bluuebunny/crossref_metadata_2025_split huggingface dataset:
Evaluating end of life care: The Quality Oncology Practice Initiative (QOPI) experience
Authors: Neuss M. N. , Jacobson J. O. , Earle C. , Desch C. E. , McNiff K. , Thacker L. , Simone J. V. 
Published: April 2020

8573 Background: Little is known about the quality of end-of-life (EOL) care provided to cancer patients, with data largely available only from administrative databases. QOPI is a practice-based system of quality self-assessment now available to any ASCO physician wishing to participate. QOPI methodology allows comparison of EOL care among practices and provides a basis for self-improvement. Methods: In Summer 2005, during the pilot phase of QOPI, several EOL questions were included in the survey instrument. Practices were requested to review the records of at least 15 patients who had died. Practice members performed standardized chart abstractions and data were entered directly on to a secure web-based application. A total of 455 charts were abstracted from 22 practices. Results: See table. Conclusion : QOPI provides an effective mechanism for collecting practice-specific EOL data. Aggregate data from the 22 QOPI pilot practices demonstrate a high level of performance compared with results reported from population-based studies. Significant variation among practices is present, representing an opportunity to improve the EOL care of cancer patients. [Table: see text] No significant financial relationships to disclose.
The use of palliative sedation for intractable symptoms in a palliative care unit (PCU) in a comprehensive cancer center
Authors: Elsayem A. , Curry E. , Boohene J. , Ibrahim H. , Pace E. , Hung S. , Bruera E. 
Published: April 2020

8577 Background: There is wide variation in the frequency of reported use of palliative sedation (PS) to control intractable and refractory symptoms. Institutions have established policies for midazolam infusion in cases of PS. The indications and outcomes of this procedure have not been well characterized Methods: Our midazolam policy for PS requires 1:1 nursing for the first 24 hours and documentation of discussions regarding sedation. We reviewed our PCU database for all admissions for the first 11 months of 2005. We used pharmacy records for all patients who received medications used for sedation (chlorpromazine, lorazepam, midazolam). We reviewed all charts of pts who received any of these drugs to establish if the indication had been PS. Results: 148/484 admissions died in the PCU [31%]. 65/484 admissions (13%), and 47/ 148 patients who died (32%) received PS. Median age of patients (pts) was 58, 42 pts were male [65%], and the most frequent primaries observed were lung 24 [37%], hematologic 12 [18%], head and neck 7 [11%], and gastrointestinal 7 [11%]. Results are indicated in the table. * 2 patients had more than one indication for sedation The main causes for PS in our patients were delirium 57 [88%], dyspnea 6 [9%], and bleeding 4 [6%]. 18/65 patients who received PS [35%] were discharged alive, versus 318/419 [76%] who did not receive PS [p< 0.001]. Midazolam was used in 11/65 episodes [17%]. 4/6 pts with PS for dyspnea received midazolam [66%], versus 8/57 with PS for delirium or bleeding [14%], p=0.01]. 18/54 pts who received PS using other drug were discharged alive [33%], versus 0/11 pts who received midazolam [p=0.02]. Conclusions: Palliative sedation was required in 32% of pts who died in the hospital. Reporting midazolam utilization rates for monitoring overall PS outcomes, results in significant under reporting. Midazolam was used more frequently in cases of progressive dyspnea and poor prognosis. Less restrictive policies in the use of midazolam may result in more use for PS. Data accrual continues. [Table: see text] No significant financial relationships to disclose.
Symptom assessment tools used in a hospital-based pain and symptom care program at the University of North Carolina–A novel proxy rating system
Authors: Bernard S. A. , Lee C. B. , Usher B. , Qaqish B. , Schwartz R. , Hanson L. C. 
Published: April 2020

