bluuebunny/crossref_metadata_2025_split huggingface dataset:
Predictors of anxiety and depression risk among individuals with lung cancer.
Authors: Stein Kevin , McManus Shauna , Gardan Pierre M. , Olson Julie S. , Miller Melissa F. , Clark Kelly , House Linda S. , Zaleta Alexandra Katherine 
Published: May 2019

e23136 Background: Lung cancer (LC) patients can face long-term symptom burden, quality of life concerns, and enduring distress. This study explored predictors of psychosocial distress among a community-based sample of LC survivors. Methods: 208 individuals with LC enrolled in Cancer Support Community’s Cancer Experience Registry, provided demographic/clinical background, and reported cancer-related distress using CancerSupportSource, a 25-item tool measuring level of concern ( 0-4) over 5 domains: emotional well-being (including 2-item depression and 2-item anxiety risk screening subscales), symptom burden and impact, body image and healthy lifestyle, health care team communication (HCTC), and relationships and intimacy. Using logistic regression, we estimate which domains influence anxiety and depression risk, controlling for significant demographic/clinical variables. Results: Participants were 68% female, 83% non-Hispanic White; mean ( SD) age = 61 (11) years; mean ( SD) years since diagnosis = 3.1 (4.5); 86% non-small cell lung cancer (NSCLC); 43% ever diagnosed as metastatic. 52% underwent surgery; 76% received chemotherapy, 65% radiation. 53% were at risk for clinically significant anxiety; 42% for clinically significant depression. Concerns about relationships and intimacy were associated with greater odds of anxiety risk ( OR= 1.70; p< .01); a positive interaction suggested that anxiety risk among individuals with NSCLC varied by HCTC concerns, with greater concerns being associated with higher risk ( p< .05). Concerns about symptom burden and impact ( OR= 1.21; p< .01) and HCTC ( OR= 1.57; p< .05) were significantly associated with greater odds of depression risk; these associations did not vary by LC type. Conclusions: Concerns around health care team communication, relationships and intimacy, and symptom burden and impact are important considerations in understanding risk for anxiety and depression among lung cancer patients and survivors. Additionally, type of lung cancer (NSCLC) can moderate the degree to which concerns about HCTC are associated with risk. Findings highlight the need for constructive patient-provider communication, particularly around relationships and intimacy and symptom burden. Clinical trial information: NCT02333604.
The ESCAPADE Study: Early supportive care for advanced cancer patients, assessing care delivery and provider engagement.
Authors: Levine Oren Hannun , Bainbridge Daryl , Pond Gregory Russell , Slaven Marissa , Dhesy-Thind Sukhbinder K. , Sussman Jonathan , Meyer Ralph M. 
Published: May 2019

e23142 Background: Advanced cancer patients benefit from early integration of palliative care (EIPC) with usual care. A proposed model of EIPC reserves specialized palliative care (SPC) for complex patients, while primary care providers (PCP) and oncologists oversee basic palliative care (PC). We studied the attitudes among patients and their healthcare providers regarding delivery of EIPC. Methods: A cross-sectional study at a tertiary cancer centre in Ontario. Patients with newly diagnosed incurable gastrointestinal (GI) cancer were surveyed using a study specific instrument for the outcomes of interest: importance of and preferences for accessing support across 8 domains of PC (disease management, physical, psychological, social, spiritual, practical, end of life care, loss and grief). Healthcare providers within the circle of care completed a parallel survey for each recruited patient. Primary analysis involved use of descriptive statistics to summarize survey results and concordance between patient and provider responses. Results: From Oct 2017 - Nov 2018, 67 patients were surveyed (median age 69, 34% female). 90% had an identified medical oncologist, and 19% had SPC. 97% had a PCP, but only 42% listed a PCP as part of the care team. Median time from first oncology assessment for advanced cancer to patient survey completion was 52.5 days. 85 providers responded (oncologist = 59, PCP = 20, SPC = 6; response rate 92%; 1-3 physician responses per patient). Disease management and physical concerns were most important to patients. In these domains, 67% and 81% of patients endorsed receiving care from the preferred provider, but concordance between patient and physician responses regarding most responsible provider was only 58% and 38%. For all other domains, 87 – 100% of patients attributed primary responsibility to self or family rather than any healthcare provider. Conclusions: Respondents did not assign responsibility to physicians early in the disease trajectory for many domains of PC. Our findings suggest that incorporating patient activation and empowerment into EIPC requires further study. PCPs appeared to have limited involvement in PC for newly diagnosed advanced GI cancer patients.
Study on influencing factors and survival analysis of patients with malignant tumors treated by music therapy.
Authors: Hong Lei , Wang Junyan , Zhang Fan , Ma Minting , Jiang Da , Wei Suju 
Published: May 2019

