Barriers to clinical trial enrollment among gynecologic oncology patients at a National Cancer Institute Comprehensive Cancer Center

2021 ◽  
Vol 162 ◽  
pp. S98
Author(s):  
Clarissa Lam ◽  
Vanessa Hwu ◽  
Susan Read ◽  
Jun-Min Zhou ◽  
Robert Wenham ◽  
...  
Keyword(s):  
Clinical Trial ◽  
National Cancer Institute ◽  
Gynecologic Oncology ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Oncology Patients ◽  
Clinical Trial Enrollment

Improving the Time to Activation of New Clinical Trials at a National Cancer Institute–Designated Comprehensive Cancer Center

2020 ◽  
Vol 16 (4) ◽  
pp. e324-e332 ◽  
Author(s):  
Erin Williams ◽  
Timothy J. Brown ◽  
Patrice Griffith ◽  
Asal Rahimi ◽  
Rhonda Oilepo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Quality Improvement ◽  
Clinical Research ◽  
National Cancer Institute ◽  
Six Sigma ◽  
Value Added ◽  
Scientific Committee ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Process Map

PURPOSE: The time it takes a performing site to activate a clinical trial can directly affect the ability to provide innovative and state-of-the-art care to patients. We sought to understand the process of activating an oncology clinical trial at a matrix National Cancer Institute–designated comprehensive cancer center. METHODS: A multidisciplinary team of stakeholders within the cancer center, university, and affiliate hospitals held a retreat to map out the process of activating a clinical trial. We applied classical quality improvement and Six Sigma methodology to determine bottlenecks and non–value-added time in activating a clinical trial. During this process, attention was paid to time to pass through each step, and perceived barriers and bottlenecks were identified through group discussions. RESULTS: The process map identified 66 steps with 12 decision points to activate a new clinical trial. The following two steps were instituted first: allow parallel scientific committee and institutional review board (IRB) review and allow the clinical research coordination committee, a group that determines university interest and feasibility, to review protocols independent of the IRB and scientific committee approval. The clinical research coordination committee continues to track the activation time, and this framework is used to identify additional improvement steps. CONCLUSION: By applying quality improvement methodologies and Six Sigma principles, we were able to identify redundancies in the process to activate a clinical trial. This allowed us to redesign the process of activating a clinical trial at a matrix comprehensive cancer center. More importantly, the process map provides a framework to maintain these gains and implement additional changes and serves as an example to deploy across the campus and at other similar institutions.

Perceptions of barriers to patient financial hardship screening differ by provider role within gynecologic oncology outpatient care.

2021 ◽  
Vol 39 (28_suppl) ◽  
pp. 317-317
Author(s):  
Jhalak Dholakia ◽  
Maria Pisu ◽  
Warner King Huh ◽  
Margaret Irene Liang
Keyword(s):  
Nurse Practitioners ◽  
Gynecologic Oncology ◽  
Financial Hardship ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Patient Centered ◽  
Staff Members ◽  
Care Plans ◽  
Patient Barriers

317 Background: Although approximately half of patients with gynecologic malignancy experience financial hardship (FH) during treatment, best practices to identify and assist patients with FH are lacking. To develop such practices, we assessed oncology provider and staff perspectives about FH screening and provision of assistance. Methods: An anonymous survey was conducted electronically within the Gynecologic Oncology outpatient office at a Comprehensive Cancer Center. Potential barriers to patient FH screening and follow-up were assessed within 2 domains: 1) logistic barriers to incorporating FH screening and follow-up into outpatient workflow and 2) perceived patient barriers to FH screening. Responses were elicited on a 5-point Likert scale from ‘very’ to ‘not at all’ significant and dichotomized into significant and not significant barriers. Results: Of 43 providers approached, 37 responded (86% response rate) of which 14 were physicians (MD)/nurse practitioners (NP) and 23 were other staff members (i.e., clinical and research nurses, social workers, pharmacists, care coordinators, lay navigators, and financial counselors). Altogether, 38% worked in their current position for >5 years (n=14), 11% for 3-5 years (n=4), and 51% for <3 years (n=19). For logistic barriers to implementing FH screening and follow-up, the most frequently reported significant barriers included lack of personnel training (69%) and lack of available staff (62%), training regarding follow-up (72%), and case tracking infrastructure (67%). The most frequent significant perceived patient barriers were lack of knowledge of whom to contact (72%), concerns about impact on treatment if FH needs were identified (72%), and lack of patient readiness to discuss financial needs (62%.) Compared to MD/NP, staff members more often indicated the following as significant barriers: difficulty incorporating FH screening into initial visit workflow (31 % vs. 57%, p=0.03), overstretched personnel (29% vs 73%, p=0.005), and patient concerns about influence on treatment (62% vs 86%, p=0.01). Conclusions: Care team members identified barriers to patient FH screening across logistic and patient-centered domains, although MD/NP less so than other staff possibly reflecting different exposures to patient financial needs during clinical encounters or burden of workflow. Implementation of universal FH screening, dedicated personnel, convenient tracking mechanisms, and multi-disciplinary provider and staff training may improve recognition of patient FH and facilitate its integration into oncology care plans.

