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.

A study of physician investigator (PI) disclosure of alternatives of care and prognostic information to advanced cancer patients (ACP) enrolling in phase I trials

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. 6508-6508
Author(s):  
C. Daugherty ◽  
N. E. Kass ◽  
D. Roter ◽  
S. Larson ◽  
J. Sugarman ◽  
...  
Keyword(s):  
Informed Consent ◽  
Phase I ◽  
Interaction Analysis ◽  
Trial Participation ◽  
Phase I Trials ◽  
Advanced Cancer Patients ◽  
Prognostic Information ◽  
Clinical Encounters ◽  
Analysis System

6508 Background: ACP in phase I trials have been described as having an inadequate understanding of several elements of informed consent. However, actual PI disclosure of alternatives to trial participation and prognostic information, and subsequent ACP understanding of these elements, have not been described. Methods: Clinical encounters between 131 ACP entering phase I trials and 25 oncologists at three institutions (University of Chicago; Johns Hopkins; and Duke University) were audio-taped. ACP completed follow-up questionnaires one week later to assess understanding of informed consent elements. Audiotapes were analyzed using the Roter Interaction Analysis System (RIAS) and specifically coded for terms associated with trial alternatives and patient prognosis. Results: To date, 85 encounters have been analyzed. Average encounters length: 30.4 min (range: 5.7–77.8 min). For ACP: median age 60y (33–83); 55% female; 88% Ca; 55% <college educ; 52% income <$60,000. The PI was recorded as discussing options other than anticancer treatment in 47% of encounters. The terms “palliative” or “hospice” were used in 1% and 2.3% of encounters respectively. In 29% of encounters the PI described the option of “doing nothing”. The PI used the terms “death” or “terminal” in 5.8% encounters. The PI was never recorded using the term “dying”. Within these encounters, no ACP was recorded as using any of the following terms: “palliative,” “hospice,” “terminal,” “death,” “dying.” Within follow-up interviews, 30% reported no alternatives to trial participation were discussed; 1% reported that palliative care/hospice was discussed. Based on coding of qualitative responses, 53% of ACP said that either their prognosis was excellent or they didn't know their prognosis. An association was found between recorded physician statements regarding general prognosis and ACP subsequently reporting having discussion regarding life expectancy (59% v. 33%, p = 0.04). Conclusions: PI communication and subsequent measured understanding regarding alternatives to trial participation and prognosis remain inadequate in the setting of phase I trial enrollment. [Table: see text]

scholarly journals Healthy Volunteers’ Perceptions of the Benefits of Their Participation in Phase I Clinical Trials

2018 ◽  
Vol 13 (5) ◽  
pp. 494-510 ◽  
Author(s):  
Jill A. Fisher ◽  
Lisa McManus ◽  
Megan M. Wood ◽  
Marci D. Cottingham ◽  
Julianne M. Kalbaugh ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Employment Status ◽  
Qualitative Interviews ◽  
Trial Participation ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Financial Compensation ◽  
Trial History

Other than the financial motivations for enrolling in Phase I trials, research on how healthy volunteers perceive the benefits of their trial participation is scant. Using qualitative interviews conducted with 178 U.S. healthy volunteers enrolled in Phase I trials, we investigated how participants described the benefits of their study involvement, including, but not limited to, the financial compensation, and we analyzed how these perceptions varied based on participants’ sociodemographic characteristics and clinical trial history. We found that participants detailed economic, societal, and noneconomic personal benefits. We also found differences in participants’ perceived benefits based on gender, age, ethnicity, educational attainment, employment status, and number of clinical trials completed. Our study indicates that many healthy volunteers believe they gain more than just the financial compensation when they accept the risks of Phase I participation.

scholarly journals Do Patients With Advanced Cancer Have the Ability to Make Informed Decisions for Participation in Phase I Clinical Trials?

2018 ◽  
Vol 36 (24) ◽  
pp. 2483-2491 ◽  
Author(s):  
Fay J. Hlubocky ◽  
Greg A. Sachs ◽  
Eric R. Larson ◽  
Halla S. Nimeiri ◽  
David Cella ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Executive Function ◽  
Phase I ◽  
Advanced Cancer ◽  
Phase I Trials ◽  
Trail Making Test ◽  
Phase I Clinical Trials ◽  
Trail Making

Purpose Patients with advanced cancer (ACPs) participating in phase I clinical trials inadequately understand many elements of informed consent (IC); however, the prevalence and impact of cognitive impairment has not been described. Patients and Methods ACPs enrolled onto phase I trials underwent neuropsychological assessment to evaluate cognitive functioning (CF) covering the following domains: memory (Hopkins Verbal Learning Test), executive functioning (Trail Making Test B), language (Boston Naming Test-Short Version and Controlled Oral Word Association Test), attention (Trail Making Test A and Wechsler Adult Intelligenence Scale-IV Digit Span), comprehension (Wechsler Adult Intelligence Scale-IV), and quality of life (Functional Assessment of Cancer Therapy–Cognitive Function). Structured interviews evaluated IC and decisional capacity. Psychological measures included distress (Hospital Anxiety Depression Scale) and depression (Beck Depression Inventory-II). Results One hundred eighteen ACPs on phase I trials were evaluated, with CF ranging from mild impairment to superior performance. Only 45% of ACPs recalled physician disclosure of the phase I trial purpose. The 50% of ACPs who correctly identified the phase I research purpose had greater CF compared with ACPs who did not, as revealed by the mean T scores for memory (37.2 ± 5.6 v 32.5 ± 5.1, respectively; P = .001), attention (29 ± 2.7 v 26.9 ± 2.4, respectively; P < .001), visual attention (35.2 ± 6.6 v 31.5 ± 6.2, respectively; P = .001), and executive function (38.9 ± 7.5 v 34 ± 7.1, respectively; P < .001). Older ACPs (≥ 60 years) were less likely to recall physician disclosure of phase I purpose than younger ACPs (30% v 70%, respectively; P = .02) and had measurable deficits in total memory (34.2 ± 5.0 v 37.3 ± 5.6, respectively; P = .002), attention (24.5 ± 2.6 v 28 ± 2.8, respectively; P < .001), and executive function (32.8 ± 7.3 v 36.4 ± 7.6, respectively; P = .01). Older ACPs, compared with younger ACPs, also had greater depression scores (10.6 ± 9.2 v 8.1 ± 5.2, respectively; P = .03) and lower quality-of-life scores (152 ± 29.6 v 167 ± 20, respectively; P = .03). After adjustment by age, no psychological or neuropsychological variable was further significantly associated with likelihood of purpose identification. Conclusion CF seems to play a role in ACP recall and comprehension of IC for early-phase clinical trials, especially among older ACPs.

