bluuebunny/crossref_metadata_2025_split huggingface dataset:
Integrating the ENABLE early palliative care approach in community cancer centers: Results of an implementation trial.
Authors: Bakitas Marie , Dionne-Odom J Nicholas , Pisu Maria , Azuero Andres , Babu Dilip Sankar , Gansauer Lucy Jean , Bearden James D. , Swetz Keith M , Minchew Leigh , Sullivan Margaret Murray , Wells Rachel , Taylor Richard A. , Turkman Yasemin E. , Ramsey Thomas , Zubkoff Lisa 
Published: November 2018

114 Background: Despite national guidelines recommending early palliative care (EPC) for individuals newly-diagnosed with metastatic cancer, it is rarely available in rural community cancer centers serving underserved populations. We conducted the first implementation trial of EPC in rural cancer centers using the evidence-based ENABLE (Educate, Nurture, Advise, Before Life Ends) model of early, concurrent oncology palliative care. Methods: Mixed methods case study of a 4-year American Cancer Society-funded 4-site, implementation trial using a virtual learning collaborative in AL and SC. Guided by the RE-AIM (Reach Effectiveness Adoption Implementation Maintenance) framework, we gathered qualitative and quantitative data via monthly reports and yearly in-person site visits using: 1) a RE-AIM Self-Assessment Tool completed by site staff to measure reach, adoption, implementation, and maintenance; 2) EPC General Organizational Index (GOI) to measure capacity for EPC services and implementation progress; and 3) field notes from site interviews and final reports. Results: Across the 4 sites, 62 patients (range: 4–31; mean: 15) and 46 caregivers (range: 2–22; mean: 12) participated. Baseline patient characteristics included: mean age of 58, 70% female, 17% Black or minority, 57% some college or college, 49% rural dwelling, and 57% non-gynecologic cancer. Sites enrolled at least 58% of the patients they planned to enroll (range: 58%–100%; average: 84%), of which 44% received 100% of ENABLE content and nearly 60% received two-thirds. Reasons for not completing all six sessions included death, unrecorded contacts, or lost to follow up. Longitudinal GOI scores indicated a trend of improved capacity for EPC services at three of the four sites. Qualitative data from site lead interviews revealed administrative (presence or lack of palliative ‘champions’), clinical (having adequate training), and economic (reimbursement) implementation barriers and facilitators. Conclusions: This pilot implementation study demonstrated feasibility and areas to enhance implementation in a larger comparative effectiveness trial to enhance scaling and spreading EPC in community practices.
Integration of palliative care consultation for patients with malignant bowel obstruction in gynecologic oncology: Qualitative approach to understand provider perspectives.
Authors: Hoppenot Claire , Chor Julie , Hlubocky Fay J. , Yamada Seiko Diane , Lee Nita Karnik 
Published: November 2018

116 Background: Gynecologic oncologists’ (GO) approaches to palliative care team (PCT) consultation for managing patients with malignant bowel obstruction (MBO) from recurrent gynecologic cancer remains unknown. Methods: GO practicing in a large metropolitan area underwent semi-structured interviews exploring their approaches to PCT involvement at the time of diagnosis of a MBO and factors leading to specific recommendations. Interviews were analyzed using theoretical and open coding qualitative analysis. Results: 15 GO completed interviews. They were in academic (93%), urban (67%) settings and at a range of timepoints in their career. GO expressed mixed feelings regarding PCT consultation for their patients with MBO. Many were comfortable managing symptoms (pain, nausea) and limited consultations to uncontrolled symptoms. Others involved PCT for ongoing support regardless of symptom severity. GO were less likely to involve PCT to help with goal-setting discussions. Many GO held a “the earlier the better” stance, preferring to involve PCT in the outpatient setting. At a high-risk decision-point, such as MBO, these physicians felt that PCT consultation was overdue. In this setting, most participants reserved PCT consultations only for patients who were not surgical candidates. Barriers to PCT consultation for women with MBO centered around GO concerns that involving another team fragments care. Participants feared involving PCT would complicate patients’ experiences by requiring additional appointments, suggesting potential abandonment from their GO, and including an additional, potentially conflicting, source of information. Many GO mentioned they chose gynecologic oncology for the continuity of care and leading role in a patient’s cancer care. Conclusions: Overall, GO expressed comfort involving PCT outside of critical decision-points, yet were reticent to involve PCT at the time of MBO due to concerns of requiring the patient to deal with another team. Early incorporation of the PCT through a standardized co-management system in a GO outpatient clinic may improve communication and reduce barriers to PCT involvement.
Patient-reported barriers for accessing supportive care among patients with metastatic cancer treated at a public cancer center in Mexico.
Authors: Alcalde Castro Mirza , Chavarri Guerra Yanin , Ramos-Lopez Wendy Alicia , Covarrubias-Gómez Alfredo , Sanchez Sofia , Quiroz Paulina , Navarro-Lara Africa , Medina-Campos Andrea , Contreras-Garduño Sergio , Moreno-García María Luisa , Pérez-Montessoro Viridiana , Goss Paul E. , Soto Perez De Celis Enrique 
Published: November 2018

