bluuebunny/crossref_metadata_2025_split huggingface dataset:
Feasibility and acceptability of a novel web portal to enhance legacy building for adults with advanced cancer.
Authors: Bernat Jennifer Kim , Johns Shelley A. , Brown Linda F. , Hook Nancy E. , Althouse Sandra , Helft Paul R. 
Published: February 2017

140 Background: Being diagnosed with advanced cancer is a painful reality encompassing physical, psychosocial, and spiritual challenges as death draws near. Some patients cope resiliently, while others struggle. Dignity therapy (DT) is an empirically supported intervention where patients reflect on meaningful memories and values during interviews. These interviews are transcribed into a legacy project (LP) that can be edited and shared with loved ones. DT has been shown to benefit patients and LP recipients; however, it requires resources to implement and is not widely available in community settings. We developed a narrative intervention based on DT using a novel web portal (ZarpZ) to disseminate the LPs. This pilot assesses the feasibility, acceptability, and efficacy of our intervention to determine if it could be an affordable, user-friendly, and accessible alternative to traditional DT. Methods: Adults (n=16) with advanced-stage solid malignancies participated in a therapist-led intervention including (1) a modified DT session; (2) orientation to ZarpZ; and (3) brief weekly phone calls to aid self-led online LP building. We collected baseline and post-intervention data on primary (acceptability) and secondary (existential well-being, dignity, demoralization, peaceful acceptance of illness, and family communication) outcomes. Results: 69% of participants completed a LP. Participants reported high satisfaction with the LP created (100%) and with the intervention, particularly the home visit with the interventionist (81%). Participants were less satisfied with ZarpZ—only 45% used it. Among ZarpZ users, 40% reported it as somewhat difficult to use. Our sample was not distressed at baseline; thus, post-intervention secondary outcomes did not significantly differ from baseline. Conclusions: Participants found value in the intervention and in the LPs created, but were generally dissatisfied with ZarpZ. Future research should aim to improve usability. Since our sample size was small and participants were not distressed at baseline, we were not able to show significant improvement in secondary outcomes. Future research should examine these outcomes in a larger and more distressed sample.
Effect of dosing interval on pharmacokinetics and safety of fentanyl pectin nasal spray.
Authors: Chen Cuiping , Bujanover Shay , Gupta Anita 
Published: February 2017

148 Background: Fentanyl pectin nasal spray(FPNS) contains fentanyl citrate and is approved for treatment of breakthrough cancer pain. Nasal delivery allows direct nasal epithelium-to-blood absorption of fentanyl, and thus rapid and effective pain relief. This study evaluated the effect of dosing interval on pharmacokinetics (PK) and safety/tolerability of FPNS. Methods: This was an open-label randomized study in healthy volunteers. Five treatments were administered under naltrexone block to the right nostril, with a ≥3-day washout period: 1 x 100 μg (A); 2 x 100 μg, 4-hr (B), 2-hr (C), and 1-hr apart (D); and 8 x 100 μg consecutively (E). Blood samples were collected and analyzed for plasma fentanyl concentrations. PK data were derived using a non-compartmental model method. Results: 13 subjects were enrolled, 10 (77%) completed the study. For the two-dose regimens, Cmax was higher after the second dose than the first; the increase was statistically significant for the 1- and 2-hr intervals, but not the 4-hr. There were no significant differences in AUC among them. Eight consecutive 100-µg doses resulted in an ~5-fold in Cmax and AUC of those of a single 100-µg dose, suggesting a less than dose proportional increase in rate (peak) and extent (AUC). No new adverse events (AEs) were observed. 53% of subjects reported ≥1 AE, with dizziness (11.9%) and somnolence (4.9%) most common. 12.9% of subjects discontinued due to AEs. All AEs rapidly decreased to sustained low levels after 4–5 weeks. Conclusions: FPNS at 100-800 µg was well tolerated. The shorter the dosing interval, the higher the second Cmax. Dosing interval had no effect on AUC. Exposure plateaued after 8 consecutive 100 µg doses to the same nostril, suggesting an additional safety feature of FPNS. [Table: see text]
Association of lower patient ratings of physician communication with need for symptom management in lung and colorectal cancer patients.
Authors: Walling Anne M. , Keating Nancy Lynn , Kahn Katherine Leslie , Dy Sydney Morss , Malin Jennifer , Arora Neeraj K. , Mack Jennifer W. , Adams John L , Antonio Anna Liza M. , Pantoja Philip , Tisnado Diana M. 
Published: February 2017

