Health Literacy Intervention for Informed Consent of Cancer Patients Considering Clinical Trial Participation
2015. november 2. frissítette: 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.
A tanulmány áttekintése
Részletes leírás
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.
Tanulmány típusa
Beavatkozó
Beiratkozás (Tényleges)
201
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Ez a rész a vizsgálatot végzők elérhetőségeit, valamint a vizsgálat lefolytatásának helyére vonatkozó információkat tartalmazza.
Tanulmányi helyek
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Missouri
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St. Louis, Missouri, Egyesült Államok, 63110
- Siteman Cancer Center
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Részvételi kritériumok
A kutatók olyan embereket keresnek, akik megfelelnek egy bizonyos leírásnak, az úgynevezett jogosultsági kritériumoknak. Néhány példa ezekre a kritériumokra a személy általános egészségi állapota vagy a korábbi kezelések.
Jogosultsági kritériumok
Tanulmányozható életkorok
18 év és régebbi (Felnőtt, Idősebb felnőtt)
Egészséges önkénteseket fogad
Nem
Tanulmányozható nemek
Összes
Leírás
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
Tanulási terv
Ez a rész a vizsgálati terv részleteit tartalmazza, beleértve a vizsgálat megtervezését és a vizsgálat mérését.
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Támogató gondoskodás
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Nincs (Open Label)
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
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Kísérleti: 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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Nincs beavatkozás: 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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Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Knowledge About Cancer Clinical Trials
Időkeret: 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
Időkeret: 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
Időkeret: 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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Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
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Self-efficacy for Communicating About Cancer Clinical Trials
Időkeret: 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 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
Időkeret: 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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Együttműködők és nyomozók
Itt találhatja meg a tanulmányban érintett személyeket és szervezeteket.
Együttműködők
Nyomozók
- Kutatásvezető: Mary C Politi, PhD, Washington University School of Medicine
Publikációk és hasznos linkek
A vizsgálattal kapcsolatos információk beviteléért felelős személy önkéntesen bocsátja rendelkezésre ezeket a kiadványokat. Ezek bármiről szólhatnak, ami a tanulmányhoz kapcsolódik.
Általános kiadványok
- 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.
Tanulmányi rekorddátumok
Ezek a dátumok nyomon követik a ClinicalTrials.gov webhelyre benyújtott vizsgálati rekordok és összefoglaló eredmények benyújtásának folyamatát. A vizsgálati feljegyzéseket és a jelentett eredményeket a Nemzeti Orvostudományi Könyvtár (NLM) felülvizsgálja, hogy megbizonyosodjon arról, hogy megfelelnek-e az adott minőség-ellenőrzési szabványoknak, mielőtt közzéteszik őket a nyilvános weboldalon.
Tanulmány főbb dátumok
Tanulmány kezdete
2014. május 1.
Elsődleges befejezés (Tényleges)
2015. május 1.
A tanulmány befejezése (Tényleges)
2015. július 1.
Tanulmányi regisztráció dátumai
Először benyújtva
2013. október 7.
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
2013. október 16.
Első közzététel (Becslés)
2013. október 17.
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Becslés)
2015. december 7.
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
2015. november 2.
Utolsó ellenőrzés
2015. november 1.
Több információ
A tanulmányhoz kapcsolódó kifejezések
Egyéb vizsgálati azonosító számok
- 201309076
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