124 Background: Although referral to supportive care (SC) services improves quality of life in patients with cancer, several barriers can hamper access to SC, particularly in developing countries with limited resources. We studied patient-reported barriers for accessing SC in a cancer center in Mexico City, and factors associated with those barriers. Methods: Patients with metastatic cancer enrolled in a randomized clinical trial of patient navigation to improve access to SC in a public cancer center in Mexico City (NCT03293849) were included. At baseline, sociodemographic and clinical characteristics were collected, and patients answered a survey in which they reported barriers to obtain cancer treatment and SC. We analyzed the frequency of reported barriers using descriptive statistics, and explored if sociodemographic factors were associated with a higher likelihood of reporting any barrier. Results: 134 patients were included between 08/17 and 04/18. Median age was 60 years (range 23-93; 51.5% male); 89.5% lived in urban areas; 42.5% had less than high school education; 12% had formal employment; and 27.3% had no insurance coverage. 61% had gastrointestinal, 16 % genitourinary, and 23 % other tumors. Home-to-hospital time was < 2 hours (h) in 60%, 2-6 h in 27%, and ≥6 h in 13%. 47.7% of the patients reported a household income of less than 630 USD/month. The mean number of reported barriers was 1.96 (Standard Deviation 1.77). 78% identified at least one barrier to care, and 35% reported ≥3 barriers (range 1-8). The most commonly reported barriers were: financial burden (47%), beliefs about treatment (28%), lack of transportation (22%), fear (19%), home-to-hospital distance (16%), patient-provider communication (13%), employment (9%), and caregiving for other people (3%). Patients living in rural areas more often reported home-to-hospital distance as a barrier than those living in urban areas (69 vs 11%, p < .01). Conclusions: Most patients with metastatic cancer seen at a cancer center in Mexico identified at least one barrier to cancer care, with some reporting up to 8. Many of the reported barriers are potentially modifiable through patient navigation or SC interventions.
Opioid education for early gynecologic oncology practitioners, filling a much-needed gap.
Authors: Hokenstad Alexis Noel , Lefkowits Carolyn , Phippen Neil T. , Bunch Kristen Paige , Wheeler Lindsay , Kumar Amanika 
Published: November 2018

