Solid Neoplasms Clinical Trial
— CONSENTOfficial title:
A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials
NCT number | NCT04407676 |
Other study ID # | CCR 5165 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 26, 2020 |
Est. completion date | March 26, 2023 |
The purpose of the trial will be to test whether providing both a short summary PIS and a link to a set of online video modules will improve patient understanding (those considering early phase clinical trials) as measured on the Quality of Informed Consent questionnaire (Part A), as compared to a control group who are provided only the normal PIS, and also to assess user acceptability and feasibility of these interventions.
Status | Recruiting |
Enrollment | 34 |
Est. completion date | March 26, 2023 |
Est. primary completion date | November 26, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion criteria 1. For randomised participation, patients must be eligible for an Investigator Initiated Trial (IIT) within the Drug Development Unit 1. RAFMEK (IRAS 102403, CCR 3808, REC ref: 12/LO/1407) 2. FRAME (IRAS 225064, CCR 4642, REC ref: 17/LO/1473) 3. ICE-CAP (IRAS 233461, CCR 4720, REC ref: 18/LO/0059), non GBM cohorts 4. ACE (IRAS Number 211557, CCR 4500, REC ref: 17/LO/0263) 5. Other IIT trials as they open, however these trials and accompanying study aids will be added as an amendment to CONSENT For participation in non-randomised secondary analysis of GBM patients, patients must be eligible for a. ICE-CAP (IRAS 233461, CCR 4720, REC ref: 18/LO/0059), GBM cohorts 2. English is the patient's primary language 3. Written (signed and dated) informed consent and be capable of co-operating with study procedures and questionnaire Exclusion criteria 1. Pre-existing visual, non-cancer related cognitive impairment, or reading impairment 2. Patients who have already consented to a trial or have prior consent knowledge |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Royal Marsden Hospital NHS Foundation Trust | London |
Lead Sponsor | Collaborator |
---|---|
Royal Marsden NHS Foundation Trust |
United Kingdom,
Dolly SO, Kalaitzaki E, Puglisi M, Stimpson S, Hanwell J, Fandos SS, Stapleton S, Ansari T, Peckitt C, Kaye S, Lopez J, Yap TA, van der Graaf W, de Bono J, Banerji U. 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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 14 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | QuIC-A score (Quality of Informed Consent questionnaire - Part A, Objective) | • To determine the QuIC Part A scores following administration of a standard PIS alone, and compare it to the QuIC Part A score following administration of a standard PIS along with a summary PIS and a suite of online educational videos. Minimum score on QuIC-A is 0, highest is 100, and higher scores indicate a higher degree of objective understanding of clinical trial principles. | Through study completion, aiming for 34 patients, expected to reach this in 12 months based on historical recruitment rates | |
Secondary | QuIC- B score (Quality of Informed Consent questionnaire - Part B, Subjective) | • To determine the QuIC Part B scores following administration of a normal PIS alone, and compare it to the QuIC Part B score following administration of a normal PIS along with a summary PIS and a suite of online educational videos. Minimum score on QuIC-B is 0, highest is 100, and higher scores indicate a higher degree of subjective understanding of clinical trial principles. | Through study completion, aiming for 34 patients, expected to reach this in 12 months based on historical recruitment rates | |
Secondary | Control arm analysis | • To determine the changes in QuIC Part A and Part B scores before and after administration of enhanced consent materials | Through study completion, aiming for 34 patients, expected to reach this in 12 months based on historical recruitment rates | |
Secondary | User feedback | • To confirm the acceptability and utility of the summary PIS and educational videos with a user feedback survey | Through study completion, aiming for 34 patients, expected to reach this in 12 months based on historical recruitment rates | |
Secondary | GBM cohort exploratory analysis | QuIC Part A and Part B scores before and after administration of enhanced consent materials in patients recruited to the GBM cohort in the ICE-CAP study | Through study completion, aiming for 15 patients, expected to reach this in 12 months based on historical recruitment rates |
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