Lopez, G., Chaoul, A., Powers-James, C., Spelman, A., Wei, Q., Engle, R., . . . Cohen, L. (2018). A pragmatic evaluation of symptom distress after group meditation for cancer patients and caregivers: A preliminary report. Journal of Pain and Symptom Management, 55, 1321-1326.e1.
To evaluate the effects of mediation group classes on patient and caregiver self-reported symptoms
This was an observational pilot that studied participants (patients and their caregivers) attending any of the three mediation group classes offered at a comprehensive cancer center. Classes were based on Tibetan mind-body mediation tradition, and spanned either 60 or 90 minutes in length, depending on type of class—power breath, sacred sounds, or movement and breath. Instructors of each mediation class consisted of mind-body therapists with at least five years of oncology experience. Participants completed a pre- and post-class Edmonton Symptom Assessment Scale (ESAS). Because participants could attend more than one meditation class, only data from the first visit of the 142 participants was examined. Data obtained from the ESAS was used to analyze symptoms individually and as subscales.
PHASE OF CARE: Multiple phases of care
Observational pilot that analyzed self-reported symptom information from patients and caregivers attending medication classes offered at a comprehensive cancer center between May and December 2015
ESAS was completed by participants before and after classes. Symptoms of the ESAS were analyzed both globally (subscales) and individually. ESAS subscales were scored as follows:
Clinically significant reduction of an individual symptom was defined as > 1; for ESAS global distress score (GDS) > 3; for physical distress score (PHS) > 2; for psychological distress score (PSS) > 2. Higher scores represented worse outcomes for the stated symptom or subscale.
For all participants there was a clinically and statistically significant decrease (improvement) in symptom of shortness of breath (mean = -1.2; p = 0.001), global distress (-5.17, p < 0.0001), fatigue (-1.34, p < 0.0001), anxiety (-1.26, p < 0.001). For patients, there was clinically significant improvement in dyspnea (mean = -1.12; p = 0.013). No clinically significant symptom change was observed when comparing class duration (60- versus 90-minute class). There was no clinically significant difference in participant symptom burden at baseline or in score reduction by group, or by attendance of one versus two or more classes.
Group mediation class, when used in conjunction to standard of therapy, shows a possible subjective improvement in shortness of breath, global distress, well-being, fatigue, and anxiety in the oncology population, but more research is warranted.
Further research on the long-term effects and continued use of group meditation on shortness of breath is warranted.
Nakano, J., Hashizume, K., Fukushima, T., Ueno, K., Matsuura, E., Ikio, Y., . . . Kusuba, Y. (2018). Effects of aerobic and resistance exercises on physical symptoms in cancer patients: A meta-analysis. Integrative Cancer Therapies, 17, 1048–1058.
Results showed exercise positively affected the symptoms of fatigue (p = 0.0004), pain (p = 0.02), insomnia (p < 0.0001), dyspnea (p = 0.001), and no significant effect on nausea/vomiting, loss of appetite, constipation, or diarrhea. For dyspnea specifically, only within the mixed exercise program subgroup (as opposed to resistance alone or aerobic exercise alone) was an improvement effect in favor of the intervention group found.
This study concluded that it had confirmed that exercise interventions improve fatigue, pain, and insomnia in cancer, and that it had a novel finding of a benefit of exercise on dyspnea, but showed no effect on nausea/vomiting, loss of appetite, or constipation/diarrhea. The analysis did show significant results in the areas listed previously, although it is difficult to determine generalizability given the unknown sample characteristics. The effect of exercise on dyspnea was only seen with the mixed exercise groups, and it is difficult to understand who was included in that subgroup of patients; unclear, in particular, with cancer type and phase of case. The mechanism of dyspnea in a heme malignancy patient is very different, for example, than for a solid tumor patient, and there was a highly limited number of patients with lung cancer in this study. Not knowing phase of care also limits the ability to understand who this could be applied to. More exploration of the effect of exercise on dyspnea should be undertaken to reach solid conclusions, but this analysis does suggest that the exploration is warranted.
With regard to dyspnea specifically, the nurse should be aware that there is a possibility that exercise may have an impact on dyspnea for some patients. It is unclear who these patients are, or what exercise regimens are most affected, so no clear recommendation can be provided to patients at this time based on this particular study.
Henshall CL., Allin L., & Aveyard H. (2018). A systematic review and narrative synthesis to explore the effectiveness of exercise-based interventions in improving fatigue, dyspnea, and depression in lung cancer survivors. Cancer Nursing, 42, 295-306.