8579 Background: Level of consciousness (LOC) often varies in the palliative care patient population. Tools are needed to reliably rate symptoms. The purpose of our analysis was to describe the patient demographics and rating distributions elicited by two distinct measurement tools, one for those able to self-rate (SR) and one for proxy-rated (PR) patients. Methods: Data obtained prospectively over the time period 1/2002–12/2004 was reviewed. A symptom distress scale using 11 items on a 5 point Likert-type scale (5=most severe) was adapted from the revised McCorkle symptom distress scale and used for alert and oriented patients. Symptoms evaluated included nausea, mood, appetite, shortness of breath (SOB), insomnia, pain, mobility, fatigue, constipation, decreased LOC, and delirium. For patients unable to SR, an advanced practice nurse rated symptoms using the Detroit Medical Center non-verbal pain scale and proxy symptom distress measures adapted from the Common Toxicity Criteria Manual, version 2. Rated symptoms included pain, vomiting, constipation, tachypnea, depressed LOC, and agitated delirium. Results: A total of 259 patients with data from visits 1 and 2 were included in the analysis. On visit 1, 46% (61/133) of PR patients were male, 70% (94/134) were ≥60yrs and 73% (98/134) were Caucasian. Symptom distress scores varied by rater and visit (Table). Conclusions: There is a need for proxy symptom distress measurement in the palliative care patient population as LOC fluctuates. Variability in symptom distress ratings between the SR and PR groups, with a trend toward lower scores in PR patients, is in accordance with the current literature. Of note, there was a consistent improvement in scores, regardless of rater, when visit 2 was compared to visit 1. We plan a prospective study of inter-rater reliability and validity of this novel symptom scoring system. [Table: see text] No significant financial relationships to disclose.
What is the value added of patient reported outcomes relative to physician rated symptom assessments?
Authors: Mandrekar S. J. , Huschka M. M. , Schaefer P. L. , Jett J. R. , Adjei A. A. , Sloan J. A. 
Published: April 2020

8580 Background: This pooled analysis examined the relationship between single-item and multiple-item quality of life (QOL) measures and assessed the agreement between changes in QOL and patient-reported adverse events (AE). Methods: Data from six lung cancer clinical trials involving 358 patients were pooled. All trials incorporated the UNISCALE and one of three multiple-item assessments: the Functional Assessment for Cancer Therapy-Lung, the Lung Cancer Symptom Scale, or the Symptom Distress Scale. A clinically significant decline (CSD) in QOL was defined as a 10-point drop from baseline. A CSD in AE was defined as a change from ≤ grade 2 at baseline to ≥ grade 3 post-baseline. Spearman rank correlations and Bland-Altman approach were used to assess agreement. The Kaplan-Meier method was used to evaluate the time to the first occurrence of a severe (grade 3+) AE and first CSD in QOL. Results: Correlations between the UNISCALE and multi-item assessments were modest (rho=0.49–0.66). At least one 10-point decline in the UNISCALE and multi-item assessments were reported by 58% and 40% respectively. At least one severe AE was reported in 44% of patients post-baseline. The percent agreement between experiencing a severe AE and a CSD in QOL was 49% and 59% for UNISCALE and the multi-item tools. For individual AE, the percent agreement between a CSD in AE and a CSD in QOL ranged from 37% to 50% for UNISCALE and 44% to 69% for the multi-item tools. The median time to the first CSD in QOL for UNISCALE and multi-item tools was 67 and 142 days respectively. The median time to the first occurrence of a severe AE was 304 days. Conclusions: QOL and AE provide quantifiably different information. A 10-point decline in QOL occurs earlier than CTC AE reporting. Patient reported outcomes may be more sensitive in identifying clinically relevant problems than physician rated symptom assessments. No significant financial relationships to disclose.
Symptom clusters in irradiated brain tumor survivors
Authors: Saconn P. A. , Ip E. , Rapp S. , D’Agostino R. B. , Naughton M. J. , Gleason J. , Shaw E. G. 
Published: April 2020

