bluuebunny/crossref_metadata_2025_split huggingface dataset:
YOCAS yoga for musculoskeletal symptoms in breast cancer patients receiving aromatase inhibitors: A URCC CCOP randomized, controlled clinical trial.
Authors: Peppone Luke Joseph , Mohile Supriya Gupta , Janelsins Michelle Christine , Sprod Lisa , Gewandter Jennifer S. , Heckler Charles E. , Chandwani Kavita Dayal , Morrow Gary R. , Ruzich Janet C. , Esparaz Benjamin , Mustian Karen Michelle 
Published: March 2020

9028 Background: Up to 50% of breast cancer patients on aromatase inhibitor therapy report significant musculoskeletal symptoms such as joint and muscle pain, which decreases treatment adherence. We conducted a secondary data analysis of a multi-site, phase III randomized, controlled, clinical trial examining the efficacy of yoga for improving musculoskeletal symptoms among breast cancer patients currently receiving hormone therapy (aromatase inhibitors [AI] or tamoxifen [TAM]) through the University of Rochester Cancer Center Community Clinical Oncology Program (CCOP). Methods: The original RCT randomized patients with any type of non-metastatic cancer without previous yoga participation into 2 arms: 1) standard care monitoring [controls] or 2) 4-week yoga intervention (2x/wk; 75 min/session) plus standard care. The yoga intervention utilized the UR Yoga for Cancer Survivors (YOCAS) program consisting of breathing exercises, 18 Hatha and Restorative yoga postures, and meditation. Only breast cancer patients currently receiving AI (N=95) or TAM (N=72) were included in this secondary analysis. Changes in musculoskeletal symptoms were assessed using ANCOVA with baseline values as covariates between the yoga and control groups. Results: Compared to TAM users at baseline, AI users reported higher levels of general pain (1-5 score: AI=2.65 vs. TAM=2.17; p=0.01), muscle aches (0-4 score: AI=2.14 vs. TAM=1.65; p=0.01), and total physical discomfort (0-24: AI=8.03 vs. TAM=5.92; p=0.01). Among AI users only, participants in the yoga group demonstrated greater reductions in general pain (CS=change score; Yoga CS= -0.37 vs. Control CS= +0.02; p=0.02), muscle aches (Yoga CS= -0.58 vs. Control CS= -0.15; p=0.03) and total physical discomfort (Yoga CS= -2.07 vs. Control CS= -0.58; p=0.04) from pre- to post-intervention than the control group. Conclusions: The severity of musculoskeletal symptoms was higher for AI users than for TAM users. Among breast cancer patients on AI therapy, the community-based YOCAS intervention significantly reduced general pain, muscle aches, and physical discomfort. Funding: NCI U10CA37420, KL2RR024136-05, K07CA120025.
The effect of pretreatment psychosocial factors on immune function and quality of life after brief presurgical stress management.
Authors: Gilts Chelsea D. , Parker Patricia A. , Pettaway Curtis A. , Cohen Lorenzo 
Published: March 2020

9031 Background: It is important to identify factors that predict who will benefit the most from psychosocial interventions in cancer populations. Methods: We examined the association between pretreatment psychosocial factors and subjective and objective outcomes from a brief cognitive-behavioral stress management program. This three-arm randomized clinical trial investigated the effects of a presurgical stress management (SM; n=53) compared to supportive attention (SA; n=54) and standard care (SC; n=52) on quality of life (QOL) and immune outcomes in men with prostate cancer scheduled for radical prostatectomy. We previously reported improved QOL 1 year after surgery in the SM and SA groups compared to the SC group and higher pro-inflammatory cytokines 48h after surgery in the SM group. We investigated the moderating effects of baseline psychosocial factors (social support (SS), dyadic adjustment (DA), distress (BSIGSI), and impact of event (IES)), on QOL (SF-36 physical (PCS) and mental (MCS) component scores) 1 year after surgery and immune response 48h after surgery. Results: Baseline SS and BSIGSI interacted with group in predicting PCS 1 year after surgery (p’s <.05). Men who reported low baseline SS and were in SM had increased PCS 1 year after surgery compared to men with low SS in the SC group (b=.36, p<.01). Conversely, men who reported high BSIGSI at baseline and were in SA had increased PCS 1 year after surgery compared to those in SM (b=11.14, p=.03), with SC having an intermediate nonsignificant effect. All four psychosocial factors (SS, DA, BSIGSI, IES) interacted with group in predicting changes in pro-inflammatory cytokines (interleukin (IL)-1, IL-6, IL-8, IL-10, tumor necrosis factor, and interferon) 48h post-surgery (all p’s <.04). In all significant interactions, men who reported greater psychosocial vulnerability at baseline and were in SM had increased immune response 48h after surgery compared to psychosocially vulnerable men in either SC (all p’s <.02) or SA (all p’s <.02). Conclusions: These findings suggest that baseline psychosocial factors are important indicators of who may benefit most from a SM intervention on both subjective and objective outcomes.
Women know, and men wish they knew, prognostic information in advanced cancer.
Authors: Fletcher Kalen M , Prigerson Holly Gwen , Maciejewski Paul K 
Published: March 2020

