Survival and informed consent understanding of elderly advanced cancer patients enrolling in phase I trials

2005 ◽  
Vol 23 (16_suppl) ◽  
pp. 8109-8109
Author(s):  
U. R. Teitelbaum ◽  
F. J. Hlubocky ◽  
C. K. Daugherty
Keyword(s):  
Informed Consent ◽  
Phase I ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Phase I Trials ◽  
Advanced Cancer Patients

A study of informed consent (IC), age, and cognitive performance (CP) among advanced cancer patients (acp) in phase I trials

2008 ◽  
Vol 26 (15_suppl) ◽  
pp. 9523-9523
Author(s):  
F. J. Hlubocky ◽  
E. Larson ◽  
G. Sachs ◽  
M. S. Lesniak ◽  
M. J. Ratain ◽  
...  
Keyword(s):  
Informed Consent ◽  
Phase I ◽  
Cancer Patients ◽  
Cognitive Performance ◽  
Advanced Cancer ◽  
Phase I Trials ◽  
Advanced Cancer Patients

scholarly journals Investigator Disclosure and Advanced Cancer Patient Understanding of Informed Consent and Prognosis in Phase I Clinical Trials

2018 ◽  
Vol 14 (6) ◽  
pp. e357-e367 ◽  
Author(s):  
Fay J. Hlubocky ◽  
Nancy E. Kass ◽  
Debra Roter ◽  
Susan Larson ◽  
Kristen E. Wroblewski ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Advanced Cancer ◽  
Interaction Analysis ◽  
Trial Participation ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Advanced Cancer Patients ◽  
Medical Benefits

Purpose: Advanced cancer patients (ACPs) who participate in phase I clinical trials often report a less-than-ideal understanding of the required elements of informed consent (IC) and unrealistic expectations for anticancer benefit and prognosis. We examined phase I clinical trial enrollment discussions and their associations with subsequent ACP understanding. Methods: Clinical encounters about enrollment in phase I trials between 101 ACPs and 29 oncologists (principal investigators [PIs] and fellows) at three US academic medical institutions were recorded. The Roter Interaction Analysis System was used for analysis. ACPs completed follow-up questionnaires to assess IC recall. Results: PIs disclosed the following phase I IC elements to ACPs in encounters: trial purpose in 40%; specific physical risks in 60%; potential specific medical benefits gained by trial participation (eg, disease stabilization) in 48.2%; and alternatives to phase I trial participation in 47.1%, with 1.1% of encounters containing palliative and 2.3% hospice information. PIs provided ACP-specific prognoses in 29.0% of encounters but used precise terms of death in only 4.7% and terminal in 1.2%. A significant association existed between PI disclosure of the trial purpose as dosage/toxicity, and ACPs subsequently correctly recalled trial purpose versus PIs who did not disclose it (85% v 13%; P < .05). Conclusion: Many oncologists provide incomplete disclosures about phase I trials to ACPs. When disclosure of certain elements of IC occurs, it seems to be associated with better recall, especially with regard to the research purpose of phase I trials.

Examining the dilemmas of prognostic information disclosure and understanding in those with terminal cancer: In-depth interviews with advanced cancer patients in phase I trials

2006 ◽  
Vol 24 (18_suppl) ◽  
pp. 8516-8516
Author(s):  
F. J. Hlubocky ◽  
C. K. Daugherty
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Qualitative Interviews ◽  
Trial Participation ◽  
Phase I Trials ◽  
Advanced Cancer Patients ◽  
Prognostic Information ◽  
Treatment Benefit ◽  
Quantitative Estimates

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.

Cognitive function (CF) and prognostic information understanding in advanced cancer patients (ACP)

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 9516-9516
Author(s):  
F. J. Hlubocky ◽  
E. Larson ◽  
M. J. Ratain ◽  
G. Sachs ◽  
C. K. Daugherty
Keyword(s):  
Cognitive Impairment ◽  
Cognitive Function ◽  
Phase I ◽  
Cancer Patients ◽  
Advanced Cancer ◽  
Digit Span ◽  
Verbal Learning ◽  
Phase I Trials ◽  
Advanced Cancer Patients ◽  
Prognostic Information

9516 Background: The role of advanced cancer patients' (ACP) cognitive function (CF) and its relationship to understanding of a terminal prognosis has never been formally evaluated. Methods: ACP CF was evaluated among a population of terminally-ill patients enrolling in phase I trials at our institution using a neuropsychological battery designed to assess several domains of decisional capacity: Memory (Hopkins Verbal Learning HVLT); Executive Functioning (Verbal Fluency and Trail-making A/B); Language (Boston Naming-short); Attention (Digit Span); Comprehension (Auditory Comprehension & WAIS comprehension). Semi-structured interviews of ACPs also evaluated md-pt communication regarding prognosis, and included the Hospital Anxiety and Depression Scale (HADS), BDI-II, and the FACT-COG. Results: To date, 110 ACP enrolling in phase I trials have been interviewed: median age 60 (23–83); 66% male; 88% Ca; 62% married; 71% >high school education; 52% GI dx. 59% of ACPs reported having a discussion regarding life expectancy, and 55% stated that the physician gave them a prognostic timeframe regarding the amount of time left to live. ACP who stated the physician did not provide them a timeframe had measurable deficits in CF as indicated by Z scores for HVLT immediate recall (-1.3 ± .84 v -.74 ± 1.1, p=.03); total recall (-1.9 ± 1.2 v -1.2 ±1.5, p=.02); delayed recall (-1.7 ± 1.6 v -1.1 ±1.6, p=.04); language (.26 ± 1.3 v .78 ± .68, p=.03); Trails B (-1.6 ± 2.5 v -.61 ± 2.2, p=.04) and WAIS comprehension ss scores (14 ± 2.9 v 16 ± 3.0, p=.06). These ACP tended to exhibit more depressive symptoms (12 ± 10 v 6 ± 3, p=.04) and had lower scores for perceived cognitive impairment (96 ± 25 v 105 ±16, p=.04); impact on quality of life (26 ± 7 v 28 ± 5, p=.03); and FACT-COG total (152 ± 31 v 164 ± 22, p=.05). Conclusions: ACP enrolling in phase I trials who could not recall specific prognostic information had measurable cognitive impairment as compared to those ACP who could recall such information. Our data indicate that CF may play a role in ACP communication and/or understanding of prognostic information. [Table: see text]

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