153 Background: Symptoms are prevalent among cancer patients, but little is known about how often patients’ needs for symptom management are met or what factors are associated with unmet needs. Methods: Patients with lung and colorectal cancer from the diverse nationally-representative Cancer Care Outcomes Research and Surveillance cohort completed a survey approximately 4-6 months following diagnosis (n=5,422). We estimated the prevalence of unmet needs for symptom management during the 4 weeks prior to the survey, with unmet needs defined as patients reporting that they wanted but did not receive help for at least one symptom (pain, fatigue, depression, nausea/vomiting, cough, dyspnea, diarrhea). Using a pre-specified conceptual model, we identified patient factors associated with unmet need using multivariable logistic regression with random effects (fixed slopes model with random intercepts for each Primary Data Collection Research site). We also tested whether clinical visits before the interview were associated with unmet need. Results: Overall, 15% (791/5,422) of patients had at least one unmet need for symptom management. Adjusting for patient sociodemographic and clinical factors, African American race, being uninsured or poor, having lung cancer versus colorectal cancer, early- vs. late-stage disease, and the presence of moderate to severe symptoms were associated with greater unmet need (all p<.05). Patients who rated their physicians communication score below 80 (on 1-100 scale) had adjusted rates of unmet need that were more than twice those of patients who rated their physicians with a perfect communication score (23.0% v. 10.0%, OR=3.05, p<0.001). Neither visits with specialty physicians (medical oncology, radiation oncology, surgery, or primary care) nor the total number of outpatient visits in the 28 days before the interview were associated with unmet need (all p>.05). Conclusions: A significant percentage of newly diagnosed lung and colorectal cancer patients report unmet needs for symptom management. Interventions to improve symptom management should consider the importance of physician communication to the experience of disease.
The frequency characteristics and outcomes among cancer patients with delirium admitted to an acute palliative care unit (APCU).
Authors: De La Cruz Maxine Grace Jaucian , Ransing Viraj , Yennu Sriram , Chisholm Gary B. , Bruera Eduardo 
Published: February 2017

158 Background: Delirium is a common neuropsychiatric condition seen in patients (pts) with severe illness such as advanced cancer. Few studies on delirium frequency and course had been undertaken in pts with advanced cancer. We aimed to determine the frequency, characteristics and outcomes of pts with advanced cancer admitted to an APCU. Methods: Medical records of 609 consecutive pts admitted to the acute palliative care unit from January 2011-December 2011 were retrospectively reviewed. Demographics, Memorial Delirium Assessment Scale (MDAS), Palliative Medicine specialist (PMS) diagnosis of delirium, delirium etiology, subtype, reversibility, late development of delirium, and discharge outcome were collected. Delirium was diagnosed with MDAS score > 7 or by a PMS using DSM-IV TR Criteria. All pts admitted to the APCU had standardized assessments and management of delirium per best practice guidelines in delirium management. Descriptive statistics were used. Results: 317/609 (52%) APCU pts had a diagnosis of delirium; 214/317 (67%) on admission and 103/317 (33%) developed delirium after admission to the APCU. Hyperactive delirium was the most frequent type of delirium 117/317 (37%) followed by hypoactive 101/317 (32%) and mixed type 91/317 (29%). Haloperidol was the most commonly used medication to treat symptoms of delirium 210/317 (66%) followed by chlorpromazine 61/317 (19%). The use of olanzapine, lorazepam and other antipsychotics were minimal. Other interventions included opioid rotation 55/119 (46%), hydration 10/119 (8%), antibiotics 2/119 (2%) and combination treatment of opioid rotation, hydration, correction of electrolytes and antibiotics 52/119 (44%). Counseling of the caregivers and patient when indicated was performed in all cases. Delirium reversed in 98/317 (31%) of episodes. The majority of pts with delirium were discharged to hospice 130/317 (41%). Conclusions: About half of the pts admitted to the APCU had delirium. The predominant type was hyperactive delirium. Reversibility occurred in only a third of cases. Haloperidol was the main pharmacological agent. Pts with delirium were more frequently discharged to hospice.
Serum-derived bovine immunoglobulin in the alleviation of irinotecan-induced mucositis.
Authors: Bateman Emma Hazel , Weaver Eric , Klein Gerald , Plews Erin , Wignall Anthony , Wozniak Belinda , White Imogen , Keefe Dorothy M. K. 
Published: February 2017

