Improving Informed Consent for Early Phase Anti-Cancer Trials

NCT04407676 | Unknown

• 1 other identifier: CCR 5165
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Solid Neoplasms

Keywords

Drug Development; Informed consent; Clinical Trials

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• QuIC- B score (Quality of Informed Consent questionnaire - Part B, Subjective)

  Through study completion, aiming for 34 patients, expected to reach this in 12 months based on historical recruitment rates

• Control arm analysis

  Through study completion, aiming for 34 patients, expected to reach this in 12 months based on historical recruitment rates

• User feedback

  Through study completion, aiming for 34 patients, expected to reach this in 12 months based on historical recruitment rates

• GBM cohort exploratory analysis

  Through study completion, aiming for 15 patients, expected to reach this in 12 months based on historical recruitment rates

Study Arms (2)

Experimental

EXPERIMENTAL

Patients eligible for an investigator initiated trial are given the standard PIS by email, and are also emailed a summary PIS and access to an online set of 10 video educational modules. They are then administered a demographic data collection form, the Quality of Informed Consent Questionnaire Parts A and B, and a user feedback survey form. They then present for their standard of care consent visit.

Other: Summary PIS and Online Video Modules

Control

PLACEBO COMPARATOR

Patients eligible for an investigator initiated trial are given the standard PIS by email and are then administered a demographic data collection form, the Quality of Informed Consent Questionnaire Parts A and B, and a user feedback survey form. They will then be emailed and are also emailed a summary PIS and access to an online set of 10 video educational modules. They will then perform the QuIC-A and QuIC-B again. They will then present for their standard of care consent visit.

Other: Summary PIS and Online Video Modules

Interventions

Summary PIS and Online Video Modules OTHER

Complex trial information presented in alternative and more accessible formats

Control; Experimental

Eligibility Criteria

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

You may qualify if:

• For randomised participation, patients must be eligible for an Investigator Initiated Trial (IIT) within the Drug Development Unit
• RAFMEK (IRAS 102403, CCR 3808, REC ref: 12/LO/1407)
• FRAME (IRAS 225064, CCR 4642, REC ref: 17/LO/1473)
• ICE-CAP (IRAS 233461, CCR 4720, REC ref: 18/LO/0059), non GBM cohorts
• ACE (IRAS Number 211557, CCR 4500, REC ref: 17/LO/0263)
• 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
• English is the patient's primary language
• Written (signed and dated) informed consent and be capable of co-operating with study procedures and questionnaire

You may not qualify if:

• Pre-existing visual, non-cancer related cognitive impairment, or reading impairment
• Patients who have already consented to a trial or have prior consent knowledge

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

Royal Marsden Hospital NHS Foundation Trust

London, SW3 6JJ, United Kingdom

RECRUITING

Related Publications (15)

• 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.

  PMID: 29787333 BACKGROUND

• 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.

  PMID: 23161617 BACKGROUND

• 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.

  PMID: 27716902 BACKGROUND

• 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.

  PMID: 21098322 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

• 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. No abstract available.

  PMID: 19697538 BACKGROUND

• 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.

  PMID: 22382459 BACKGROUND

• 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. No abstract available.

  PMID: 19552233 BACKGROUND

• 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;2014(5):CD003717. doi: 10.1002/14651858.CD003717.pub3.

  PMID: 24809816 BACKGROUND

• 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.

  PMID: 28249847 BACKGROUND

• 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.

  PMID: 24892447 BACKGROUND

• 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. doi: 10.1093/jnci/93.2.139.

  PMID: 11208884 BACKGROUND

• 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.

  PMID: 22009665 BACKGROUND

• 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.

  PMID: 29679770 BACKGROUND

• Pal A, Stapleton S, Yap C, Lai-Kwon J, Daly R, Magkos D, Baikady BR, Minchom A, Banerji U, De Bono J, Karikios D, Boyle F, Lopez J. Study protocol for a randomised controlled trial of enhanced informed consent compared to standard informed consent to improve patient understanding of early phase oncology clinical trials (CONSENT). BMJ Open. 2021 Sep 6;11(9):e049217. doi: 10.1136/bmjopen-2021-049217.

  PMID: 34489282 DERIVED

Study Officials

• Juanita Lopez, MRCP PhD

  The Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Juanita Lopez, MRCP PhD

CONTACT

+44 8642 6011; juanita.lopez@icr.ac.uk

Abhijit Pal, MBBS FRACP

CONTACT

+44 8642 6011; abhijit.pal@icr.ac.uk

Study Design

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

Model Details: Randomised

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 29, 2020
• Study Start: June 26, 2020
• Primary Completion: November 26, 2022
• Study Completion: March 26, 2023
• Last Updated: March 4, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)