8581 Background: Symptom clusters, whereby ≥2 symptoms coexist within patients, occur with cancer and its treatment. Identification and treatment of symptom clusters may improve functional status and health-related quality of life (HRQL). We report the characterization of symptom clusters occurring in irradiated brain tumor survivors. Materials/Methods: 34 adult survivors of primary or metastatic brain tumors following partial or whole brain irradiation ≥6 months prior were enrolled in an open-label Phase II study of donepezil, an acetylcholinesterase inhibitor (Rapp et al and Shaw et al, Neuro-Oncology 6:357 and 358, 2004). Eligibility criteria included life expectancy ≥30 weeks, no imaging evidence of progressive brain disease ≥3 months, stable/decreasing steroid dose, Karnofsky Performance Status (KPS) ≥70, and no brain tumor therapy during the study period. Patients received donepezil 5mg/day for 6 weeks, then 10mg/day for 18 weeks, followed by 6 weeks observation off drug. Symptoms were assessed at baseline, 6, 12, 24, and 30 weeks with the Functional Assessment of Cancer Therapy - Brain (FACT-Br) and Profile of Mood States (POMS). Factor analysis, multidimensional scaling and multivariate cluster analysis were used to characterize symptom clustering. Results: Of 34 patients enrolled, 24 remained on study for 24 weeks and 21 remained for the entire 30 weeks. Utilizing the HRQL data, all three methods of analysis demonstrated 3 distinct symptom clusters: mood, cognition and energy. The factor analysis table below illustrates such findings. Conclusions: Three symptom clusters with symptoms related to mood, cognitive function and energy were identified in this group of irradiated brain tumor survivors. Further research should focus on therapeutic interventions for symptom clusters rather than the traditional emphasis on single-symptom therapy. This study was supported by NCI grant 1 U10 CA81851. [Table: see text] No significant financial relationships to disclose.
Evaluation of quality of life (QoL) in 1,210 patients (pts) with metastatic colorectal cancer (MCRC) treated with capecitabine (X) in Brazil: Udated results from a large pt cohort with analysis as a function of pts’ ECOG PS
Authors: Beato C. A. , Van Eyll B. , Federico M. H. , Skare N. , Perdicaris M. R. , Franke F. A. , Oliveira C. , Cabral S. , Ribeiro R. , Gampel O. 
Published: April 2020

8586 Background: The oral fluoropyrimidine X has superior efficacy and improved safety vs. 5-FU/LV in MCRC and early-stage colon cancer. Consequently, X is replacing 5-FU/LV as the backbone of MCRC therapy and is moving into the adjuvant setting. The QoL benefits of oral agents like X over traditional i.v. drugs are becoming more important in MCRC. Methods: Pts with MCRC who received standard oral X (1,250 mg/m2 twice daily on days 1–14, every 3 weeks) until progressive disease or unacceptable toxicity completed EORTC QLQ C-30 (v3.0) and CR-38 questionnaires at baseline, before cycle 1, at weeks 7 and 13, and at end of treatment. The proportion of pts with improvement, stabilization or worsening of QoL scores from week 7 was analyzed using linear models with repeated measures (generalized estimating questions technique) and SAS (v8.2). Each questionnaire item was analyzed as a function of pts’ ECOG status before first cycle and the evaluation periods. Results: Here we report QoL findings in 1210 pts (male/female, 51%/49%); median age 60 years (range 20–91); 53% of males and 57% of females had ECOG 0 at baseline. Almost half of the pts completed QoL questionnaires through to the end of treatment. Around 42% of pts who presented ECOG ≥1 had ECOG 0 at the end of treatment. Regardless of the baseline ECOG score, pts had significant improvements (p<0.0001 unless stated) in pain (p<0.0002), stoma-related problems (p=0.0003), defecation problems (p=0.0112), appetite loss (p=0.001), weight loss, insomnia (p=0.0074), constipation, body image (p=0.0142), emotional functioning, social functioning (p=0.0170), financial problems (p=0.0407), future perspective, and global health status (p=0.0003). Conclusions: X was associated with improved QoL, with significant benefits observed in most functional/symptomatic QoL domains. The efficacy, safety and convenience benefits of X as reported previously appear to have a direct impact on QoL. These data support its increasing use in the first-line and adjuvant settings. No significant financial relationships to disclose.
National survey of advanced prostate cancer patients reveals disparity between perceptions and reality of treatment
Authors: Kirk T. N. , Moyad M. A. 
Published: April 2020

8590 Background: Over 50,000 men developed hormone refractory prostate cancer (HRPC) in 2005 (CancerMetrics 2005). The objective of this analysis is to understand patient attitudes towards advancing prostate cancer (PC) and treatment. Methods: Patients were recruited from NexCura’s database of users and links from PC websites: UsTOO, PCRI, PCF and PAACT. Board certified physicians who treat HRPC were recruited by J. Reckner & Assoc. Responses were collected via online survey and analyzed by TSC, a division of Yankelovich. Grant funding from Abbott. The scale was “agree”, strongly agree”, “disagree” or “strongly disagree.” Results: 409 HRPC patients (P), 236 caregivers (C), 100 urologists (U) and 104 oncologists (O) participated. 45% of patients have metastatic HRPC. Mean patient age was 65.7 and age at diagnosis was 60.2. Conclusions: Many patients and caregivers have difficulty with advancing PC. Respondents recognize the survival benefit associated with chemotherapy, but attitude on its impact on quality of life varies significantly. Disparity exists between patients, caregivers and physicians on the impact of treatment on quality of life. Additional education, enhanced dialogue and additional treatment options are needed for HRPC patients, caregivers and physicians. [Table: see text] [Table: see text]
The time taken to complete quality of life questionnaires in an advanced cancer trial
Authors: Stockler M. R. , Heritier S. , Nowak A. K. , Goldstein D. , Turner J. , Jefford M. , Glasgow A. , Abdi E. , Beale P. J. , Carter C. 
Published: April 2020