9037 Background: Little is known about gender differences in advanced cancer patient communication with oncologists. The few studies conducted have explored differences in preferences for prognostic disclosure. Our data allow us to test for gender differences in actual rates of audio-recorded, patient and oncologist reported, prognostic disclosures. We studied a group of advanced cancer patients to determine whether gender disparities exist in: a.) reported rates of prognostic disclosures from physicians and b.) willingness to estimate (versus not) one’s prognosis (i.e., amount of time left to live). Among patients who report never receiving a prognosis from their physician, we also tested for gender difference in wishing that this had been discussed. Methods: Coping with Cancer II is an NCI -funded multi-site, prospective longitudinal study of advanced cancer patients. Patients were interviewed after receiving scan results and asked if they have received a prognosis from their oncologist either at their most recent visit or at any time in the course of their disease. They are also asked if they would be willing to estimate their prognosis. Patients who state that they have not received a prognosis are asked if they wish that they had. Results: Among the advanced cancer patients studied (N=51; men=23, women=28), male cancer patients were significantly more likely to state never receiving a prognosis from their physician than female patients (OR=3.5; χ2=4.49, df=1, p=0.034). Male cancer patients were also significantly less willing to provide a life-expectancy estimate (OR=5.6; χ2=5.06, df=1, p=0.025). Among patients who stated never receiving a prognosis (N=27; men=16, women=11), male patients tended to be more likely than female patients to wish that their prognosis had been discussed (OR=7.8; χ2=3.11, df=1, p=0.078). Conclusions: Male advanced cancer patients are less likely than female cancer patients to state that they have received prognostic information and less willing to provide a life-expectancy estimate. Although male patients receive less open prognostic disclosure than female patients, male patients tend to be more likely than female patients to want prognostic information.
Psychosocial correlates of sleep architecture in women with advanced breast cancer.
Authors: Gerry Arianna Aldridge , Jo Booil , Palesh Oxana , Zeitzer Jamie , Neri Eric , Spiegel David 
Published: March 2020

9051 Background: Sleep disturbance is prevalent among metastatic breast cancer (MBC) patients and few studies have objectively evaluated this problem using polysomnography (PSG). Disturbed sleep negatively affects quality of life. The current study examines the relationship of mood and family structure with sleep parameters assessed over three nights of PSG (2 at-home, 1 in-lab). Methods: MBC patients (n = 103) and healthy controls (n = 27) were recruited. Patients were 57.8 years (SD = 7.7), non-Hispanic white (86.3%), and had Karnofsky ratings of at least 70%. Multiple regression analyses assessed relationships among depression, cohabitation, and sleep parameters. Results: Among patients, sleep architecture was significantly related to depression and marital status/cohabitation. Women reporting more depressive symptoms had less deep sleep: lower percentage (B = -.26, p = .01) and fewer minutes of REM (B = -.23, p = .02), lower % (B = -.25, p = .02) and fewer minutes of stage 2 sleep (B = -.28, p = .01), and more % stage 1 sleep (B = .28, p = .01). Marriage/cohabitation was positively related to sleep quality indicators: less wake time after sleep onset (B = -.20, p = .05), better sleep efficiency (B = .28, p = .01), more total sleep time (B = .30, p < .01), more minutes of REM (B = .23, p = .02), more stage 2 sleep (B = .27, p < .01), and less % stage 1 sleep (B = -.27, p = .01). Relative to healthy women, patients had more sleep stage transitions/hour (B = .21, p = .03), more awakenings (B = .18, p = .04), and more time awake after sleep onset (B = .21, p = .02). Slow wave (deep, non-REM) sleep was shorter for patients as measured by both minutes (B = -.20, p = .04) and % of stage 4 sleep (B = -.23, p = .02). Conclusions: Depressed patients or those living alone have greater reductions in deep sleep. Relative to healthy women, patients’ sleep disturbance and quality was worse. These findings demonstrate that the architecture of deep sleep is linked to depression and family structure.
Randomized double-blind evaluation of dronabinol for the prevention of chemotherapy-induced nausea.
Authors: Grunberg Steven M. , Munsell Mark F. , Morrow Phuong Khanh H. , Giguere Jeffrey Kent , Ule Ulla Jo , Saccaro Steven J. , Onitilo Adedayo A. , Metzner-Sadurski Joanna K. , Fisch Michael ,   M. D. Anderson Community Clinical Oncology Program Research Base
Published: March 2020

