Phase I clinical trials as a therapeutic option for patients with metastatic renal cell carcinoma (mRCC).

2020 ◽  
Vol 38 (15_suppl) ◽  
pp. 5073-5073
Author(s):  
Andrew W Hahn ◽  
Omar Alhalabi ◽  
Funda Meric-Bernstam ◽  
Aung Naing ◽  
Eric Jonasch ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Checkpoint Inhibitors ◽  
Therapeutic Option ◽  
Phase I Clinical Trial ◽  
Cancer Center ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Entire Cohort

5073 Background: Immune checkpoint inhibitors, multi-kinase VEGF agents, and mTOR inhibitors are approved for mRCC. Due to the overlapping mechanisms of action of the twelve approved therapies for mRCC, select patients are referred for phase I clinical trials after progression on multiple lines of treatment. We sought to evaluate the efficacy of phase I trials in patients with mRCC. Methods: Patients with all histologies of mRCC were included if they received treatment on a phase I clinical trial at MD Anderson Cancer Center. Baseline clinical characteristics and outcomes data were retrospectively collected. The historical control was a study of 1112 patients with mRCC who received third-line treatment in the IMDC database (PMID: 27318422). Time to event endpoints were calculated using Kaplan-Meier methods. Hazard ratios (HR) were calculated using the Cox proportional hazard model. Results: Between 2014 and 2019, there were 106 cases where 82 patients with mRCC were enrolled in a phase I clinical trials (40 unique trials). 30% (32/108) of the cases were in patients with non-clear cell RCC (nccRCC), and the most prevalent nccRCC histologies were papillary (n = 7) and renal medullary carcinoma (n = 7). The median number of prior systemic therapies was 2 (range 0-9). Across the entire cohort, median PFS was 5.9 months (m), median OS was 31.2 m, and the ORR was 23% (Table). In patients who received at least two prior lines of therapy (n = 70), the median PFS was 4.8 m and median OS was 24.9 m. In patients with metastatic nccRCC, median OS, PFS, and ORR were numerically lower, but statistically did not contradict the supposition that these outcomes did not differ from ccRCC (Table). Conclusions: In the largest pooled phase I clinical trial experience for patients with mRCC, phase I trials may have therapeutic value when compared to historical controls, where median PFS was 3.9 m, median OS was 12.4 m, and ORR was 10.5%. Patients with all histologies of mRCC may derive clinical benefit from phase I clinical trials, yet patients with ccRCC had numerically better outcomes. Patients with mRCC should be considered for phase I clinical trials. [Table: see text]

A pilot study of the patient-reported outcomes version of the common terminology criteria for adverse events (PRO-CTCAE) in a phase I clinical trial.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 6587-6587 ◽  
Author(s):  
Rui Qin ◽  
Amylou C. Dueck ◽  
Daniel Satele ◽  
Julian R. Molina ◽  
Charles Erlichman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Pilot Study ◽  
Adverse Events ◽  
Phase I ◽  
Patient Reported Outcomes ◽  
Point Of View ◽  
Phase I Clinical Trial ◽  
Phase I Clinical Trials ◽  
Patient Reported

