Irwin, M.R., Olmstead, R., Carrillo, C., Sadeghi, N., Nicassio, P., Ganz, P.A., & Bower, J.E. (2017). Tai chi chih compared with cognitive behavioral therapy for the treatment of insomnia in survivors of breast cancer: A randomized, partially blinded, noninferiority trial. Journal of Clinical Oncology, 35, 2656–2665.
The purpose was to examine whether tai chi chih (TCC) is noninferior in effect to cognitive behavioral therapy (CBT-I) in reducing insomnia in breast cancer survivors.
Participants were randomly assigned to two groups: those receiving CBT-I and those receiving TCC. Prior to the intervention, participants were enrolled in a 2-month phase-in period to establish their degree of insomnia. CBT-I and TCC groups were comprised of 7-10 participants and consisted of weekly 120-minute sessions. Interventions were held over two months, with a third month of skill consolidation and adherence (three months total intervention exposure). Remission of insomnia was also measured by an interviewer blinded to intervention exposure who evaluated remission according to DSM-IV-TR criteria. Assessments of insomnia, a daily sleep diary, polysomnography levels, levels of fatigue, sleepiness, depressive symptoms, body mass index, and physical activity levels were collected at month 2 (baseline data), month 3 (post intervention), and follow-up assessments at months 6 and 15.
PHASE OF CARE: Late effects and survivorship
Two groups were established in a randomized, partially blinded, noninferiority trial. Participants were blinded to the hypothesis and the alternate treatment group.
Responsiveness to CBT-I or TCC treatment was comparable with a responsiveness rate of 43.6% and 46.7%, respectively. The noninferiority margin for this study’s purposes was set at 50%, and noninferiority of TCC was observed at month 3 (p = 0.02), month 6 (p =< 0.01), and month 15 (p = 0.02). Both treatments resulted in comparable insomnia remission rates at month 15 (46.2% and 37.9%, respectively). Differences in change of PSQI or AISI, as well as change in sleep time and wake after sleep onset, and effects on fatigue, sleepiness, or depression from baseline were not significant in comparing treatment groups (p > 0.3, p > 0.4, p > 0.5, respectively). PSG did not demonstrate treatment effects or differences across groups of significance.
CBT-I and TCC demonstrated high patient responsiveness and sustainable insomnia reduction at follow up yet yielded nonsignificant differences between treatment groups, thereby demonstrating noninferiority of TCC to CBT-I. Improvements in sleep quality, fatigue, sleepiness, and depressive symptoms were observed among both groups, but group differences were again not significant.
Given not only the prevalence, but debilitative effect insomnia has on patients with cancer, alternative treatments to CBT-I, such as TCC, are important for nurses to assess and identify for patients, who may have variances in access to clinical CBT-I treatment.
Zhang, B., Dong, J.N., Sun, P., Feng, C., & Liu, Y.C. (2017). Effect of therapeutic care for treating fatigue in patients with breast cancer receiving chemotherapy. Medicine, 96, e7750.
The purpose was to evaluate the effect of therapeutic care (TC) with acupressure on fatigue in patients with breast cancer receiving chemotherapy.
Patients were randomized to the intervention or sham control arm. The intervention consisted of acupressure to three points related to energy in the human body (bilateral Hegu, Zusanli, & Sanyinjiao) administered 30 minutes per day, 10 minutes per point, 3 days a week for 12 weeks. Sham control included three points reported to have no relationship to alleviate cancer-related fatigue, first metacarpal head, patella, and inner ankle with same treatment administration, frequency, and duration. Fatigue, anxiety, depression, and sleep were measured at baseline, 6 weeks, and 12 weeks.
PHASE OF CARE: Active antitumor treatment
Randomized control trial
Multidimensional fatigue inventory (MFI), Hospital Anxiety and Depression Scale (HADS), and Pittsburgh Sleep Quality Index (PSQI)
For those in the intervention group, fatigue improved statistically (p < 0.01) at 6 weeks and maintained improvement at 12 weeks (p < 0.01). Anxiety, depression, and sleep quality improved at 12 weeks (p < 0.01).
Acupressure may be an effective method or type of complementary and alternative therapy in improving fatigue, anxiety, depression, and sleep in patients with breast cancer receiving chemotherapy.
Acupressure focused on points known to help energy may be useful in treating cancer-related fatigue, anxiety, depression, and sleep quality.
Lo Vecchio, A., Schaffzin, J.K., Ruberto, E., Caiazzo, M.A., Saggiomo, L., Mambretti, D., . . . Guarino, A. (2016). Reduced central line infection rates in children with leukemia following caregiver training: A quality improvement study. Medicine, 95, e3946.
