Use of a theoretical framework to examine declines in clinical trial enrollment
| Autor: | Kerry Hepler, Joanna Brooks, Christine B. Mackay, Christine M. Daley |
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| Rok vydání: | 2019 |
| Předmět: | |
| Zdroj: | Journal of Clinical Oncology. 37:e18037-e18037 |
| ISSN: | 1527-7755 0732-183X |
| Popis: | e18037 Background: Clinical trial enrollment at a group of community oncology sites dropped significantly surrounding acquisition by an academic medical center. While previous research used empirical data to identify enrollment barriers, this study used a theoretical framework to investigate research site personnel behavior associated with enrollment, and to further explore clinical trial enrollment barriers. Methods: Data from focus groups and interviews were analyzed using the integrated TDF and COM-B theoretical framework [1] . [1] Theoretical Domains Framework with Capability, Opportunity, Motivation Behavior Wheel. Results: Fifty-six community personnel [2] participated in focus groups and interviews about enrollment experiences before and after the acquisition. Participants described how changes in the workplace and resources affected their Opportunity to enroll: "It's kind of hard to put somebody on a study when you don't have one available." -cs "You can't grow a research department by cutting staff. What message does it send to the organization as far as the importance of research? …it makes you wonder whether the organization truly backs the research effort." -m Physician participants specifically shared that the lack of time and staff devoted to research hampered enrollment efforts, consequently affecting their Motivation: “Current road block is that doc doesn't have time to go through the patient records, so if [the study coordinator] could determine eligibility before the patient visit, that would be helpful.” -p Participants expressed frustration in not knowing the processes for opening trials, therefore their Capability was affected. “I think [in the past], we knew more about what was out there, where I don't see as much of that here now. I don't know if it's because we don't have a research nurse or we are not getting a list [of trials] anymore or what is going on." -cs [2] Quotes from personnel cs = clinic staff, m = manager, p = provider. Conclusions: Participants perceived many barriers to clinical trial enrollment after the acquisition. To optimally continue providing services as expected, support systems need to be maintained. This study provided evidence of using the TDF for exploring enrollment barriers. |
| Databáze: | OpenAIRE |
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