Background: Oral therapies are increasingly common in oncology care. However, data are lacking regarding the physical and psychologic symptoms patients experience, or how these factors relate to medication adherence and quality of life (QoL). Materials and Methods: From December 2014 through August 2016, a total of 181 adult patients who were prescribed oral targeted therapy or chemotherapy enrolled in a randomized study of adherence and symptom management at Massachusetts General Hospital Cancer Center. Patients completed baseline assessments of adherence with electronic pill cap, QoL, symptom severity, mood, social support, fatigue, and satisfaction with clinicians and treatment. Relationships among these factors were examined using Pearson product-moment correlations and multivariable linear regression. Results: At baseline, the mean electronic pill cap adherence rate showed that patients took 85.57% of their oral therapy. The most commonly reported cancer-related symptoms were fatigue (88.60%), drowsiness (76.50%), disturbed sleep (68.20%), memory problems (63.10%), and emotional distress (60.80%). Patients who reported greater cancer-related symptom severity had lower adherence (r= −0.20). In a multivariable regression, greater depressive and anxiety symptoms, worse fatigue, less social support, lower satisfaction with clinicians and treatment, and higher symptom burden were associated with worse QoL (F[10, 146]=50.53; adjusted R 2=0.77). Anxiety symptoms were most strongly associated with clinically meaningful decrements in QoL (β= −7.10; SE=0.22). Conclusions: Patients prescribed oral therapies struggle with adherence, and cancer-related symptom burden is high and related to worse adherence and QoL. Given perceptions that oral therapies are less impairing, these data underscore the strong need to address adherence issues, symptom burden, and QoL for these patients.
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Jamie M. Jacobs, Molly E. Ream, Nicole Pensak, Lauren E. Nisotel, Joel N. Fishbein, James J. MacDonald, Joanne Buzaglo, Inga T. Lennes, Steven A. Safren, William F. Pirl, Jennifer S. Temel and Joseph A. Greer
Naresh Ramarajan, Farzana Begum and Gitika Srivastava
Background: Availability of care is an important characteristic of effective primary healthcare systems. Imbalanced oncologist to patient ratios (∼1600: 1.8 M in India, ∼23,000: 15 M in USA), impedes access to expertise. On average it takes a week or more to get an online expert review from leading cancer hospitals in the United States and in India. Such delays have an important psychosocial impact on the patient and caregivers. Patients worldwide often race to start treatments at non-expert centers and may experience worse health outcomes from lack of expert tumor board review of their cases. This study aimed to examine the impact of Navya, a health services technology, on reducing the patient wait time in real-time treatment decision making. Methods: Navya generates personalized treatment plans that maps 98.8% within NCCN Resource Stratified Guidelines [SABCS 2017, NCCN 2018]. This is vetted on mobile by oncologists at tertiary centers like TMC NCG to provide expert opinion reports to patients. Since 2015, approximately 25,775 patients from 60 countries have reached out for an online opinion. On the ground, 78% of patients received evidence-based treatments recommended by Navya [ASCO 2017]. The Navya system releases preliminary system-generated opinions for patients whose treatment plans fit high confidence based on NCCN Guidelines and prior expert reviews. The mean reduction in time between a system-generated opinion and an expert-reviewed opinion was studied in a prospective cohort of patients between July 1, 2017, and August 30, 2018. Results: 313 patients received a system-generated treatment plan in the study period. Only approximately 10% of these plans were modified by experts to add additional treatment details since these were cases with high confidence in treatment decision-making. Navya delivered a preliminary treatment plan on an average of 86 hours (SD, 153 hours) prior to the expert response time. Of the 313 patients studied, 44% of patients would have waited an additional 3 days longer to receive an expert-reviewed recommendation. Conclusions: Navya’s NCCN and evidence-based treatment plans reduce the patient waiting times for an expert opinion average by 86 hours. This rapid confirmation of the right treatment plan at the time of patient need has potential to relieve patient anxieties at critical junctures in treatment decision-making and helps improve the treatment-planning process.
