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A study of motivations and expectations of patients seen in phase 1 oncology clinics

BACKGROUND: To better inform clinical practice, this study was aimed at capturing patients' motivations for enrolling in phase 1 trials and at quantifying their expectations of the benefits, risks, and commitment associated with clinical trials and the impact of the initial consultation on thei...

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Autores principales: Dolly, Saoirse O., Kalaitzaki, Eleftheria, Puglisi, Martina, Stimpson, Sarah, Hanwell, Janet, Fandos, Sonia Serrano, Stapleton, Sarah, Ansari, Thushara, Peckitt, Clare, Kaye, Stan, Lopez, Juanita, Yap, Timothy A., van der Graaf, Winette, de Bono, Johann, Banerji, Udai
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley and Sons Inc. 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5111585/
https://www.ncbi.nlm.nih.gov/pubmed/27716902
http://dx.doi.org/10.1002/cncr.30235
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author Dolly, Saoirse O.
Kalaitzaki, Eleftheria
Puglisi, Martina
Stimpson, Sarah
Hanwell, Janet
Fandos, Sonia Serrano
Stapleton, Sarah
Ansari, Thushara
Peckitt, Clare
Kaye, Stan
Lopez, Juanita
Yap, Timothy A.
van der Graaf, Winette
de Bono, Johann
Banerji, Udai
author_facet Dolly, Saoirse O.
Kalaitzaki, Eleftheria
Puglisi, Martina
Stimpson, Sarah
Hanwell, Janet
Fandos, Sonia Serrano
Stapleton, Sarah
Ansari, Thushara
Peckitt, Clare
Kaye, Stan
Lopez, Juanita
Yap, Timothy A.
van der Graaf, Winette
de Bono, Johann
Banerji, Udai
author_sort Dolly, Saoirse O.
collection PubMed
description BACKGROUND: To better inform clinical practice, this study was aimed at capturing patients' motivations for enrolling in phase 1 trials and at quantifying their expectations of the benefits, risks, and commitment associated with clinical trials and the impact of the initial consultation on their expectations. METHODS: This was a single‐center, prospective, quantitative study of newly referred adult patients considering their first phase 1 oncology trial. Participants completed questionnaires before they were seen and an abbreviated follow‐up version after their consultation. RESULTS: Questionnaires were completed by 396 (99%) and 301 (76%) before and after the clinic, respectively. Participants ranked the possibility of tumor shrinkage (84%) as the most important motivation for considering a phase 1 trial; this was followed by no alternative treatments (56%), their physician's recommendation (44%), and the fact that the research might benefit others (38%). When they were asked about the potential personal benefit, 43% predicted tumor shrinkage initially. After the consultation, this increased to 47%. Fourteen percent of patients expected a cure. When asked about risks, 71% of the participants expected moderate side effects. When asked about expectations of time commitments, a majority of patients did not anticipate weekly visits, although this was understood by 93% of patients after the consultation. Overall, patients were keen to consider trials and when asked before and after the consultation 72% and 84% were willing to enroll in studies, respectively. CONCLUSIONS: This study reports that more than 80% of patients enroll in early‐phase clinical oncology trials motivated by the potential of a clinical benefit, with approximately half expecting tumor shrinkage and approximately a tenth anticipating a cure. The typical phase 1 response rate is 4% to 20%, and this discrepancy exemplifies the challenges faced by patients and healthcare professionals during their interactions for phase 1 studies. Cancer 2016;122:3501–3508. © 2016 American Cancer Society
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spelling pubmed-51115852016-11-16 A study of motivations and expectations of patients seen in phase 1 oncology clinics Dolly, Saoirse O. Kalaitzaki, Eleftheria Puglisi, Martina Stimpson, Sarah Hanwell, Janet Fandos, Sonia Serrano Stapleton, Sarah Ansari, Thushara Peckitt, Clare Kaye, Stan Lopez, Juanita Yap, Timothy A. van der Graaf, Winette de Bono, Johann Banerji, Udai Cancer Original Articles BACKGROUND: To better inform clinical practice, this study was aimed at capturing patients' motivations for enrolling in phase 1 trials and at quantifying their expectations of the benefits, risks, and commitment associated with clinical trials and the impact of the initial consultation on their expectations. METHODS: This was a single‐center, prospective, quantitative study of newly referred adult patients considering their first phase 1 oncology trial. Participants completed questionnaires before they were seen and an abbreviated follow‐up version after their consultation. RESULTS: Questionnaires were completed by 396 (99%) and 301 (76%) before and after the clinic, respectively. Participants ranked the possibility of tumor shrinkage (84%) as the most important motivation for considering a phase 1 trial; this was followed by no alternative treatments (56%), their physician's recommendation (44%), and the fact that the research might benefit others (38%). When they were asked about the potential personal benefit, 43% predicted tumor shrinkage initially. After the consultation, this increased to 47%. Fourteen percent of patients expected a cure. When asked about risks, 71% of the participants expected moderate side effects. When asked about expectations of time commitments, a majority of patients did not anticipate weekly visits, although this was understood by 93% of patients after the consultation. Overall, patients were keen to consider trials and when asked before and after the consultation 72% and 84% were willing to enroll in studies, respectively. CONCLUSIONS: This study reports that more than 80% of patients enroll in early‐phase clinical oncology trials motivated by the potential of a clinical benefit, with approximately half expecting tumor shrinkage and approximately a tenth anticipating a cure. The typical phase 1 response rate is 4% to 20%, and this discrepancy exemplifies the challenges faced by patients and healthcare professionals during their interactions for phase 1 studies. Cancer 2016;122:3501–3508. © 2016 American Cancer Society John Wiley and Sons Inc. 2016-09-26 2016-11-15 /pmc/articles/PMC5111585/ /pubmed/27716902 http://dx.doi.org/10.1002/cncr.30235 Text en © 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society. This is an open access article under the terms of the Creative Commons Attribution (http://creativecommons.org/licenses/by/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.
spellingShingle Original Articles
Dolly, Saoirse O.
Kalaitzaki, Eleftheria
Puglisi, Martina
Stimpson, Sarah
Hanwell, Janet
Fandos, Sonia Serrano
Stapleton, Sarah
Ansari, Thushara
Peckitt, Clare
Kaye, Stan
Lopez, Juanita
Yap, Timothy A.
van der Graaf, Winette
de Bono, Johann
Banerji, Udai
A study of motivations and expectations of patients seen in phase 1 oncology clinics
title A study of motivations and expectations of patients seen in phase 1 oncology clinics
title_full A study of motivations and expectations of patients seen in phase 1 oncology clinics
title_fullStr A study of motivations and expectations of patients seen in phase 1 oncology clinics
title_full_unstemmed A study of motivations and expectations of patients seen in phase 1 oncology clinics
title_short A study of motivations and expectations of patients seen in phase 1 oncology clinics
title_sort study of motivations and expectations of patients seen in phase 1 oncology clinics
topic Original Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5111585/
https://www.ncbi.nlm.nih.gov/pubmed/27716902
http://dx.doi.org/10.1002/cncr.30235
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