8592 Background: Respondent burden is important when designing trials in advanced cancer. We determined the time taken to complete a set of quality of life questionnaires (TTTCQ) in a randomized trial of sertraline in advanced cancer. Methods: Participants recorded the times they started and finished an 11 page questionnaire of 187 items including the Centre for Epidemiologic Studies Depression Scale, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy General and Fatigue scales, and 4 other validated instruments. Determinants of the TTTCQ were sought amongst the self-ratings of anxiety, depression, fatigue, trouble concentrating, other aspects of quality of life, and other characteristics including age, Karnofsky Performance Status (KPS) and treatment. Distributions are summarised by their median, interquartile range (25th to 75th percentiles, IQR) and interdecile range (10th to 90th percentiles, IDR). Associations were assessed with Spearman’s rank correlation coefficient (r), and differences with the Mann-Whitney test. All p-values are two-sided. Results: The TTTCQ was available for 128 of 150 subjects (85%). Median age was 66 (IQR 59 to 73), median KPS was 80 (IQR 70 to 90), and 63% were male. The median TTTCQ was 30 mins (IQR 23 to 40, IDR 15 to 50), equating to a median of 10 secs per item (IQR 7 to 13, IDR 5 to 16). The TTTCQ was modestly correlated with age and KPS (r = 0.19, p = 0.04 for both). Age and KPS were not correlated (r = 0.03, p = 0.8). Subjects aged 60 or older had a median TTTCQ 10 mins longer than those 59 or younger (35 v 25 mins, p = 0.002). Subjects with a KPS of 100, 90, 80, and 70 or less had a median TTTCQ of 20, 25, 31, and 35 mins respectively. TTTCQ was modestly correlated with self-ratings of: problems coping with treatment, dry mouth, feeling dizzy or lightheaded (r = 0.22 to 0.25, p = 0.01). Correlations were weak or non-existent with all measures of depression, anxiety, trouble concentrating, emotional well-being, and overall well-being (r = 0.10 to 0.18, p = 0.04 to 0.25). TTTCQ was unaffected by gender, opioids, steroids and number of previous cytotoxic regimens. Conclusions: Respondent burden was less of a problem than anticipated and little affected by treatments or self-rated psychological problems. No significant financial relationships to disclose.
Quality of life (QoL) improvements in 1,464 patients (pts) with metastatic breast cancer (MBC) receiving capecitabine (X) in Brazil: Updated results from a large pt cohort, including analysis as a function of pts’ ECOG PS
Authors: Oliveira C. , Ribeiro R. , Segalla J. G. , Tessaro S. , Cabral S. , Franke F. A. , De Paula U. , Moura G. L. , Perdicaris M. R. , Garicochea B. 
Published: April 2020

8599 Background: The oral fluoropyrimidine capecitabine is highly active and well tolerated as single-agent therapy and extends survival when added to docetaxel in pretreated MBC. QoL data would enhance understanding of X’s pt benefits. Methods: QoL was evaluated in women with anthracycline ± taxane-pretreated MBC while receiving X (baseline, before cycle 1, at weeks 7 and 13, and at treatment end) using EORTC QLQ C-30 (v3.0) and BR-23 questionnaires. We used linear models with repeated measures (generalized estimating questions technique) and SAS (v8.2) to determine improvement, stabilization or worsening of QoL scores from week 7 onwards. Each questionnaire item was analyzed as a function of pts’ ECOG status before first cycle and the evaluation periods. Results: Baseline characteristics of the 1,464 evaluable pts were: median age 54 years (range 22–92); 42% had ECOG 0. As expected, pts with worse initial PS (ECOG ≥2) had lower mean scores during treatment. Regardless of baseline ECOG score, X therapy was associated with significant (p<0.0001 unless stated) improvements in pts’ perception of: role functioning (p=0.001), pain, nausea/vomiting, fatigue, constipation, emotional functioning, and global health status. Capecitabine was also associated with significant improvements in pts’ perception of systemic therapy side effects (p<0.0001), breast symptoms (p<0.0001), arm symptoms (p=0.0047), hair loss (p<0.0001), and future perspective (p<0.0001). Conclusions: Pts receiving X had substantial improvements in almost all functional and symptomatic QoL domains. These findings highlight the importance of considering QoL and other measurable benefits of oral treatments alongside well-established measures of clinical evaluation in pts with metastatic disease. The QoL benefits, together with other proven clinical outcomes, suggest that early use of X in MBC would be of benefit to pts. No significant financial relationships to disclose.
The Life Tape Project, an existential intervention for cancer patients: A report on perceived benefits and changes in quality of life
Authors: Rosenbaum E. H. , Garlan R. W. , Siegel A. L. , Henderson S. , Hirschberger N. , Butler L. D. , Spiegel D. 
Published: April 2020

