Health care worker attitudes about clinical trials at a comprehensive cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e20633-e20633
Author(s):  
Erica Leigh Campagnaro ◽  
Seunghee Margevicius ◽  
Barbara J. Daly ◽  
Jennifer Rachel Eads ◽  
Tyler G. Kinzy ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Self Efficacy ◽  
Small Sample Size ◽  
Educational Interventions ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Normative Beliefs ◽  
The Impact

e20633 Background: Cancer patient (pt) participation in clinical trials (CT) is low. Little is known about the beliefs and attitudes of health care workers (HCW) and how they impact intention to discuss CT with pts. The overall goal of this project was to develop a conceptual model to guide future interventions to enhance communication about CT between HCW and cancer pts. Methods: Two email surveys of non-physician HCW at an NCI-designated comprehensive cancer center were conducted. The first was sent to a random sample of 150 HCW. The second was sent to 80 who completed the first survey. Based on our prior work (Eads et al. ASCO 2011) and Ajzen’s Theory of Planned Behavior, domains of the first included CT knowledge (19 items, agree/disagree) and attitudes (27 items, 5-point Likert); the second included normative beliefs about institutional attitudes toward CT (6 items, 5-point Likert), self-efficacy about engaging in discussion about CT (14 items, 5-point Likert), and intention to discuss CT with pts (4 items, 7-point Likert). Results: 41 HCW completed both anonymous surveys; 27 could be matched by demographics. Median age of matched respondents was 44.3 yrs (range 24-63), 26 female, 22 caucasian, 9 nurses. Overall, CT knowledge was high (median 17/19 items correct). There were strong associations between attitudes and self-efficacy (Spearman r=-0.425, p=0.03), as well as perceived normative beliefs and self-efficacy (r=0.651, p=0.0002). These associations were strong amongst nurses (r=-0.818, p=0.007 and r=0.656, p=0.05, respectively), with a particularly strong correlation between self-efficacy and intention to discuss clinical trials with pts (r=0.891, p=0.001). Conclusions: In spite of a small sample size, these pilot data strongly support a behavioral framework to understand and address the impact of HCW attitudes and beliefs about CT on discussions of CT with pts. Insofar as HCW (especially nurses) have substantial pt contact, and serve as a resource for pts regarding treatment decisions, educational interventions to address HCW barriers to discussing CT with pts (i.e. attitudes, beliefs, and self-efficacy) could positively impact pt attitudes and improve decision making.

Molecular profiling of TOPO1: A way to evaluate irinotecan treatment in colorectal cancer?

2016 ◽  
Vol 34 (4_suppl) ◽  
pp. 546-546
Author(s):  
Julia Marie Cunningham ◽  
Petra Prins ◽  
Brian Conkright ◽  
Simina Boca ◽  
Shruti Rao ◽  
...  
Keyword(s):  
Colorectal Cancer ◽  
Small Sample Size ◽  
Predictive Marker ◽  
Molecular Profiling ◽  
Small Sample ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Control Group ◽  
Similar Response ◽  
Second Line

546 Background: Front-line chemotherapy for metastatic colorectal cancer (mCRC) consists of a fluoropyrimidine backbone plus either oxaliplatin (FOLFOX or XELOX) or irinotecan (FOLFIRI or XELIRI). Large, prospective trials enrolling chemotherapy-naïve patients (pts) show FOLFOX and FOLFIRI treatment to be equivalent with similar response rates. Methods: Irinotecan inhibits TOPO1, which is now a candidate marker for irinotecan treatment benefit. Thus, we retrospectively analyzed TOPO1 expression level in 49 pts with mCRC who were treated with irinotecan-containing regimens at the Lombardi Comprehensive Cancer Center between 2009 and 2014. Patient characteristics and outcomes were compiled through chart review and the effect of TOPO1 expression on clinical outcomes was assessed. TOPO1 expression in tumor tissue from each pt was analyzed using a commercially available molecular profiling (MP) service (Caris Life Sciences). Results: The median overall survival (OS) for all pts was 33.9 months (mo), defined as the time from metastasis to death or censorship. When grouped by “high” or “low” TOPO1 expression, as defined by Caris at the time of the testing, 29 pts were high-expressers and 20 were low-expressers. High TOPO1 expressers receiving irinotecan (n = 22) had a median OS of 27.2 mo, compared with median 41.5 mo for low-expressers (n = 14) (p = 0.27). Irinotecan is conventionally given as second-line therapy. The median OS of pts receiving second-line irinotecan was 38.2 mo for high-expressers [n = 11] vs. 68.5 mo for low-expressers [n = 5]) (p = 0.32). Conclusions: Our limited data do not support the use of TOPO1 expression levels as a predictive marker for irinotecan therapy in mCRC. However, our conclusions are limited by small sample size, lack of a control group to distinguish prognostic from predictive markers, and timing of TOPO1 measurement, which in many cases was after irinotecan therapy. Physicians currently lack an evidence-based way to choose between potentially efficacious regimens for mCRC. More rigorous studies are needed to assess the benefit of MP in mCRC care. We are currently planning a prospective study with the hope of validating the use of TOPO1 expression as a predictive marker for treatment of this disease.