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

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 6548-6548
Author(s):  
F. J. Hlubocky ◽  
E. Larson ◽  
G. Sachs ◽  
C. K. Daugherty
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Digit Span ◽  
Verbal Learning ◽  
Psychological Status ◽  
Trial Participation ◽  
Phase I Trials ◽  
Ethical Concerns ◽  
Trail Making

6548 Background: Ethical concerns exist about acps’ ability to provide adequate informed consent (IC) for phase I trials. While cognitive impairment (CI) among acp is well-recognized due to multiple factors, e.g., previous effects of chemotherapy, age, psychological status, the prevalence of CI among acp in phase I trials has never been described. Methods: Acp CF was assessed using a neuropsychological battery of instruments: Hopkins Verbal Learning (HVLT); Verbal Fluency; Mini-Cognitive Assessment; Trail-making (Parts A& B); Boston Naming (short); WAIS subtests (Comprehension and Digit Span). Acp underwent semi-structured interviews to evaluate elements of IC, and completed the FACT-COG and the Hospital Anxiety and Depression Scale (HADS). Results: To date, a total of 34 acp enrolling in Phase I trials have been studied. Median age: 63y (range: 38–81y); 77% male; 77% Caucasian; 67% > HS education. Regarding IC understanding: Only 20% of responding acp correctly identified the purpose of Phase I trials; all subjects could recall risks of side effects, correctly stated they could refuse trial participation, and stated they could withdraw at anytime; 53% believed the trial was their only option. Older acp (>age 55y) were less likely to correctly describe the research purpose of the trial (29% v. 71% p=0.02). Older acp had measurable deficits in CF: Boston Naming (14±0.9 v.15±0.3, p=0.09); HVLT Total Recall (14±2 v.26±6, p<0.00) and Discrimination Index (7.5±3 v.11±1, p=0.03); Digit Span-Backwards (4±2 v.7±2, p<0.00); Trail-making B (244±64 v.188±51, p=0.04). While there were no differences in perceived CI (95±18 v.101±19, p=0.5) or impact on quality of life (25±7 v. 27±5, p=0.5), both groups had scores well below prior reported means. Older acp tended to report depressive symptoms more than younger acp (8±2 v.6±1, p=0.07). Conclusions: Our data suggest that CF may play a role in acp understanding of IC for clinical trials, especially among the elderly. Further research is needed, given ethical concerns regarding elderly acp in clinical trials of experimental agents who may have CI. No significant financial relationships to disclose.

scholarly journals Healthy volunteers in US phase I clinical trials: Sociodemographic characteristics and participation over time

PLoS ONE ◽  
2021 ◽  
Vol 16 (9) ◽  
pp. e0256994
Author(s):  
Corey A. Kalbaugh ◽  
Julianne M. Kalbaugh ◽  
Lisa McManus ◽  
Jill A. Fisher
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
New Drugs ◽  
Trial Participation ◽  
Sociodemographic Characteristics ◽  
Phase I Trials ◽  
Full Time ◽  
Phase I Clinical Trials ◽  
Over Time

Background Increasing the diversity of research participants is an important focus of clinical trials. However, little is known regarding who enrolls as healthy volunteers in Phase I clinical trials, which test the safety and tolerability of investigational new drugs. Despite the risk, healthy volunteers can derive no medical benefit from their participation, and they are financially compensated for enrolling. Objective This study’s purpose is to describe sociodemographic characteristics and clinical trial participation histories of healthy people who enroll in US Phase I trials. Methods The HealthyVOICES Project (HVP) is a longitudinal study of healthy individuals who have enrolled in Phase I trials. We describe self-reported sociodemographic information and Phase I trial history from HVP recruitment (May-December 2013) through the project’s end three years later (December 2016). Trial experiences are presented as medians and quartiles. Results The HVP included 178 participants. Nearly three-fourths of participants were male, and two-thirds were classified as racial and ethnic minorities. We found that some groups of participants were more likely to have completed a greater number of clinical trials over a longer timeframe than others. Those groups included participants who were male, Black, Hispanic, 30-39-years-old, unemployed, had received vocational training in a trade, or had annual household incomes of less than $25,000. Additionally, the greater the number of clinical trials participants had completed, the more likely they were to continue screening for new trials over the course of three years. Participants who pursued clinical trials as a full-time job participated in the greatest number of trials and were the most likely to continuing screening over time. Implications Participation as a healthy volunteer in US Phase I trials is driven by social inequalities. Disadvantaged groups tend to participate in a greater number of clinical trials and participate longer than more privileged groups.

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.

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
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