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

NCT01964222 | Completed Results DMC

• 1 other identifier: 201309076
• Study Type: interventional
• Target: 201
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Cancer; Clinical trials; Informed consent; Health literacy

Outcome Measures

Primary Outcomes (3)

• Knowledge About Cancer Clinical Trials

  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.

  1 day (Immediately following either showing the participant the experimental or control information (same day)

• Clarity of Values

  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.

  1 day (Immediately following either showing the participant the experimental or control information (same day)

• Uncertainty in Choice

  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.

  1 day Immediately following either showing the participant the experimental or control information (same day)

Secondary Outcomes (2)

• Self-efficacy for Communicating About Cancer Clinical Trials

  1 day (Immediately following either showing the participant the experimental or control information (same day)

• Attitudes About Cancer Clinical Trials

  1 day (Immediately following either showing the participant the experimental or control information (same day)

Study Arms (2)

Decision Aid (DA)

EXPERIMENTAL

The decision aid (DA) will be provided to patients randomized to the experimental/intervention group.

Behavioral: Decision Aid (DA)

Control

NO INTERVENTION

Participants randomized to the control group will receive usual care and will be shown Siteman Cancer Center website about clinical trials.

Interventions

Decision Aid (DA) BEHAVIORAL

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.

Decision Aid (DA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with cancer in the past 6 months
• English speaking
• At least 18 years old

You may not qualify if:

• Past participation in a clinical trial for treatment

Sponsors & Collaborators

• Washington University School of Medicine: lead
• University of Miami: collaborator

Study Sites (1)

Siteman Cancer Center

St Louis, Missouri, 63110, United States

Location

Related Publications (20)

• 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.

  PMID: 15187053 BACKGROUND

• 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.

  PMID: 19748204 BACKGROUND

• 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/

  PMID: 20669487 BACKGROUND

• 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.

  PMID: 11246299 BACKGROUND

• 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.

  PMID: 19385786 BACKGROUND

• 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.

  PMID: 7931491 BACKGROUND

• 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.

  PMID: 10491242 BACKGROUND

• 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.

  PMID: 9794849 BACKGROUND

• 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.

  PMID: 11734235 BACKGROUND

• 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.

  PMID: 11229946 BACKGROUND

• 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.

  PMID: 11651387 BACKGROUND

• 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.

  PMID: 20332406 BACKGROUND

• 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.

  PMID: 12610182 BACKGROUND

• 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.

  PMID: 9586663 BACKGROUND

• 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.

  PMID: 15467062 BACKGROUND

• 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.

  PMID: 18816317 BACKGROUND

• 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.

  PMID: 18651981 BACKGROUND

• 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.

  PMID: 23897588 BACKGROUND

• 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.

  PMID: 9456210 BACKGROUND

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

  BACKGROUND

MeSH Terms

Conditions

Neoplasms

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Mary C. Politi, PhD
• Organization: Washington University's School of Medicine

politim@wudosis.wustl.edu

314-747-1968

Study Officials

• Mary C Politi, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 17, 2013
• Study Start: May 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: December 7, 2015
• Results First Posted: December 7, 2015

Record last verified: 2015-11

Locations

US (1)