9061 Background: Although great progress has been made in the control of chemotherapy-induced vomiting (CIV), prevention of chemotherapy-induced nausea (CIN) has been less successful. Preliminary data suggests that some families of lesser used antiemetic agents, such as the cannabinoids, may have greater efficacy against nausea than against vomiting. Methods: Adult solid tumor patients (pts) receiving cyclophosphamide ≤ 1500 mg/m2 (C) and/or doxorubicin ≥ 40 mg/m2 (A) were eligible. Pts could have received prior mildly emetogenic chemotherapy (EC). Pts were not eligible who were receiving other moderately or highly EC, were receiving cranial, abdominal or pelvic radiotherapy, had CIV/CIN with previous chemotherapy, had other causes for nausea/vomiting besides chemotherapy, or were scheduled to receive other antiemetics. Pts with habitual cannabinoid use were not eligible. All pts received palonosetron 0.25 mg (PALO) and dexamethasone 10 mg (DXM) IV before chemotherapy. Patients were randomized double-blind to receive dronabinol 5 mg (D) or matching placebo (P) 3 times a day for 5 days. Nausea, vomiting and toxicity data was collected daily for 5 days. Results: 62 pts were entered on study – female/male 61/1, White/Black/Hispanic/Other 45/14/2/1, median age (range) 58 (29-76). No significant difference was noted in CIV-dependent endpoints (including No Vomiting, Complete Response, or Complete Protection) or in rescue medication use. However pts receiving D had a shorter duration of nausea – Mean number of days of nausea (D vs P) 1.86 days vs 3.10 days (p=0.027) – and a trend toward greater frequency of No Nausea (D vs P) 37% vs 17% (p=0.143). Common toxicities included fatigue (D/P 17/11), headache (D/P 16/16), dizziness (D/P 14/7), constipation (D/P 14/11), and diarrhea (D/P 13/6) No pt discontinued therapy due to mood changes. Conclusions: Low-dose D decreased the duration of CIN and increased the frequency of No Nausea in pts receiving C and/or A. Agents to prevent CIV (such as PALO and DXM) and to prevent CIN (such as D) have complementary activity and result in improved overall control when used together.
Effect of complementary and alternative medicine on the survival and health-related quality of life among terminally ill cancer patients: A prospective cohort study.
Authors: Yun Young Ho , Lee Myung Kyung , Park Sang Min , Kim Young Ae 
Published: March 2020

9066 Background: Few have examined the effect of complementary and alternative medicine (CAM) use on survival and health-related quality of life (HRQOL) in cancer patients. Methods: From July 2005 to October 2006, we conducted a prospective cohort study of 481 terminally ill cancer patients at 11 university hospitals and the National Cancer Center in Korea. We assessed how the use of CAM affected HRQOL and survival. Results: In a follow-up of 481 patients and 163.8 person-years, we identified 466 deceased cases. On multivariate analyses, CAM users did not have better survival than nonusers (adjusted hazard ratio (aHR), 0.91; 95% confidence interval (CI), 0.74-1.10). Among biologically based therapies, dietary supplements (aHR, 0.70; 95% CI, 0.48–1.01) and ginseng (aHR, 0.73; 95% CI, 0.52–1.04) did not show significantly better survival. Among mind-body interventions, prayer showed significantly worse survival (aHR,1.56; 95% CI, 1.00–2.43). Clinically, CAM users reported significantly worse cognitive functioning (-11.6 v -1.3; p < 0.05) and fatigue (9.9 v -1.0; p < 0.05) than non-users. Compared with non-users in subgroup analysis, users of alternative medical treatments, prayer, vitamin supplements, mushrooms, or rice and cereal reported clinically significant worse changes in some HRQOL subscales. Conclusions: While CAM did not provide any definite survival benefit, CAM users reported clinically significant worse HRQOLs.
Attrition rates, reasons, and predictive factors in supportive/palliative oncology clinical trials at a comprehensive cancer center.
Authors: Glitza Isabella Claudia , Hui David , Chisholm Gary B. , Bruera Eduardo 
Published: March 2020