131 Background: Gynecologic oncologists report a lack of knowledge and comfort with palliative care topics including opioid management, despite their clinical importance. The objective of this study is to evaluate the impact of an online opioid educational module among gynecologic oncologists. Methods: A 25-minute video module was developed to provide an overview and example cases for opioid initiation, titration, and conversion. Fellows and early career gynecologic oncologists were invited to participate in a 24-question online survey addressing demographics, palliative care education in training, and preparedness and opioid-related knowledge. After viewing the module, participants completed a post-intervention survey, which was comprised of the same six knowledge-based questions and an assessment of the module. Responses were anonymous. A 3 month follow up survey will be sent to assess knowledge retention. Results: A total of 38 participants completed the initial and post-module survey, including 14 residents, 12 fellows, and 12 candidate members. Nineteen (50%) respondents had been previously taught to calculate a 24-hour oral morphine equivalent (OME) and to titrate opioids, but only 7 (18%) had received formal teaching on opioid rotation. Twenty four (63%) participants rated the quality of teaching overall in their fellowship as good, very good, or excellent, but only 15 (39%) rated palliative care education as at least good. Eleven (30%) respondents had a palliative care rotation in fellowship. Knowledge scores improved from pre-module to post-module, 49.5% correct answers compared to 74.6% (p<0.001). Thirty five (92%) of respondents were satisfied or very satisfied with this module and are interested in additional palliative care modules. Conclusions: A single online palliative care education module was associated with significantly improved participant knowledge on opioid management. Over 90% of respondents were satisfied with the module demonstrating an opportunity for improvement in palliative care education in gynecologic oncology via online education.
Multidisciplinary approach to endobronchial HDR brachytherapy as an alternative to external beam radiation for palliating malignant airway obstruction.
Authors: AL-Halabi Hani , Bechara Rabih , Snyder Will , Harpool Kristyn , Schantz Patricia , Law Tony , Shakibnia Lily , Swanson John , Cavanaugh Sean Xavier 
Published: November 2018

132 Background: Concerns over the safety of high-dose-rate (HDR) endobronchial brachytherapy (EBB) has limited its widespread use in palliating pulmonary airway obstruction. Morbidity following EBB is commonly attributed to fatal hemoptysis and fistula formation. We implemented a procedure to deliver EBB under general anesthesia to minimize procedure risks, while maintaining treatment effectiveness. We hereby report outcomes of consecutive patients treated using this approach to palliate airway obstruction. Methods: We retrospectively reviewed charts of consecutive patients treated with EBB. Treated patients had obstructive lesions >2cm distal to the carina and central structures, who were deemed candidates for EBB by a multidisciplinary team of interventional pulmonologists (IP) and radiation oncologists (RO). All patients were treated under general anesthesia. Bronchoscopy and localization of target lesions was performed by IP. HDR catheters carrying a marker wire were advanced past obstructive lesion. CT simulation was performed to confirm catheter placement, and perform CT-based 3D treatment planning. A dose of 6 -7 Gy/fraction was prescribed at 1 cm from catheter surface. Results: 25 patients (ages 29 -71, mean 52 years) were treated with EPP. 5 had previously received external beam radiation (EBRT) and 3 had concurrent EBRT and EPP. Overall, a total of 76 EBB treatments were performed, with a median of 3 weekly fractions per patient (range 1-6) to total dose of 18Gy. There were no incidences of major bleeding (>50 mL) or fatal hemoptysis in the 30 days following EPP. Moreover, there were no cases of severe (Grade 3 or higher) CTCAE toxicity reported. After a median follow up of 30 months (range 4-42) only 1 out of 17 patients treated with EPP alone required additional EBRT for airway obstruction, 12 months following EPP. Conclusions: Our data suggest the safety and efficacy of an expert multidisciplinary approach to palliating pulmonary airway obstruction using EPP. This approach provides effective palliation of airway obstruction and decreased the need for additional EBRT in majority of treated patients.
Outpatient acupuncture effects on patient self-reported symptoms in oncology care: A retrospective analysis of real-world data.
Authors: Lopez Gabriel , Garcia M. Kay , Liu Wenli , Spano Michael , Underwood Susan , Williams Janet L. , Moguel Rocio , Li Yisheng , Dibaj Seyedeh , Bruera Eduardo , Cohen Lorenzo 
Published: November 2018

