Information when patients participate in a phase I trial: A systematic review.

2017 ◽  
Vol 35 (5_suppl) ◽  
pp. 85-85
Author(s):  
Katrine Toubro Gad ◽  
Ulrik Niels Lassen ◽  
Paul Morten Mau Sorensen ◽  
Mette Terp Høybye ◽  
Christoffer Johansen
Keyword(s):  
Systematic Review ◽  
Decision Making ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Risk Of Bias ◽  
Phase I Trials ◽  
Potential Value ◽  
New Anticancer Drugs ◽  
Unrealistic Expectations

85 Background: While phase I trials are essential for the development of new anticancer drugs, there is a limited chance of benefitting for cancer patients participating in such trials. The information dialogue is therefore of substantial importance for providing a foundation to make a decision, and the support from relatives of potential value for the patient. This systematic review investigated patients’ prerequisites for deciding to participate in a phase I trial by summarizing the existing knowledge regarding patients’ decision-making when entering a phase I trial, and patients’ and their relatives’ perception of the information prior to enrollment. Methods: The review is based on the principles of Preferred Reporting Items for Systematic Reviews. A comprehensive systematic search was performed using the PubMed, Embase and PsycInfo databases and supplemented by a search for unpublished literature. Results: We identified 36 studies for inclusion in this review. When patients are offered participation in a phase I trial, information procedures as well as the patients’ individual approach influence the decision-making and the perception of the information provided. Across the studies exploring patients’ perception of information, there was a limited understanding of trial purpose and unrealistic expectations of benefit. The relatives’ perception of information remains unexplored. Evaluation of the included studies demonstrated a comprehensive risk of bias in the majority of studies. Conclusions: The information dialogue between physician and the patient concerning participation in a phase I trial seems to benefit from exact information taking account of the perspectives for each individual patient as well as the need for further discussion of trial. While relatives intuitively function as resources for patients entering a phase I trial, this topic is still not investigated.

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.

Complementary and Alternative Medicine Among Advanced Cancer Patients Enrolled on Phase I Trials: A Study of Prognosis, Quality of Life, and Preferences for Decision Making

2007 ◽  
Vol 25 (5) ◽  
pp. 548-554 ◽  
Author(s):  
Fay J. Hlubocky ◽  
Mark J. Ratain ◽  
Ming Wen ◽  
Christopher K. Daugherty
Keyword(s):  
Quality Of Life ◽  
Decision Making ◽  
Phase I ◽  
Cancer Patients ◽  
Early Phase ◽  
Phase I Trials ◽  
Advanced Cancer Patients ◽  
Cancer Trial ◽  
Cam Use

Purpose We sought to describe complementary and alternative medicine (CAM) usage among phase I trial participants and to describe these patients' treatment decision-making preferences, awareness of prognosis, survival, and quality of life. Patients and Methods Advanced cancer patients enrolling onto phase I trials were surveyed regarding biologically based CAM use. Decision-making preferences and awareness of prognosis were assessed using validated and/or standardized instruments. The Functional Assessment of Cancer Therapy–General instrument was used to assess quality of life. Univariate and multivariate analyses were performed to detect differences between CAM users and nonusers. Results Of 212 interviewed patients, 34% (n = 72) described taking biologically based CAM. Median age of those taking biologically based CAM was 55 years, compared with 62 years for nonusers (P < .005). There were no statistically significant differences found between CAM usage and preferences for degree of patient involvement in medical decision making. Those patients who acknowledged that their deaths were likely to occur within 1 year were more likely to admit to prior CAM use (70% v 34%; P = .02). CAM users had poorer overall quality of life compared with nonusers (87.0 ± 12.4 v 91.2 ± 14.7; P = .007). No differences in survival were identified. Conclusion Prior CAM use among phase I cancer trial patients studied was common and associated with age, stated acknowledgment of prognosis, and quality of life. Patients enrolling onto early-phase trials should be questioned about CAM use. Additional study is needed to determine the frequency of use of those biologically based CAM agents that threaten the accuracy of early-phase cancer trial data.

