Abstract 3427
Background
Extensive research has demonstrated that patients considering early phase oncology trials do not appreciate the design or purpose of these trials and also harbour unrealistic expectations of the personal benefit they can expect from the trial. There have been few interventional studies examining the informed consent process in this setting and they have shown limited effectiveness. We aimed to use a qualitative methodology to understand the perspectives of key stakeholders and identify the areas of need and the potential opportunities for an intervention to improve our informed consent processes.
Methods
We used an experience-based co-design framework which consisted of a semi-structured interview script of ten key questions. Two trained interviewers performed interviews of three consultant medical oncologists, nine clinical fellows, two study managers, two clinical nurse specialists, two focus groups with four patients each and two regulatory officers. We also interviewed four members of our investigator-initiated sponsor team to obtain an understanding of the sponsor perspective. All audio interviews were transcribed, and thematic analysis was performed on the narrative text to extract core themes.
Results
Consistent themes raised by participants included 1. The core elements that participants need to comprehend prior to consenting are that trials are experiments and not treatment, the low prospect of benefit, potential toxicity and the significant time commitment. 2. Participant information sheets (PIS) are too long, too complex and the information is not provided in a patient centred manner. Sponsors were in strong support of shorter and more accessible PIS. 3. Digital media would be acceptable and useful but to be mindful of subgroups of patients who are not as comfortable with digital media.
Conclusions
There is widespread understanding that improvement is required in the length, design and style of participant information sheets for phase 1 oncology trials. Furthermore, digital media would be acceptable to all stakeholders but its development will require ongoing stakeholder engagement to ensure user acceptability.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Drug Development Unit - Royal Marsden Hospital, Sutton.
Funding
Cancer Research UK (CRUK), Experimental Cancer Medicine Centres (ECMC), National Institute of Health Research (NIHR) Royal Marsden Biomedical Research Centre.
Disclosure
J. Lopez: Advisory / Consultancy: Genmab; Advisory / Consultancy: Novartis; Research grant / Funding (institution): Roche/Genentech; Research grant / Funding (institution): Basilea; Travel / Accommodation / Expenses: Basilea; Travel / Accommodation / Expenses: Roche/Genentech. All other authors have declared no conflicts of interest.
Resources from the same session
5939 - Matrix metalloproteinases and their tissue inhibitors genes abnormal DNA methylation in breast cancer
Presenter: Olga Simonova
Session: Poster Display session 1
Resources:
Abstract
2703 - Uveal melanoma cell lines depend on multiple signaling pathways for survival
Presenter: John Park
Session: Poster Display session 1
Resources:
Abstract
4849 - XAF1 and ZNF313 complex stimulates ER stress-induced apoptosis via direct GRP78 inhibition.
Presenter: Sungchan Jang
Session: Poster Display session 1
Resources:
Abstract
4801 - XAF1 assembles a destructive complex to induce BRCA1-mediated apoptosis via suppressing ERa and switching estrogen function
Presenter: Seung-hun Jang
Session: Poster Display session 1
Resources:
Abstract
3416 - Cancer associated fibroblasts promote cancer progression via Wnt2 secretion in colorectal cancer
Presenter: Hideaki Karasawa
Session: Poster Display session 1
Resources:
Abstract
4273 - Paired-related homeobox 1 overexpression promotes invasion and metastasis and is a prognostic factor for worse disease-free survival in patients with lung cancer
Presenter: Jung-jyh Hung
Session: Poster Display session 1
Resources:
Abstract
4241 - LncRNA-GC1 contributes to gastric cancer chemo-resistance through inhibition of miR-551b-3p and the overexpression of dysbindin
Presenter: Xin Guo
Session: Poster Display session 1
Resources:
Abstract
5388 - GLPG 1790, a new selective EPHA2 inhibitor, is active in colorectal cancer cell lines belonging to the CMS4/mesenchymal-like subtype
Presenter: Pietro Paolo Vitiello
Session: Poster Display session 1
Resources:
Abstract
5208 - Characterisation of growth hormone signal transduction in primary melanoma cell lines
Presenter: Karla Sousa
Session: Poster Display session 1
Resources:
Abstract
3156 - LAPTM5 protein can regulate TGF-β mediated MAPK and Smad signaling pathways in ovarian cancer cell
Presenter: Yan Gao
Session: Poster Display session 1
Resources:
Abstract