The Influence of Race on the Attitudes of Radiation Oncology Patients Towards Clinical Trial Enrollment

2006 ◽  
Vol 29 (6) ◽  
pp. 593-599 ◽  
Author(s):  
Charles G. Wood ◽  
S Jack Wei ◽  
Margaret K. Hampshire ◽  
Pamela A. Devine ◽  
James M. Metz
Keyword(s):  
Clinical Trial ◽  
Radiation Oncology ◽  
Oncology Patients ◽  
Clinical Trial Enrollment

Development of a Rapid Response Team in an Outpatient Free-Standing National Cancer Institute–Designated Comprehensive Cancer Center

2010 ◽  
Vol 1 (2) ◽  
Author(s):  
Kim Blumenfeld, RN, BS, CCRN ◽  
Iris Delfakis, RN, BSN, OCN® ◽  
Sandra E. Kurtin, RN, MS, AOCN®, ANP-C ◽  
Patricia Stumbo, RN, OCN®, MBA ◽  
Kirsten Jonasson, RN ◽  
...  
Keyword(s):  
National Cancer Institute ◽  
Rapid Response Team ◽  
Rapid Response ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Free Standing ◽  
Response Team

Metastatic colorectal cancer (mCRC) patterns of care: Implications for clinical trial design

2007 ◽  
Vol 25 (18_suppl) ◽  
pp. 4079-4079 ◽  
Author(s):  
C. S. Denlinger ◽  
M. A. Collins ◽  
Y. Wong ◽  
S. Litwin ◽  
N. J. Meropol
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Trial Design ◽  
Clinical Trial Design ◽  
New Drugs ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Treatment Change ◽  
Therapy Regimen

4079 Background: New approaches have expanded options for patients (pts) with mCRC. To characterize current practice paradigms that might bear on clinical trial design, we analyzed decision-making and treatment patterns in pts treated at a Comprehensive Cancer Center since the introduction of cetuximab (CET), and bevacizumab (BV). Methods: A retrospective review of all pts diagnosed with mCRC between 3/1/04 and 8/28/06 treated at Fox Chase Cancer Center. Results: 160 pts were treated, with 157 pts receiving at least one therapy regimen by 10 attending oncologists. There were 350 changes in therapy with 246 (70%) including continuation of at least one prior drug (92 BV, 111 fluoropyrimidines, 43 other). The most common reasons for treatment change were toxicity (33%), progressive disease (PD) (29%), treatment breaks (15%), and metastasectomy (11%) ( Table ). PD was a more common cause for treatment discontinuation in later phases of treatment (18% initial regimen vs. 36% subsequent regimens, p=0.0002). 24% of pts treated with oxaliplatin (OX) discontinued due to neuropathy. Hypersensitivity caused discontinuation in 5% of pts with OX and 7% of pts with CET. Resection of metastases was undertaken in 38% of pts. 43% of these pts received neoadjuvant therapy, and 56% received adjuvant therapy. 30% of pts have died, 29% remain on active treatment, 28% are on a treatment break, 3% are on hospice, and 11% are lost to follow-up. Conclusions: PD is no longer the primary reason for change of therapy in pts with mCRC. Metastasectomy is common and OX neuropathy is often treatment-limiting. These findings have important implications for endpoint selection and design of clinical trials in mCRC. Future clinical trials in mCRC must recognize treatment complexities and capture key components of decision-making that may result in prolonged survival. Furthermore, treatment breaks represent a potential window for the evaluation of new drugs. [Table: see text] No significant financial relationships to disclose.

Predictors of referral to outpatient specialty palliative care (SPC) in gynecologic cancer (GC) patients.