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.

scholarly journals Protocol for systematic review: patient decision aids for total hip and knee arthroplasty decision-making

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Lissa Pacheco-Brousseau ◽  
Marylène Charette ◽  
Dawn Stacey ◽  
Stéphane Poitras
Keyword(s):  
Systematic Review ◽  
Decision Making ◽  
Knee Arthroplasty ◽  
Patient Involvement ◽  
Decision Aids ◽  
Risk Of Bias ◽  
Decision Making Process ◽  
Patient Decision Aids ◽  
Patient Decision ◽  
Hip And Knee Arthroplasty

Abstract Background Total hip and knee arthroplasty are a highly performed surgery; however, patient satisfaction with surgery results and patient involvement in the decision-making process remains low. Patient decision aids (PtDAs) are tools used in clinical practices to facilitate active patient involvement in healthcare decision-making. Nonetheless, PtDA effects have not been systematically evaluated for hip and knee total joint arthroplasty (TJA) decision-making. The aim of this systematic review is to determine the effect of patient decision aids compared to alternative of care on quality and process of decision-making when provided to adults with hip and knee osteoarthritis considering primary elective TJA. Methods This systematic review will follow the Cochrane Handbook for Systematic Reviews. This protocol was reported based on the PRISMA-P checklist guidelines. Studies will be searched in CINAHL, MEDLINE, Embase, PsycINFO, and Web of Science. Eligible studies will be randomized control trial (RCT) evaluating the effect of PtDA on TJA decision-making. Descriptive and meta-analysis of outcomes will include decision quality (knowledge and values-based choice), decisional conflict, patient involvement, decision-making process satisfaction, actual decision made, health outcomes, and harm(s). Risk of bias will be evaluated with Cochrane’s risk of bias tool for RCTs. Quality and strength of recommendations will be appraised with Grades of Recommendation, Assessment, Development and Evaluation (GRADE). Discussion This review will provide a summary of RCT findings on PtDA effect on decision-making quality and process of adults with knee and hip osteoarthritis considering primary elective TJA. Further, it will provide evidence comparing different types of PtDA used for TJA decision-making. This review is expected to inform further research on joint replacement decision-making quality and processes and on ways PtDAs facilitate shared decision-making for orthopedic surgery. Systematic review registration PROSPERO CRD42020171334

Phase I-trial of a methotrexate — Albumin conjugate (MTX-HSA) in cancer patients

1997 ◽  
Vol 33 ◽  
pp. S249-S250 ◽  
Author(s):  
G. Hartung ◽  
G. Stehle ◽  
H. Sinn ◽  
H.H. Schrenk ◽  
S. Heeger ◽  
...  
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial

Phase I trial of the thioether phospholipid analogue BM 41.440 in cancer patients

Lipids ◽  
1987 ◽  
Vol 22 (11) ◽  
pp. 962-966 ◽  
Author(s):  
Dieter B. J. Herrmann ◽  
Herbert A. Neumann ◽  
Wolfgang E. Berdel ◽  
Manfred E. Heim ◽  
Michael Fromm ◽  
...  
Keyword(s):  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial

PHASE I TRIAL OF MURINE ANTI-GANGLIOSIDE (GD2) MONOCLONAL ANTIBODY (Mab) 14G2A IN CANCER PATIENTS

1992 ◽  
Vol 11 (2) ◽  
pp. 135 ◽  
Author(s):  
J. L. Murray ◽  
J. E. Cunningham ◽  
H. M. Brewer ◽  
M. H. Janus ◽  
D. A. Podoloff ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Ganglioside Gd2

scholarly journals A Phase I Trial of a Guadecitabine (SGI-110) and Irinotecan in Metastatic Colorectal Cancer Patients Previously Exposed to Irinotecan

2018 ◽  
Vol 24 (24) ◽  
pp. 6160-6167 ◽  
Author(s):  
Valerie Lee ◽  
Judy Wang ◽  
Marianna Zahurak ◽  
Elske Gootjes ◽  
Henk M. Verheul ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Phase I ◽  
Metastatic Colorectal Cancer ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Colorectal Cancer Patients

scholarly journals Provider Recommendations for Phase I Clinical Trials Within a Shared Decision-Making Model in Phase I Cancer Clinical Trial Discussions

