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We thank the patients who participated in this study and their families, the Royal Marsden patient advocacy group, Debarati Goswami, and Kirsty Moran.
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.
Patient Characteristics
Between September
2012 and March 2015, questionnaires were given to 402 prospective adult
patients at their first attendance in the new patient phase 1 clinic of
the Drug Development Unit. Ninety nine percent (n = 396) gave written
consent to participate and completed the preclinic questionnaire; 301
patients returned the postclinic questionnaire (76%). The mean age was
57.4 years (standard deviation, 12.9 years); there was a slight
preponderance of females (56.3%), and there was an even distribution of
participants leaving formal education before and after the age of 17
years (46.2 vs 44.7%; Table 1).
The commonest cancers were gastrointestinal, gynecological, and lung
cancers, with their respective cancer specialists being the major
primary referrers for 87.1% of the patients (Table 1).
Cancer site, No. (%)
| Breast | 40 (10.1) | |
| Gastrointestinal | 153 (38.6) | |
| Gynecological | 66 (16.7) | |
| Lung | 58 (14.6) | |
| All others | 79 (19.9) Total 396 (100.00) | |
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