166 Background: Gastrointestinal (GI) mucositis is associated with diarrhoea and intestinal barrier dysfunction caused by apoptosis, immune dysfunction, and microbiome alterations. Serum-derived bovine immunoglobulin (SBI) has been shown to ameliorate inflammation in colitis models, has been shown to improve HIV-induced enteropathy and nutritional status, and is being investigated in post-surgical recovery in oncology patients. We investigated in a rat model whether SBI was effective in alleviating symptoms of GI mucositis. Methods: Animals were gavaged with 250 or 500mg/kg of SBI twice daily, before intraperitoneal administration of 200mg/kg irinotecan on day 4, and for 6 days post-irinotecan. Animals were monitored for bodyweight and diarrhoea. Tissues were collected at necropsy 6, 48, 96 and 144 hours post-irinotecan. H&E-stained colon and jejunum were analysed for histological damage. Results: The overall incidence, severity and duration of diarrhoea, and clinical symptoms of mucositis, were decreased in irinotecan-treated animals that had received SBI. Animals receiving 500 mg SBI/kg also tended to lose less bodyweight than animals treated only with irinotecan (P>0.10). Animals receiving SBI had less pronounced irinotecan-induced changes in neutrophil levels (P≈0.02), and lower tissue damage scores than those receiving irinotecan alone (P<0.0001). Conclusions: Twice-daily oral gavage of SBI was well-tolerated, and reduced the incidence, severity and duration of irinotecan-induced mucositis. SBI was associated with less pronounced changes in inflammatory cell levels and intestinal tissue damage. Ongoing experiments aim to explore the mechanisms of SBI-associated gastrointestinal protection.
Frequency and burden of patient-reported chemotherapy toxicities in community-based oncology practices.
Authors: Friese Christopher Ryan , Stella Philip J. , Lavasseur Beth , Adams Paul T. , Swafford Lauren , Lewis JoAnn , Mendelsohn-Victor Kari Michigan 
Published: February 2017

178 Background: Patient-reported outcomes measurement is recommended to improve care delivery. Toxicities are important to study given their impacts on treatment completion. We captured patient-reported toxicities in community-based oncology practices and identified toxicities associated with excess health care service use. Methods: We surveyed newly-diagnosed patients who completed their first chemotherapy cycle at 5 community practices. Exclusion criteria were prior cancer history, non-English speakers, psychiatric diagnosis, and clinical trial participation. At the second cycle return visit, patients completed a questionnaire that measured the severity of nausea, vomiting, diarrhea, constipation, mouth sores, intravenous catheter problem, pain, fever/chills, extremity edema, and dyspnea. These were rated on a 5-point scale (1= did not experience to 5 = very severe). Patients also reported unscheduled oncologist visits, emergency department visits, or inpatient hospitalization. Results: Of 117 eligible patients, 106 (91%) participated. Most patients (98%) were white, 25.5% were male, and the mean(SD) age was 60 (11) years. The most frequent diagnoses were breast (43%), lung (21%), colorectal cancer (13%), and non-Hodgkin lymphoma (13%). Between cycle 1 and 2, frequent severe or very severe toxicities were nausea (30%), pain (18%), diarrhea (9%), and mouth sores (9%). 15% of patients had an unscheduled oncologist visit, 18% had an emergency department visit, and 9% of patients were admitted. Nausea (11.3%) and diarrhea (6.6%) were frequent reasons for unscheduled oncology visits; nausea and pain (both 5%) for emergency department visits, and; pain and dyspnea (both 2%) for hospitalization. Conclusions: Patient-reported toxicity monitoring is feasible and informative in community-based oncology practices. Despite widespread antiemetic use, nausea is a pervasive problem for newly-treated patients and drives excess service use. Pain assessment and management strategies are needed to reduce emergency department visits and hospitalizations.
The benefits of early integration of palliative care as a part of standard outpatient oncology care.
Authors: Srivastava Piyush 
Published: February 2017