2015 ◽  
Vol 33 (29_suppl) ◽  
pp. 159-159
Author(s):  
Rachel Ruskin ◽  
Michelle Renee Rowland ◽  
Katherine N Moore ◽  
Katrina Slaughter ◽  
Adam Walter ◽  
...  
Keyword(s):  
Palliative Care ◽  
Sexual Dysfunction ◽  
Gynecologic Oncology ◽  
Gynecologic Cancer ◽  
Routine Care ◽  
Multivariate Model ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Future Research ◽  
Cross Sectional

159 Background: Prior studies in GC patients have described predictors of inpatient palliative care (PC) consultation, but predictors of outpatient SPC consultation have not been elucidated. We sought to identify factors predictive of referral and associated care outcomes. Methods: We performed a cross-sectional study of GC patients seen in the gynecologic oncology clinic at a comprehensive cancer center over a three month period. As a part of routine care, patients completed a symptom questionnaire. Patients previously seen at the outpatient PC clinic were compared to those who had not with respect to demographics, disease characteristics, symptom scores, and provider factors using univariate statistics. A multivariate model was created to identify independent predictors of referral. Results: 913 patients completed the symptom survey. 76 patients (8%) had been seen in the outpatient PC clinic. Disease factors associated with referral included site (p < 0.01), stage (p < 0.01), evidence of disease (p < 0.01), active treatment (p < 0.01), and time point in the disease trajectory (p < 0.01). Women with moderate to severe pain (p < 0.01), sadness (p = 0.03), distress (p < 0.01), fatigue (p < 0.01), neuropathy (p = 0.03), and sexual dysfunction (p < 0.01) were more likely to have seen PC. Marital status, number of symptoms, and patient provider were also predictive of referral (all p < 0.01). In a multivariate model, site, stage, number of symptoms, moderate to severe sexual dysfunction, and provider were independently associated with referral. Compared to women who had not been referred, patients seen in the PC clinic were more likely to have a health care proxy documented in the electronic medical record (p < 0.01). Among patients with related symptoms, patients referred to PC more often had an opioid prescribed for pain (p < 0.01) and medications prescribed for depression (p < 0.01), anxiety (p = 0.04), insomnia (p < 0.01), and fatigue (p < 0.01). Conclusions: Women with depression, anxiety, insomnia, and fatigue were more likely to receive pharmacologic treatment for these symptoms from a SPC provider. Future research should identify referral triggers for those patients most likely to benefit from outpatient SPC consultation.

Improving transitions of care through implementation of a standardized handoff at a comprehensive cancer center.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 242-242
Author(s):  
Diane C. Bodurka ◽  
Mohamed Ait Aiss ◽  
Helene P Phu ◽  
Lakeisha R Day ◽  
Varkey Abraham ◽  
...  
Keyword(s):  
Pediatric Oncology ◽  
Medical Errors ◽  
Gynecologic Oncology ◽  
Skills Training ◽  
Illness Severity ◽  
Transitions Of Care ◽  
Comprehensive Cancer Center ◽  
Cancer Center ◽  
Post Intervention

242 Background: Communication failures cause two-thirds of sentinel events in hospitals. These adverse occurrences are often both fatal and preventable. Consequently, improving the quality of handoffs has been identified by multiple accreditation constituents as a top priority patient safety goal. This project was part of an institutional initiative to standardize handoffs among physicians, trainees, and midlevel providers. Methods: Four subgroups were identified as pilot areas: Gynecologic Oncology (Gyn Onc) fellows to nocturnalists, Surgical Oncology fellows, Pediatric Oncology residents and fellows, and Emergency Center attending staff to inpatient hospitalists. This abstract focuses on the Gyn Onc and Pediatric Oncology services. All teams used a PDSA cycle (Plan, Do, Study, Act) to conduct its pilot study. A gap analysis, root cause analysis, and process mapping were performed in each area to identify specific handoff issues. A validated standardized handoff tool, I-PASS (Illness severity, Patient summary, Action list, Situational awareness and contingency planning, and Synthesis by receiver), was selected. Of note, “Illness severity” highlights patients identified at higher risk for complications and denotes their status as “watcher” or “unstable.” Interventions included I-PASS skills training and utilization of the I-PASS mnemonic. Each service developed a standardized definition to identify patients classified as “watchers.” Medical errors, ICU transfers, and provider satisfaction were assessed pre- and post-intervention. Results: Results from 40 handoff surveys showed communication errors dropped by 10% (16.49 vs 14.93). Minor harm as result of a problematic handoff decreased by 45% (2.55 vs 1.39), with a 55% reduction in ICU transfers. There was an overall increase in handoff satisfaction using I-PASS and 100% standardization of handoffs across the Gyn Onc and Pediatric Oncology units. Conclusions: Implementation of I-PASS, a validated standardized handoff was associated with reductions in medical errors and improvement in communication. Our institution is moving toward implementing I-PASS across all units to increase the safety and quality of patient care.

Sign in / Sign up

Export Citation Format

Share Document