A quality improvement project to educate caregivers on CL management and CLABSI prevention among children
The intervention consisted of nine in-person classes for education and practice on children and mannequins.
QI project for in-person caregiver training classes; no ICF needed.
CLABSI rate per 1,000 CL days in children with acute leukemia. The baseline was calculated based on previous 12 months of the QI project between March 2012 and April 2013 and was compared with cumulative CLABSI rates computed with 95% confidence intervals (CI).
A total of 118 children were diagnosed with acute leukemia and included in the study. 120 caregivers of 118 children agreed to participate. Baseline CLABSI rate was 6.86 per 1,000 CL days; within 8 months, 3.7 per 1,000 CL days; 46.1% reduction attributable to intervention alone.
Implementing an education intervention for the reduction of CLABSI occurrences using evidence-based practices resulted in dramatic improvement of CLABSI rates and, in turn, survival rates of leukemic children.
Subject withdrawals 10% or greater
Nursing is synonymous for teaching and educating the patient population. Nurses would be at the forefront of this intervention creating a comprehensive explanation of the disease process in a palatable form for caregivers as well as reinforcement and encouragement.
Vicente, M., Al-Nahedh, M., Parsad, S., Knoebel, R.W., Pisano, J., & Pettit, N.N. (2017). Impact of a clinical pathway on appropriate empiric vancomycin use in cancer patients with febrile neutropenia. Journal of Oncology Pharmacy Practice, 23, 575–581.
To determine the appropriateness of vancomycin prescribing, based on consistency with guideline (IDSA and NCCN) recommendations before and after implementation of FN clinical pathway. Secondary endpoint was to determine influence of comorbidities with inconsistent vancomycin use based on guideline recommendations.
Using IDSA and NCCN guidelines for prescribing vancomycin in adults patients with cancer with FN and a risk assessment tool for adverse clinical outcomes a pathway was developed to increase compliance with guidelines. 337 patient records were analyzed to evaluate effectiveness of FN clinical pathway at academic medical center. Patients admitted with FN and no allergy to beta-lactam were included. Four groups were evaluated: pre-pathway vancomycin use consistent with guidelines, post-pathway vancomycin use consistent with guidelines, post-pathway vancomycin use inconsistent with guidelines and post-pathway vancomycin use inconsistent with guidelines. Vancomycin use was defined as use for at least 48 hours to exclude those receiving it for procedural prophylaxis.
Evaluate appropriate prescribing of vancomycin based on consistency with guideline recommendations pre- and post-implementation of a FN clinical pathway.
Antimicrobial usage report generated from electronic medical record. Hematopoietic Cell Transplantation Comorbidity Index (HCT CI)
The rate of vancomycin use, inconsistent with guideline recommendations in the pre-pathway implementation time frame, was significantly greater (n = 74, 35.9%) versus use in the post-pathway implementation time frame (n = 5, 11.4%; p = 0.001). No comorbidities or specific HCT CI scores were predictive of vancomycin without indication on multivariate analysis.
Implementation of a guideline-based pathway for FN in adult patients with cancer can significantly improve adherence to guideline recommendations for antimicrobial (vancomycin) use
Use of clinical pathways can improve compliance with guidelines for managing at-risk patients, leading to better outcomes.
Vanderway, J., Vincent, C., Walsh, S.M., & Obrecht, J. (2017). Implementation of a pathway for the treatment of fever and neutropenia in pediatric patients with cancer. Journal of Pediatric Oncology, 34, 315–321.
Implement a pathway to achieve Time To Antibiotics (TTA) in less than 60 minutes form presentation for outpatient evaluation of FN in pediatric patients with cancer. Other endpoint was to improve bedside nurses’ understanding of fever, neutropenia, and importance of Rapid Time To Antibiotics (RTTA).
Implementation of Clinical Pathway for RTTA in less than 60 minutes
Inservice and poster board used to educate nurses about fever and neutropenia. Knowledge measured with pre- and post-tests.
TTA was tracked using retrospective chart review to determine pre-pathway metrics.
Retrospective chart review using electronic health record filters was used for pre-pathway data collection. A computerized spreadsheet was used for post-pathway data collection.
Nursing knowledge was tested using a 9-item Fever and Neutropenia Questionaire. A bulletin board with key FN concepts and an in-service by APNs were sources of education.
Nurses had a mean score of 7.5 correct answers for the pre-education questionnaire and an 8.92 mean score for post-education (p = 0.0002).
Improvement in nurses knowledge of FN was improved with education and TTA was improved with a clinical pathway. The study included a very small sample of pediatric patients and nurses from one cancer center, resulting in limited application to other settings.