Invisible Barriers to Clinical Trials: The Impact of Structural, Infrastructural, and Procedural Barriers to Opening Oncology Clinical Trials

2006 ◽  
Vol 24 (28) ◽  
pp. 4545-4552 ◽  
Author(s):  
David M. Dilts ◽  
Alan B. Sandler
Keyword(s):  
Clinical Trials ◽  
The United States ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Community Practice ◽  
Home Office ◽  
Scientific Review ◽  
Oncology Research ◽  
Oncology Clinical Trials ◽  
The Impact

Purpose To investigate the administrative barriers that impact the opening of clinical trials at the Vanderbilt-Ingram Cancer Center (VICC) and at VICC Affiliate Network (VICCAN) sites. Methods VICC, a National Cancer Institute–designated comprehensive cancer center, and three VICCAN community practice sites were studied. Methodology used was identification and mapping of existing processes and analysis of historical timing data. Results At course granularity, the process steps required at VICC and VICCAN main office plus local sites are 20 v 17 to 30 steps, respectively; this gap widens with finer granularity, with more than 110 v less than 60 steps, respectively. Approximately 50% of the steps are nonvalue added. For example, in the institutional review board (IRB) process, less than one third of the steps add value to the final protocol. The numbers of groups involved in the approval processes are 27 (VICC) and 6 to 14 (VICCAN home office and local sites). The median times to open a trial are 171 days (95% CI, 158 to 182 days) for VICC and 191 days (95% CI, 119 to 269 days) for the VICCAN sites. Contrary to expectations, the time for IRB review and approval (median, 47 days) is the fastest process compared with the scientific review committee review and approval (median, 70 days) and contracts and grants review (median, 78.5 days). Opening a cooperative group clinical trial is significantly (P = .05) more rapid because they require fewer review steps. Conclusion There are numerous opportunities to remove nonvalue-added steps and save time in opening clinical trials. With increasing numbers of new agents, fewer domestic principal investigators, and more companies off-shoring clinical trials, overcoming such barriers is of critical importance for maintenance of core oncology research capabilities in the United States.

scholarly journals E-Mail Communication Practices and Preferences Among Patients and Providers in a Large Comprehensive Cancer Center

2016 ◽  
Vol 12 (7) ◽  
pp. 676-684 ◽  
Author(s):  
Natalie Cook ◽  
Manjula Maganti ◽  
Aditi Dobriyal ◽  
Michal Sheinis ◽  
Alice C. Wei ◽  
...  
Keyword(s):  
Health Care ◽  
Patient Care ◽  
Health Care Team ◽  
Care Team ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cross Sectional ◽  
Factors Associated ◽  
The Impact ◽  
E Mail

Purpose: Little is known about how electronic mail (e-mail) is currently used in oncology practice to facilitate patient care. The objective of our study was to understand the current e-mail practices and preferences of patients and physicians in a large comprehensive cancer center. Methods: Separate cross-sectional surveys were administered to patients and physicians (staff physicians and clinical fellows) at the Princess Margaret Cancer Centre. Logistic regression was used to identify factors associated with current e-mail use. Record review was performed to assess the impact of e-mail communication on care. Results: The survey was completed by 833 patients. E-mail contact with a member of the health care team was reported by 41% of respondents. The team members contacted included administrative assistants (52%), nurses (45%), specialist physicians (36%), and family physicians (18%). Patient factors associated with a higher likelihood of e-mail contact with the health care team included younger age, higher education, higher income, enrollment in a clinical trial, and receipt of multiple treatments. Eighty percent of physicians (n = 63 of 79) reported previous contact with a patient via e-mail. Physician factors associated with a greater likelihood of e-mail contact with patients included older age, more senior clinical position, and higher patient volume. Nine hundred sixty-two patient records were reviewed, with e-mail correspondence documented in only 9% of cases. Conclusion: E-mail is commonly used for patient care but is poorly documented. The use of e-mail in this setting can be developed with appropriate guidance; however, there may be concerns about widening the gap between certain groups of patients.

