tbuckley/cabot-search huggingface dataset:
Persistence of quality improvement in a Veterans Affairs (VA) academic practice assessed by Quality Oncology Practice Initiative (QOPI).
Authors: Kathleen L. Kiernan, Christina D. Williams, Arif Kamal, Michael J. Kelley
Journal: Journal of Clinical Oncology (2012)

209 Background: The success of quality improvement (QI) efforts is usually assessed initially within a year of implementation but performance may later decline. We sought to determine the longer-term effectiveness of practice improvement interventions and the characteristics of interventions associated with persistent improvement. Methods: The Durham VA Hem-Onc fellowship program affiliated with Duke University participated in QOPI twice yearly in 2007 to 2010 and Spring (Sp) 2012. Four interventions were implemented focused on treatment planning (TP; Sp07), treatment summary (TS; Fa07), consent (C; Sp07), and aprepitant use (A; Sp09). Effectiveness was determined by reassessment of 4, 3, 1, and 1 measures, respectively. The TP, TS, and C interventions were policy-dictated use of templated documentation or written consent, and, for TP and C, required conformance prior to chemotherapy administration; TS is not linked to a process. The A intervention modified order set templates to include A for highly emetogenic regimens. For each measure, we compared conformance pre-intervention with post-intervention conformance and, for quality indicators not targeted for improvement, the baseline with each subsequent assessment using chi-square. Results: Considering only measures in the core or symptom management modules with unchanged or similar definitions throughout the study period, 13 of 28 measures had conformance &gt; 85% in the baseline 2007 data. TP conformance increased from 64% to 88, 94, 92, and 96% in subsequent years (p &lt; 0.01). TS was 45% at baseline, 43% (p = NS) in the first post-intervention year, decreased to 24% for two years (p &lt; 0.01) and then increased to 38% (p = NS). C increased from 64% to 97, 91, 94, and 100% (p &lt; 0.01). Conformance with A increased from 9% to 78 and 86% (p &lt; 0.01). Among measures not targeted by intervention, smoking assessment and counseling increased in later years. Conclusions: In this single practice experience, QI improvement interventions integrated into physician processes resulted in substantial and persistent improvement while no improvement was observed as a result of policy-required use of standard documentation alone.
Central reporting of human epidermal growth factor receptor-2 (HER2) status and adherence to testing and adjuvant trastuzumab treatment guidelines in Ontario.
Authors: Craig Earle, Ilia L. Ferrusi, Maureen E. Trudeau, Natasha B. Leighl, Eleanor Pullenayegum, Hoa Khong, Jeffrey Hoch, Deborah Marshall
Journal: Journal of Clinical Oncology (2012)

166 Background: Quality monitoring pertaining to trastuzumab treatment requires knowledge of 1) HER2 status, 2) testing methods and sequence, and 3) treatment received. We examined the patterns of HER2 test documentation for early-stage breast cancer (ESBC) patients in Ontario and the adherence of practice patterns to Canadian HER2 testing consensus guidelines and adjuvant trastuzumab treatment guidelines from Cancer Care Ontario (CCO). Methods: Using tumor pathology reported centrally to the Ontario Cancer Registry (OCR) a population-based retrospective cohort of ESBC patients diagnosed in 2006 or 2007 was identified. We evaluated the use of subsequent HER2 fluorescence in situ hybridisation (FISH) after initial immunohistochemical testing, and predictors of trastuzumab use. HER2 test type, sequence, result(s) and status, tumour grade, and hormone receptor status were determined. Trastuzumab treatment was determined from linked drug funding records. Sociodemographic characteristics, prior surgical, radiation and anthracycline treatment, and comorbidity were also determined from administrative data sources. Logistic models estimated adjusted odds ratios for factors associated with guideline (non-)adherence. Results: A HER2 test was documented for 66% of the 13,396 patient cohort. HER2 equivocal tumors were more likely to be retested vs. positive: OR 116 (95% confidence interval [CI] 79, 169). Patients diagnosed with stage III disease had higher odds of having a FISH test vs. stage I (OR 1.5 [CI 1.1, 2.1]). HER2 status was the largest predictor of trastuzumab use, with HER2 equivocal, negative or unknown patients less likely to receive treatment than positive. Patients with advanced age (≥70y) had lower odds of trastuzumab treatment compared to younger patients (OR 0.48 [0.32, 0.73]). Higher tumor grade was associated with higher odds of treatment. Reporting, testing, and treatment all varied significantly by region. Conclusions: Despite limitations in centrally-reported tumour pathology at the time, the use of FISH testing and trastuzumab treatment in Ontario was largely consistent with guidelines, though practices vary across regions.
Updated results of INT70/09 phase II study of pazopanib (PZP) monotherapy for patients with relapsed/refractory urothelial cancer (UC).
Authors: A. Necchi, N. Nicolai, C. Ortega, T. Sava, C. Messina, C. Sacco, F. Crippa, C. Morosi, R. Lanocita, M. Colecchia, L. Mariani, N. Zaffaroni, R. Salvioni
Journal: Journal of Clinical Oncology (2011)