Dimeo et al. (2004): After three weeks of exercises and relaxation, no significant results were noted for dyspnea, but were significant for fatigue (p = 0.67 and 0.54)
Glattki et al. (2012): In a study with pulmonary rehab measured using modified research council (MRC), the dyspnea scale was significant (p = 0.007, 0.26, SD = 0.61) for improvement in dyspnea.
Peddle-McIntyre et al. (2012): The MRC dyspnea scale was measured after 10 weeks and was not significant (pre = 1.6, SD = 0.6; post = 1.4, SD = 0.8).
Riesenberg and Lubbe (2010): The study showed significant improvements in dyspnea after four weeks of QLQ testing (p < 0.001) and also for fatigue (mean difference = -13.7).
Spruit et al. (2006): Using the BORG scale, no significant difference was found (p = 0.2969)
Overall, six studies reported statistically significant reductions in fatigue, two reported significant improvement in dyspnea, and one had significant reduction in depression.
Although there were some studies that showed that exercise interventions could possibly be effective for relief of symptoms such as dyspnea, the results were mixed, and there are unclear variations between programs and high dropout rates, so no recommendations can be made based on this particular analysis.
Nurses should be aware that there is the possibility that exercise may benefit some patients, and there is little risk of harm, but nurses should be aware that it is unclear what patients or what programs would be of benefit; therefore, no recommendations can be made at this time.
Henke, C.C., Cabri, J., Fricke, L., Pankow, W., Kandilakis, G., Feyer, P.C., & de Wit, M. (2014). Strength and endurance training in the treatment of lung cancer patients in stages IIIA/IIIB/IV. Supportive Care in Cancer, 22, 95–101.
To test the effects of a specially designed strength and endurance training on the independence and quality of life (QOL) in patients with stages III/IV lung cancer while undergoing chemotherapy
Endurance training and breathing techniques were performed five days per week, and strength training was performed every other day while patients received three cycles of inpatient chemotherapy (platinum based). Endurance training consisted of walking and stair exercises. Strength training consisted of four different endurance exercises (trunk stability, leg, arm, and abdominal musculature), as well as breathing techniques (active cycle of breathing) combined with conventional physiotherapy. Control arm received conventional physiotherapy. Evaluations were conducted at baseline and after three cycles of chemotherapy.
PHASE OF CARE: Active anti-tumor treatment
Randomized controlled trial
6 minute walk test, staircase walking (number of steps), Barthel Index (primary outcome measure), European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30, Modified Borg Scale
After intervention, the intervention group had a significantly higher Barthel Index (p = 0.003), indicating higher independence with ADLs. In the single scores of the EORTC QLQ-C30, the intervention group reported higher physical functioning (p = 0.025), lower hemoptysis (p = 0.019), lower pain in the arms/shoulders (p = 0.048), peripheral neuropathy (p = 0.05) and cognitive functioning (p = 0.05). There were significant differences in ability on 6 minute walk test and stair walking as well as strength capacity (all p < 0.05). The level of dyspnea decreased significantly in the intervention group while performing submaximal walking activities.
This study shows both feasibility and effects of a strength and endurance program during chemotherapy for lung cancer. The effects were significantly positive for the intervention group in every area (strength, endurance, QOL, independence). There were many issues with the study, however, making it difficult to apply to other populations. One huge issue is that it is unclear how many of the patients were SCLC versus NSCLC. These populations would have a wide difference in the natural history of disease on platinum regimen for the first few cycles; therefore, not knowing the content of each group is problematic. There were also large differences at baseline, so the effects are harder to evaluate. There was a very small sample size and large dropout rate. The intervention was feasible, but only given inpatient, so it is unclear if it is feasible for an outpatient population and these regimens are currently most typically administered outpatient in the United States. Although promising, it would need to be repeated to be generalizable.
Nurses should take away from this study that there is the possibility that endurance, strength, and QOL are improved by a program of strength and endurance training during chemotherapy. The results are not generalizable and would need further studies to confirm. There was no harm, but it cannot be recommended based solely on this study at this time.
Maeda, T., & Hayakawa, T. (2017). Dyspnea-alleviating and survival-prolonging effects of corticosteroids in patients with terminal cancer. Progress in Palliative Care, 25, 117–120.
To evaluate the effectiveness of corticosteroid to improve dyspnea and prolong survival in patients with terminal cancer
Retrospective chart review of 52 patients with terminal cancer who received corticosteroid for dyspnea. Effectiveness of corticosteroid to reduce dyspnea was assessed using the Support Team Assessment Schedule (STAS-J) and patients were classified as responders (n = 30) and non-responders (n = 22) based on STAS-J scores. Survival was compared between the groups, with patient survival being the primary endpoint.
