TY - JOUR
T1 - A study of motivations and expectations of patients seen in phase 1 oncology clinics
AU - Dolly, Saoirse O.
AU - Kalaitzaki, Eleftheria
AU - Puglisi, Martina
AU - Stimpson, Sarah
AU - Hanwell, Janet
AU - Fandos, Sonia Serrano
AU - Stapleton, Sarah
AU - Ansari, Thushara
AU - Peckitt, Clare
AU - Kaye, Stan
AU - Lopez, Juanita
AU - Yap, Timothy A.
AU - van der Graaf, Winette
AU - de Bono, Johann
AU - Banerji, Udai
N1 - Publisher Copyright:
© 2016 The Authors. Cancer published by Wiley Periodicals, Inc. on behalf of American Cancer Society.
PY - 2016/11/15
Y1 - 2016/11/15
N2 - 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.
AB - 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.
KW - cancer
KW - oncology clinical trials
KW - patient expectations
KW - patient motivations
KW - phase 1 trials
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U2 - 10.1002/cncr.30235
DO - 10.1002/cncr.30235
M3 - Article
C2 - 27716902
AN - SCOPUS:84992455967
SN - 0008-543X
VL - 122
SP - 3501
EP - 3508
JO - Cancer
JF - Cancer
IS - 22
ER -