4618 Background: Discouraging results have been achieved in relapsed/refractory UC with the use of either single agents or combination therapies (Rx), including targeted Rx. Promising phase II results with PZP, a multitargeted drug with distinct anti-angiogenic activity, were recently reported (ESMO 2010, LBA23). An update of trial results is presented. Methods: Eligible patients (pts) include histologically confirmed UC unresponsive/relapsing after ≥1 CDDP-based Rx for metastatic disease (perioperative Rx excluded). PZP 800 mg once daily until disease progression or unacceptable toxicity was planned. All pts underwent CT scan and FDG-PET/CT scan at baseline and q4weeks thereafter. An optimal 2-stage Simon’s design was applied with the 1st stage recruiting 21 pts and, if ≥2 responses, a full enrollment of 41 pts. RECIST v.1.1 was used; response-rate (RR) was the primary endpoint. Results: 30 pts were enrolled from 02 to 12/2010. Median age was 64 yrs (43-79). 12 pts (29%) had UC of the upper urinary tract and 18 had a bladder primary tumor. All but one pt had multiple sites of metastases (median 3, range 1-5). Median number of prior cytotoxic agents was 3 (2-8), of prior Rx lines was 2 (1-4) and median number of prior platinum-based cycles was 5 (2-12). 8/30 pts had received RT. 26 pts (84%) had visceral metastases (hepatic in 16 pts). Median ECOG PS was 1 (0-2). 4 pts (13%) had a confirmed RECIST-defined partial response (PR), 20 had a stable disease (80% clinical benefit). 19 pts (63%) had a clear necrotic evolution of multiple metastases and/or a decreased SUV at PET consistent with PR. G3 hypertension occurred in 2 pts, G1-2 asthenia in 11, diarrhoea in 5, anemia and hand-foot syndrome in 3 pts each. No discontinuations/dose reductions were needed. Conclusions: Potential anti-tumor activity of PZP is demonstrated in relapsed/refractory UC. Although the RR by RECIST is low, a significant number of tumor responses were observed by CT-densitometry and PET. The observations are consistent with the mechanism of action of PZP, and highlight the need for new criteria or modifications to existing criteria to assess response of angiogenesis inhibitors. Mature efficacy data will be available in May 2011.
Preliminary results of the validation of a questionnaire to measure health related quality of life (HRQoL) in patients (P) with advanced colorectal cancer (CCRA-Qol)
Authors: M. Benavides, A. Cervantes, F. Gil, J. Sastre, J. Tabernero, M. Pérez, C. Vila, X. Marfà, X. Badía, L. Lizán
Journal: Journal of Clinical Oncology (2005)

6058 Background: HRQoL is an important measure to asses the impact of disease in cancer P. QLQ-CR38 is designed to measure HRQoL in colon cancer P, but it is not specifically designed for the advanced stage of the disease (ACC). Thus, we designed an ACC-specific questionnaire and conducted a validation study of its psychometric properties Methods: Validity and reliability of the CCRA-QoL were assessed throughout an epidemiologic, prospective and multicentric study. 216 P with ACC were included in two groups: 41 P in the reliability group (P for whom no clinical change was foreseen in the following 15 days) and 175 in sensitivity to change (SC) group (P that started a treatment or had a treatment switch). Main endpoint of the study was to assess measuring proprieties of “CCRA - QoL questionnaire”, that was obtained through Rasch analysis, and contains 20 items: 16 items splitted between 4 dimensions and 4 items for colostomized patients. Other characteristics collected were: diagnosis date, stage, disease signs and symptoms, previous treatment, Rotterdam Symptom CheckList (RSC) and ECOG/Karnofsky score Results: The mean (SD) age of the P was 61,8 (10,7), mostly men (71,8%). 72,6% of the SC group P started chemotherapy on the first visit with mainly 5-FU or Capecitabine plus Oxaliplatin based chemotherapy (38,33%). The questionnaire was fully answered by 81% of P. Factorial analysis showed 4 dimensions that explained 56,14% of the variance: physical health problems, psychological impact, disease impact and general health status. Regarding validity, the CCRA-QoL scoring showed a significant relationship with scoring assessed through RSC (R= -0,71 -0,62; P<0,01), ECOG /Karnofsky score (p=0,017), general health status (p<0,01) and visual analogical scale of pain (P<0,01). Internal consistency was assessed through the α Cronbach (α= 0,89). The intraclass correlation coefficient (test - retest reliability) was 0,89, showing right correlation and stability of the questionnaire Conclusions: Preliminary results of CCRA-QoL validation showed good psychometric properties of validity and reliability. Sensitivity to change will be analysed at the end of the study Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration sanofi-aventis Health Outcomes Research Europe Group
The “little big things”: A qualitative study of ovarian cancer survivors and their experiences with the health care system.
Authors: Ana Isabel Tergas, Ana Angarita, Angelica Cristello, Melissa Lippitt, Amanda Nickles Fader, Kara Long
Journal: Journal of Clinical Oncology (2016)

