Clinical trial · Interventional
Improving Informed Consent for Early Phase Anti-Cancer Trials
A Randomised Controlled Trial of Enhanced Informed Consent Compared to Standard Informed Consent To Improve Patient Understanding of Early Phase Oncology Clinical Trials
NCT04407676CI-TRIAL-00056891CONSENTunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Neoplasms | Solid Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Summary PIS and Online Video Modules | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental
- description
- 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.
- interventionNames
- Other: Summary PIS and Online Video Modules
- type
- PLACEBO_COMPARATOR
- label
- Control
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (15)
- BACKGROUNDHlubocky 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
- BACKGROUNDMiller 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
- BACKGROUNDDolly 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
- BACKGROUNDJenkins 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
- BACKGROUNDJoffe 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
- BACKGROUNDKoyfman 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
- BACKGROUNDFallowfield 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.