Surbhi Agarwal, Ruta Rao and David Ansell
Background: NCCN quality measures for breast cancer include (1) radiation therapy administered within 1 year of diagnosis for women under age 70 receiving breast-conserving surgery; (2) chemotherapy considered in 4 months of diagnosis for women under 70 with T1c or stage II/III ER/PR- tumors; (3) endocrine therapy administered within 1 year of diagnosis for women with AJCC T1 or stage II/III ER/PR+ breast cancer. These evidence-based measures promote accountability for providers and allow transparency in quality of care. Black women are less likely than white women to receive these therapies that are associated with a survival benefit. Improving adherence to guidelines can decrease the gap in mortality rates for minority women with breast cancer. Methods: We performed a retrospective chart review on patients with breast cancer between April 2010 and October 2015 at Rush University. Information collected included time of diagnosis, clinical stage, ER/PR status, surgical procedures, radiation, chemotherapy, endocrine therapy, and demographics. Chi-squared analysis was done to compare percent of black versus white women who met each quality guideline. Results: In total, 2,436 women were analyzed, of whom 30.3% were black, 66% were white, and 3.7% were other. Of this cohort, 779 women met inclusion criteria for quality guideline 1, and there was no significant difference between black and white women who did not receive radiation therapy (P=.21; 24.7% vs 20.4%). For quality guideline 2 (n=382), there was also no significant difference between black and white women who did not get chemotherapy within 4 months of diagnosis (P=.32; 36.6% vs 31.4%). However, for quality guideline 3 (n=1,222), there was a statistically significant difference between black and white women who did not get hormone therapy within a year of diagnosis (P=.0008; 36.9% vs 26.1%). Conclusions: Endocrine therapy reduces risk of recurrence and mortality in women with ER/PR positive breast cancer; however, there is a disparity between black versus white women who meet this NCCN quality measure. Further studies are needed to understand the reason for this gap in quality of care so that specific interventions can be implemented to eliminate this disparity.
Stuart Atkinson, Raoul S. Concepcion, John A. McLane, Deborah Boldt-Houle and Eleni Efstathiou
Background: Achieving and maintaining effective testosterone (T) suppression is key to treatment of advanced prostate cancer (PCa), for which LHRH agonists are standard of care. Increasing evidence suggests maintaining very low T levels to <20 ng/dL with androgen deprivation therapy (ADT) is desirable and correlates with disease-specific survival in patients with advanced PCa. Consistent drug delivery is important in providing continuous T suppression throughout the course of treatment without T rising above castrate level (T breakthrough). However, T breakthrough may occur between administrations, especially if a subsequent dose is delayed. Contributing factors to late administrations may include scheduling challenges, shortage of available appointments, and increasing number of patients. While FDA approvals for ADT drugs are based on a 28-day month, insurers may mandate full calendar months between doses for reimbursement. This study explored timeliness of subsequent LHRH agonist administrations and its relationship with T breakthrough. Methods: A retrospective review of electronic medical records from January 1, 2007 and June 30, 2016 of 85,030 LHRH agonist administrations for PCa treatment was conducted to evaluate the percentage of late subsequent dosing and impact on frequencies of T breakthrough, defined as T>50 ng/dL. Late administrations were defined as those on or after day 33, 98, 129, and 195 for 1, 3, 4, and 6 month formulations, respectively. Results: 26.9% of all subsequent LHRH agonist administrations were late: 14.4% were ≤1 week late, 3.1% were between 1–2 weeks late, and 9.4% were >2 weeks late. While only 4% of T values exceeded 50 ng/dL when doses were administered early/on time, 21% of T values exceeded 50 ng/dL when administrations were late. Conclusions: Over a quarter of subsequent administrations were defined as late, leading to >20% incidence of T values exceeding 50 ng/dL. Considering the clinical benefits of maintaining effective T suppression throughout a course of ADT, clinicians should administer treatments within approved dosing instructions, routinely monitor T levels, and consider prescribing treatments with proven efficacy through the dosing interval to maintain T at castrate levels.