The impact of placements on students’ self-efficacy

2014 ◽  
Vol 4 (3) ◽  
pp. 228-241 ◽  
Author(s):  
Matt Edwards
Keyword(s):  
Self Efficacy ◽  
Large Scale ◽  
Positive Impact ◽  
Small Sample Size ◽  
Small Sample ◽  
Content Type ◽  
Work Placement ◽  
Before And After ◽  
The Impact ◽  
The Relationship

Purpose – The purpose of this paper is to investigate the relationship between work placements and employability, through an analysis of the impact of a work placement on students’ self-efficacy. Design/methodology/approach – The basis of this paper is a large-scale work-based learning module at the University of Birmingham, the “Professional Development Module”. Students completed questionnaires both before and after they undertaken their placements and the results from the questionnaires were compared. These results were then combined with the results of semi-structured interviews undertaken with students. Findings – The paper's findings support the view that a work placement has a positive impact on students’ self-efficacy, especially in relation to their confidence in making applications and/or attending interviews, and in articulating their skills and strengths. Research limitations/implications – While the relatively small sample size means that the paper's conclusions must remain provisional, it highlights the need for careers practitioners to encourage students to engage in critical self-reflection. The paper suggests that it is important for careers practitioners and researchers to engage in more collaborative projects in order for a fully rounded picture of the relationship between placements and employability to emerge. The paper shows that more research is needed into the relative impact of short- and long-term placements. Originality/value – The paper demonstrates the value of assessing students’ views both before and after their work placements so that these views can be compared directly.

Patient barriers to participation in clinical trials at a community cancer center.

2013 ◽  
Vol 31 (31_suppl) ◽  
pp. 17-17
Author(s):  
Praveen Ramakrishnan Geethakumari ◽  
Joann R. Ackler ◽  
Mahasweta Gooptu ◽  
Leonard E Braitman ◽  
William J. Tester
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Family Support ◽  
Small Sample Size ◽  
Small Sample ◽  
Cancer Center ◽  
Final Decision ◽  
Continuous Variables ◽  
Drug Side Effects ◽  
Barriers To Participation

17 Background: Clinical trials are fundamental to innovative oncology. Participation rates in trials have declined nationally to < 5%. Barriers to participation exist at patient, physician, and protocol levels. This study seeks to identify barriers to enrollment in clinical trials at a community cancer center serving a diverse patient population. Methods: We conducted a descriptive cross-sectional study, including 160 eligible patients offered enrollment in 27 clinical trials from July 2010-December 2012. A standardized questionnaire was delivered by mail or in person. Patients who enrolled (acceptors) and decliners were compared using Fisher’s exact test for nominal variables and t test for normally distributed continuous variables. Results: Fifty-seven patients (36%) (males: 10, females: 47) returned the questionnaire. Thirty-three (58%) were enrolled in a clinical trial. Mean age of acceptors was 57 compared to 64 for decliners (p=0.007). Stage IV disease patients were more likely to enroll (Spearman rho= 0.33, p=0.01). Among patients with family support, 66% accepted participation compared to 40% of those without [p=0.05]. Twenty-eight of 33 (85%) who felt trust in their doctor affected their decision enrolled. Of those “comfortable with randomization,” 86% enrolled compared to 29% who were not [p<0.001]. 74% patients would participate in a trial if maximal information could be gathered before making a final decision. Acceptors stated altruism, contribution to research, trust in doctor and hope for cure while decliners mentioned uncertainty in research, drug side effects, mistrust in pharmaceutical industry and depression as most important reasons for their decision. Conclusions: Our results confirm barriers among diverse patients treated at a community cancer center. Study limitations include small sample size and predominance of female gender. Factors influencing enrollment identified include age, family support, patient’s insight into conduct of randomized trials, perceived drug side effects and the doctor-patient relationship. Success lies in bridging knowledge and communication gaps, careful protocol design, and establishing trusting relationships.

scholarly journals Cancer-Related Internet Use and Online Social Networking Among Patients in an Early-Phase Clinical Trials Clinic at a Comprehensive Cancer Center