Retrospective chart review of terminal patients who received either oral or IV corticosteroids. Patients were classified as responders or non-responders and survival was compared between the groups.
Effectiveness of corticosteroids to alleviate dyspnea was assessed using the Support Team Assessment Schedule (STAS-J) dividing patients into responders and non-responders. The Mann-Whitney U test compared survival between responders and non-responders, the chi-square test analyzed patient background information, and the Common Terminology Criteria for Adverse Events (CTCAE), version 4, evaluated adverse effects.
There was significant improvement in survival for patients who responded to corticosteroids with reduced dyspnea then those that did not using the Mann-Whitney U test (8.5 versus 5 days, p = 0.0019). Side effects observed with corticosteroids included insomnia (15.4%), delirium (11.5%), and hyperglycemia (3.8%).
The use of corticosteroid alone or in combination with opioid did reduce dyspnea in some patients at end of life and, therefore, resulted in prolonged survival. However, side effects of corticosteroids must be taken into consideration when assessing reduced dyspnea and evaluating the benefit of prolonged survival.
Dyspnea occurs at end of life and can be difficult to manage. Therapies to effectively reduce dyspnea at end of life are needed. Corticosteroid therapy may alleviate dyspnea in some patients at end of life. Nurses must continue to assess effectiveness of corticosteroids to reduce dyspnea along with side effects that may occur from therapy.
Starlight therapy consists of a moving low-light image of green stars against a dark blue background with moving clouds projected via a laser light lamp on the ceiling in the patient’s room.
Liu, F., Du, Y., Cai, B., Yan, M., Yang, W., & Wang, Q. (2017). A clinical study of polyethylene glycol recombinant human granulocyte colony-stimulating factor prevention neutropenia syndrome in patients with esophageal carcinoma and lung cancer after concurrent chemoradiotherapy. Journal of Cancer Research and Therapeutics, 13, 790–795.
To compare the efficacy and safety of PEG-rhG-CSF (prevention cohort) and rhG-CSF (delayed therapy cohort) for febrile neutropenia and, therefore, hospitalization of concurrent chemoradiation treatment of esophageal carcinoma and patients with lung cancer
Prophylactic application: G-CSF administered 24 hours after chemotherapy completion, 100 μg/mg PEG-rhG-CSF subcutaneously injected, whereas 150 μg of rhG-CSF was subcutaneously injected; the injection was performed once daily until leukocytes >10×109. Delayed application: G-CSF administered 5 days after the completion of chemotherapy.
Active treatment study for neutropenia-related hospitalizations for patients receiving concurrent chemoradiotherapy
SPSS, version 22.0, software (α = 0.05)
Comparison between the prevention group and the delayed group showed that the incidence of neutropenia-related hospitalizations were 4.44% and 14.62%, respectively (OR = 0.272, 95% CI [0.115, 0.642], p = 0.002). Comparison between the prevention group and the delayed group showed that the incidence of febrile neutropenia was 5.56% and 18.46%, respectively (OR = 0.26, 95% CI [0.12, 0.565], p = 0.001).
Prophylactic use of GCF decreased hospitalization rates and the use of IV antibiotics.
Nursing would teach effects of chemotherapy and depletion of white cells which could lead to hospitalizations and neutropenic fever. Administering this medication prophylactically would ensure less hospitalizations and less severe fevers as well as decrease use of antibiotics.
Blackwell, K., Gascon, P., Krendyukov, A., Gattu, S., Li, Y., & Harbeck, N. (2018). Safety and efficacy of alternating treatment with EP2006, a filgrastim biosimilar, and reference filgrastim: A phase III, randomised, double-blind clinical study in the prevention of severe neutropenia in patients with breast cancer receiving myelosuppressive chemotherapy. Annals of Oncology, 29, 244-249.
To confirm the safety and efficacy of the cost-effective filgrastim biosimilar EP2006 through a phase III, randomized, double blind study from the original PIONEER study, analyzing alternating treatments of EP2006 and reference filgrastim among patients receiving myelosuppressive chemotherapy. The alternating treatments were used to show there was no difference in efficacy, safety, or immunogenicity compared to patients who received EP2006 or filgrastim only.