e23144 Background: Music therapy is not easy to carry out. After carrying out music therapy propaganda, many patients still question the efficacy of it, and won’t be included in music therapy group. This study retrospectively analyzed the related factors and survival analysis of patients enrolled in music therapy, and provided reference for appropriate music therapy propaganda methods. Methods: From March 2014 to January 2016, 258 patients with malignant tumors diagnosed in Fourth Hospital of Hebei Medical University were collected. Music therapy was divided into control group and intervention group according to whether they were willing to be included in the group or not. Questionnaire survey was used to investigate the effect of factors on music therapy in the two groups. Follow-up was conducted by telephone to analyze the effect of music therapy on PFS. Single factor analysis was used to analyze the relationship between factors and music therapy. The differences of PFS between control group and intervention group was analyzed by Log-Rank test (P < 0.05). Results: A total of 258 patients were enrolled in the questionnaire survey, and 240 patients completed the questionnaire effectively. Age, education level, music hobby, and knowledge of illness had significant influence on whether the patients were enrolled in music therapy group (P < 0.05). Gender, occupation, type of disease, stage of disease and DT score had no significant effect on whether patients were enrolled in music therapy group (P > 0.05). Age and music preference were independent influencing factors of music therapy (P = 0.025, P = 0.000). The median PFS of lung cancer patients was 8 months and 8 months, respectively (P = 0.760). The median PFS of breast cancer patients was 9 months and 8 months, respectively (P = 0.726). The median PFS of digestive tract cancer patients was 8 months and 10 months, respectively (P = 0.684). The median PFS of gynecologic tumor patients was 8 months and 8 months, respectively (P = 0.310). Conclusions: Age, education level, music hobby and condition information have significant influence on whether patients are included in music therapy group or not. Age and music hobby are independent influencing factors of music therapy. PFS of patients with malignant tumors who are willing to be included in music therapy group tends to prolong, but there is no statistical significance.
How often do metastatic brain disease patients prescribed ten fractions of whole brain radiation therapy die without completing treatment?
Authors: McClelland Shearwood , Agrawal Namita , Shiue Kevin , Bartlett Gregory , Zellars Richard C. , Watson Gordon A , Ellsworth Susannah G. 
Published: May 2019

e23146 Background: Palliative whole brain radiation therapy (WBRT) is an established treatment modality for optimizing intracranial disease control in patients with metastatic brain disease, most commonly prescribed to a dose of 30 Gy in 10 fractions. The fidelity of WBRT course completion has not been rigorously evaluated. Methods: Two prospective institutional databases evaluating patients treated from April 2015 through December 2018 identified patients who received WBRT. Information analyzed included prescribed and delivered dose/fractionation, Karnofsky Performance Status (KPS), admission status, treatment duration, and time between WBRT completion and patient hospice referral/death. Results: 52 consecutive patients prescribed WBRT to 30 Gy in 10 fractions were evaluated. Twenty-six (50%) were inpatients, and only 17 (33%) had a KPS of 70 or greater (able to care for self). More than 30% failed to finish more than 5 of their 10 scheduled fractions before either death or hospice referral; only 29 of 52 patients (56%) finished WBRT as prescribed. Twenty-five patients (48%) died within 30 days of WBRT. Of the 29 patients who finished WBRT as prescribed, 9 (31%) died within 30 days of completing treatment. Of the 23 patients who failed to complete standard fractionation WBRT, nearly 70% died within 30 days of receiving their final radiation therapy fraction. Conclusions: These findings indicate that greater than 40% of patients prescribed the standard 10 fraction regimen of WBRT do not remain well enough to tolerate the full duration of treatment. With nearly half of patients dying within 30 days of standard fraction WBRT, there should be strong incentive to reduce the physical and financial burden on this patient population by prescribing WBRT with significantly shorter (i.e. single-fraction or 20 Gy in 5 fractions) fractionation schemes.
Oncology Associated Symptoms and Individualized strategies (OASIS): Precision symptoms management for rural patients with advanced cancer.
Authors: Vikas Praveen , Gilbertson-White Stephanie , Saeidzadeh Tannaz , Perkhounkova Yelena 
Published: May 2019