David da Silva Dias, Catarina Jorge, Mafalda Baptista, Ana Júlia Arede, Paulo Luz, Tânia Madureira and Beatriz Gosalbez
Introduction: Febrile neutropenia (FN) induced by chemotherapy (ChT) arises until 6 weeks after the last cycle, usually between 5 and 10 days post-ChT. Infection risk is 20%–30%. It is difficult to stratify patients with low risk of complications due to FN. MASCC index is useful but has limitations. This correlates with unnecessary hospital admissions, complications, and costs. Methods: Retrospective study of patients with diagnosis of FN induced by ChT, admitted to our center between 2012 and 2016. Primary goal was to describe this population. Secondary goal was to re-stratify the risk of FN using MASCC and CISNE indexes, clinical judgement, and social/logistic factors. SPSS v23 was used for statistical analysis. Results: 211 patients were included; median age, 66 years. Median hospital stay was 6 days (1–89). 25% were nosocomial admissions. At admission 46% of patients presented with stage IV cancer. 75% were solid neoplasms and 25% were hematologic. Profound neutropenia was observed in 43% and severe neutropenia in 36%. Overall mortality rate was 13%. Sepsis was diagnosed in 24 patients (11%), with a mortality rate of 54%. Only 12.3% of patients had prophylaxis with granulocyte-colony stimulating factor. At admission, 64% of patients had no obvious focal infection; 20% had probable focus; and in 16% a microorganism was identified, most commonly gram-negative Enterobacteriaceae. Most used antibiotics were piperacillin/tazobactam (44%) and its combination with aminoglycoside (34%). This combination showed benefit against some extended-spectrum beta-lactamase (ESBL)–producing strains and multiresistant (MR) Pseudomonas aeruginosa (2.8%). MASCC index identified 31% of patients with low risk FN. After applying the CISNE index, clinical judgement, and social/logistic factors, only 11% were identified as low-risk FN and did not benefit from admission. This translates to an avoidable cost of €48,000 according to the center’s annual report. Conclusion: The combination of β-lactam and aminoglycoside is overused in our practice. It is not recommended in hemodynamically stable patients and contradictory in unstable ones; still it shows some effect versus MR and ESBL strains. A study to evaluate their incidence in our center is now in progress. Low risk FN was observed in 11% of admitted patients. Our center has an internal protocol and has been able to provide a good overall response.
Efrat Dotan, Elizabeth Handorf, Caitlin R. Meeker, Bianca Lewis, Kelly Filchner, Jennifer S. Winn and Lori J. Goldstein
Introduction: Geriatric assessment (GA) is recommended for evaluating an older cancer patient’s fitness for treatment; however, it is underutilized in the community. We sought to define the gaps that exist in community oncology practices in the assessment and management of older MBC patients through implementation and training on the use of GA for the care of older MBC patients. Methods: The first phase evaluated community oncology providers using questionnaires regarding their assessment and management of older MBC patients. The second phase included training through implementation of a patient self-administered GA among patients ≥65-years-old with MBC. The providers were blinded to the results of the GA and provided their assessment. Comparison of the 2 evaluations was conducted. The GA was ultimately shared with the providers, who were questioned about the effect of the results on care recommendations. Results: 43 providers from 10 practices were enrolled. Phase I revealed the majority (77%) of providers recognized the utility of GA, yet only 42% routinely conducted a GA pretreatment. Most providers (77%) reported evaluating various GA domains through patient interview rather than validated assessments. Validated scales were used in low rates to evaluate cognition (23%), psychosocial status (12%), and toxicity risk (9%). The limited use of validated assessment tools was not influenced by the provider’s demographics or their views of GA utility. Eighty patients took part in the training phase of the study to date, with average age 74 (range, 65–90) and 84% Caucasian. The majority of patients had subtype ER/PR+, HER2- (75%) and 46% were on first-line therapy. 277 recommended interventions were identified: 174 immediate interventions and 103 suggested interventions. Following review of these results, providers reported being surprised in 40% of the cases, mainly with lower than expected cognitive or social support scores. The providers reported plans for change in management in 44% of the patients as a result of the GA findings. Conclusion: Despite acknowledgement of the value associated with pretreatment GA, it is rarely used in the community. Furthermore, interview rather than validated assessment tools are used to identify age-related concerns. In our preliminary results, the GA identified a large number of deficient areas that had not been identified through the provider’s assessment, and resulted in management change. Additional updated results will be presented at the conference.
Lori L. DuBenske, Sarina B. Schrager, Terry A. Little and Elizabeth S. Burnside
Background: National health organizations offer contrasting guidelines for women aged 40–49 regarding when to begin and how often to use mammography screening for breast cancer. The ACS recommends average risk women aged 40–44 receive annual screening “if they wish to do so” and annual screening for women aged 45–54. The United States Preventive Services Task Force recommends individualized screening for average-risk women before age 50 advised by risk assessment and shared decision-making (SDM). Clinicians lack guidance on how to conduct and what elements to include in mammography SDM. Our prior work identified core elements via scoping review applied to a modified Delphi consensus process involving patients, primary care physicians (PCP), and healthcare decision scientists (HDS). This study examines stakeholder group differences in endorsing core SDM elements. Methods: The Delphi consensus included 10 patients, 10 PCP, and 10 HDS and fielded 48 items to codify core elements of mammography SDM. A threshold of 80% agreement across all participants was set to establish consensus for retaining or dropping an item. In this study, separate stakeholder groups’ endorsement rates for each item were calculated. Items were deemed to have stakeholder discrepancy if one group differed from the 2 others in either meeting or not meeting the 80% threshold criteria. Results: 16 items (13 retained, 3 dropped in Delphi) had a discrepant group. For all retained items, the discrepant group fell below 80% criteria for retaining. For 2 of the dropped items, discrepant groups achieved threshold for retaining the item. One item was dropped despite most participants voting to retain it (>80%) due to the discrepant group’s rating <80%. Patients rated less importance to educating women about risks and recommendations. PCPs rated lower importance to training PCPs and women for discussions about mammograms and having discussions on a regular basis. HDSs rated greater importance to considering mammogram procedures and costs in SDM. Discussion: Leading healthcare organizations are increasingly recommending SDM in breast cancer screening, among other decisions. Guidelines enumerating core elements of SDM are needed to effectively direct clinicians. This study, by illuminating differences between stakeholder group perspectives, highlights the importance of eliciting varied perspectives in identifying core elements of SDM when informing healthcare practices and policy.