135 Background: Increased access to complementary therapies such as acupuncture at academic medical centers has created new opportunities for management of cancer and cancer treatment related symptoms. Methods: Patients presenting for acupuncture treatment during calendar year 2016 at an outpatient integrative medicine clinic in a comprehensive cancer center were asked to complete a modified Edmonton Symptom Assessment Scale (ESAS; 16 symptoms, score 0-10, 10 worst possible) before and after each visit. ESAS subscales analyzed included global (GDS; score 0-90), physical (PHS, 0-60), and psychological distress (PSS, 0-20). ESAS symptom score change pre/post treatment and from baseline visit to first follow up were evaluated by paired t-test. Results: Of 375 participants [mean age 55.6, 68.3% female, 73.9% white, most common cancer diagnosis of breast (32.8%) and thoracic/head&neck (25.9%)], 73.3% had at least one follow-up treatment [mean 4.6 (SD 5.1) treatments]. Highest/worst symptoms at baseline were poor sleep (3.92), fatigue (3.43), well-being (3.31), and pain (3.29). Statistically significant reduction/improvement (pre/post) was observed for all ESAS symptoms and subscales for the initial treatment (p <0.001). Hot flashes had the highest mean reduction (-1.93), followed by fatigue (-1.72), numbness/tingling (-1.70), and nausea (-1.67). Clinically significant reductions were also observed for ESAS subscales of GDS (-12.2), PHS (-8.5), and PSS (-2.6). For symptom change from initial treatment to first follow-up (pre/pre), statistically and clinically significant improvement was observed for spiritual pain (-1.10; p<0.001) and ESAS subscale of GDS (-6.09; p=0.048). Clinical response rates (reduction ≥1) on follow-up were highest for symptoms of spiritual pain (58.9%), dry mouth (57.8%) and nausea (57.3%). Conclusions: Outpatient acupuncture was associated with immediate and longitudinal significant improvement across a range of symptoms commonly experienced by individuals during cancer care. Further research is needed to better understand frequency of treatments needed in clinical practice to help maintain benefit.
Financial burden at end of life: Findings from interviews with caregivers of patients with cancer.
Authors: McDermott Cara L. , Engelberg Ruth , Ramsey Scott David , Curtis J. Randall , Woo Cossette , Starks Helene 
Published: November 2018

14 Background: Studies have described financial burden during and after cancer treatment, but little data are available on financial burden to patients and caregivers at end of life. We conducted a qualitative study with bereaved caregivers and discussed the impact of cancer-associated medical and nonmedical costs on family finances. Methods: From October-December 2017, we audio-recorded semi-structured phone interviews with 35 adults who were primary caregivers for a family member who died with cancer (July-December 2016). We asked about ability to meet costs of care. Drawing from previous studies, we defined substantial financial burden as incurring debt, selling assets or draining savings to meet health care costs. Two analysts coded transcripts using qualitative content analysis and summarized results as major themes. Results: Patients ranged from 30-88 years old, caregivers 34-85. Most caregivers were white (91%), female (63%) and spouses (89%). Ten patients (29%) were insured commercially, 24 (69%) had Medicare, and one (2%) had Medicaid. Ten caregivers (29%) reported substantial financial burden, irrespective of patients’ insurance coverage. Issues associated with substantial financial burden were: 1) insurance hurdles: “my husband’s dying and…I have to run interference with insurance companies, which is frustrating;” 2) limited financial resources: “It is hard when…you really don't have a lot of savings because…you never really made a lot of money” and 3) financial burden that continues after the patient’s death : “I went broke, basically, looking after my parents.” “We lost two incomes and we had to live on our savings.” Three other caregivers noted their family did not experience financial burden because they switched health insurance plans or had a supplemental insurance plan. Conclusions: In this pilot study of caregivers of advanced cancer patients, a substantial portion of commercially insured patients and Medicare enrollees with limited savings and income reported financial burden associated with cancer treatment and end-of-life care that persisted after the patient’s death. Future research is needed to determine best ways to mitigate financial burden among patients and their survivors.
Potential Medicare beneficiary out-of-pocket cost reductions through use of biosimilar filgrastim-sndz over reference filgrastim among patients with lung cancer: A simulation model analysis.
Authors: Balu Sanjeev , Puckrein Gary , Xu Liou , Ryan Alan , Campbell Kim 
Published: November 2018