e23155 Background: Rural cancer patients have limited access to symptom management specialists. OASIS is an 8-week, web-based intervention addressing this access gap by providing the right symptom management to the right patients at the right time. This feasibility study seeks to describe recruitment and retention patterns and evaluate symptom severity, distress, and interference at 4, 8, and 12 weeks. Methods: Eligibility included: advanced cancer diagnosis, > 18 years old, and living in small town or rural area. Reasons for non-enrollment and dropout were collected. Descriptive statistics were calculated to evaluate recruitment and retention rates along with symptom severity and interference at each time point. The mean severity and distress scores using the 0-10 NRS of the five symptoms with the highest rating was computed for each time point (i.e., baseline, week 4, and week 8). By averaging the five highest rated symptoms, we evaluated the worst symptoms the individual is experiencing at each data point. Results: Fifty-nine people were approached about the study over 18 months, 38 people signed consents, 12 dropped before completing baseline questionnaires, and 9 completed baseline questionnaires but did not start the intervention. Seventeen people completed baseline questionnaires and started the intervention. The recruitment rate was 66%, the retention rates were 50% and 33% at 4 and 12 weeks.Reasons for drop out included lack of bothersome symptoms, too busy, and generally overwhelmed. Mean age of sample was 62 years and majority men (62.5%). Fatigue (M = 6.4), drowsiness (M = 5.4), numbness/tingling (M = 4.4), and sleep disturbance (M = 4.4) were the most severe symptoms at baseline. Mean symptom severity was M = 3.03 and mean interference was M = 2.53 at baseline. For participants who received the full OASIS-WN intervention, between baseline and week 8, the mean interference rating decreased by 1.6±2.1 points (p = .019), mean severity and distress ratings for the five worst symptoms decreased by 1.72±1.72 (p = .004) and 2.2±2.4 (p = .006), respectively. Conclusions: Symptom severity, distress, and interference improved for participants who received the full intervention. Reasons for early drop out suggest symptom management ought to be provided when the situation is optimal for learning. Future research will evaluate the efficacy of OASIS.
The efficacy of placebo for the treatment of cancer-related fatigue: A systematic review and meta-analysis.
Authors: Barreto Carmelia Maria Noia , Aguiar Pedro Nazareth , Cubero Daniel de Iracema Gomes , Del Giglio Auro 
Published: May 2019

e23157 Background: Cancer-related fatigue (CRF) is a common symptom among patients with cancer. The efficacy of placebo, however, was never the main objective of any meta-analysis. Predicting the efficacy of placebo may facilitate researchers in designing future clinical trials for the treatment of CRF. Methods: We performed a systematic review searching for prospective clinical trials comparing any treatment versus placebo for the treatment of CRF. We included studies that enrolled patients with any primary site of neoplasia and any stage of cancer. We excluded all studies that assessed fatigue related to any treatment. The primary endpoint of this study is the mean effect of placebo on fatigue according to the Functional Assessment of Chronic Illness (FACIT-F) and Brief Fatigue Inventory (BFI) scales. The secondary endpoint was the proportion of patients who reported improvement in fatigue (response rate). Results: We found 520 studies, and 29 studies with 3,758 participants were included in the meta-analysis. Placebo had a mean effect of +4.88 (95%CI +2.45 to +7.29) using the FACIT-F scale, although it was statistically worse than the interventions studied (p = 0.005). Using the BFI scale, placebo had an average effect of +0.64 (95%CI +0.02 to +1.30), although it was also worse than the other interventions studied (p = 0.002). In terms of the response rate, 29% (95%CI 25%–32%) of patients taking a placebo reported a significant improvement in CRF compared to 36% of patients treated with other interventions (p = 0.030). Conclusions: Placebo treatments had a significant effect on CRF, and predicting these effects may help design future studies for CRF.
eMouvoir: Randomized study estimating the impact of a personalized and remote support centered on physical activity (PA) for patients (pts) after breast cancer (BC).
Authors: Vanlemmens Laurence , Anota Amelie , Bogart Emilie , Nerich Virginie , Cauchois Didier , Dewitte Alain , Dormeuil Etienne , Lartigau Eric , Le Gall Flora , Mocaer Hervé , Thenot Aurelie , Brochard Marc-Antoine , Le Deley Marie-Cecile 
Published: May 2019

