Study of cohort-specific consent and patient control in phase I cancer trials.

1998 ◽  
Vol 16 (7) ◽  
pp. 2305-2312 ◽  
Author(s):  
C K Daugherty ◽  
M J Ratain ◽  
H Minami ◽  
D M Banik ◽  
N J Vogelzang ◽  
...  
Keyword(s):  
Informed Consent ◽  
Phase I ◽  
Cancer Patients ◽  
Dose Escalation ◽  
Trial Design ◽  
Phase I Trial ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Phase I Trials

PURPOSE To address the challenging ethical dilemmas created from the participation of advanced cancer patients in phase I trials, we assessed the feasibility of a clinical trial design that uses an interactive informed consent process in which patient-subjects can choose to become directly involved in decisions of dose escalation. PATIENTS AND METHODS Subjects were advanced cancer patients in the Hematology/Oncology Clinics at the University of Chicago who were eligible to participate in a phase I trial in which they underwent a three-step informed consent process that used cohort-specific consent and allowed them the option to choose their own doses of the chemotherapeutic agents under study, vinorelbine (NVB) and paclitaxel (TAX), within predetermined limits. NVB and TAX were administered in conventional 21- to 28-day cycles for two cycles while on study. Dose escalation occurred when a patient-subject chose a higher untested dose after they received information on all previously assessable patient-subjects. In addition to the phase I trial itself, a survey that consisted of structured interviews, which sought to evaluate patients' experiences with the interactive subject-choice phase I trial design and consent process, was conducted with participating subjects. The phase I trial itself sought to determine the associated toxicities of the agents under study. The survey results were compared with a similar survey of a matched control population of subjects who participated in other concurrently active conventional phase I trials at our institution. RESULTS Twenty-nine patient-subjects participated in the phase I trial, with 24 who agreed to and completed the survey interviews. Seventy-six percent of patient-subjects opted to choose their dose of the agents under study, and 28% chose the highest available doses. More than half of the patient-subjects (56%) felt some degree of comfort in being asked to choose their dose of chemotherapy, with 53% stating that being asked to choose their dose made them feel in control, fully informed, or content. However, there were no statistically significant improvements in objective measures of the informed consent process, which included surveyed subjects' stated understanding of either provided information about phase I trials and alternatives to trial participation or of the research purpose of phase I trials. By making choices, the group of patients in the interactive subject choice trial changed the size of the dose cohorts and modified the process of dose escalation in this phase I study. CONCLUSION Although complex, our innovative phase I trial design is feasible. In addition to the use of cohort-specific consent, the trial design may reduce the magnitude of many of the commonly recognized ethical dilemmas associated with this form of clinical research, which include difficulties with information provision and the understanding of possible risks and benefits of phase I trial participation, through direct subject involvement in research decision making by otherwise potentially vulnerable cancer patients.

Telephone-based nursing intervention improves the effectiveness of the informed consent process in cancer clinical trials.

1996 ◽  
Vol 14 (3) ◽  
pp. 984-996 ◽  
Author(s):  
N K Aaronson ◽  
E Visser-Pol ◽  
G H Leenhouts ◽  
M J Muller ◽  
A C van der Schot ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Informed Consent ◽  
Cancer Patients ◽  
Intervention Group ◽  
Nursing Intervention ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Oncology Nurse

PURPOSE Here we report the results of a randomized study undertaken to test the efficacy of a supplementary, telephone-based nursing intervention in increasing patients' awareness and understanding of the clinical trials in which they are asked to participate. METHODS During a 12-month period, 180 cancer patients who were approached to participate in a phase II or III clinical trial were randomized to undergo either of the following: (1) standard informed consent procedures based on verbal explanations from the treating physician plus written information (controls); or (2) standard informed consent procedures plus a supplementary, telephone-based contact with an oncology nurse (intervention). For purposes of evaluation, face-to-face interviews were conducted with all patients approximately 1 week after the informed consent process had been completed. RESULTS The two groups were comparable with regard to sociodemographic and clinical variables. Both groups had a high level of awareness of the diagnosis and of the nature and objectives of the proposed treatments. The intervention group was significantly (P < .01) better informed about the following: (1) the risks and side effects of treatment; (2) the clinical trial context of the treatment; (3) the objectives of the clinical trial; (4) where relevant, the use of randomization in allocating treatment; (5) the availability of alternative treatments; (6) the voluntary nature of participation; and (7) the right to withdraw from the clinical trial. The intervention did not have any significant effect on patients' anxiety levels or on rates of clinical trial participation. Patients reported high levels of satisfaction with the intervention. CONCLUSION The use of a supplementary, telephone-based nursing intervention is a feasible and effective means to increase cancer patients' awareness and understanding of the salient issues that surround the clinical trials in which they are asked to participate.

