PI-REAL: A study of informed consent (IC) communication in real-time during phase I clinical trial encounters.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 22-22
Author(s):  
Manish Sharma ◽  
Fay J. Hlubocky ◽  
Mark J. Ratain ◽  
Mark Siegler ◽  
Christopher Daugherty
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Real Time ◽  
Phase I Trial ◽  
Phase I Clinical Trial ◽  
Research Purpose ◽  
Median Income ◽  
Phase I Clinical Trials ◽  
Verbal Skills ◽  
Video Recordings

22 Background: Advanced cancer patients (ACP) in phase I clinical trials are unable to recall significant elements of IC, yet the actual verbal and non-verbal content of trial discussion between oncology fellows and ACP consenting in real time to such trials has not been well described. Methods: Phase I Communication in Real Time Fellow-ACP Encounters (PI-REAL) study is an evidence-based intervention designed to improve communication about phase I clinical trial IC. ACP completed follow-up questionnaires after new patient visits to assess understanding of IC elements, such as research purpose. Video recordings were analyzed using CanCode for verbal and non-verbal skills associated with IC elements. Results: To date, 61 ACP-fellow clinical encounter video recordings were available for analysis. Average length of encounters: 45.4 min (range: 5.7-87.8 min). ACP demographics included: median age 60y (33-83); 55% male; 89% Caucasian; 55% median income > $60,000. Fellows were coded as verbally disclosing: 1. Purpose of phase I trial as dose-determining in 49% of encounters; 2. Physical risks of trial in 75% of encounters; 3. Potential benefits (e.g. improved QOL) gained by ACP participation in trial in 70% of encounters; 4. Alternatives to trial entry (e.g. other trials, palliative/supportive care) in 55% of encounters. A significant association existedbetween coded fellow empathic statements and ACP subsequently recalling the purpose of the trial as dose-determining, with 72% of subjects who heard empathic statements identifying “dosage” compared to 10% of subjects who did not (72% v. 10%, p < 0.05). Regarding non-verbal skills, fellows: leaned toward ACP in 64% of encounters; observed ACP face directly in 72% of encounters; had relaxed body posture in 55% of encounters; and displayed responsive facial expressions in 77% of encounters. Conclusions: Empathic statements by fellows appear to be associated with improved ACP understanding of Phase I trial research purpose as dose-determining. Additional encounters continue to undergo video recording and analysis.

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.

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.

scholarly journals Potential Survival Benefit of Anti-Apoptosis Protein: Survivin-Derived Peptide Vaccine with and without Interferon Alpha Therapy for Patients with Advanced or Recurrent Urothelial Cancer—Results from Phase I Clinical Trials

2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Toshiaki Tanaka ◽  
Hiroshi Kitamura ◽  
Ryuta Inoue ◽  
Sachiyo Nishida ◽  
Akari Takahashi-Takaya ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Interferon Alpha ◽  
Urothelial Cancer ◽  
Peptide Vaccine ◽  
Phase I Clinical Trial ◽  
Control Group ◽  
Phase I Clinical Trials ◽  
Metastatic Urothelial Cancer ◽  
Apoptosis Protein

We previously identified a human leukocyte antigen (HLA)-A24-restricted antigenic peptide, survivin-2B80–88, a member of the inhibitor of apoptosis protein family, recognized by CD8+cytotoxic T lymphocytes (CTL). In a phase I clinical trial of survivin-2B80-88 vaccination for metastatic urothelial cancer (MUC), we achieved clinical and immunological responses with safety. Moreover, our previous study indicated that interferon alpha (IFNα) enhanced the effects of the vaccine for colorectal cancer. Therefore, we started a new phase I clinical trial of survivin-2B80–88 vaccination with IFNαfor MUC patients. Twenty-one patients were enrolled and no severe adverse event was observed. HLA-A24/survivin-2B80–88 tetramer analysis and ELISPOT assay revealed a significant increase in the frequency of the peptide-specific CTLs after vaccination in nine patients. Six patients had stable disease. The effects of IFNαon the vaccination were unclear for MUC. Throughout two trials, 30 MUO patients received survivin-2B80–88 vaccination. Patients receiving the vaccination had significantly better overall survival than a comparable control group of MUO patients without vaccination(P=0.0009). Survivin-2B80–88 vaccination may be a promising therapy for selected patients with MUC refractory to standard chemotherapy. This trial was registered withUMIN00005859.

