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.

Entering a Clinical Trial: Is It Right For You?–A randomized study of the Clinical Trials Video and its impact on the informed consent process

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 9072-9072
Author(s):  
S. Hitchcock-Bryan ◽  
B. Hoffner ◽  
S. Joffe ◽  
M. Powell ◽  
C. Parker ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Informed Consent ◽  
Randomized Study ◽  
Informed Consent Process ◽  
Consent Process ◽  
Provider Communication ◽  
Patient Provider Communication ◽  
Source Of Information

9072 Background: In an effort to improve the informed consent process for subjects considering participation in a clinical trial, we created an educational video: “Entering a Clinical Trial: Is it Right for You?” In this randomized study, we assessed the effect of the video on patients’ understanding and perceptions of clinical trials. We also assessed patient satisfaction with the video and how the video impacted decision-making and patient-provider communication. Methods: We recruited 90 adults considering cancer clinical trials of whom 77 participated. After discussing the trial with the physician and reading the trial consent form, patients were randomized to receive (n=38) or not receive (n=39) the study video. Using a validated questionnaire, we interviewed subjects to assess objective understanding of the trial, our primary endpoint, and self-reported understanding of clinical trials. All subjects completed a second interview assessing secondary endpoints, including patient-provider communication, satisfaction with video, and decision-making. We used linear regression (two-sided tests) to conduct the primary analysis and the Wilcoxon rank-sum test and descriptive statistics to analyze the secondary aims. Results: Neither objective nor self-reported understanding of clinical trials differed between the two groups (Mean 86.5 vs. 87, p=0.75). 85% (61/72) indicated the video was an important source of information about clinical trials; 89% of those who watched the video with their family/friends (n=37) said the video helped loved ones better understand clinical trials; 73% indicated it helped their family accept their decision about participation. 81% (58/72) felt better prepared to discuss the trial with their physician after watching the video. Of those who found the video helpful with decision- making, 80% (21/26) were considering a trial for the first time compared with 19% (5/26) veterans who had previously participated in a clinical trial. Conclusions: The video did not measurably improve subjects’ understanding of their clinical trials. However, subjects reported that the video was an important source of information, helped them educate their families, and enhanced patient-provider communication. No significant financial relationships to disclose.

Comparing two methods for delivering clinical trial informed consent information to older adults: singular versus stepped approach

2018 ◽  
Vol 15 (6) ◽  
pp. 610-615
Author(s):  
Fleur O’Hare ◽  
Zachary Flanagan ◽  
Mark Nelson ◽  
Andrea Curtis ◽  
Stephane Heritier ◽  
...  
Keyword(s):  
Older Adults ◽  
Clinical Trial ◽  
General Practice ◽  
Informed Consent ◽  
Informed Consent Process ◽  
Consent Process ◽  
Trial Participation ◽  
Delivery Method ◽  
Significant Difference ◽  
Baseline Screening

Background Adapting the informed consent process to the needs of older adults may enhance engagement and willingness to participate in a clinical trial. A key aspect of the process is being provided with written clinical trial information and consent documents and having an opportunity to discuss the information with the researcher. However, there are no guidelines on the most appropriate method for delivering this information to older adults and it is not known whether the delivery method is a facilitator or barrier towards clinical trial participation. Aims To compare two delivery methods of informed consent on recruitment, refusal to continue and randomisation rates in a general practice-based clinical trial involving older adults. Methods In a matched cohort sub-study as part of the STAtins in Reducing Events in the Elderly clinical trial, 520 participants were allocated into two groups by age, gender and attending general practice location, to receive the trial information and consent form in the mail (Method 1) prior to the first baseline visit or in person (Method 2) at the visit where a comprehensive informed consent process took place. Results Compared with Method 1, potential participants assigned to Method 2 were more likely to agree to attend the first baseline screening visit (refusal rate 20% vs 13.5%, respectively, p = 0.05). However, there was no significant difference in the proportion of participants recruited into the trial by providing written informed consent at the first baseline screening visit. For each informed consent delivery method, similar proportions of participants refused to take part in the trial by the end of the screening phase. Randomisation rates in the two groups were also similar. Time to conduct the informed consent procedure took significantly longer with Method 2 compared with Method 1 (median time 20 vs 15 min, respectively, p < 0.01). Interest in the research trial topic was the main reason cited (33.4%) for considering trial participation. Conclusion Later delivery of informed consent documents to potential participants in this trial was associated with a small increase in attendance at the first, in person, screening visit. However, the randomisation rate of participants into the trial was not affected by the method and timing of delivery of informed consent information. Similar randomisation rates occurred whether potential participants were mailed informed consent documents prior to the first in person screening visit or were given the information at the screening visit.

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.