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.

scholarly journals Hope and Persuasion by Physicians During Informed Consent

2014 ◽  
Vol 32 (29) ◽  
pp. 3229-3235 ◽  
Author(s):  
Victoria A. Miller ◽  
Melissa Cousino ◽  
Angela C. Leek ◽  
Eric D. Kodish
Keyword(s):  
Palliative Care ◽  
Informed Consent ◽  
Phase I ◽  
Phase I Trial ◽  
Physician Communication ◽  
Phase I Trials ◽  
Positive Outcomes ◽  
Parent Ratings ◽  
Persuasive Messages ◽  
Perceived Pressure

Purpose To describe hopeful and persuasive messages communicated by physicians during informed consent for phase I trials and examine whether such communication is associated with physician and parent ratings of the likelihood of benefit, physician and parent ratings of the strength of the physician's recommendation to enroll, parent ratings of control, and parent ratings of perceived pressure. Patients and Methods Participants were children with cancer (n = 85) who were offered a phase I trial along with their parents and physicians. Informed consent conferences (ICCs) were audiotaped and coded for physician communication of hope and persuasion. Parents completed an interview (n = 60), and physicians completed a case-specific questionnaire. Results The most frequent hopeful statements related to expectations of positive outcomes and provision of options. Physicians failed to mention no treatment and/or palliative care as options in 68% of ICCs and that the disease was incurable in 85% of ICCs. When physicians mentioned no treatment and/or palliative care as options, both physicians and parents rated the physician's strength of recommendation to enroll in the trial lower. Conclusion Hopes and goals other than cure or longer life were infrequently mentioned, and a minority of physicians communicated that the disease was incurable and that no treatment and/or palliative care were options. These findings are of concern, given the low likelihood of medical benefit from phase I trials. Physicians have an important role to play in helping families develop alternative goals when no curative options remain.

Comprehension and recall from the informed consent process by phase I healthy volunteers before dose administration

2019 ◽  
Vol 16 (3) ◽  
pp. 283-289 ◽  
Author(s):  
Rami Tadros ◽  
Gillian E Caughey ◽  
Sally Johns ◽  
Sepehr Shakib
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Phase I ◽  
Healthy Volunteers ◽  
Drug Administration ◽  
Study Drug ◽  
Informed Consent Process ◽  
Consent Process ◽  
Phase I Clinical Trials ◽  
Study Drug Administration

Aims/Background A fundamental part of all clinical trials is informed consent, reflecting the respect for the volunteer’s autonomy. Research participation is voluntary; therefore, certain aspects of the proposed study must be disclosed so that volunteers can make an informed decision. In this study, we aimed to examine the level of comprehension and recall of healthy volunteers from the informed consent process. Methods The study was carried out at a single phase I clinical trials unit. A questionnaire was administered to each volunteer to assess recall of important aspects of the study at the day-1 visit following the informed consent process. The questionnaire contained seven questions regarding study objectives, route, frequency and type of drug administration, adverse effects, number of subjects previously exposed and remuneration. One point was awarded for each correct answer. Results A total of 266 volunteers were administered the questionnaire. The mean total score (±standard deviation) for all volunteers was 4.5 ± 1.1 points out of 7, with a range of 0.8–6.7. For all 10 studies, 91% of volunteers responded correctly when answering about the route of administration, and 90% were able to accurately state the correct payment amount. Only 7% were able to repeat the aims of the study correctly. Conclusion The poor performance of our study volunteers raises concerns about recall of information prior to study drug administration. This has implications for the volunteer’s safety and ability to provide true informed consent. Interventions to improve recall prior to dosing should be undertaken.

scholarly journals Informal professionalization of healthy participants in phase I clinical trials in Russia

2019 ◽  
Vol 16 (6) ◽  
pp. 563-570 ◽  
Author(s):  
Olga Zvonareva ◽  
Igor Pimenov ◽  
Natalia Kutishenko ◽  
Igor Mareev ◽  
Sergey Martsevich ◽  
...  
Keyword(s):  
Phase I ◽  
Phase I Trial ◽  
Trial Participation ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Skilled Workers ◽  
Structured Interviews ◽  
Two Phase ◽  
Trial Participants ◽  
Healthy Participants

