Patient Knowledge and Expectations About Return of Genomic Results in a Biomarker-Driven Master Protocol Trial (SWOG S1400GEN)

2021 ◽  
pp. OP.20.00770
Author(s):  
Joshua A. Roth ◽  
Meghna S. Trivedi ◽  
Stacy W. Gray ◽  
Donald L. Patrick ◽  
Debbie M. Delaney ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Telephone Survey ◽  
Sociodemographic Factors ◽  
Patient Knowledge ◽  
New Paradigm ◽  
Network Biomarker ◽  
Oncology Clinical Trials ◽  
Previously Treated ◽  
Genomic Results

PURPOSE: Biomarker-driven master protocols represent a new paradigm in oncology clinical trials, but their complex designs and wide-ranging genomic results returned can be difficult to communicate to participants. The objective of this pilot study was to evaluate patient knowledge and expectations related to return of genomic results in the Lung Cancer Master Protocol (Lung-MAP). METHODS: Eligible participants with previously treated advanced non–small-cell lung cancer were recruited from patients enrolled in Lung-MAP. Participants completed a 38-item telephone survey ≤ 30 days from Lung-MAP consent. The survey assessed understanding about the benefits and risks of Lung-MAP participation and knowledge of the potential uses of somatic testing results returned. Descriptive statistics and odds ratios for associations between demographic factors and correct responses to survey items were assessed. RESULTS: From August 1, 2017, to June 30, 2019, we recruited 207 participants with a median age of 67, 57.3% male, and 94.2% White. Most participants “strongly/somewhat agreed” with statements that they “received enough information to understand” Lung-MAP benefits (82.6%) and risks (69.5%). In items asking about potential uses of Lung-MAP genomic results, 87.0% correctly indicated that the results help to select cancer treatment, but < 20% correctly indicated that the results are not used to confirm cancer diagnosis, would not reveal risk of developing diseases besides cancer, and would not indicate if family members had increased cancer risk. There were no associations between sociodemographic factors and proportions providing correct responses. CONCLUSION: In a large National Clinical Trials Network biomarker-driven master protocol, most participants demonstrated incorrect knowledge and expectations about the uses of genomic results provided in the study despite most indicating that they had enough information to understand benefits and risks.

Integrating biomarkers into clinical trials: methodological issues for a new paradigm in nonsmall cell lung cancer

2011 ◽  
Vol 23 (1) ◽  
pp. 106-111 ◽  
Author(s):  
Gérard Zalcman ◽  
Emmanuel Bergot ◽  
Christian Creveuil ◽  
Guénaëlle Levallet ◽  
Emmanuèle Lechapt
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Cell Lung Cancer ◽  
Nonsmall Cell Lung Cancer ◽  
Methodological Issues ◽  
New Paradigm

scholarly journals Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer

2015 ◽  
Vol 4 (12) ◽  
pp. 205846011558810 ◽  
Author(s):  
Naoko Sueoka-Aragane ◽  
Naomi Kobayashi ◽  
Eric Bonnard ◽  
Colette Charbonnier ◽  
Junta Yamamichi ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trials ◽  
Kinase Inhibitors ◽  
Target Lesion ◽  
Cloud Services ◽  
Overall Response ◽  
Oncology Clinical Trials ◽  
Egfr Tyrosine Kinase Inhibitors ◽  
Selection Of ◽  
Time Point

Background Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. Purpose To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. Material and Methods Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. Results KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. Conclusion The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites.

scholarly journals Clinical trials in advanced stage lung cancer: a survey of patients’ opinion about their treatment

2011 ◽  
Vol 6 ◽  
Author(s):  
Bojan Zaric ◽  
Branislav Perin ◽  
Aleksandra Ilic ◽  
Ivan Kopitovic ◽  
Jovan Matijasevic ◽  
...  
Keyword(s):  
Lung Cancer ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Tumor Type ◽  
Advanced Stage ◽  
Inclusion Criteria ◽  
Gender Education ◽  
Previously Treated ◽  
Advanced Stage Lung Cancer ◽  
Stage Lung Cancer

Background: The major aim of this study was to investigate what patients with advanced stage lung cancer, enrolled in a clinical trial, thought about their treatment. We also wanted to investigate if there exist any characteristics that could influence patients’ opinion about the clinical trial. Patients and methods: Over the period from June 2008 to June 2009, 59 eligible patients were enrolled in this study. The major inclusion criteria were: participation in a clinical trial, previously treated advanced stage lung cancer, and good per- formance status (ECOG 0-2). All patients were asked to answer a questionnaire designed to investigate their impres- sions about participation in a clinical trial. The questionnaire was deposited in a sealed box which was opened at the end of the study. We investigated a possible influence of age, gender, education, lung cancer stage, chemotherapy line and tumor type on the patients' opinion about some aspects of the clinical trial. Results: The majority of the patients were aware they were participating in the clinical trial and a significant number of them were very satisfied with the treatment. Of the investi- gated factors, only the level of education had a statistically significant influence on some of the questions raised in the questionnaire. Conclusions: Patients participating in clinical trials are satis- fied with their treatment, ready to proceed with it and would recommend it to other patients. It depends mainly on health professionals to maintain this level of confidence and justify their trust.

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