Dataset Information

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

ABSTRACT:

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.

SUBMITTER: Dolly SO

PROVIDER: S-EPMC5111585 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Dolly Saoirse O SO Kalaitzaki Eleftheria E Puglisi Martina M Stimpson Sarah S Hanwell Janet J Fandos Sonia Serrano SS Stapleton Sarah S Ansari Thushara T Peckitt Clare C Kaye Stan S Lopez Juanita J Yap Timothy A TA van der Graaf Winette W de Bono Johann J Banerji Udai U

Cancer 20160926 22

<h4>Background</h4>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.<h4>Methods</h4>This was a single-center, prospective, quantitative study of newly referred adult patients considering their first phase 1 oncology trial. Participants completed quest ...[more]

PMID: 27716902

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Dataset Information

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

Background

Methods

Results

Conclusions

Publications

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

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