252 Background: Navigating a complex and ever-changing health care system can be stressful and detrimental to psychosocial well-being for patients with serious illness. This study explored women’s experiences navigating the health care system during treatment of ovarian cancer. Methods: Focus groups moderated by trained investigators were conducted with ovarian cancer survivors at an academic cancer center. Personal experiences with cancer treatment, provider relationships, barriers to care, and the health care system were explored. Sessions were audiotaped, transcribed, and coded using grounded theory. Subsequent one-on-one interviews were conducted to further evaluate common themes. Results: Sixteen ovarian cancer survivors with a median age of 59 years participated in the focus group study.Provider consistency, personal touch, and patient advocacy positively impacted care experience.Treatment with a known provider, who was well acquainted with the individual’s medical history, was deemed an invaluable aspect of care. Negative experiences that burdened patients, referred to as the “Little Big Things”, included systems-based challenges: scheduling, wait times, pharmacy, transportation, parking, financial, insurance and discharge. Consistency, a “care-team” approach, effective communication, and efficient connection to resources were suggested as ways to improve patients’ experiences. Conclusions: Systems-based challenges were perceived as burdens to ovarian cancer survivors. The role of a consistent, accessible care team and efficient delivery of resources in the care of women with ovarian cancer should be explored further.
Relationship of overall survival and the frequency of performing transrectal ultrasound-guided biopsy of the prostate in those patients with low-risk tumors electing active surveillance.
Authors: David D. Buethe, Christopher Russell, Binglin Yue, Hui-Yi Lin, Julio M. Pow-Sang
Journal: Journal of Clinical Oncology (2013)

238 Background: Limited derived benefit from definitive treatment has been observed with respect to prostate cancer−specific mortality (PCSM) in those low−risk disease and only small absolute risk reductions in both overall PCSM and incidence of metastasis have been demonstrated. Thus, active surveillance (AS) strategies have been adopted to monitor for disease progression with intent for intervention at time of disease reclassification. Yet, the timing and frequency of surveillance remain without evidence-based standardization. We assessed the relationship between the frequency of surveillance prostate biopsies and the oncologic outcomes in those patients with low−risk prostate cancer (CaP) managed by AS. Methods: An IRB approved retrospective chart review identified 114 patients placed on AS for their CaP between November of 1997 and November of 2000. Of those, 96 patients meet study inclusion criteria mandating a Gleason sum of &lt; 7, tumor presence in &lt; 4 sextets, involvement of &lt;50% of any single biopsy core. Eligible patients were surveyed by serum PSA, DRE, and surveillance TRUS−guided biopsies at physician determined intervals. Results: At diagnosis, the mean age was 70.3 (SD±5.3) years with a mean PSA value of 8.2 (SD±8.2) ng/dL. While on AS, patients underwent a median of 3.5 (SD±2.02) TRUS−guided biopsies; at a frequency approaching 1 biopsy every 18 months. At a median follow−up of 134.8 months (95%CI: 114.5, 148.7), multivariate analysis found more frequent prostatic biopsy acquisition to be inversely associated a worse prognosis with respect to both progression−free (p&lt;0.0001) and overall survival (p=0.0002). Both progression−free (p&lt;0.0001) and overall survival (p=0.0207) were progressively shorter as the interval between biopsies declined from greater than 2 years, to 1−2 years, and then less than 1 year. Conclusions: No survival advantage was achieved by frequent re−biopsy of the prostate. Patients biopsied more frequently were paradoxically found have poorer survival outcomes.
Outpatient palliative care at a tertiary cancer center: Perceptions, pathways, and pitfalls.
Authors: Kavitha Ramchandran, Sandy Trieu, Stephanie Harman, Judy Passaglia, Janet Rodriguez, Patricia Dwyer, Ryan Oden
Journal: Journal of Clinical Oncology (2012)