Impact of Therapeutic Research on Informed Consent and the Ethics of Clinical Trials: A Medical Oncology Perspective

1999 ◽  
Vol 17 (5) ◽  
pp. 1601-1601 ◽  
Author(s):  
Christopher K. Daugherty
Keyword(s):  
Clinical Trials ◽  
Informed Consent ◽  
Clinical Research ◽  
Controlled Trial ◽  
Informed Consent Process ◽  
Communication Process ◽  
Consent Process ◽  
Future Research ◽  
Trial Participation ◽  
Therapeutic Research

PURPOSE: To create a more meaningful understanding of the informed consent process as it has come to be practiced and regulated in clinical trials, this discussion uses the experience gained from the conduct of therapeutic research that involves cancer patients. DESIGN: After an introduction of the ethical tenets of the consent process in clinical research that involves potentially vulnerable patients as research subjects, background that details the use of written consent documents and of the term “informed consent” is provided. Studies from the cancer setting that examine the inadequacies of written consent documents, and the outcome of the consent process itself, are reviewed. Two ethically challenging areas of cancer clinical research, the phase I trial and the randomized controlled trial, are discussed briefly as a means of highlighting many dilemmas present in clinical trials. Before concluding, areas for future research are discussed. RESULTS: Through an exclusive cancer research perspective, many current deficiencies in the informed consent process for therapeutic clinical trials can be critically examined. Also, new directions for improvements and areas of further research can be outlined and discussed objectively. The goals of such improvements and research should be prevention of further misguided or ineffective efforts to regulate the informed consent process. CONCLUSION: To ignore this rich and interesting perspective potentially contributes to continued misunderstanding and apathy toward fulfilling the regulatory and ethically obligatory requirements involved in an essential communication process between a clinician-investigator and a potentially vulnerable patient who is considering clinical trial participation.

scholarly journals Informed Consent Process in the New Millennium

2018 ◽  
Vol 5 (2) ◽  
pp. 22-24
Author(s):  
Ranabir Pal ◽  
Swapan K Paul
Keyword(s):  
Health Care ◽  
Clinical Trial ◽  
Developing Countries ◽  
Clinical Trials ◽  
Informed Consent ◽  
Emerging Market ◽  
Informed Consent Process ◽  
Consent Process ◽  
Autonomous Decision ◽  
New Millennium

ABSTRACT In this new millennium, the clinical trial is inseparably linked with an upgrade of health care by generating invaluable data in preventive, promotive and curative health. Globally research experts have concerns regarding ensuring financial and other compensations along with optimum health benefits for research participants in clinical trials in the emerging market economy. A significant number of human healthy volunteers (participants) take part in researches in both developed and developing countries. Participants are frequently unaware that the informed consent process is mandatory for investigators, funders and participants and their free will must be documented. There are sparse published medical works of literature that attempted to assess the extent to which all the norms of the informed consent process are followed in Indian settings in this area to the best of our knowledge. We need to conduct researches on the preparedness of the clinical trials participants towards their awareness of the criticality of the informed consent process and their motives for participation. This narrative review enlightened the facts that very patient, extensive and careful transparent narration and dissemination of the information can only ensure truly informed and autonomous decision improving the validity of the study.

scholarly journals A parental educational intervention to facilitate informed consent for pediatric procedural sedation in the emergency department: a parallel group randomized controlled trial

2020 ◽  
Author(s):  
Yen-Ko Lin ◽  
Yung-Sung Yeh ◽  
Chao-Wen Chen ◽  
Wei-Che Lee ◽  
Chia-Ju Lin ◽  
...  
Keyword(s):  
Emergency Department ◽  
Informed Consent ◽  
Controlled Trial ◽  
Intervention Group ◽  
Informed Consent Process ◽  
Consent Process ◽  
Procedural Sedation ◽  
Control Group ◽  
Randomized Controlled ◽  
Video Assisted

Abstract Background Obtaining valid parental informed consent for pediatric procedures in the emergency department (ED) is challenging. This study compared a video-assisted informed consent intervention with conventional consent discussion to inform parents about pediatric procedural sedation in the ED. Methods A video-assisted informed consent intervention was developed to explain the process, benefits, risks, and alternatives of pediatric procedural sedation. A prospective randomized controlled trial was conducted with a convenience sample of parents of children recommended for procedural sedation for facial laceration in the ED. Intervention group participants watched the video. Control group participants received information from physicians during conventional discussion. Participants completed pre- and post-education knowledge tests and rated their satisfaction with the informed consent process. The primary outcome was efficacy of the video intervention compared with conventional discussion. Secondary outcomes were parental satisfaction and consent refusal. A covariate-controlled multivariable regression model was used to analyze between-group differences in knowledge and satisfaction. Results There were 32 participants in the intervention group and 30 in the control group. Mean knowledge scores were higher in the intervention group (91.67 ± [standard deviation] 12.70) than in the control group (73.33 ± 19.86). The intervention group showed significantly greater knowledge score differences (coefficient: 18.931, 95% confidence interval: 11.146–26.716). Intervention group participants showed greater satisfaction than control group participants. Conclusions Video-assisted informed consent was superior to conventional discussion for informing parents during an ED informed consent process. Video-assisted informed consent may improve parents’ understanding of pediatric procedural sedation and satisfaction with the informed consent process in the ED. Institutions should develop structured methods and strategies to better inform parents, facilitate treatment decisions, and improve parent satisfaction in the ED. Trial registration: The ClinicalTrials.gov Identifier is NCT01850329. Registered 9 May, 2013 - Retrospectively registered, https://www.clinicaltrials.gov/ct2/show/study/NCT01850329

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