Article Text

Download PDFPDF
243 Development of a pictorial encounter decision aid for early phase cancer clinical trials
  1. Emilien Schultz1,
  2. Géraldine Cazorla1,
  3. Marie-Anne Durand2,3,4,
  4. Julien Mancini1,5
  1. 1SESSTIM (Economic and Social Sciences of Health and Medical Information Processing), Aix Marseille Univ, INSERM, IRD, ISSPAM, Marseille, France
  2. 2CERPOP, Inserm, University of Toulouse III Paul Sabatier, Toulouse, France
  3. 3The Dartmouth Institute for Health Policy and Clinical Practice, Dartmouth College, Lebanon, NH, USA
  4. 4Unisanté, University Centre for General Medicine and Public Health, CH-1011 Lausanne, Switzerland
  5. 5Public Health department (BIOSTIC), Hop Timone, APHM, Marseille, France

Abstract

Introduction Advances in cancer care depend on clinical trials (CTs), yet the number of adults enrolled is suboptimal. Early-phase CTs are complex and particularly difficult to discuss as participants mainly have advanced cancer and are unlikely to receive any therapeutic benefit. Limited health literacy can also be a barrier to participation.1 Our aim was to develop a pictorial encounter decision aid (pEDA)2 to facilitate general and neutral discussions about CT enrolment.

Methods A multidisciplinary, participatory group involving patient partners and other stakeholders drafted a first version of the pEDA. Its acceptability was assessed in interviews with a convenience sample of patients and healthcare professionals. An online survey, including the HLS19-Q12 health literacy questionnaire, was distributed to Seintinelles members (a French national non-profit organization facilitating recruitment for cancer studies).

Results In 2023, 989 complete surveys were collected among participants without cancer (69.8%) or at least one year after ending their active treatment (30.2%). Most of them were women (95.6%) with adequate health literacy (64.3%) who had never heard of early-phase CTs (62.3%).

The mean recommendation of the pEDA was 8.1/10. It was considered easy to understand (98.1%), of suitable length (90.2%) and neutral (66.4%). Health literacy was significantly but poorly correlated with understanding (Spearman’s ρ=0.12) and recommendation (ρ=0.09) of the pEDA, not with perceived neutrality or length of the document. Respondents gave many suggestions (n=2353) for improving the pEDA (content and pictorial design). The two most important sections of the pEDA were the presentation of early CTs, and of risks and side effects.

Discussion A coproduced pEDA was well received, even among low-literate patients. The large sample size obtained provided a broad (but feminine) view of the document and many valuable comments.

Conclusion After new revisions, the coproduced pEDA should be tested to confirm it can facilitate discussions about early-phase CTs.

References

  1. Ousseine YM, Bouhnik AD, Mancini J. Health literacy and clinical trial participation in french cancer patients: a national survey. Curr. Oncol. 2022;29:3118–3129.

  2. Durand, MA, Alam S, Grande SW, Elwyn G. ‘Much clearer with pictures’: using community-based participatory research to design and test a picture option grid for underserved patients with breast cancer. BMJ Open. 2016;6(2):e010008.

Statistics from Altmetric.com

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.