A Protocol for an Evaluation Study of Patient Follow-Up and Cancer Clinical Trial Complexity: the EFACCT study.

Jones, Helene Markham, Bridle, C. and Ahmed, Tanweer (2017) A Protocol for an Evaluation Study of Patient Follow-Up and Cancer Clinical Trial Complexity: the EFACCT study. In: NCRI Cancer Conference 2017, 05-08 November 2017, BT Convention Centre Liverpool.

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Abstract

Abstract Background Clinical research delivery is crucial in advancing treatment and care options for cancer. There is a burgeoning problem internationally in delivering cancer trials due to complex protocols, stratified treatments and increasing patient populations in follow-up with extended needs. The EFACCT study will evaluate the phenomena of cancer clinical trial delivery at NHS secondary care sites identifying burdens and implications for participants and organisations. Method This mixed-methods study adopting grounded theory will analyse operational processes and protocols at sites delivering Phase I-IV cancer trials for commercial and non-commercial studies. Research professionals and cancer patients who have participated in clinical trials will contribute to the development of an objective methodology defining and quantifying trial complexity, intensity and workload to enhance models of trial delivery. This in-depth study involving a two-arm e-Delphi, questionnaires, semi-structured interviews as well as trial documentation, database and systematic reviews will optimise clinical trial performance data in combination with qualitative evidence to form optimal models for cancer clinical trial delivery. Data from 12 geographically dispersed sites will be synthesised and continually compared until saturation is achieved. A total UK sample of 185 participants and documentation sample of 100 studies incorporates theoretical, purposive, quota and snowball sampling techniques leveraging the benefits of health informatics and rich participant contextual data. Results Data analysis will include descriptive statistics, thematic content analysis, theoretical, open, axial and selective coding and constant comparison methods. Statistical summaries will use measures of central tendency and levels of dispersion. Conclusion The study outcomes will involve the implementation of a trial rating and complexity assessment tool (TRACAT) and an evaluative theoretical model for cancer research operational management. These elements will create new knowledge supporting future research models, strategic planning, trial implementation and evaluation alongside the provision of a mechanism to optimise recruitment and enhance patient outcomes.

Item Type:	Conference or Workshop Item
Additional Information:	This item is available from the research repository at University of Lincoln.
Depositing User:	Rachel Stewart
Date Deposited:	14 Mar 2019 12:02
Last Modified:	23 Jul 2019 14:20
URI:	https://bgro.repository.guildhe.ac.uk/id/eprint/479

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