Background: Previous social science research has shown how some healthy phase I trial participants identify themselves as workers and rely on trials as a major source of income. The term “professionalization” has been used to denote this phenomenon. Purpose: We aim to examine a component of healthy trial participants’ professionalization that has not yet been systematically studied: how repeat phase I trial participants develop and claim expertise that distinguishes them from others and makes them uniquely positioned to perform high-quality clinical trial labor. We also aim to explain the significance of these research results for protection of healthy participants in phase I trials. Methods: This qualitative exploratory study was conducted in Russia, in two phase I trial units. It involved semi-structured interviews with 28 healthy trial participants with varying lengths of experience in trials, observations of work done in trial units, and interpretive conversations with investigative staff. Results: Interviewed healthy individuals who repeatedly participate in phase I trials describe developing knowledge and skills that involve appreciating the meaning of trial procedures, coming up with techniques to efficiently follow them, organizing themselves and others in the course of a trial, and sharing tacit ways of doing trial work well with other less experienced participants. Our results suggest that a prerequisite for such expertise-centered professionalization is the emergence of a positive identity linked to seeing value in trial participation work. A crucial component of professionalization thus understood is the development of a work ethic that entails caring about results and being reliable partners for investigators. Limitations: The attitudes and behaviors presented in this article are not suggested to be universally shared among healthy trial participants, but rather represent a particular instance of professionalization that coexists with other views and tactics. Conclusions: A way of better protecting healthy trial participants begins with recognizing their skills, knowledge, and the centrality of the contribution they are making to pharmaceutical research. Currently, the expertise of experienced trial participants is recognized on the work floor only; therefore, the professionalization we described is informal. Yet, the informal professionalization process is inherently risky as it does not involve any change in the formal conditions of trial participants’ work. Instituting formal measures for protecting healthy trial participants as skilled workers combined with recognition of their expertise is essential.

scholarly journals Risks of COVID‐19 for surgical cancer patients: The importance of the informed consent process

2020 ◽  
Vol 122 (4) ◽  
pp. 608-610 ◽  
Author(s):  
Alberto Julius Alves Wainstein ◽  
Ana Paula Drummond‐Lage ◽  
Reitan Ribeiro ◽  
Héber Salvador Castro Ribeiro ◽  
Rodrigo Nascimento Pinheiro ◽  
...  
Keyword(s):  
Informed Consent ◽  
Cancer Patients ◽  
Informed Consent Process ◽  
Consent Process

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.

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]

Perceptions of cancer patients and their physicians involved in phase I trials.

1995 ◽  
Vol 13 (5) ◽  
pp. 1062-1072 ◽  
Author(s):  
C Daugherty ◽  
M J Ratain ◽  
E Grochowski ◽  
C Stocking ◽  
E Kodish ◽  
...  
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Therapeutic Benefit ◽  
Survey Study ◽  
Phase I Trials ◽  
Perceived Knowledge ◽  
Dose Determination ◽  
Adequate Understanding ◽  
Investigational Agents

PURPOSE In an attempt to understand some of the complex issues related to the participation of cancer patients in phase I trials, and the perceptions of patients toward these trials, we conducted a pilot survey study of 30 cancer patients who had given informed consent to participate in a phase I trial at our institution. Concurrently, the oncologists identified by the surveyed patients as responsible for their care were surveyed as well. PATIENTS AND METHODS Twenty-seven of 30 consecutive patients agreed to and completed the survey. Patients were surveyed before they received any investigational agents. Eighteen oncologists participated in this survey study. RESULTS Eighty-five percent of patients decided to participate in a phase I trial for reasons of possible therapeutic benefit, 11% because of advice/trust of physicians, and 4% because of family pressures. Ninety-three percent said that they understood all (33%) or most (60%) of the information provided about the trials in which they had decided to participate. Only 33% were able to state the purpose of the trial in which they were participating, with patients able to state the purpose of phase I trials being more educated (P = .01). Surveyed oncologists had wide-ranging beliefs regarding expectations of possible benefits and toxicities for their patients participating in phase I trials. CONCLUSION Cancer patients who participate in phase I trials are strongly motivated by the hope of therapeutic benefit. Altruistic feelings appear to have a limited and inconsequential role in motivating patients to participate in these trials. Cancer patients who participate in phase I trials appear to have an adequate self-perceived knowledge of the risks of investigational agents. However, only a minority of patients appear to have an adequate understanding of the purpose of phase I trials as dose-escalation/dose-determination studies.

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