6587 Background: Recently the Patient-Reported Outcomes version of the CTCAE was developed to augment clinically graded adverse events with information reported directly by patients on clinical trials (Basch, 2009). The validation and potential application of PRO-CTCAE in phase I clinical trials are of great interest as toxicity is the primary endpoint. Methods: Selected PRO-CTCAE items (21 items measuring 12 symptomatic adverse events) corresponding to the major adverse events required to be graded clinically were collected in an ongoing phase I clinical trial of weekly cilengitide and paclitaxel in patients with advanced solid malignancies (NCT01276496). PRO-CTCAE was administered in a paper booklet by a clinical research associate prior to treatment on days 1, 8 and 15 of their regular visits. These PRO-CTCAE items were summarized descriptively in comparison to clinician-assessed CTCAE ver 4.0 (NCI, 2009) during the first cycle. As a pilot study to assess feasibility of PRO-CTCAE in phase I trials, PRO-CTCAE was not intended for determination of dose-limiting toxicity. Results: Twelve patients were accrued to two separate doses of cilengitide and paclitaxel. The median age was 56 (range 36—67) and half of patients were female. All patients had an ECOG performance score <= 1. Over 90% of patients had received prior surgery and chemotherapy. All but one patient completed weekly PRO-CTCAE during the first cycle, the only patient refused to complete weeks 2 and 3 did not give a reason. PRO-CTCAE captured most of the symptomatic adverse events reflected in clinician-assessed CTCAE. Some symptomatic adverse events were not reported clinically by CTCAE but were reported by patients by PRO-CTCAE. Overall, PRO-CTCAE items indicated slightly more severe degree of symptoms experienced by patients than those reported in CTCAE. Conclusions: This is the first study that PRO-CTCAE items were integrated within regular study visits in a phase I trial. The administration of PRO-CTCAE has been proved feasible and fruitful, providing consistent and enhanced symptomatic toxicity from the patient point of view. The addition of PRO-CTCAE did not significantly increase patient burden. Clinical trial information: NCT01276496.

Survival and clinical outcomes of ovarian cancer patients enrolled in phase I clinical trials.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 5559-5559
Author(s):  
Bradley Corr ◽  
Marisa Moroney ◽  
Jeanelle Sheeder ◽  
Brandon Sawyer ◽  
S. Gail Eckhardt ◽  
...  
Keyword(s):  
Risk Factors ◽  
Ovarian Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Cancer Patients ◽  
Ca 125 ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Heavily Pretreated

5559 Background: Ovarian cancer patients who enroll in Phase I clinical trials are typically platinum resistant, heavily pretreated patients with a poor prognosis. Historically, clinical benefit of Phase I trials in this patient population has been uncertain. We assessed prognostic factors and survival in women with recurrent, previously treated ovarian cancer who enrolled in Phase I clinical trials. Methods: We performed a retrospective analysis of all ovarian cancer patients who were treated on Phase I clinical trials from 2008 through 2018 at the University of Colorado Cancer Center. Patient characteristics, treatment-related toxicities and survival data were assessed. Descriptive statistics and Cox proportional hazards models were utilized to identify risk factors associated with survival time. Results: A total of 132 individual patients were treated on Phase I clinical trials. Patients had a median age of 59 years (range 33-88) with a median of 5.5 (range 1-13) previous chemotherapy lines. 53/132 (40%) of patients were treated on multiple Phase I trials with a median of 1 (range 0-5) prior Phase 1 clinical trial enrollments. All patients had an ECOG performance status of 0 or 1. Overall response rate (defined as complete or partial response) was 9% and disease control rate (defined as complete or partial response or stable disease as best response) was 33%. Median overall survival (OS) was 11.5 months (95% CI: 9.3-13.7). Two patients died on trial due to progression of disease while no patients died due to treatment-related toxicity. In multivariate analysis, independent risk factors predicting shorter survival were elevated CA-125 (HR 2.8; 95% CI: 1.6-5.2) and albumin < 3.5 g/dL (HR 2.5; 95% CI: 1.65-3.79). BMI > 25 predicted longer survival (HR 0.65; 95% CI: 0.44-0.96). Conclusions: Phase I clinical trials for heavily pretreated ovarian cancer patients are safe by a standard of no patients experiencing toxicity-related deaths in our study. They are clinically efficacious with patients experiencing OS of 11.5 months, which is comparable to existing approved therapies. Elevated CA-125 and low albumin levels predict shorter survival, while BMI > 25 predicts longer survival. Phase I clinical trial options should be considered for all heavily pretreated ovarian cancer patients if available to them.

scholarly journals A Simple Scoring System for Identifying Relapsed/Refractory Lymphoma Patients Prematurely Withdrawn from Phase I Trials: The Gustave Roussy Experience

