Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation - Full Text View

Purpose

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	Intervention
Cancer	Behavioral: Decision Aid (DA)


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Health Literacy

U.S. FDA Resources

Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:

Knowledge about cancer clinical trials [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.

Secondary Outcome Measures:

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) ] [ Designated as safety issue: No ]
A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.
Attitudes about cancer clinical trials [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.
Satisfaction with the information presented [ Time Frame: 1 day (Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.
Confidence in choice [ Time Frame: 1 day Immediately following either showing the participant the experimental or control information (same day) ] [ Designated as safety issue: No ]
A questionnaire will be administered to assess participant self efficacy for communicating about cancer clinical trials immediately following either showing the participant the decision aid (DA) and the Siteman Cancer Center's website about clinical trials or only the Siteman Cancer Center's website about clinical trials. Participation in study concludes upon completion of questionnaire.


Estimated Enrollment:	180
Study Start Date:	May 2014
Estimated Study Completion Date:	December 2015
Estimated Primary Completion Date:	September 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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's website about clinical trials.

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.

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01964222

Contacts


Contact: Mary C Politi, PhD	314-747-1967	mpoliti@wustl.edu
Contact: Hannah E Perkins, MPA	314-362-2419	perkinsh@wudosis.wustl.edu

Locations


United States, Missouri
Siteman Cancer Center	Recruiting
St. Louis, Missouri, United States, 63110
Principal Investigator: Mary C Politi, PhD

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

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.


Responsible Party:	Washington University School of Medicine
ClinicalTrials.gov Identifier:	NCT01964222 History of Changes
Other Study ID Numbers:	201309076
Study First Received:	October 7, 2013
Last Updated:	December 8, 2014
Health Authority:	United States: Washington University School Medicine IRB and Siteman Cancer Center Protocol Review Committee

Keywords provided by Washington University School of Medicine:


Cancer Clinical trials Informed consent Health literacy

ClinicalTrials.gov processed this record on February 25, 2015