28 Background: To describe an outpatient palliative care program at a quaternary cancer center- Stanford Cancer Institute. Outpatient palliative care (PC) programs are still in their nascency. Best practices are still being developed and key performance metrics are being delineated. This is a description of Stanford Cancer Institute outpatient PC program. Methods: Observational study of the first six months of encounters to the outpatient PC program. Description of potential barriers to launch and growth, as well as description of resources required for continued success. Data evaluated included program volume, referral patterns, advance care planning, symptom assessment and team structure as collected by the clinical team. Results: Initial barriers to program initiation included lack of funding and infrastructure. Additional barriers included coordination between teams, flow of care (patients late for next appointments), and cultural perceptions of palliative care as equal to end of life care. There are 32 referring practitioners to the program. Over the first six months the outpatient PC program has seen growth with volume increasing from 10 consults per month to 26 consults per month for a total of 60 patients. At the time of initial consult, 11 of the 60 patients seen had an advance directive. Only 1 patient had a physician order for life sustaining treatment (POLST). Code status was documented in 21 of the 60 patients. Conclusions: Our program had multiple barriers to launch: perceptions that palliative care equaled end of life care, lack of infrastructure and funding, and difficulty with coordination between teams. With administrative support the program secured funding, developed infrastructure with the assistance of IT, Cancer Center administration, and Care Coordination. Consults now come from a wide range of providers. Based on preliminary data indicating a very low percentage of completion of these tasks by patients on initial consult there is need for outpatient palliative care for advance care planning. Future growth will include continued penetration of the cancer center, increasing volume of consults, and additional assessments of patient satisfaction, symptom improvement, and hospital utilization.
Clinical practice guidelines (CPGs) for adjuvant chemotherapy (aCT) in colorectal cancer: A population-based analysis of adherence and non-receipt.
Authors: D. Rayson, R. Urquhart, E. Grunfeld, M. Cox, C. Kendell, M. Jorgensen, B. Colwell, G. A. Porter
Journal: Journal of Clinical Oncology (2011)

6064 Background: Although CPGs recommend adjuvant chemotherapy (aCT) for stage IIB/III colon and aCT/radiation for stage II/III rectal cancer, population-based data on adherence and reasons for non-receipt is limited. Our objectives were to determine; (i) the proportion receiving aCT according to CPGs (ii) when aCT was administered, the proportion receiving it within 12 weeks of surgery and (iii) reasons for non-receipt of aCT within 12 weeks of surgery in Nova Scotia (NS), Canada. Methods: All patients with a diagnosis of stage IIB/III colon and stage II/III rectal cancer undergoing curative-intent surgery in NS between 2001-05 were identified through the NS cancer registry (NSCR). Linkage of NSCR and other administrative databases (hospital discharge, physician billing, national census) provided clinical, demographic, diagnostic and treatment data. Standardized cancer center chart abstraction was conducted to determine aCT receipt and timing, or reasons for non-receipt. Eligibility required aCT to begin 3m prior, to 6 months after, curative-intent surgery. Results: 1151 patients met inclusion criteria and 679 (59%) received aCT. On multivariate analysis, factors predicting for aCT receipt were; male sex, age < 75, no readmission < 30 days post-surgery, no previous cancer diagnosis, unknown number of examined lymph nodes, primary rectal (vs colon) cancer, no (vs 2+) co-morbidities and stage III (vs IIB) disease (all p < 0.05). Of the 472 (41%) who did not receive aCT, 250 (53%) did not receive a medical oncology (MO) consult. Among those with aCT receipt, 497 (73.2%) met the 12 week benchmark. Factors associated with meeting this benchmark included; male sex, urban residence, less social deprivation, primary colon cancer and increased length of hospital stay (all p < 0.05). Conclusions: Despite widespread acceptance of CPGs for aCT following curative-intent surgery for colorectal cancer, a significant minority of those eligible did not receive aCT. The most common reason for non-receipt was lack of MO consultation which may suggest early selection of those deemed not candidates for aCT.
Preferences for treatment to delay bone metastases (BM) in patients with castration-resistant prostate cancer (CRPC) at high risk of developing BM.
Authors: Yi Qian, A. Brett Hauber, Juan Marcos Gonzalez, Joshua Posner, Ateesha F Mohamed, Bertrand Tombal, Jean-Jacques Body, Francesca Gatta, Jorge Arellano
Journal: Journal of Clinical Oncology (2014)