2018 ◽  
pp. 1-14 ◽  
Author(s):  
Goldy C. George ◽  
Adrianna Buford ◽  
Kenneth Hess ◽  
Sarina A. Piha-Paul ◽  
Ralph Zinner ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Phase I ◽  
Internet Use ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Information ◽  
The Internet ◽  
Phase I Clinical Trials ◽  
Experimental Drugs ◽  
The Impact

Purpose We examined patterns, correlates, and the impact of cancer-related Internet use among patients with advanced cancer in a phase I clinical trials clinic for molecularly targeted oncologic agents. Methods An anonymous questionnaire on Internet use for cancer-related purposes that incorporated input from phase I clinical trial oncologists and patients was self-administered by patients age ≥ 18 years in a phase I clinic. Multivariable modeling was used. Data were analyzed for the overall sample and by generation, which was defined by year of birth. Results Of 291 patients (52% women, 82% non-Hispanic white, 50% age ≤ 60 years), 62% were cancer-related Internet users (CIUs). Cancer-related Internet use was associated with an income of ≥ $60,000 (odds ratio, 2.42; P = .004). CIUs used the Internet to learn about their cancer (85%), treatment adverse effects (65%), clinical trials (52%), new alternative treatments (42%), and symptom management (41%). CIUs most frequently used the hospital Web site (70%) to learn about clinical trials, followed by ClinicalTrials.gov (42%) and search engines (41%). The emotional impact of Internet-derived cancer information on CIUs varied—56% felt empowered, 34% anxious, 29% relieved, and 17% confused. Cancer-related Internet information made 51% of patients from the Millennial (born after 1990) and Generation X/Y (born 1965 to 1990) CIU populations anxious compared with < 29% of CIUs from older generations (born 1964 and before). Most CIUs desired more online information about new experimental drugs (91%) and US Food and Drug Administration–approved drugs for cancer (72%). Conclusion As most phase I patients use the Internet for cancer-related purposes, the Internet overall and hospital Web sites should provide more extensive, pertinent, and helpful information on clinical trials and cancer treatment to phase I patients.

Patient barriers to participation in clinical trials in a community cancer center.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. e17578-e17578
Author(s):  
Praveen Ramakrishnan Geethakumari ◽  
Joann R. Ackler ◽  
Mahasweta Gooptu ◽  
Leonard E Braitman ◽  
William J. Tester
Keyword(s):  
Clinical Trials ◽  
Side Effects ◽  
Small Sample Size ◽  
Small Sample ◽  
Cancer Center ◽  
Trial Participation ◽  
Continuous Variables ◽  
Drug Side Effects ◽  
Foreign Born ◽  
Barriers To Participation

e17578 Background: Clinical trials are fundamental to research and innovative oncology treatment. Participation rates in trials have declined nationally to < 5%. Barriers to participation exist at patient, physician and protocol levels. Methods: We conducted a descriptive cross-sectional study in a community cancer center serving a diverse patient population. A total of 160 eligible patients offered enrollment in various clinical trials from July 2010-December 2012 were included. A standardized questionnaire was delivered by mail or in person. Electronic medical records and patient charts were used for disease specific data. Acceptors and decliners were compared using Fisher’s exact test for nominal variables and t test for normally distributed continuous variables. Results: Forty-nine patients (males: 9, females: 40) returned the questionnaire. Twenty-eight had accepted and 21 declined trial participation. Mean age of acceptors was 56.2 ± 2.2 compared to 63.96 ± 1.6 for decliners (p=0.007). Acceptance was highest for stage IV disease (85.71%) [p=0.077]. Of foreign-born patients, 71.4% patients were decliners [p=0.122]. Of those “comfortable with randomization,” 85.2% were acceptors compared to 22.7% who were not [p<0.001]. Of respondents encouraged by knowing that they could leave the study at any time and receive standard treatment, 79.4% were acceptors [p<0.001]. Of patients who valued trust in their doctor, 85.7% accepted compared to 19.05% who did not [p<0.001]. Among most important reasons for their decision, acceptors valued altruism, contribution to research, trust in doctor and hope for cure while decliners mentioned uncertainty in research, drug side effects, depression and need for family support. Conclusions: Results confirm barriers among diverse patients treated in a community cancer center and suggest the type of patient likely to participate in clinical trials. Study limitations include small sample size and majority of female respondents. Key factors included age, patient’s insight into the conduct of randomized trials, perceived drug side effects and the doctor-patient bond. Success lies in bridging knowledge and communication gaps, careful protocol design, and establishing trusting relationships.

