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Strategies to improve recruitment to a de-escalation trial : a mixed-methods study of the OPTIMA prelim trial in early breast cancer
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(2020) Strategies to improve recruitment to a de-escalation trial : a mixed-methods study of the OPTIMA prelim trial in early breast cancer. Clinical Oncology . doi:10.1016/j.clon.2020.01.029 ISSN 0936-6555.
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Official URL: http://dx.doi.org/10.1016/j.clon.2020.01.029
Abstract
Aims
De-escalation trials are challenging and sometimes may fail due to poor recruitment. The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus ‘test-directed’ chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice. Despite encountering challenges, OPTIMA Prelim reached its recruitment target ahead of schedule. This study reports the root causes of recruitment challenges and the strategies used to successfully overcome them.
Materials and methods
A mixed-methods recruitment intervention (QuinteT Recruitment Intervention) was used to investigate the recruitment difficulties and feedback findings to inform interventions and optimise ongoing recruitment. Quantitative site-level recruitment data, audio-recorded recruitment appointments (n = 46), qualitative interviews (n = 22) with trialists/recruiting staff (oncologists/nurses) and patient-facing documentation were analysed using descriptive, thematic and conversation analyses. Findings were triangulated to inform a ‘plan of action’ to optimise recruitment.
Results
Despite best intentions, oncologists' routine practices complicated recruitment. Discomfort about deviating from the usual practice of recommending chemotherapy according to tumour clinicopathological features meant that not all eligible patients were approached. Audio-recorded recruitment appointments revealed how routine practices undermined recruitment. A tendency to justify chemotherapy provision before presenting the randomised controlled trial and subtly indicating that chemotherapy would be more/less beneficial undermined equipoise and made it difficult for patients to engage with OPTIMA Prelim. To tackle these challenges, individual and group recruiter feedback focussed on communication issues and vignettes of eligible patients were discussed to address discomforts around approaching patients. ‘Tips’ documents concerning structuring discussions and conveying equipoise were disseminated across sites, together with revisions to the Patient Information Sheet.
Conclusions
This is the first study illuminating the tension between oncologists' routine practices and recruitment to de-escalation trials. Although time and resources are required, these challenges can be addressed through specific feedback and training as the trial is underway.
| Item Type: | Journal Article | ||||||||
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| Subjects: | R Medicine > R Medicine (General) R Medicine > RC Internal medicine R Medicine > RM Therapeutics. Pharmacology |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School | ||||||||
| Library of Congress Subject Headings (LCSH): | Clinical trials , Breast -- Cancer , Breast -- Cancer -- Chemotherapy | ||||||||
| Journal or Publication Title: | Clinical Oncology | ||||||||
| Publisher: | Elsevier Science London | ||||||||
| ISSN: | 0936-6555 | ||||||||
| Official Date: | 2020 | ||||||||
| Dates: |
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| DOI: | 10.1016/j.clon.2020.01.029 | ||||||||
| Status: | Peer Reviewed | ||||||||
| Publication Status: | Published | ||||||||
| Access rights to Published version: | Restricted or Subscription Access | ||||||||
| Date of first compliant deposit: | 5 March 2020 | ||||||||
| Date of first compliant Open Access: | 20 February 2021 | ||||||||
| RIOXX Funder/Project Grant: |
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