18 Background: It is well known that palliative care (PC) services are skillful in aligning patients' goals of care with healthcare team’s plan of care and treating symptoms related to an advanced disease. The culture of PC is now focusing efforts upstream since earlier interaction fosters more thoughtful discussion of goals and more effective symptom management. Decreased or late access to PC services has traditionally been due to physician factors, including inaccuracies in prognostication, personal bias and lack of awareness of PC mission. With this understanding, we have consciously constructed a robust, standardized, formalized process in the oncology setting for patient identification and automatic referral to the outpatient PC clinic as a part of usual care to diminish the influence of oncologists. Methods: Due to the wide geographic area of our population, there are five ½ day outpatient PC clinics, two of which are embedded in outpatient oncology centers at two medical centers. These are staffed by an MD and RN, with option of chaplain and social work interventions. The Edmonton Symptom Assessment Scale serves as our tool to monitor patient’s clinical course. We have created a reproducible, patient selection and outreach process to make PC as part of ‘normal’ cancer care. Results: 330 oncology patients were seen over a 20 month period. Of these only 8 PC clinic patients received chemotherapy in the last 30 days prior to death vs 153 patients who were not seen in PC clinic. Within the last 14 days of life no patients who were seen in PC clinic received chemotherapy vs 54 patients who were not seen in clinic. This compares well to the national average of 10%. 55% were referred to hospice compared to the national average of only 11%. The average LOS for hospice was 50.8 days compared to the national average of 40.6 days. ER visits decreased by 15% and hospital admissions decreased by 63% for patients with PC clinic encounters. Subjectively, patient’s symptoms improved by 75%. Conclusions: These upstream encounters facilitate more thoughtful medical decision making for patients with terminal cancer diagnosis, improving quality of care and QOL and positively affecting hospital utilization.
Association of opioid requirement and cancer pain with survival in advanced non-small cell lung cancer.
Authors: Zylla Dylan Michael , Kuskowski Michael , Gupta Kalpna , Gupta Pankaj 
Published: February 2017

183 Background: Pain is associated with shorter survival in non-small cell lung cancer (NSCLC). Lung cancer cells express opioid receptors. Opioids promote angiogenesis, tumor growth and metastases, and shorten survival in animal models. Methods: To examine if long-term opioid requirement, independently of chronic pain, is associated with survival, we studied 209 patients treated with chemotherapy for stage IIIB/IV NSCLC. Pain was stratified by proportion of time patients reported specific levels of pain. Opioids were converted to oral morphine equivalents (OME) for comparison. The effects of pain, opioid requirement, and known prognostic variables on survival were analyzed in univariable and multivariable models. Results: Both severity of pain and greater opioid requirement in first 90 days after starting chemotherapy were strongly predictive of shorter survival on univariable analysis. Patients with no/mild chronic pain and requiring <5 mg/day OME during first 90 days had nearly 12 months longer median survival compared to patients requiring ≥5 mg/day OME and/or experiencing more pain. Differences in survival remained remarkably similar when chronic pain and opioid requirement were assessed over the entire clinical course (until death or last follow-up). In multivariable models, both opioid requirement and chronic pain remained independent predictors of survival, after adjustment for age, stage and performance status. Conclusions: Severity of chronic cancer-related pain or greater opioid requirement are associated with shorter survival in advanced NSCLC, independently of known prognostic factors. While pain adversely influences prognosis, controlling it with opioids does not improve survival. Prospective studies should determine if achieving pain control using opioid-sparing approaches improves outcomes.
Hypertension, proteinuria, and overall survival in elderly cancer patients treated with bevacizumab.
Authors: Launay-Vacher Vincent , Janus Nicolas , Ray-Coquard Isabelle Laure , Gligorov Joseph , Selle Frédéric , Beuzeboc Philippe , Daniel Catherine , Spano Jean-Philippe , Thery Jean Christophe , Goldwasser Francois , Mir Olivier , Rey Jean-Baptiste , Jouannaud Christelle , Morere Jean F. , Oudard Stephane , Deray Gilbert , Scotte Florian 
Published: February 2017