Based on literature review and limited findings of this QI project, clinical pathways and nursing education are successful ways to improve care of patients with FN. Recommendations for implementing in other settings will need larger studies demonstrating success with these interventions to demonstrate applicability.
Weycker, D., Bensink, M., Wu, H., Doroff, R., & Chandler, D. (2017). Risk of chemotherapy-induced febrile neutropenia with early discontinuation of pegfilgrastim prophylaxis based on real-world data from 2010 to 2015. Current Medical Research and Opinion, 33, 2115–2120.
To estimate the odds of FN, beginning with second chemotherapy cycle, among patients who received prophylactic pegfilgrastim in that cycle and all previous cycles versus those who received prophylactic pegfilgrastim in all previous cycles only.
This is a descriptive study using a retrospective matched-cohort design utilizing pooled data from two healthcare claims repositories, the MarketScan Database and LifeLink Database, spanning the period from January 1, 2010 through September 30, 2015. The study is not prospective, but rather completes a secondary analysis of existing data.
PHASE OF CARE: Active anti-tumor treatment
Retrospective matched-cohort design
Comparison of the incidence and odds ratios of FN were determined between comparison and pegfilgrastim patients. Data was evaluated using generalized estimating equation regression models. No standardized measurement or instrument used; data obtained from charts.
Second-cycle incidence of FN was greater is the comparison patients with an odds ratio of 1.7 and p < 0.001 (broad definition). Second-cycle incidence proportions for FN was greater in the comparison group (narrow definition), with an odds ratio of 4.3 and p < 0.001. All cycles from the third through course completions, the odds ratio for FN was 1.6 with p < 0.001 (broad definition).
In this retrospective, matched-cohort study, those who did not continue pegfilgrastim prophylaxis subsequent to the first cycle of chemotherapy had a higher risk for FN compared to those who continue pegfilgrastim prophylaxis after each cycle of chemotherapy. Therefore, the administration of pegfilgrastim following each chemotherapy cycle (as opposed to abbreviated use) appears to have a protective effective in reducing the incidence of FN.
This retrospective, matched-cohort study indicates that premature discontinuation of pegfilgrastim prophylaxis following chemotherapy is commonplace in U.S. practice and is associated with additional febrile neutropenia events. The decision to prematurely discontinue pegfilgrastim prophylaxis following chemotherapy should be carefully weighed against the associated risk of FN. Although this study was a retrospective design, the findings continue to support the importance of adhering to current standards of nursing care practice with pegfilgrastim prophylaxis for the prevention of FN. Additional independent research is necessary, particularly evaluating the risk of FN in the older adult and publicly insured populations, which are under-represented in this study.
Morrison, V.A., Weller, E.A., Habermann, T.M., Li, S., Fisher, R.I., Cheson, B.D., & Peterson, B.A. (2017). Patterns of growth factor usage and febrile neutropenia among older patients with diffuse large B-cell non-Hodgkin lymphoma treated with CHOP or R-CHOP: The Intergroup experience (CALGB 9793; ECOG-SWOG 4494). Leukemia and Lymphoma, 58, 1814–1822.
To describe GCSF use and incidence of febrile neutropenia in patients aged 60 years or older with diffuse large B-cell lymphoma receiving initial CHOP or R-CHOP therapy.
Patients enrolled on the United States Intergroup Trial (CALGB 9793/ECOGSWOG 4494) were randomized to CHOP or RCHOP chemotherapy for the initial treatment of diffuse large B-cell lymphoma. The protocol did not allow CSF use for the first cycle.
If day 1 ANC was less than 1,500 cells/mm3, treatment was delayed a week. If FN occurred in the prior treatment cycle, cyclophosphamide and doxorubicin doses were reduced by 50% in the next cycle. These doses could be increased by 25% if the subsequent cycle was well tolerated, with no grade 3/4 hematologic toxicities.
Colony stimulating factor (CSF) could be used starting with second cycle to maintain dose intensity in event of neutropenic fever or dose reduction/delay.
Observational study
Data measured included the timeliness of chemotherapy administration (treatment delay), CSF use, reason for CSF use, febrile neutropenia, neutropenia, and chemotherapy dose reduction.
49% of patients received CSF during therapy. The median number of cycles for which CSF was used was three (range = 1-7) and the median duration of CSDF use was nine days. CSF was used to prevent chemotherapy dose reduction/dose delay in approximately 60% of patients, and for secondary prophylaxis in cycle(s) following FN hospitalization in one third of patients. Overall CSF was used during 16% of administered chemotherapy cycles. Significantly more patients were treated with CSF in later cycles of therapy. FN occurred in 41% of patients, and 38% of the episodes occurred in cycle 1.
For patients with diffuse large B-cell lymphoma who are 60 years of age and older who are receiving initial therapy with CHOP or RCHOP, CSFs helped maintain dose intensity and to prevent febrile neutropenia.