9069 Background: Attrition is common among supportive/palliative oncology clinical trials. Few studies have documented the reasons and predictors for dropout. We aimed to determine the rate, reasons and factors associated with attrition both before reaching the primary endpoint (PE) and the end of study (EOS). Methods: We conducted a review of all prospective interventional supportive/palliative oncology trials by our department between 1999-2010. Patient and study characteristics and attrition data were extracted. We determined factors associated with attrition using multivariate logistic regression analysis. Results: 15 blinded randomized trials and 3 single arm trials were included. 16 of 18 studies did not reach accrual target. Baseline demographics for the 1214 patients were: median age 60 (range 23-93 years), female 56%, Caucasians 69%, ECOG performance status ≥3 41%, gastrointestinal malignancies (23%), median fatigue 7/10, appetite 5/10 and pain 4/10. Attrition rate was 26% (N=311) for PE and 44% (N=535) for EOS. Common reasons for EOS dropout were patient preference (N=93, 17%), symptom burden (N=87, 16%), death (N=45, 8%) and hospital admission (N=43, 8%), and were similar for PE dropouts. No predictors were identified for PE attrition. The Table shows poor performance status, anorexia and dyspnea are associated with EOS attrition in multivariate analysis. Conclusions: We found that attrition rate was high amongsupportive/palliative oncology clinical trials, and was associated with poor function and high baseline symptom burden. These findings have implications for future study designs including eligibility criteria and sample size calculation. [Table: see text]
A randomized, double blind, placebo-controlled crossover trial of a sustained release methylphenidate in cancer-related fatigue.
Authors: Escalante Carmelita P. , Meyers Christina A. , Reuben James M. , Wang Xuemei , Qiao Wei , Manzullo Ellen F. , Alvarez Ricardo H. , Morrow Phuong Khanh H. , Gonzalez-Angulo Ana M. , Mendoza Tito R. , Wang Xin Shelley , Liu Wenli , Holmes Holly Michelle , Hwang Jessica , Pisters Katherine , Overman Michael J. , Cleeland Charles S. 
Published: March 2020

9072 Background: Cancer-related fatigue (CRF) is common and distressing. This study assessed the efficacy of OROS methylphenidate 18 mg daily (OM) vs. placebo (P) for CRF reduction. Other objectives were to compare the effects of OM vs. P on other symptoms, cognitive function, work yield, patient (pt) perceptions and preferences, and an exploratory analysis of cytokines. Methods: Initially, pts were randomly assigned (1:1) to receive OM-P or P-OM for 4 weeks (wks). Pts were crossed to the other treatment after 2 wks. Assessments were done at baseline, 2 and 4 wks. Continuous and categorical variables were assessed using Wilcoxon signed rank tests and McNemar tests, respectively. The primary efficacy end point was the change of “fatigue worst” on the Brief Fatigue Inventory (BFI) at the end of each 2 wk period. Results: 42 female breast cancer pts were enrolled (3 ineligible, 6 unevaluable); 33 pts were studied. The mean age was 58 (range, 32-79), 30% had metastasis, 82% were receiving chemotherapy (ctx), 9% hormonal therapy (ht), and 9% both ctx and ht. 94% were ECOG <1 and 52% were employed. 45% were on pain medicines and none on antidepressants. The mean baseline BFI was 5.7 (range 4.1-8.6). Fatigue worst did not differ between OM and P (p= 0.54) or in other symptoms. There was significance in WAIS-III Digit Symbol between OM and P (p=0.01), and Hopkins Verbal Learning Test with BFI interfere and BFI active (p=0.04, p=0.03, respectively). Hours (hrs) missed due to health (p=0.03) and hrs worked (p=0.04) differed in OM vs. P. At study end, pts were asked if OM improved CRF and if they wanted to stay on OM. 64% felt improved. Of these, 58% wanted to continue. There were no serious adverse events due to OM. There were differences in serum IL6 (p=0.03), IL10 (p=0.0004), and TNFα (p=0.02) among OM and P. Conclusions: Low dose OM did not show improvement in CRF on fatigue worst of BFI. Pts taking OM had better cognition and less work absences. Pts tolerated OM well and a majority felt better and wanted to continue OM. Future studies examining higher doses or longer treatment duration with OM, pt preferences and impact on productivity are necessary. Changes in serum cytokine levels should be further explored.
In-hospital and long-term outcomes in patients with malignancy undergoing percutaneous endoscopic gastrostomy (PEG).
Authors: Keung Emily Zhi-Yun , Liu Xiaoxia , Nuzhad Afrin , Rabinowits Guilherme , Patel Vihas 
Published: March 2020