TPS11631 Background: BC pts can reduce their health-related quality of life (HRQoL) encompassing physical, psychological and social components due to cancer and treatments (trts). Despite the strong evidence of the beneficial effects of EPA for BC pts on HRQoL, the cancer pts’ EPA levels most often decline after diagnosis and trts due to physical and psychological components, accessibility to exercise programs, time constraints. Connected watches can now contribute to pts’ deeper commitment to their program by providing reliable trends of their EPA metrics. Notwithstanding this recent progress, cancer pts keep facing challenges to maintain a regular EPA. We aim at evaluating a holistic intervention including a physical activity educator, coaching pts remotely for 4 months (mo), to improve HRQoL after BC. Methods: eMouvoir is a multicenter randomized, controlled phase 3 trial started 4-6 mo after the end of trt among non-metastatic BC pts. It assesses the benefit of a personalized remote EPA coaching, including a connected watch, access to a digital platform, personalized objectives, ≥2 messages per week, weekly lessons, for a 4-mo duration, compared to the standard supportive approach (recommendations for EPA made during visits with the oncologist) in terms of HRQoL. The randomization is balanced 1:1 and controlled for HRQoL at inclusion, trts, exercise practice, age, access to the Internet and center. Main eligibility criteria are: age ≥18; adjuvant or neoadjuvant trt for non-metastatic BC; medical certificate for sports practice. Patients without a connected device are eligible. HRQoL is evaluated using the SF-36 questionnaire, at 4, 8 and 12 mo. Both components (physical and mental summary) at 12 mo are used as co-primary endpoints. The study includes a health-economics evaluation, using EQ-5D and EQ VAS, to estimate the incremental cost-utility ratio. Based on the following assumptions: expected mean difference for each SF-36 component at 12 mo =3 points, standard deviation=15, power=90%, 2-sided alpha=2.5%, 10% drop-outs, 1242 evaluable pts are required, leading to 1380 pts. The trial is funded by the French ministry of health and should open enrollment soon.
Understanding and predicting fatigue, cardiovascular (CV) decline, and events after breast cancer treatment (UPBEAT): A prospective cardio-oncology study.
Authors: Reding Kerryn , D'Agostino Ralph , Lesser Glenn Jay , Klepin Heidi D. , Wagner Lynne I. , Kitzman Dalane , Brubaker Peter H. , Mihalko Shannon , Jordan Jennifer , Avis Nancy E. , Winkfield Karen Marie , Ky Bonnie , Dent Susan Faye , Crotts Teresa , Calhoun Tonya , Lane Kimberly , Hundley W. Gregory 
Published: May 2019