140 Background: G-CSFs are utilized to lower the incidence of febrile neutropenia (FN) in patients with cancers treated with chemotherapy. In 2015 filgrastim-sndz was the first biosimilar to be approved and launched in the US. Limited data exists on the impact of biosimilars on patient out-of-pocket (OOP) expenditures. The objective of this simulation model is to estimate potential OOP cost savings through use of filgrastim-sndz (FIL-S) over reference filgrastim (FIL-REF) from a Medicare lung cancer patient perspective. Methods: An Excel simulation analysis was conducted among lung cancer patients treated with biosimilar FIL-S or FIL-REF (identified through HCPCS codes). Data from the 2016 Medicare Limited Data Set was used to populate the model. Average Medicare payment to the provider and beneficiary OOP responsibility per claim of either FIL-S or FIL-REF were calculated. The average OOP reduction per claim for a FIL-S beneficiary relative to a FIL-REF beneficiary was multiplied to a hypothetical FN prevalent population of 100,000 beneficiaries (average of 10 claims per beneficiary) to estimate the potential OOP savings. Results: Data from 525 FIL-S and 621 FIL-REF claims were analyzed. The average Medicare allowed charge amount per claim for a FIL-S beneficiary was $381.7 versus $419.1 for a FIL-REF beneficiary, while corresponding average Medicare payments to the provider were $299.3 and $327.4, respectively. On an average, OOP responsibility for a FIL-S beneficiary was lower compared to a FIL-REF beneficiary ($76.4 vs. $85.0) leading to a cost saving per claim of approximately $8.60. When extrapolated to 100,000 beneficiaries (1,000,000 claims), the overall cost saving was projected to be around $8.6 million. Conclusions: Our simulation model estimated potential OOP Medicare lung cancer beneficiary savings of around $8.6 million, based on a hypothetical population of 100,000 FN beneficiaries, with the use of biosimilar FIL-S over FIL-REF. Further real-world analyses are required to evaluate the true cost savings potential with the use of biosimilars over reference biologics.
A review of phase III clinical trials of CDK4/6 inhibitor combination therapy in premenopausal women.
Authors: Yardley Denise A. 
Published: November 2018

141 Background: Clinical guidelines for the treatment of hormone receptor–positive (HR+), HER2− advanced breast cancer (ABC) are similar regardless of menopausal status, except for the role of ovarian suppression. However, breast cancers in premenopausal women frequently have an aggressive phenotype and a distinct underlying disease biology unaffected by ovarian suppression. Methods: We compared published trial designs, baseline characteristics, and efficacy and safety results of Phase 3 trials of cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitors including premenopausal women with HR+, HER2− ABC. Results: The MONALEESA-7 trial (NCT02278120) investigated ribociclib (or placebo) with a nonsteroidal aromatase inhibitor or tamoxifen + goserelin ovarian suppression in premenopausal women with ≤1 line of prior chemotherapy for ABC (N = 672); 40% had de novo metastases. Median progression-free survival (PFS) was 23.8 vs 13.0 months with ribociclib (n = 335) vs placebo (n = 337). In the PALOMA-3 trial (NCT01942135), 108 of 521 patients were premenopausal and treated with palbociclib (n = 72) or placebo (n = 36) + fulvestrant + goserelin; 75% had prior endocrine therapy (ET) or chemotherapy for ABC. Median PFS in the palbociclib vs placebo group was 9.5 vs 5.6 months. Adverse events common to both ribociclib and palbociclib ( > 30%) were neutropenia, leukopenia, and nausea. The MONARCH 2 trial (NCT02107703) evaluated abemaciclib (or placebo) with fulvestrant in 669 women with no prior chemotherapy for ABC (38% had 1 line of ET for ABC). In the premenopausal subset (abemaciclib, n = 72; placebo, n = 42; all with ovarian suppression), abemaciclib prolonged PFS (hazard ratio, 0.415 [95% confidence interval, 0.246–0.698]). Conclusions: While trial and patient characteristics differed substantially, safety and efficacy established in the MONALEESA-7 trial of premenopausal women and premenopausal subsets of the PALOMA-3 and MONARCH 2 trials support the activity and use of CDK4/6 inhibitor combination therapy in these patients. The treatment benefit observed in these trials was consistent with that in Phase 3 trials of postmenopausal women with HR+, HER2− ABC treated with CDK4/6 inhibitor combination therapy.