9086 Background: PEG is widely performed in cancer patients as a means of providing nutrition or palliation. Although considered safe, PEG-associated outcomes in these patients remain poorly described. We examined the safety and benefits of PEG placement in this patient population. Methods: A five year retrospective review of all patients with malignancy (excluding head/neck, thoracic) who underwent attempted PEG at our institution was performed. Results: PEG was placed in 187 of 189 patients; 64 with hematologic malignancy (H-M), 125 non-hematologic malignancy (NH-M). Median age at time of PEG was 60.8 years. Indication was nutritional support (100%) in H-M, enteral access (59.2%) and management of obstructive symptoms (38.4%) in NH-M. A minority were able to return home (27.5%), discontinue parenteral nutrition (22%), advance diet for nutrition (24.6%) or comfort (17.1%) with the rest remaining NPO. Overall rates of PEG-related major (aspiration, tube dislodgement/leakage, bleeding, visceral injury, respiratory failure after procedure, cardiac arrest) and minor (superficial infection, ileus) complications were 21.4% and 11.3%, respectively, with higher rates in H-M (34.4% and 20.3% vs 14.4% and 6.4%). All cause in-hospital mortality was high: 31.3% H-M, 13.6% NH-M. Median time from PEG placement to death was 54 days. Leading cause of death differed by malignancy: respiratory failure and sepsis in H-M (31% and 21%), primary malignancy in NH-M (75%). Overall one year mortality was 56%. Code status was changed in 21% of patients after PEG (“Full Code” to “Do Not Resuscitate/Do No Intubate” or “Comfort Measures Only”). Multivariate/subgroup analyses will be presented at time of meeting. Conclusions: PEG placement in this study population was associated with significant procedure-related complications and failed to achieve TPN independence or advancement of diet. Nearly 25% of patients declined aggressive resuscitation strategies after undergoing surgery for PEG. Thus, higher burden of counseling is needed to carefully weigh the risk and benefit of PEG placement in these patients. Further studies are needed to elucidate the factors affecting the decision process and patient selection.
Symptoms (Sx) in English (E) and Spanish (S) speaking children with cancer.
Authors: Zhukovsky Donna S. , Wells Robert J. , Robert Rhonda J. , Chisholm Gary B. , Palmer J. Lynn , Cohen Marlene Z. , Rozmus Cathy L. , Allo Julio , Bruera Eduardo 
Published: March 2020

9096 Background: Sx in children receiving treatment for cancer are poorly described and often reported by proxies. Study aims were to 1. Characterize sx of pediatric oncology outpatients 2. Evaluate the agreement between patient (pt) and proxy reports 3. Report the association between pt assessed sx and treatments prescribed by physicians (MD). Methods: The pediatric Memorial Symptom Assessment Scale (pMSAS) is a validated tool that evaluates frequency, intensity and distress of 8 sx (version 7-12) or 30 sx (version 10-18) for pts of corresponding ages. Higher scores indicate greater sx burden. pMSAS was translated into S versions. Pt eligibility included ages 7-18, E or S speaking, advanced cancer, pediatric assent/parent consent and E or S speaking family caregiver (CG) with IRB approved consent for self participation. Pts and CG were administered age appropriate pMSAS in E or S independently just prior to MD visit and consenting MDs, the corresponding pMSAS after the visit. Subscale scores included total pMSAS score (TOTAL), psychological, physical and global distress index for older group (OG) and TOTAL for younger group (YG). Statistical analysis included Spearman correlation coefficients and weighted kappas. Results: E and S results were similar and combined. 60 children [age mean +SD 12 +.5, 62% male, 35 S] and their CG completed the pMSAS. 14 MD completed pMSAS for 20 pts. 9 pts (15%) had no sx and 38 (63%), ≥2. The most common sx for ages 7-10 were tired (N=12, 40%) and itch (N=9, 30%) and for ages 11-18, pain (15/30, 50%) and energy (13/29, 45%). Subscale score agreement varied by proxy type and subscale. For TOTAL, highest correlation was 0.6 (p<.001) for YG and 0.7 (p<.001) for OG. For individual sx, agreement between patient and proxy was highly variable (Table). Of symptomatic patients, 6% (3/51) received sx recommendations. Conclusions: Sx in children with cancer are common and undertreated. CG and MD ratings are often not congruent with pt reports which may explain the apparent under treatment of sx. [Table: see text]