Assessment of quality of life using FACT-G survey in a phase I trial in cancer patients

2009 ◽  
Vol 27 (15_suppl) ◽  
pp. e20709-e20709
Author(s):  
G. Jung ◽  
D. Knight ◽  
A. Moadel ◽  
K. Desai ◽  
I. Chaudhary ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Phase I ◽  
Phase I Trial ◽  
Statistical Significance ◽  
Well Being ◽  
Phase I Clinical Trials ◽  
The Mean

e20709 Background: Quality of life (QoL) assessment in clinical trials has been gaining more attention. FACT-G surveys have been validated to assess QoL in clinical trials involving oncology patient (Cella DF et al, J Clin Oncol 11:570–579, 1993). However, there is paucity of evaluation of QoL in patients with advanced cancer participating in Phase I clinical trials. Methods: FACT-G surveys were conducted within the context of a Phase I trial to identify a safe dose and potential drug-drug interations of capecitabine and irinotecan combination (Goel, S et al, Invest New Drugs 25:237–245, 2007). The FACT-G survey consists of 28 questions in 5 sections, namely, physical well-being, social/family well-being, emotional well-being, relationship with doctor, and functional well-being). Patients were requested to complete the FACT-G surveys at baseline and every two cycles thereafter (each cycle of 3 weeks duration). Results: Forty-one of 47 patients with advanced solid tumors who participated in the clinical trial completed FACT-G surveys. Mean scores were calculated for each time point. The mean QoL scores at baseline and post cycle 2 were 53 and 58, respectively (p = 0.1). Post cycle 4, the mean QoL score was 62 [p = 0.01, (vs. baseline)]. Following cycle 4, the number of respondents decreased to the extent where we were unable to ascertain any further changes in the QoL scores. Conclusions: It is feasible to use FACT-G survey as a tool to assess QoL in patients participating in an oncology phase I clinical trial. Although the sample size of the patient population was not powered for any statistical significance, there was a trend toward improving QoL based on FACT-G survey scores. This suggests that phase I clinical trials may provide improvement of QoL for some patients. FACT-G is a useful tool in assessing QoL in oncology phase I trial study population. No significant financial relationships to disclose.

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.

scholarly journals Convection-Enhanced Delivery of a First-in-Class Anti-β1 Integrin Antibody for the Treatment of High-Grade Glioma Utilizing Real-Time Imaging

Pharmaceutics ◽  
2020 ◽  
Vol 13 (1) ◽  
pp. 40
Author(s):  
Chibueze D. Nwagwu ◽  
Amanda V. Immidisetti ◽  
Gabriela Bukanowska ◽  
Michael A. Vogelbaum ◽  
Anne-Marie Carbonell
Keyword(s):  
Clinical Trial ◽  
Phase I ◽  
Real Time ◽  
Study Design ◽  
Tumor Resection ◽  
Drug Application ◽  
Phase I Clinical Trial ◽  
Β1 Integrin ◽  
High Grade ◽  
Convection Enhanced Delivery

Introduction: OS2966 is a first-in-class, humanized and de-immunized monoclonal antibody which targets the adhesion receptor subunit, CD29/β1 integrin. CD29 expression is highly upregulated in glioblastoma and has been shown to drive tumor progression, invasion, and resistance to multiple modalities of therapy. Here, we present a novel Phase I clinical trial design addressing several factors plaguing effective treatment of high-grade gliomas (HGG). Study Design: This 2-part, ascending-dose, Phase I clinical trial will enroll patients with recurrent/progressive HGG requiring a clinically indicated resection. In Study Part 1, patients will undergo stereotactic tumor biopsy followed by placement of a purpose-built catheter which will be used for the intratumoral, convection-enhanced delivery (CED) of OS2966. Gadolinium contrast will be added to OS2966 before each infusion, enabling the real-time visualization of therapeutic distribution via MRI. Subsequently, patients will undergo their clinically indicated tumor resection followed by CED of OS2966 to the surrounding tumor-infiltrated brain. Matched pre- and post-infusion tumor specimens will be utilized for biomarker development and validation of target engagement by receptor occupancy. Dose escalation will be achieved using a unique concentration-based accelerated titration design. Discussion: The present study design leverages multiple innovations including: (1) the latest CED technology, (2) 2-part design including neoadjuvant intratumoral administration, (3) a first-in-class investigational therapeutic, and (4) concentration-based dosing. Trial registration: A U.S. Food and Drug Administration (FDA) Investigational New Drug application (IND) for the above protocol is now active.

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.

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]

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