References

Asher N, Raphael A, Wolf I, Pelles S, Geva R. Oncologic patients' misconceptions may impede enrollment into clinical trials: a cross-sectional study. BMC Med Res Methodol. 2022; 22:(1) https://doi.org/10.1186/s12874-021-01478-5

Bhatt A. Improving quality of informed consent in clinical research. J Postgrad Med. 2015; 61:(4)221-222 https://doi.org/10.4103/0022-3859.166508

Braun V, Clarke V. Thematic analysis. In: Cooper H, Camic PM, Long DL, Panter AT, Rindskopf D, Sher KJ (eds). : American Psychological Association; 2012 https://doi.org/10.1037/13620-004

Cancer Research UK. Phases of clinical trials. 2022. https://tinyurl.com/2xdkmutc (accessed 1 August 2023)

Castillo G, Lalu MM, Asad S Navigating choice in the face of uncertainty: using a theory informed qualitative approach to identifying potential patient barriers and enablers to participating in an early phase chimeric antigen receptor T (CAR-T) cell therapy trial. BMJ Open. 2021; 11:(3) https://doi.org/10.1136/bmjopen-2020-043929

Cook N, Hansen AR, Siu LL, Abdul Razak AR. Early phase clinical trials to identify optimal dosing and safety. Mol Oncol. 2015; 9:(5)997-1007 https://doi.org/10.1016/j.molonc.2014.07.025

Fraval A, Chandrananth J, Chong YM, Tran P, Coventry LS. Internet based patient education improves informed consent for elective orthopaedic surgery: a randomized controlled trial. BMC Musculoskelet Disord. 2015; 16:(1)1-6

Halpern J, Paolo D, Huang A. Informed consent for early-phase clinical trials: therapeutic misestimation, unrealistic optimism and appreciation. J Med Ethics. 2019; 45:(6)384-387 https://doi.org/10.1136/medethics-2018-105226

Hood B. Using patient and public involvement to improve the clinical pathway for participants in clinical trials.: Cancer Nursing Practice; 2020 https://doi.org/10.7748/cnp.2020.e1730

Hood B. Understanding the experiences of cancer patients referred for a clinical trial during the COVID-19 pandemic. Br J Nurs. 2023; 32:2:82-87 https://doi.org/10.12968/bjon.2023.32.2.82

Kraft SA, Doerr M. Engaging populations underrepresented in research through novel approaches to consent. Am J Med Genet C Semin Med Genet. 2018; 178:(1)75-80 https://doi.org/10.1002/ajmg.c.31600

Lentz J, Kennett M, Perlmutter J, Forrest A. Paving the way to a more effective informed consent process: recommendations from the Clinical Trials Transformation Initiative. Contemp Clin Trials. 2016; 49:65-69 https://doi.org/10.1016/j.cct.2016.06.005

Marcus HJ, Jain A, Grieve J, Dorward NL. Informed consent for patients undergoing transsphenoidal excision of pituitary adenoma: development and evaluation of a procedure-specific online educational resource. World Neurosurg. 2018; 118:e933-e937 https://doi.org/10.1016/j.wneu.2018.07.102

Millum J, Bromwich D. Informed consent: what must be disclosed and what must be understood?. Am J Bioeth. 2021; 21:(5)46-58 https://doi.org/10.1080/15265161.2020.1863511

Olver IN, Whitford HS, Denson LA, Peterson MJ, Olver SI. Improving informed consent to chemotherapy: A randomized controlled trial of written information versus an interactive multimedia CD-ROM. Patient Educ Couns. 2009; 74:(2)197-204 https://doi.org/10.1016/j.pec.2008.08.021

Ruske J, Sharma G, Makie K Patient comprehension necessary for informed consent for vascular procedures is poor and related to frailty. J Vasc Surg. 2021; 73:(4)1422-1428 https://doi.org/10.1016/j.jvs.2020.06.131

Simonds VW, Garroutte EM, Buchwald D. Health literacy and informed consent materials: designed for documentation, not comprehension of health research. J Health Commun. 2017; 22:(8)682-691 https://doi.org/10.1080/10810730.2017.1341565

Svobodova M, Jacob N, Hood K Developing principles for sharing information about potential trial intervention benefits and harms with patients: report of a modified Delphi survey. Trials. 2022; 23:(1) https://doi.org/10.1186/s13063-022-06780-1

Togaç HK, Yılmaz E. Effects of preoperative individualized audiovisual education on anxiety and comfort in patients undergoing laparoscopic cholecystectomy: randomised controlled study. Patient Educ Couns. 2021; 104:(3)603-610 https://doi.org/10.1016/j.pec.2020.08.026

Wexler A, Choi RJ, Ramayya AG Ethical issues in intraoperative neuroscience research: assessing subjects' recall of informed consent and motivations for participation’. AJOB Empir Bioeth. 2022; 13:(1)57-66 https://doi.org/10.1080/23294515.2021.1941415

Williams N. The GAD-7 questionnaire. Occupational Medicine. 2014; 64:(3) https://doi.org/10.1093/occmed/kqt161

Zhang MH, Haq ZU, Braithwaite EM, Simon NC, Riaz KM. A randomized, controlled trial of video supplementation on the cataract surgery informed consent process. Graefes Arch Clin Exp Ophthalmol. 2019; 257:(8)1719-1728 https://doi.org/10.1007/s00417-019-04372-5

Impact of an educational intervention for advanced cancer patients referred for early phase clinical trials

17 August 2023
Volume 32 · Issue 15

Abstract

A 2017 service evaluation identified a lack of information and knowledge among patients who were referred on to early phase oncology clinical trials (Hood, 2020). An educational booklet was developed to improve patients' knowledge and experience. To build upon this work, a patient co-designed website was developed. This study examined the impact, if any, of a patient co-designed educational intervention within the clinical pathway for patients who are referred for an early phase oncology clinical trial at an experimental cancer medicine centre (ECMC). Aims: 1. To understand the experiences of patients who have been referred to an ECMC for an early phase clinical trial pre- and post-intervention. 2. To investigate if the intervention reduced anxiety levels in newly referred patients. Method: A convergent mixed-methods design was used in this study, to collect quantitative and qualitative data in parallel. Outcomes: This study examined the experiences of advanced cancer patients who attended their initial research outpatient appointment to discuss the possibility of taking part in an early phase clinical trial and the impact of an educational resource.

Patient comprehension is an important component of the informed consent process within clinical research (Ruske et al, 2021). Nevertheless, studies have indicated that clinical trial patients remember little of the information that is discussed during the informed consent process, and their level of understanding around essential information is often overestimated (Ruske et al, 2021). Systematic reviews into the informed consent process have outlined that the level of patient knowledge gained from informed consent is frequently inadequate and that further educational interventions need to be developed (Castillo et al, 2021).

There has been longstanding criticism of informed consent within clinical research, and it is often seen as a process that meets only the regulatory requirements imposed, rather than a truly ethical process that produces informed and voluntary participation within clinical research (Wexler et al, 2022).

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