CSF is recommended for patients with diffuse large B-cell lymphoma who are 60 years of age and older who are receiving initial therapy with CHOP or RCHOP to prevent febrile neutropenia and maintain dose intensity. This is consistent with current standard practice.
Lyman, G.H., Allcott, K., Garcia, J., Stryker, S., Li, Y., Reiner, M.T., & Weycker, D. (2017). The effectiveness and safety of same-day versus next-day administration of long-acting granulocyte colony-stimulating factors for the prophylaxis of chemotherapy-induced neutropenia: A systematic review. Supportive Care in Cancer, 25, 2619–2629.
STUDY PURPOSE: To evaluate the relative merits of same-day versus next-day dosing of long-acting G-CSFs. Study aims are to conduct a broad search of the literature, to examine the volume of data on same day versus next-day long acting G-CSFs, and to explore the relationship between timing of administration and efficacy, effectiveness, and safety
TYPE OF STUDY: Systematic review
DATABASES USED: Ovid MEDLINE®, Embase®, Congress abstracts
YEARS INCLUDED: (Overall for all databases) no limit up to May 8, 2016 (Ovid MEDLINE and Embase); January 1, 2011 to April 6, 2016 (Congress abstracts)
INCLUSION CRITERIA: Followed the 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Publications reporting results from studies in humans in the English language, intervention included long-acting G-CSFs (pegfilgrastim, balugrastim, lipegfilgrastim, and empegfilgrastim) for the prophylaxis of chemotherapy-induced neutropenia were included. Included comparisons included long-acting G-CSF administration on the same day as chemotherapy and administration of long-acting G-CSF on the next day within the same study. Outcomes included neutropenia, leukopenia, FN, ANC, neutropenia-related infection, hospitalization, anti-infective use, or G-CSF--related safety outcome. Acceptable study designs included RCTs, prospective and retrospective non-randomized trials, longitudinal studies, registry studies, and open-label studies
EXCLUSION CRITERIA: Studies were excluded if they did not meet inclusion criteria (most notably had no relevant outcomes, no relevant comparison between same-day and next-day long-acting G-CSF administration, wrong indication, or were not in humans), were duplicate studies, or were not deemed to be an acceptable design
TOTAL REFERENCES RETRIEVED: 1,736 publications, of which 11 were found to meet all inclusion criteria and were included in the review
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Participants, interventions, comparisons, outcomes, and study design (PICOS) criteria were prospectively defined. Identified abstracts through the broad search were analyzed by two reviewers using PICOS criteria to determine eligibility. Full-text publications from the initial eligibility review were examined by two independent reviewers to confirm eligibility. Conflicts were resolved by a third senior reviewer. Data from eligible publications were extracted into a purpose-created data table; however, no formal statistical analysis was planned nor completed.
PHASE OF CARE: Active anti-tumor treatment
Safety: Safety results showed only small differences in the rates of all-grade adverse events and serious adverse events between the same-day and next-day pegfilgrastim groups
Neutropenia: Of the 11 publications included in the review, six reported higher rates and longer duration of neutropenia and/or FN for same-day LA G-CSF administration compared with next day administration (included data from two randomized studies and four retrospective). In these studies, same-day LA G-CSF administration was associated with increased grade 4 neutropenia compared with next-day administration in up to four treatment cycles. Retrospective safety studies and a large cohort study using claims data from more than 45,000 patients support the findings from the randomized trials that demonstrated next-day LA G-CSF administration resulted in lower rates of grade 3/4 neutropenia and/or FN compared with same-day LA G-CSF. Five studies showed lower or comparable rates and duration of neutropenia and/or FN for same-day compared to next-day LA G-CSF administration. These studies generally included small patient populations, retrospective designs, or did not have an adequate control arm to allow for accurate comparison. Nearly all studies reporting safety outcomes showed only small differences in the rates of all-grade adverse events and serious adverse events for same-day LA G-CSF versus next-day LA G-CSF.
Administration of pegfilgrastim at least 24 hours after chemotherapy (next day LA G-CSF) resulted in improved outcomes for patients with various tumor types receiving chemotherapy, including reduced incidence of grade 3/4 neutropenia and/or FN. Additionally, safety results for same-day LA G-CSF versus next-day LA G-CSF showed only small differences in the rates of all-grade adverse events and serious adverse events.
Findings show that administration of pegfilgrastim 24 to 72 hours after the completion of myelosuppressive chemotherapy (next-day LA G-CSF) is more effective than same-day LA G-CSF in preventing neutropenia and/or febrile neutropenia and is associated with fewer incidences of grade 3/4 neutropenia