2020 ◽  
Vol 16 (9) ◽  
pp. e859-e867
Author(s):  
Rachel S. Hianik ◽  
Gavin P. Campbell ◽  
Eli Abernethy ◽  
Colleen Lewis ◽  
Christina S. Wu ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Phase I ◽  
Shared Decision Making ◽  
Phase I Trial ◽  
Performance Status ◽  
Shared Decision ◽  
Phase I Clinical Trials ◽  
Decision Making Model

PURPOSE: Debate continues over whether explicit recommendations for a clinical trial should be included as an element of shared decision making within oncology. We aimed to determine if and how providers make explicit recommendations in the setting of phase I cancer clinical trials. METHODS: Twenty-three patient/provider conversations about phase I trials were analyzed to determine how recommendations are made and how the conversations align with a shared decision-making framework. In addition, 19 providers (9 of whose patient encounters were observed) were interviewed about the factors they consider when deciding whether to recommend a phase I trial. RESULTS: We found that providers are comprehensive in the factors they consider when recommending clinical trials. The two most frequently stated factors were performance status (89%) and patient preferences (84%). Providers made explicit recommendations in 19 conversations (83%), with 12 of those being for a phase I trial (12 [63%] of 19). They made these recommendations in a manner consistent with a shared decision-making model; 18 (95%) of the 19 conversations during which a recommendation was made included all steps, or all but 1 step, of shared decision making, as did 11 of the 12 conversations during which a phase I trial was recommended. In 7 (58%) of these later conversations, providers also emphasized the importance of the patient’s opinion. CONCLUSION: We suggest that providers not hesitate to make explicit recommendations for phase I clinical trials, because they are able to do so in a manner consistent with shared decision making. With further research, these results can be applied to other clinical trial settings.

scholarly journals First-in-human phase I trial of anti-hepatocyte growth factor antibody (YYB101) in refractory solid tumor patients

2020 ◽  
Vol 12 ◽  
pp. 175883592092679
Author(s):  
Seung Tae Kim ◽  
Jung Yong Hong ◽  
Se Hoon Park ◽  
Joon Oh Park ◽  
Young Whan Park ◽  
...  
Keyword(s):  
Growth Factor ◽  
Hepatocyte Growth Factor ◽  
Phase I ◽  
Cancer Patients ◽  
Phase I Trial ◽  
Maximum Tolerated Dose ◽  
Safety And Efficacy ◽  
Hepatocyte Growth

Background: YYB101, a humanized monoclonal antibody against hepatocyte growth factor (HGF), has shown safety and efficacy in vitro and in vivo. This is a first-in-human trial of this antibody. Materials and Methods: YYB101 was administered intravenously to refractory cancer patients once every 4 weeks for 1 month, and then once every 2 weeks until disease progression or intolerable toxicity, at doses of 0.3, 1, 3, 5, 10, 20, 30 mg/kg, according to a 3+3 dose escalation design. Maximum tolerated dose, safety, pharmacokinetics, and pharmacodynamics were studied. HGF, MET, PD-L1, and ERK expression was evaluated for 9 of 17 patients of the expansion cohort (20 mg/kg). Results: In 39 patients enrolled, no dose-limiting toxicity was observed at 0.3 mg/kg, and the most commonly detected toxicity was generalized edema ( n = 7, 18.9%) followed by pruritis and nausea ( n = 5, 13.5%, each), fatigue, anemia, and decreased appetite ( n = 4, 10.8%, each). No patient discontinued treatment because of adverse events. YYB101 showed dose-proportional pharmacokinetics up to 30 mg/kg. Partial response in 1 (2.5%) and stable disease in 17 (43.5%) were observed. HGF, MET, PD-L1, and ERK proteins were not significant predictors for treatment response. However, serum HGF level was significantly lowered in responders upon drug administration. RNA sequencing revealed a mesenchymal signature in two long-term responders. Conclusion: YYB101 showed favorable safety and efficacy in patients with refractory solid tumors. Based on this phase I trial, a phase II study on the YYB101 + irinotecan combination in refractory metastatic colorectal cancer patients is planned. Conclusion: ClinicalTrials.gov Identifier: NCT02499224

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