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1759-1759
Author(s):  
Lina Benajiba ◽  
Capucine Baldini ◽  
Laura Faivre ◽  
Jean-Marie Michot ◽  
Andrea Varga ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Hodgkin Lymphoma ◽  
Scoring System ◽  
Cell Lymphoma ◽  
Therapeutic Option ◽  
Performance Status ◽  
Phase I Trials ◽  
Phase I Clinical Trials ◽  
Refractory Lymphoma

Abstract Background: Treating relapsed/refractory non-Hodgkin and Hodgkin lymphoma in fit young and elderly patients represents a considerable challenge for clinicians. Combined cytotoxic agents are rapidly ineffective, especially when relapse occurs after autologous stem cell transplantation (ASCT). Alternative regimens are often sparse. In the era of personalized medicine, phase I clinical trials offer an alternative therapeutic option through a multitude of immunotherapy and targeted drugs in development. Phase I trials aim to determine the recommended phase II dose (RP2D) through toxicity and pharmacokinetic assessments. Documenting signal of activity is also a major objective, underlying the importance of including patients susceptible to remain on study until first lymphoma response evaluation (usually 6 weeks, 2 cycles). We aimed to assess a simple scoring system that could identify patients who will discontinue phase I studies before 6 weeks. Patients and Methods: Data from all lymphoma patients treated within a phase I trial in Gustave Roussy (GR) Cancer Center were retrospectively collected. 83 consecutive patients were enrolled in 17 phase I trials at GR between January 2008 and May 2014. All patients had progressive lymphoma at time of enrollment, after a median of 3 prior therapeutic lines (range 1;13). 37 patients (45%) received an ASCT prior to phase I inclusion. Median age was 67 years (range: 23-92) and WHO performance status (PS) was 0 in 36 patients (43%), 1 in 43 patients (52%) and 2 in 4 patients (5%). Median time from lymphoma diagnosis to phase I inclusion was 47 months. Lymphoma histological subtypes were represented as follows: 21% Hodgkin lymphoma, 36% aggressive non-Hodgkin lymphoma (83% diffuse large B cell lymphoma, 17% T cell lymphoma), 24% indolent non-Hodgkin lymphoma (70% follicular lymphoma, 25% marginal zone lymphoma, 5% Waldenström macroglobulinemia) and 19% mantle cell lymphoma. Univariate analysis on this cohort allowed identifying simple factors significantly associated with overall survival (OS). A simple scoring system, predictive for OS was pre-established and validated through a multivariate analysis in 2 large cohorts of various hematological malignancies by our group. Statistical tests were conducted on this relapsed/refractory lymphoma cohort, to evaluate this score's OS and early study discontinuation predictive ability. Results: Within a median follow up of 19 months, median OS and progression free survival (PFS) were respectively 18 (CI95%: 12; 37) and 3 (CI95%: 1.7; 3.6) months. Best overall response rate (ORR) and disease control rate (DCR: objective response and stable disease rates) were respectively 18% and 61%. Thirty-four patients (41%) experienced grade 3 or 4 adverse events and 7 patients (8%) a dose limiting toxicity (DLT). WHO performance status (PS) > 0 at inclusion, baseline albumin ≤ 35 g/l and baseline LDH ≥ 250 UI/L were significantly associated with poorer OS. The predefined GR prognostic score combined 2 simple variables, PS and baseline serum albumin (+1 if PS 0, +1 if albumin≤ 35 g/l). In our lymphoma cohort, patients with a GR score = 0 experienced significantly better OS compared to patients with a score = 1 and a score = 2 (37 months vs 17 months vs 9 months; p = 0.007). This simple score, distinguishes patients most likely to remain on study for more than 6 weeks, considered as the minimum required period for response and toxicity evaluation (classical DLT and targeted therapies associated long term toxicities). Among patients prematurely withdrawn from clinical trials, 91% had a GR score ≥ 1 (p=0,007). Main study discontinuation reason was progressive disease (77%), drug related toxicity was only responsible for study discontinuation in 13 % of cases. Conclusion: Our data demonstrate efficacy and safety of phase I clinical trials in lymphoma, thus offering an interesting alternative therapeutic option for fit young and elderly relapsed/refractory lymphoma patients. The GR simple score, can both help in selecting patients most likely to benefit from a phase I trial (better OS) and to determine the phase II recommended dose (reduced early trial discontinuation). Disclosures No relevant conflicts of interest to declare.

