4 “WAS IT WORTH IT?” A PILOT STUDY OF ADVANCED CANCER PATIENTS' RETROSPECTIVE PERCEPTIONS OF BENEFIT FROM PHASE I TRIAL PARTICIPATION.

2007 ◽  
Vol 55 (2) ◽  
pp. S347.4-S347
Author(s):  
J. Y. Bruce ◽  
F. J. Hlubocky ◽  
C. K. Daugherty
2011 ◽  
Vol 29 (15_suppl) ◽  
pp. 3023-3023 ◽  
Author(s):  
H. A. Henary ◽  
R. Kurzrock ◽  
G. S. Falchook ◽  
A. Naing ◽  
S. L. Moulder ◽  
...  

1990 ◽  
Vol 32 (1) ◽  
pp. 67-70 ◽  
Author(s):  
François Boue ◽  
Zulay Pastran ◽  
Marc Spielmann ◽  
Thierry Le Chevalier ◽  
Rosana Subirana ◽  
...  

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8516-8516
Author(s):  
F. J. Hlubocky ◽  
C. K. Daugherty

8516 Background: Timely and accurate prognostic information is essential if patients are to make ethically appropriate medical decisions. Yet, prior research indicates advanced cancer patients (acp) with limited prognoses either misunderstand or fail to receive physician (md)-disclosed information regarding prognoses. Methods: Using semi-structured quantitative and qualitative interviews, acp were queried about prior discussions of prognosis (dop) with md and perceptions about treatment benefit. Results: To date, 87 (93%) acp receiving experimental (phase I) chemotherapy have been interviewed: median age 61 (33–82); 52% male; 80% Ca; 90% married; 58% >high school education. Quantitative interview data include: Likert scores (1–10) of likelihood of chemotherapy in: “stabilizing” cancer (mean 7.6); “halting” cancer (mean 7.1); producing “remission” (mean 6.9); and “curing” (mean 2.9). In response to a specific query, only 52% reported having dop with their md regarding life expectancy and 42% actually stated they initiated this dop. Although 45% denied any dop with md, a significant number of this group provided subsequent qualitative descriptions of dop within our interviews. As well, 61% described receiving specific quantitative estimates indicating a priori dop. When asked about their own thoughts on prognosis, only 4% described quantitative estimates or timeframes. Overwhelmingly so, patients were hopeful for a positive outcome or prolonged survival due to phase I trial participation. Several were currently deferring further dop. Conclusions: Despite prior data indicating that acp have a poor understanding of their prognoses, our findings indicate that at least 75% of interviewed acp recalled having had at least one specific dop and two-thirds describe having received a quantitative estimate of their prognosis. The majority of acp in phase I trials continue to have significant beliefs in the benefits of further therapy. No significant financial relationships to disclose.


2015 ◽  
Vol 64 (9) ◽  
pp. 1159-1173 ◽  
Author(s):  
Maria Grazia Cusi ◽  
Cirino Botta ◽  
Pierpaolo Pastina ◽  
Maria Grazia Rossetti ◽  
Elena Dreassi ◽  
...  

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 19670-19670
Author(s):  
J. Y. Bruce ◽  
F. J. Hlubocky ◽  
C. K. Daugherty

19670 Background: Subjects who enroll in phase I cancer trials generally are those with advanced and terminal disease. Although all such patients (pts) undergo an informed consent process, there is evidence that these pts may not appreciate the primary aims of a phase I trial and have unrealistic expectations of therapeutic benefit. However, these perceptions of benefit have not been described in pts after trial enrollment. Methods: As a pilot study, pts previously enrolled on Phase I trials were interviewed regarding their retrospective perceptions of benefit. A total of 9 pts have been interviewed to date: median age: 72 yr (range: 59–82 yr); 55% male; 77% Caucasian. The interview included open-ended questions assessing patient experiences with the trial, including reasons for enrollment, impressions of quality of life, costs incurred, and other benefits. Pts’ qualitative responses were recorded and analyzed for content and themes. Results: Reasons for enrollment included hope, prior treatment failure, altruism, and family influence. Described perceptions of anticipated benefit included stabilization of disease and close monitoring of their disease. Unexpected costs involved time spent during clinic visits, financial costs, time taken off work by family members, time spent away from family, and additional trial procedures. Issues of quality of life revolved around side effects from the investigational agent. Many interviewed pts (44%) described improved quality of life off the trial as compared to during trial participation. The majority of interviewed pts (67%) believed that the trial had no effect on their survival. Conclusions: Our data suggest that pts’ perceptions of therapeutic benefit after trial enrollment may be different from pre-enrollment expectations. There would also appear to be potentially significant and otherwise undescribed out-of-pocket expenses incurred by subjects as a result of phase I enrollment. Further research is needed to examine how side effects, unexpected costs, and lack of improved survival contribute to these pts’ perceptions of trial benefit. No significant financial relationships to disclose.


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