8604 Background: Facing cancer, most patients struggle with mortality and threats to their emotional equilibrium and that of their families. Families may become closer, but often communication difficulties and isolation increase. The Life Tape Project (LTP) is an intervention—involving a two hour video-taped genealogy and life story in the presence of family—designed to help patients and families confront this existential crisis. An important aspect is the cultivation of Symbolic Immortality—that some important part of the person continues to exist symbolically, even after death—helping patients identify with things greater and more enduring than themselves, and providing a sense of what will remain with the family after they are gone. Observation and pilot data suggested patients receive substantial benefits from the LTP. Results from an ongoing study designed to quantify and extend these observations are reported. Method: Adults with any cancer diagnosis are recruited from the general population. Patients complete baseline questionnaires before the LT interview and follow-up packets two and ten weeks after. Measures include the FACT-G for Quality of Life (QOL) and a Perceived Benefits Questionnaire covering eight themes suggested by previous research. A final semi-structured interview probes for unwanted effects. Results: At first follow-up (N = 23 as of 1/8/06) repeated measure t-tests revealed significant increases in FACT-G Functional and QOL (Total) scales; and a majority of patients reported substantial benefits (endorsing “very” or “extremely true for me”) in at least one theme. Final interviews revealed no unwanted effects. Conclusions: The LTP is a powerful, safe, and accessible intervention that can improve family communication and connectedness, promote personal growth, and reduce existential anxiety through the creation of symbolic immortality. Requiring minimal equipment and time, it would make an excellent addition to any supportive care program. [Table: see text] No significant financial relationships to disclose.
Benefits of exercise in combination with epoetin alfa for multiple myeloma
Authors: Coleman E. A. , Coon S. K. , Kennedy R. , Lockhart K. , Anaissie E. J. , Barlogie B. 
Published: April 2020

8605 Background: Epoetin alfa increases hemoglobin levels and reduces the need for RBC transfusions in diverse groups of patients with cancer-related anemia. Interest in other potential benefits led to this study comparing outcomes relative to the duration of epoetin alfa therapy and exercise for patients receiving intensive therapy for multiple myeloma while enrolled in a randomized, controlled trial of a home-based individualized exercise program. Outcomes of interest included the number of attempts at and days of stem cell collection relative to exercise and the time to recovery post transplant, response to treatment, as well as RBC and platelet transfusions relative to the duration of epoetin alfa and exercise. Methods: The patients were enrolled in a treatment protocol consisting of high dose chemotherapy and tandem stem cell transplants. Participants were randomized to exercise (n = 54) or usual care (n = 57) groups as they enrolled in the treatment protocol. Participants in both groups received epoetin alfa according to an algorithm. All participants were in the study for approximately 15 weeks through stem cell collection. Sixty-nine (69) of 70 consecutive eligible patients continued in the study for approximately 15 weeks more through their first transplant. Results: All groups of patients were equivalent for age, gender and race and the exercise and usual care groups were equivalent for duration of epotein alfa. There were non significant findings for post transplant recovery and response to treatment relative to the duration of epoetin alfa therapy and exercise program. Patients who received epoetin alfa for the longer duration had significantly (p < .01) higher mean hemoglobin levels during the transplant period but there was no significant difference at discharge from transplant. Patients in the exercise group had significantly (p < .05) fewer RBC and platelet transfusions and significantly (p < .05) fewer attempts at stem cell collection and total days of collection. Conclusions: These findings suggest that exercise in combination with prophylactic epoetin alfa therapy benefits patients by reducing the number of RBC and platelet transfusions and the number of attempts at and number of days of stem cell collection. [Table: see text]