| Title: |
A study of motivations and expectations of patients seen in phase 1 oncology clinics. |
| Authors: |
Dolly, SO; Kalaitzaki, E; Puglisi, M; Stimpson, S; Hanwell, J; Fandos, SS; Stapleton, S; Ansari, T; Peckitt, C; Kaye, S; Lopez, J; Yap, TA; van der Graaf, W; de Bono, J; Banerji, U |
| Contributors: |
Lopez, Juanita; De Bono, Johann; Banerji, Udai |
| Publisher Information: |
WILEY-BLACKWELL |
| Publication Year: |
2016 |
| Collection: |
The Institute of Cancer Research (ICR): Publications Repository |
| 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 ... |
| Document Type: |
article in journal/newspaper |
| File Description: |
Print-Electronic; 3508; application/pdf |
| Language: |
English |
| ISSN: |
1097-0142; 0008-543X |
| Relation: |
Cancer, 2016, 122 (22), pp. 3501 - 3508; https://repository.icr.ac.uk/handle/internal/179 |
| DOI: |
10.1002/cncr.30235 |
| Availability: |
https://doi.org/10.1002/cncr.30235; https://repository.icr.ac.uk/handle/internal/179 |
| Rights: |
https://creativecommons.org/licenses/by/4.0 |
| Accession Number: |
edsbas.9224FDE5 |
| Database: |
BASE |