Status:
UNKNOWN
Improving Informed Consent for Early Phase Anti-Cancer Trials
Lead Sponsor:
Royal Marsden NHS Foundation Trust
Conditions:
Solid Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
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 clinic...
Detailed Description
i. General background Early phase oncology clinical trials are becoming increasingly complex with a rapidly increasing array of investigational agents, combinations of these agents and a variety of t...
Eligibility Criteria
Inclusion
- Inclusion criteria
- 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
- Exclusion criteria
- Pre-existing visual, non-cancer related cognitive impairment, or reading impairment
- Patients who have already consented to a trial or have prior consent knowledge
Exclusion
Key Trial Info
Start Date :
June 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 26 2023
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04407676
Start Date
June 26 2020
End Date
March 26 2023
Last Update
March 4 2022
Active Locations (1)
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1
Royal Marsden Hospital NHS Foundation Trust
London, United Kingdom, SW3 6JJ