scholarly journals Qualitative study investigating the underlying motivations of healthy participants in phase I clinical trials

BMJ Open ◽  
2019 ◽  
Vol 9 (1) ◽  
pp. e024224 ◽  
Author(s):  
Kerry J Manton ◽  
Cassandra S Gauld ◽  
Katherine M White ◽  
Paul M Griffin ◽  
Suzanne L Elliott
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Time Frame ◽  
Phase I Clinical Trial ◽  
Trial Participation ◽  
Phase I Clinical Trials ◽  
Conducting Phase ◽  
Patient Health ◽  
Healthy Participants

ObjectivesIf patients are to reap the benefits of continued drug development, an understanding of why healthy participants take part in phase I clinical trials is imperative. The current study aimed to explore the nature of these underlying motivations which may, in turn, improve the overall participant experience and assist in the development of more effective recruitment and retention strategies.DesignThis study used a qualitative design based on the theory of planned behaviour. Specifically, it explored healthy participants’ underlying behavioural, control and normative beliefs which influence their participation in phase I clinical trials.SettingThis study took place at a company that specialises in conducting phase I and phase II clinical trials in the Australian state of Queensland.ParticipantsParticipants (n=31) were either currently undergoing a phase I clinical trial or had previously taken part in a phase I clinical trial.ResultsResults showed that the motivations were varied and not solely centred on financial gains. Reported advantages of participation included altruism, while inconvenience was most often reported as a disadvantage. Friends were reported as those most likely to approve, while one’s mother was reported as most likely to disapprove. Having a suitable time frame/flexible scheduling and feeling comfortable taking part in the trial were both the most commonly reported facilitators, while inflexible scheduling/time commitment was the most commonly reported barrier.ConclusionsPractical implications included the need for organisations involved in clinical trials to be mindful of inflexible scheduling and exploring the possibility of making educational materials available to family members who may be concerned about the risks associated with participation. Overall, it is anticipated that the results of this study will improve the understanding of factors that influence phase I clinical trial participation which may, ultimately, help develop new therapeutics to improve patient health.

Survey results from a patient’s perspective during a phase I/research clinic visit.

2019 ◽  
Vol 37 (27_suppl) ◽  
pp. 216-216
Author(s):  
Stefanie Valeria Beltran ◽  
Jessica MacIntyre ◽  
Dalissa Tejera ◽  
Jaime R. Merchan ◽  
Justin M. Watts
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Nurse Practitioners ◽  
Clinic Visit ◽  
Phase I Clinical Trial ◽  
Comprehensive Cancer Center ◽  
Free Text ◽  
Phase I Clinical Trials ◽  
Survey Results

216 Background: The University of Miami’s Phase I Program is South Florida’s only academic Phase I center dedicated to drug development for cancer patients. On April 2018, Sylvester Comprehensive Cancer Center opened the Phase I/Experimental Therapeutics (ET) Clinic dedicated to research patients enrolled in Phase I clinical trials and established a multi-disciplinary care team. As Phase I clinical trials are evolving, it is necessary to improve on the patient experience as it pertains to research care. Methods: Using a Likert-type scale, dual language survey (English and Spanish), patients were asked 11 questions about the Phase I/ET Clinic visit ranging from the beginning of their Phase I clinical trial enrollment all the way to provider care during the visit. The survey was conducted from January 2019-April 2019 through a secure, HIPAA compliant online Research Electronic Data Capture software (REDCap). Results: Of the 30 patients that were approached, 26 responded (Renal 26.9%, Myelofibrosis 19.2%, Bladder 15.4%, Head and Neck 7.7%, Acute Myeloid Leukemia 15.4%, Myelodysplastic Syndrome 7.7%, and Other 7.7%). Our results found that 100% of research patients would recommend a Phase I clinical trial to another participant. In addition, 96.2% of patients felt there was continuation of their care through their clinical trial process. As a note, 19.2% of patients positively recognized a Phase I provider including Nurse Practitioners (NPs) and physicians. Of these 19.2% of patients, 50% praised an NP in the free text area of the survey. Lastly, 42.3% of patients positively mentioned the team support received in the Phase I Clinic in the free text area of the survey. Conclusions: Our conclusion based on survey results show that having committed providers and clinic space for research patients on a Phase I clinical trial provided an overall positive and personalized experience. Additionally, the survey reflects on how patients are more inclined to refer to a clinical trial due to a good experience. Future directions should look at developing a similar clinic for all phases of research considering the exceptional patient feedback emphasizing on provider care.

