Clinical trial NCT04407676 - References

Solid Neoplasms — Improving Informed Consent for Early Phase Anti-Cancer Trials

Citation(s)

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  A study of motivations and expectations of patients seen in phase 1 oncology clinics. Cancer. 2016 Nov 15;122(22):3501-3508. doi: 10.1002/cncr.30235. Epub 2016 Sep 26.
•   Fallowfield LJ, Solis-Trapala I, Jenkins VA
  Evaluation of an educational program to improve communication with patients about early-phase trial participation. Oncologist. 2012;17(3):377-83. doi: 10.1634/theoncologist.2011-0271. Epub 2012 Mar 1.
•   Hlubocky FJ, Kass NE, Roter D, Larson S, Wroblewski KE, Sugarman J, Daugherty CK
  Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials. J Oncol Pract. 2018 Jun;14(6):e357-e367. doi: 10.1200/JOP.18.00028. Epub 2018 May 22. Erratum in: J Oncol Pract. 2018 Jul;14(7):452.
•   Hoffner B, Bauer-Wu S, Hitchcock-Bryan S, Powell M, Wolanski A, Joffe S
  "Entering a Clinical Trial: Is it Right for You?": a randomized study of The Clinical Trials Video and its impact on the informed consent process. Cancer. 2012 Apr 1;118(7):1877-83. doi: 10.1002/cncr.26438. Epub 2011 Aug 25.
•   Jenkins V, Solis-Trapala I, Langridge C, Catt S, Talbot DC, Fallowfield LJ
  What oncologists believe they said and what patients believe they heard: an analysis of phase I trial discussions. J Clin Oncol. 2011 Jan 1;29(1):61-8. doi: 10.1200/JCO.2010.30.0814. Epub 2010 Nov 22.
•   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.
•   Joffe S, Cook EF, Cleary PD, Clark JW, Weeks JC
  Quality of informed consent: a new measure of understanding among research subjects. J Natl Cancer Inst. 2001 Jan 17;93(2):139-47.
•   Juraskova I, Butow P, Bonner C, Bell ML, Smith AB, Seccombe M, Boyle F, Reaby L, Cuzick J, Forbes JF
  Improving decision making about clinical trial participation - a randomised controlled trial of a decision aid for women considering participation in the IBIS-II breast cancer prevention trial. Br J Cancer. 2014 Jul 8;111(1):1-7. doi: 10.1038/bjc.2014.144. Epub 2014 Jun 3.
•   Kass NE, Sugarman J, Medley AM, Fogarty LA, Taylor HA, Daugherty CK, Emerson MR, Goodman SN, Hlubocky FJ, Hurwitz HI, Carducci M, Goodwin-Landher A
  An intervention to improve cancer patients' understanding of early-phase clinical trials. IRB. 2009 May-Jun;31(3):1-10.
•   Koyfman SA, McCabe MS, Emanuel EJ, Grady C
  A consent form template for phase I oncology trials. IRB. 2009 Jul-Aug;31(4):1-8.
•   Miller FG, Joffe S
  Phase 1 oncology trials and informed consent. J Med Ethics. 2013 Dec;39(12):761-4. doi: 10.1136/medethics-2012-100832. Epub 2012 Nov 17.
•   Spellecy R, Tarima S, Denzen E, Moore H, Abhyankar S, Dawson P, Foley A, Gersten I, Horwitz M, Idossa L, Joffe S, Kamani N, King R, Lazaryan A, Morris L, Horowitz MM, Majhail NS
  Easy-to-Read Informed Consent Form for Hematopoietic Cell Transplantation Clinical Trials: Results from the Blood and Marrow Transplant Clinical Trials Network 1205 Study. Biol Blood Marrow Transplant. 2018 Oct;24(10):2145-2151. doi: 10.1016/j.bbmt.2018.04.014. Epub 2018 Apr 18.
•   Synnot A, Ryan R, Prictor M, Fetherstonhaugh D, Parker B
  Audio-visual presentation of information for informed consent for participation in clinical trials. Cochrane Database Syst Rev. 2014 May 9;(5):CD003717. doi: 10.1002/14651858.CD003717.pub3. Review.
•   Tattersall MH, Jefford M, Martin A, Olver I, Thompson JF, Brown RF, Butow PN
  Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials. BMJ Open. 2017 Mar 1;7(3):e012666. doi: 10.1136/bmjopen-2016-012666.

A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials

Details for clinical trial NCT04407676