186 Background: MARS is a multicentric, non-interventional, prospective study which first reported the high prevalence of both baseline and de novo hypertension (HTN) and proteinuria (Pu) in several sub group of cancer patients [Gligorov J et al. SABCS 2013; Ray-Coquard I et al. ASCO GI 2014; Ray-Coquard I et al. ASCO GU 2014; Goldwasser F et al. ECC 2013; Launay-Vacher V et al. ASCO 2013]. In this sub-group analysis, we focused on elderly cancer (EC) patients treated by bevacizumab. Methods: MARS included 1,124 patients, all naïve of any previous anti-VEGF treatment. A First Renal Assessment was performed at baseline before the anti-VEGF was started with periodic follow-up for 1 year. Elderly was defined as age ≥65 years at inclusion. Univariate (UA) and multivariate analyses (MA) tested the associations of HTN and Pu, at baseline or de novo, with overall survival (OS) (pre-planned) in EC patients. Results: 845 patients treated with bevacizumab were included. Among them 226 were EC patients (colorectal 81, breast 78, ovarian 26, lung 22). At inclusion, HTA was statistically higher in EC patients (table), mean aMDRD was 79.6 ml/min/1.73m2 and 15.1% had aMDRD<60. De novo HTA; de novo Pu and Scr increase were not statistically more frequent in EC patients than in non-EC patients. In addition, renal function decreased by -4.1 ml/min/1.73m²/year and 16.2% had aMDRD<60 at the end of follow-up. Baseline and de novoHTN and Pu were not associated with reduced OS in EC patients in both UA and MA analyses. Conclusions: There were no differences in term of renovascular safety in EC patients treated by bevacizumab. Furthermore, HTN and Pu were not associated with OS in EC patients treated by bevacizumab. Therefore, renovascular events should not be contraindicated at the initiation of the treatment or when the patient is already on treatment. [Table: see text]
Assessing the value of progression-free survival (AVALPROFS).
Authors: Fallowfield Lesley , Matthews Lucy , Catt Susan L. , MacKenzie Mairead , Gath Jacqui , Jenkins Valerie A. 
Published: February 2017

187 Background: Controversy exists about progression free survival (PFS) as an endpoint in novel cancer therapy trials. PFS is attractive for practical and methodological reasons but is not always a surrogate for overall survival. It is debatable whether or not PFS has discernable clinical benefit for patients (pts), the main treatment (tmt) goal. Also overlooked are pt perceptions. Few trials directly address if disease stabilisation is worth tmt side effects (SEs) or include relevant patient reported outcome (PRO) measures. AVALPROFS examines longitudinally pts’ understanding of therapeutic intent, PFS and the value placed on drugs that control cancer but have SEs. We report the pilot study here. Methods: The primary pilot aim was to obtain feedback from pts having drugs offering only PFS or modest OS gains, about the acceptability and comprehensibility of PROs for use in a longitudinal study. These included validated quality of life and anxiety measures and 4 study specific interview schedules. In close collaboration with Independent Cancer Patients’ Voices (ICPV) and using an iterative process, draft interviews (pre-tmt, on-tmt, at withdrawal due to toxicity or progression) were developed. Pilot study pts’ clinic consultations were taped prior to home interviews by researchers. Results: 11/19 eligible pts with metastatic breast, lung and head and neck cancers at different treatment phases participated. No pt recalled the phrase PFS being used in consultations. Few knew their latest scan results. Some were confused about the therapeutic aims of further tmt, 4/10 thought it would extend survival. All had experienced or anticipated considerable toxicity. None found the interview schedules too upsetting; all provided comprehensive feedback about these and the trade-off questions. Conclusions: PFS is confusing and questions remain about its true value. Involvement of ICPV in potentially distressing research about study design and PROs at the outset was invaluable. Inclusion of feedback from pilot study pts permitted further refinements to the AVALPROFS study which is currently open and recruiting. Clinical trial information: 16342. [Table: see text]