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 Race and ethnicity representation in clinical trials: findings from a literature review of Phase I oncology trials

2021 ◽  
Author(s):  
D Ross Camidge ◽  
Haeseong Park ◽  
Karen E Smoyer ◽  
Ira Jacobs ◽  
Lauren J Lee ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Predominantly White ◽  
Race And Ethnicity ◽  
Phase I Trials ◽  
Minimal Representation ◽  
Phase I Clinical Trials ◽  
Demographic Representation ◽  
The Usa ◽  
Race Ethnicity

Aim: To provide an assessment of published literature on the demographic representation in Phase I trials of biopharmaceutical oncology agents. Materials & methods: We conducted a rapid evidence assessment to identify demographic representation reported in Phase I clinical trials for biopharmaceutical oncology agents published in 2019. Results: Globally, the population was predominantly White/Caucasian (62.2%). In the USA, the distribution was heavily skewed toward White/Caucasian (84.2%), with minimal representation of Blacks/African–Americans (7.3%), Asians (3.4%), Hispanics/Latinos (2.8%) or other race/ethnicity groups. Conclusion: Our data highlight that Phase I oncology trials do not reflect the population at large, which may perpetuate health disparities. Further research is needed to understand and address barriers to participation, particularly among under-represented groups

A Study on the Characteristics of Healthy Volunteers who Participate in Phase I Clinical Trials in Korea

2021 ◽  
pp. 155626462110342
Author(s):  
Ji-Hye Seo ◽  
Ock-Joo Kim ◽  
Sang-Ho Yoo ◽  
Eun Kyung Choi ◽  
Ji-Eun Park
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Healthy Volunteers ◽  
Health Science ◽  
Trial Participation ◽  
Phase I Clinical Trials ◽  
Financial Reward ◽  
Therapeutic Purpose ◽  
The Republic

The phase I trial is the first step in administering a drug to humans, but it has no therapeutic purpose. Under the absence of therapeutic purpose, healthy volunteers demonstrated different motivations, unlike the actual patients participating in trials. There were many reported motivations, such as financial motivation, contributing to the health science, accessing ancillary health care benefits, scientific interest or interest in the goals of the study, meeting people, and general curiosity. The aim of this study was to identify the motivation and characteristics of healthy volunteers participating in phase I trials in the Republic of Korea. We gave surveys to 121 healthy volunteers to study their demographic characteristics and the reasons of participation. We identified whether the decision to participate in the research was influenced by demographic factors and whether the perception and attitudes toward the research were influenced by the characteristics of the healthy volunteers. After completion of the first survey, 12 healthy volunteers who had participated in a phase I clinical trial were selected to answer the second interview. According to our survey, most healthy volunteers were unmarried men and economically dependent. Most of them participated in the study because of financial reward. The most important factor to measure financial reward was the research period. Also, 43% of the volunteers were university students, 42% answered “university graduation” and 55% were residing in family-owned houses. Many healthy volunteers were found to be living in family homes and to have a student status or lack of economic independence. Results of the survey showed that 64% of respondents indicated having more than one clinical trial participation. In-depth interviews showed that healthy volunteers had diverse motivation to participate in research and that healthy volunteer perceive the clinical trial positively. The main motivation for healthy volunteers’ participation in research was “financial reward.” Healthy volunteers also considered research schedules, processes, and safety, and had a positive perception of clinical trials, but they thought that the public has a negative perception.

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 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.

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