scholarly journals The Impact of Insurance on Access to Cancer Clinical Trials at a Comprehensive Cancer Center

2010 ◽  
Vol 16 (24) ◽  
pp. 5997-6003 ◽  
Author(s):  
Justin F. Klamerus ◽  
Suanna S. Bruinooge ◽  
Xiaobu Ye ◽  
Mandi L. Klamerus ◽  
Dorothy Damron ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Cancer Clinical Trials ◽  
The Impact

scholarly journals Microbial dysbiosis is associated with aggressive histology and adverse clinical outcome in B-cell non-Hodgkin lymphoma

2021 ◽  
Vol 5 (5) ◽  
pp. 1194-1198
Author(s):  
Catherine S. Diefenbach ◽  
Brandilyn A. Peters ◽  
Huilin Li ◽  
Bruce Raphael ◽  
Tibor Moskovits ◽  
...  
Keyword(s):  
B Cell ◽  
Treatment Outcomes ◽  
Hodgkin Lymphoma ◽  
Small Sample Size ◽  
B Cell Lymphoma ◽  
Small Sample ◽  
Cancer Center ◽  
Healthy Controls ◽  
Non Hodgkin Lymphoma ◽  
The Impact

Abstract B-cell non-Hodgkin lymphoma cell survival depends on poorly understood immune evasion mechanisms. In melanoma, the composition of the gut microbiota (GMB) is associated with immune system regulation and response to immunotherapy. We investigated the association of GMB composition and diversity with lymphoma biology and treatment outcome. Patients with diffuse large B-cell lymphoma (DLBCL), marginal zone (MZL), and follicular lymphoma (FL) were recruited at Mayo Clinic, Minnesota, and Perlmutter Cancer Center, NYU Langone Health. The pretreatment GMB was analyzed using 16S ribosomal RNA gene sequencing. We examined GMB compositions in 3 contexts: lymphoma patients (51) compared with healthy controls (58), aggressive (DLBCL) (8) compared with indolent (FL, MZL) (18), and the association of GMB with immunochemotherapy treatment outcomes (8 responders, 6 nonresponders). Respectively, we found that the pretreatment GMB in lymphoma patients had a distinct composition compared with healthy controls (P &lt; .001); GMB compositions in DLBCL patients were significantly different than indolent patients (P = .01) with a trend toward reduced microbial diversity in DLBCL patients (P = .08); and pretreatment GMB diversity and composition were significant predictors of treatment responses (P = .01). The impact of these pilot results is limited by our small sample size, and should be considered a proof of principle. If validated, our results could lead toward improved treatment outcomes by improving medication stewardship and informing which GMB-targeted therapies should be tested to improve patient outcomes.

An influence of social isolation on the level of physical activity as well as on well-being and mental state of people during the coronavirus COVID-19 pandemic

2019 ◽  
Vol 129 (4) ◽  
pp. 127-131
Author(s):  
Agnieszka Parfin ◽  
Krystian Wdowiak ◽  
Marzena Furtak-Niczyporuk ◽  
Jolanta Herda
Keyword(s):  
Physical Activity ◽  
Social Isolation ◽  
Small Sample Size ◽  
Statistical Tests ◽  
Population Group ◽  
Well Being ◽  
Small Sample ◽  
Subjective Well Being ◽  
Tract Infections ◽  
The Impact

AbstractIntroduction. The COVID-19 is the name of an infectious disease caused by a new strain of coronavirus SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2). It was first diagnosed in December 2019 in patients in Wuhan City, Hubei Province, China. The symptoms are dominated by features of respiratory tract infections, in some patients with a very severe course leading to respiratory failure and, in extreme cases to death. Due to the spread of the infection worldwide, the WHO declared a pandemic in March 2020.Aim. An investigation of the impact of social isolation introduced due to the coronavirus pandemic on selected aspects of life. The researchers focused on observing changes in habits related to physical activity and their connections with people’s subjective well-being and emotional state.Material and methods. The study was carried out within the international project of the group „IRG on COVID and exercise”. The research tool was a standardized questionnaire.Results. Based on the data collected and the analysis of the percentage results, it can be observed that the overwhelming majority of people taking up physical activity reported a better mood during the pandemic. However, statistical tests do not confirm these relationships due to the small sample size.Conclusions. Isolation favours physical activity. Future, in-depth studies, by enlarging the population group, are necessary to confirm the above observations.

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