A study has been published in Cancer aimed at capturing patients’ motivations for enrolling in phase 1 oncology 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.
This was a single-centre, 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.
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.
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 the authors conclude this discrepancy exemplifies the challenges faced by patients and healthcare professionals during their interactions for phase 1 studies.
You can read the full study here.
Dolly, S. O., Kalaitzaki, E., Puglisi, M., Stimpson, S., Hanwell, J., Fandos, S. S., Stapleton, S., Ansari, T., Peckitt, C., Kaye, S., Lopez, J., Yap, T. A., van der Graaf, W., de Bono, J. and Banerji, U. (2016), A study of motivations and expectations of patients seen in phase 1 oncology clinics. Cancer. doi:10.1002/cncr.30235