Eric Gratias, David Spangler and Margaret Rausa
Background: eviCore healthcare uses the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to support its proprietary program for medical oncology drug management. All treatment regimens assigned NCCN Category of Evidence 1, 2A, or 2B are considered NCCN-adherent treatment selections in the eviCore program. The purpose of this study was to evaluate the pattern of NCCN adherence during the first year following program launch in regional payer markets. Methods: All cancer drug treatment authorization requests submitted in month 1 and month 12 following program launch for 4 regional third-party payers representing 13 different states were included, each of whom had management of high cost oncology drugs in place prior to eviCore program launch. Month 1 data were used as a surrogate for pre-program NCCN adherence, which is an overestimate as there is significant eviCore program impact on patients initiating therapy during that time. Requests with incomplete clinical data were excluded from analysis. Included requests were stratified by month 1 or month 12 from initial program launch date for each health plan. NCCN adherence was assigned based on the results of the clinical decision support and peer consultation processes utilized by eviCore to adjudicate the treatment request. NCCN adherence rate was calculated for each subgroup and a cumulative NCCN adherence rate for all included cases was calculated using weighted average accounting for volume differences by market. Results: There were 2,028 treatment regimen requests that were fully evaluable, with 1,285 occurring in month 1 and 743 occurring in month 12 following program launch. The rate of NCCN adherence increased for each health plan during the first program year, ranging from 69%–84% in month 1 and rising to 79%–91% in month 12. The weighted cumulative NCCN adherence during month 1 for all included plans was 75% and rose to 88% at month 12 following program launch. Conclusions: Use of clinical decision support supplemented by peer consultation is an effective means of increasing oncologists’ adherence to NCCN-recommended therapies across a broad range of regional provider markets. Additional study is warranted to determine whether this methodology can be applied to NCCN Categories of Preference to direct more patients toward preferred regimens with superior efficacy, safety, and affordability to further improve quality of care and lower total medical costs.
Bridgett Harr, Joanna Bodmann and Helen Tackitt
Background: Survivorship care (SC) has evolved since its inception, as there are many approaches to provide care for the cancer survivor. In review of disease-specific programs offered, it was determined there were varying levels of commitment and resources within the same institution. Due to Commission on Cancer (CoC) requirements for eligible patients to be offered SC, a project was undertaken to standardize SC by: (1) establishing a comprehensive, standardized assessment for SC, (2) delivering consistent SC across disease groups, (3) encouraging evidence-based multidisciplinary management, and (4) meeting CoC standards of SC plan (SCP) delivery. Methods: SC is delivered by embedded, disease-specific advanced practice providers (APPs). All patients receive a personalized SCP, along with general survivorship education. Due to differences in resources and survivorship expertise, not all patients receive the same care quality. An APP committee was created to review the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Survivorship and develop a comprehensive program. A questionnaire was created to address survivorship-specific concerns. An order set was created to highlight available resources. Additionally, evidence-based practice guidelines were created for each survivorship concern to assist the provider in identification and management. This was added to standard materials, and tailored education is given based on concerns identified during the visit. Referrals and orders are placed as appropriate. Results: Across the institution, SCP delivery is on track to meet CoC standards for 2018. A database has been developed to track and audit completion of SCP delivery. The standardized survivorship questionnaire was implemented to enhance the meaningfulness of the survivorship visit. This was executed during the 4th quarter of this year with review and revision underway. Conclusions: Standardized delivery of SC is improving with positive feedback from the patients. The survivorship questionnaire and supporting materials have been well-received by APP staff to assist in quality care. Some areas continue to lack adequate resources for implementation and will pose challenges in the future to meet accrual metrics. Future goals include creating pre-visit electronic questionnaires and repeat assessments to address survivors’ evolving needs. Prospective data will be collected on survivors to assess unmet needs and population differences.