TPS11634 Background: Modern treatment for breast cancer (BC) has led to improved survival; however, this improvement can be offset by an increase in cancer therapy-related morbidity and mortality. Over one-third of early stage BC patients treated with cancer therapy experience CV injury, left ventricular (LV) dysfunction, exercise intolerance, or fatigue. CV disease is a leading cause of mortality in BC survivors. There is limited information on the time course and long-term CV health of BC survivors. UPBEAT, a multicenter study, will prospectively evaluate CV risk factors and outcomes in early stage BC patients,treated with modern cancer therapies. This will facilitate evaluation of primary CV prevention strategies in this patient population. Methods: This is a prospective cohort study of 840 patients with early stage (I-III) BC treated with chemotherapy +/- radiation and 160 controls. Baseline and serial longitudinal measures will examine the influence of cancer treatment on CV function, exercise capacity and fatigue, and future development of CV events. The comprehensive assessment of factors includes ascertainment of cardiac biomarkers, CV risk factors, comorbidities, functional status (e.g., disability measures, Expanded SPPB), neurocognitive tests, behavioral risk factors, socio-demographics, and quality of life at baseline, 3-, 12-, and 24-mos. Outcomes measured at the same time points, include a deep phenotyping of CV dysfunction (via cardiac MRI assessing LV end diastolic volume, LV end systolic volume, LV ejection fraction, myocardial strain, strain rate, left atrial volumes and mass, and aortic stiffness), exercise intolerance (submaximal as 6-minute walk test and maximal as VO2peak via cardiopulmonary exercise test), fatigue (via FACT-F). Eligibility criteria are: age >18 years; ECOG 0-2, able to walk without symptoms; and for BC patients, treatment with chemotherapy. 143 participants are accrued and currently enrolling through ECOG and NCORP sites. Participants will be followed for 9 years with active surveillance of CV events, i.e., heart failure, myocardial infarction, stroke, all-cause and CV death. Clinical trial information: NCT02791581.
Biomarker-directed precision oncology of pembrolizumab-based combination therapy for non-small cell lung cancer: Phase II KEYNOTE-495/KeyImPaCT study.
Authors: Gutierrez Martin , Hellmann Matthew David , Gubens Matthew A. , Aggarwal Charu , Tan Daniel Shao Weng , Felip Enriqueta , Chiu Joanne Wing Yan , Lee Jong Seok , Yang James Chih-Hsin , Garon Edward B. , Basso Andrea , Ma Hua , Fong Lawrence , Snyder Alex , Yuan Jianda , Herbst Roy S. 
Published: May 2019

TPS9117 Background: Pembrolizumab-based combination immunotherapy aims to improve clinical outcomes over pembrolizumab monotherapy. A biomarker-based therapeutic approach may be associated with improved response to different combination therapies of immune checkpoint inhibitors and may improve overall outcomes in NSCLC. The randomized, multicenter, open-label, phase 2 KEYNOTE-495 trial ( NCT03516981 ) will evaluate the clinical usefulness of biomarker-informed, pembrolizumab-based combination therapy in patients with treatment-naive, advanced NSCLC. Methods: This is a group-sequential, adaptive randomization trial. Patients will have histologically or cytologically confirmed treatment-naive, advanced NSCLC, documented absence of EGFR and B-Raf mutations and ALK and ROS1 gene rearrangements, measurable disease per RECIST v1.1, and ECOG PS 0-1. Tumor tissue from patients will be initially screened for 2 validated, independent, next-generation biomarkers: T cellinflamed gene expression profile (GEP) and tumor mutational burden (TMB). Based on results of biomarker screening, patients will be assigned to 1 of 4 groups: TMBlowGEPlow, TMBhighGEPlow, TMBlowGEPhigh, and TMBhighGEPhigh. Within each group, patients will be randomly assigned to receive pembrolizumab 200 mg Q3W intravenously (IV) combined with either MK-4280 200 mg Q3W (antiLAG-3) IV or lenvatinib 20 mg orally once daily, with the randomization assignment adaptively modified based on interim efficacy analyses. Response will be assessed by imaging every 9 weeks for the first year and every 12 weeks thereafter using RECIST v1.1. Treatment will continue for 35 cycles (~2 years). Patients in the pembrolizumab + lenvatinib arm who complete 35 treatments may continue with lenvatinib monotherapy until disease progression or toxicity. Treatment arms may be terminated during the interim analysis due to safety, prespecified futility criteria, or both. Primary end point is investigator-assessed objective response rate (RECIST v1.1). Secondary end points are progression-free survival, overall survival, and safety. Recruitment and screening are ongoing in more than 8 countries. Clinical trial information: NCT03516981.