Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials
Background: Clinical research coordinators play a pivotal role in phase I cancer clinical trials. Purpose: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators&...
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doaj-da841115af9541e48e67b5d580d531e22020-11-24T23:37:49ZengElsevierContemporary Clinical Trials Communications2451-86542017-12-018C15616110.1016/j.conctc.2017.09.009Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trialsNoriko Fujiwara0Ryota Ochiai1Yuki Shirai2Yuko Saito3Fumitaka Nagamura4Satoru Iwase5Keiko Kazuma6School of Health Sciences and Nursing, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JapanSchool of Health Sciences and Nursing, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JapanSchool of Health Sciences and Nursing, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JapanFormerly of the Clinical Trial Coordination Office, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, JapanIMSUT Hospital, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, JapanIMSUT Hospital, The Institute of Medical Science, The University of Tokyo, 4-6-1 Shirokanedai, Minato-ku, Tokyo 108-8639, JapanSchool of Health Sciences and Nursing, Graduate School of Medicine, University of Tokyo, 7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, JapanBackground: Clinical research coordinators play a pivotal role in phase I cancer clinical trials. Purpose: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials. Method: Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practices; perceptions of patients' expectations; and the challenges that occur before, during, and after phase I cancer clinical trials. Discussion: Qualitative content analysis showed that most clinical research coordinators observed that patients have high expectations from the trials. Most listened to patients to confirm patients' understanding and reflected on responses to maintain hope, but to avoid excessive expectations; clinical research coordinators considered avoiding unplanned endings; and they aimed to establish good relationships between patients, medical staff, and among the professional team. Conclusions: Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials.http://www.sciencedirect.com/science/article/pii/S2451865417300522Cancer researchClinical research coordinatorPhase I cancer trialResearch nurse |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Noriko Fujiwara Ryota Ochiai Yuki Shirai Yuko Saito Fumitaka Nagamura Satoru Iwase Keiko Kazuma |
spellingShingle |
Noriko Fujiwara Ryota Ochiai Yuki Shirai Yuko Saito Fumitaka Nagamura Satoru Iwase Keiko Kazuma Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials Contemporary Clinical Trials Communications Cancer research Clinical research coordinator Phase I cancer trial Research nurse |
author_facet |
Noriko Fujiwara Ryota Ochiai Yuki Shirai Yuko Saito Fumitaka Nagamura Satoru Iwase Keiko Kazuma |
author_sort |
Noriko Fujiwara |
title |
Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials |
title_short |
Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials |
title_full |
Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials |
title_fullStr |
Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials |
title_full_unstemmed |
Qualitative analysis of clinical research coordinators' role in phase I cancer clinical trials |
title_sort |
qualitative analysis of clinical research coordinators' role in phase i cancer clinical trials |
publisher |
Elsevier |
series |
Contemporary Clinical Trials Communications |
issn |
2451-8654 |
publishDate |
2017-12-01 |
description |
Background: Clinical research coordinators play a pivotal role in phase I cancer clinical trials.
Purpose: We clarified the care coordination and practice for patients provided by clinical research coordinators in phase I cancer clinical trials in Japan and elucidated clinical research coordinators' perspective on patients' expectations and understanding of these trials.
Method: Fifteen clinical research coordinators participated in semi-structured interviews regarding clinical practices; perceptions of patients' expectations; and the challenges that occur before, during, and after phase I cancer clinical trials.
Discussion: Qualitative content analysis showed that most clinical research coordinators observed that patients have high expectations from the trials. Most listened to patients to confirm patients' understanding and reflected on responses to maintain hope, but to avoid excessive expectations; clinical research coordinators considered avoiding unplanned endings; and they aimed to establish good relationships between patients, medical staff, and among the professional team.
Conclusions: Clinical research coordinators were insightful about the needs of patients and took a meticulous approach to the phase I cancer clinical trial process, allowing time to connect with patients and to coordinate the inter-professional research team. Additionally, education in advanced oncology care was valuable for comforting participants in cancer clinical trials. |
topic |
Cancer research Clinical research coordinator Phase I cancer trial Research nurse |
url |
http://www.sciencedirect.com/science/article/pii/S2451865417300522 |
work_keys_str_mv |
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1725518918795132928 |