Applicable

Detailed Description:

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	201 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Supportive Care
Official Title:	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
Study Start Date :	May 2014
Actual Primary Completion Date :	May 2015
Actual Study Completion Date :	July 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Decision Aid (DA); The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.	Behavioral: Decision Aid (DA); 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.
No Intervention: Control; Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.

Outcome Measures

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Primary Outcome Measures :

1. Knowledge About Cancer Clinical Trials [ Time Frame: 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 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.
2. Clarity of Values [ Time Frame: 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 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.
3. Uncertainty in Choice [ Time Frame: 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 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.

Secondary Outcome Measures :

1. Self-efficacy for Communicating About Cancer Clinical Trials [ Time Frame: 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.
2. Attitudes About Cancer Clinical Trials [ Time Frame: 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 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, Missouri
Siteman Cancer Center
St. Louis, Missouri, United States, 63110

Sponsors and Collaborators

Washington University School of Medicine

University of Miami

Investigators

Principal Investigator:	Mary C Politi, PhD	Washington University School of Medicine

More Information

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Publications:

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.

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.

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.

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.

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.

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.

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.

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.

Young DR, Hooker DT, Freeberg FE. Informed consent documents: increasing comprehension by reducing reading level. IRB. 1990 May-Jun;12(3):1-5.

Krumholz HM. Informed consent to promote patient-centered care. JAMA. 2010 Mar 24;303(12):1190-1. doi: 10.1001/jama.2010.309.

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.

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.

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. Review.

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.

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, Glück 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.

Office of Human Research Protections (OHRP): Compliance Determination Letters. US Department of Health and Human Services. Washington, DC: 2002.

Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01964222 History of Changes
Other Study ID Numbers:	201309076
First Posted:	October 17, 2013
Results First Posted:	December 7, 2015
Last Update Posted:	December 7, 2015
Last Verified:	November 2015

Keywords provided by Washington University School of Medicine:

Cancer; Clinical trials; Informed consent; Health literacy