117 Background: Limited treatments are available for patients with non-metastatic CRPC. Prophylactic treatment may be associated with adverse events (AE). We evaluated patient preferences for a medication delaying bone metastases (BM) with a risk of AE.Methods: UK and Swedish adults with CRPC at high risk for BM (on androgen-deprivation or hormone therapy for ≥ 3 yrs) completed an online discrete-choice experiment with 10 choice questions. Patients were asked if they would prefer to receive a hypothetical prophylactic medication (HPM) with a risk of osteonecrosis of the jaw (ONJ) to prevent BM or to decline HPM thus not receiving any treatment benefit or risk. HPMs were defined by delay in BM (0-23 months) and risk of ONJ (0-9%). The proportion of patients who chose HPM with different combinations of BM delay and ONJ risk was calculated. To further evaluate the impact of BM to patients, time tradeoff was used to assess patients’ willingness to trade off between life years with and without bone complications (i.e., skeletal-related events, including spinal cord compression, surgery or radiation to bone, and pathologic fracture).Results: A total of 201 UK patients and 200 Swedish patients completed the survey. As shown in the table, even a HPM with the lowest level of BM delay (5 months) and the highest level of ONJ risk (9%) was acceptable to the majority of patients in both countries. Furthermore, when asked about the tradeoff between life years with and without bone complications, 52% of UK patients and 26% of Swedish patients were willing to trade off 5 months of survival to avoid bone complications; nearly three-quarters of the patients were willing to trade off 3 months of survival to avoid bone complications. Conclusions: A majority of patients in the UK and Sweden were willing to take HPMs to delay BM, despite a treatment-related risk of ONJ and were willing to trade off 3 to 5 months of survival to avoid bone complications. [Table: see text]
Fatigue and grades of quality of life (QoL) impairment in advanced cancer
Authors: T. I. Ionova, A. A. Novik, A. V. Kishtovich, S. A. Kaliadina, I. A. Koroleva, M. V. Kopp, D. A. Fedorenko, I. V. Rikov, G. I. Gorodokin
Journal: Journal of Clinical Oncology (2005)

8207 Background: Fatigue is the most distressing symptom in cancer patients which has a great burden on a patient’s QoL. The effect of fatigue severity level on a patient’s QoL is under-reported. Understanding of fatigue interference with a patient’s QoL provides the basis for better cancer management. The goal of this research was to study fatigue prevalence and severity in patients with advanced cancer and to investigate the relationship of QoL impairment to fatigue severity level. Methods: 250 advanced cancer patients: 123 solid tumors (ST), and 127 hematological malignancies (HM) (male/female 151/99; mean age 60.5) were enrolled in the study. To compare with controls a gender- and age-adjusted sample from the St.Petersburg population norm was used. SF-36 and Brief Fatigue Inventory were used for patient-reported outcome assessment. QoL impairment was evaluated on the basis of QoL Index (calculated by the Integral Profile Method). The following grades of QoL impairment as compared to a population norm (PN) were used: mild (25% decrease from a PN), moderate (25–50% decrease), severe (50–75% decrease), and critical (>75% decrease). Results: Fatigue was observed in 92.4% of patients under investigation: 94.3% of ST and 90.6% of HM. The majority of patients experienced severe (7–10) and moderate (4–6) fatigue (11.2 and 47.2%, respectively). Severe fatigue resulted in critical QoL impairment. The majority of patients with moderate fatigue also had critical QoL impairment (61.0%). In patients with mild (1–3) fatigue (34% of the sample) the following distribution between grades of QoL impairment was observed: critical - 15.3%, severe -23.5%, moderate -10.6%, mild - 20%, no impairment -30.6%. Patients with no fatigue (7.6% of the sample) exhibited no or mild QoL impairment. Conclusions: The majority of patients with advanced cancer experience severe and moderate fatigue which in most cases results in critical QoL impairment as compared to a population norm. Assessment of fatigue severity and grading of QoL impairment is worthwhile to provide adequate management of advanced cancer. No significant financial relationships to disclose.