South, Annabelle Eileen;
(2023)
Showing RESPECT: a mixed methods study into communicating the results of a Phase III clinical trial to trial participants.
Doctoral thesis (Ph.D), UCL (University College London).
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Abstract
INTRODUCTION: Clinical trials depend on volunteers participating, often accepting increased risk and/or inconvenience. Most participants want to receive the results of trials they have participated in, while few actually receive them. There is little evidence to guide researchers on how best to share results with people taking part in trials. METHODS: I conducted a mixed methods, cluster randomised factorial trial of different approaches to sharing results with participants in the ICON8 ovarian cancer trial. (ICON8 tested two weekly chemotherapy schedules against the standard three-weekly schedule, and found no difference between the arms). I collected quantitative and qualitative data from patients and site staff. RESULTS: Patients at hospitals that were randomised to the Posted Printed Summary were more satisfied with how the results were shared and more likely to find out the results than those at hospitals not randomised to the Printed Summary. Women who received the results said that the information was easy to understand and find, and told them everything they wanted to know. Most were glad to receive the results, and did not regret finding them out, although some were, at the same time, disappointed that ICON8 interventions did not improve outcomes. This links back to their motivation for joining the trial: to benefit themselves and future patients. Site staff were supportive of sharing results with participants, seeing it as a way of respecting and valuing participants, and repaying trust. Staff at most sites found the process used to share results straight-forward and not too time-consuming. Sharing results by post increased site costs by ~£14 per participant. CONCLUSION: My findings can inform how future trials share results with participants, helping improve participants’ trial experience. Further research is required to look at how different patient populations, trial results and settings influence participant satisfaction with how results are shared.
| Type: | Thesis (Doctoral) |
|---|---|
| Qualification: | Ph.D |
| Title: | Showing RESPECT: a mixed methods study into communicating the results of a Phase III clinical trial to trial participants |
| Open access status: | An open access version is available from UCL Discovery |
| Language: | English |
| Additional information: | Copyright © The Author 2023. Original content in this thesis is licensed under the terms of the Creative Commons Attribution 4.0 International (CC BY 4.0) Licence (https://creativecommons.org/licenses/by/4.0/). Any third-party copyright material present remains the property of its respective owner(s) and is licensed under its existing terms. Access may initially be restricted at the author’s request. |
| UCL classification: | UCL UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Inst of Clinical Trials and Methodology > MRC Clinical Trials Unit at UCL |
| URI: | https://discovery.ucl.ac.uk/id/eprint/10167867 |
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