Two patient groups from the original PIONEER study in which patients were randomized into one of four arms in a 1:1:1:1 ratio was analyzed in this study. Patients received an initial dose of either EP2006 or filgrastim and then alternated treatments over six cycles of chemotherapy TAC regimen (docetaxel 75 mg/m2, doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2). The filgrastim was administered as 5 µg/kg body weight per day, subcutaneous injection from the second day of chemotherapy until reaching ANC ≥ 10 x 109/l following nadir or for a maximum of 14 days.
PHASE OF CARE: Active anti-tumor treatment
Randomized, double-blind, parallel-group, multicenter study of women (aged 18 years and older) with breast cancer receiving myelosuppressive chemotherapy
Multiple variables from the original dataset were measured including: FN (oral temperature 38.3 C and ANC < 0.5x109/l on the same day), incidence of infections, incidence of hospitalizations due to FN, time and depth of ANC nadir (the patient’s lowest ANC in the respective chemotherapy cycle), time to ANC recovery, and ANC profile. Adverse events were also evaluated across all cycles of chemotherapy and included patients who received one or more dose of study medication and had one or more post-baseline safety assessment and the switched safety population of all patients who received one or more dose of study medication after cycle 1. Immunogenicity was evaluated.
Comparing the switched groups (n = 109) to the filgrastim reference group (n = 52), there were three patients (3.4%) in the switched group who had febrile neutropenia across cycles 2-6 compared to no patients with FN in the reference group. Infections occurred in 9.3% of patients in the switched group and 9.9% in the reference group. There were no differences between groups for depth of ANC nadir, time of ANC nadir, and time course of ANC recovery. Treatment emergent adverse events were similar between groups with 42.1% in the switched group and 39.2% in the reference group. No neutralizing antibodies against recombinant human G-CSF were detected.
The biosimilar EP2006 is as safe and effective as filgrastim. There was no compromise in immunogenicity in EP2006, and EP2006 was shown to be equally clinically meaningful to filgrastim, but is more cost-effective.
Knowledge regarding risks for infections in women with breast cancer receiving TAC therapy and the utilization of EP2006 as an alternative to filgrastim for cost-effective improved outcomes.
Zhang, R., Chen, J., Huang, H., Ma, J., Meng, F., Tang, Y., . . . Han, M. (2017). Primary fungal prophylaxis in acute leukemia patients with different risk factors: retrospective analysis from the CAESAR study. International Journal of Hematology, 106, 221-228.
To identify subgroups of patients undergoing treatment for leukemia who would receive the most benefit from primary antifungal prophylaxis (PAP).
Retrospective subgroup analysis of the observational China Assessment of Antifungal Therapy in Hematological Disease (CAESAR) study. Invasive Fungal Disease (IFD) was defined per the European Organization for Research and Treatment of Cancer/Invasive Fungal Infections Cooperative Group and the NIH/NIAID Mycoses Study Group criteria and classified as possible, probable, and proven. Treatments were categorized as antifungal prophylaxis, empirical treatment, preemptive therapy, and treatment of established IFD.
Retrospective subgroup analysis of a large observational study.
Data analyzed from previously collected variables from patient medical records. Variables measured included demographic information, laboratory values (albumin [decreased y/n], chemotherapy, neutropenia status, renal dysfunction [y/n], indwelling central line [y/n], corticosteroid use [y/n], parenteral nutrition [y/n], primary antifungal prophylaxis (PAP) administered [y/n]). Type of antifungal medications were also analyzed.
Among the 2015 patients in this sub-study of patients with acute leukemia, 2,274 courses of chemotherapy were administered: 1,410 courses of chemotherapy for acute myeloid leukemia and 864 courses for acute lymphocytic leukemia. Patients treated for AML incurred more IFDs than patients with ALL (11.8% versus 7.1%, p < 0.001). IFD was also higher among patients who received induction chemotherapy (21.6%) compared to consolidation chemotherapy (3.7%) (p < 0.0001). IFD risk factors included decreased albumin, indwelling central line, parenteral nutrition, and being male. Receiving PAP was protective against IFD; significant for patients on induction chemotherapy (p < 0.0001).
PAP is effective against IFD in patients undergoing induction chemotherapy for acute leukemia. PAP may reduce the risk of IFD in patients receiving consolidation chemotherapy, having a decreased serum albumin, indwelling central line, receiving parenteral nutrition, or having severe neutropenia.
Risk of bias (no control group)
Understanding the risks for invasive fungal disease and recommending primary antifungal prophylaxis for patients receiving chemotherapy (particularly induction chemotherapy) for the treatment of acute leukemia.
Pana, Z.D., Kourti, M., Vikelouda, K., Vlahou, A., Katzilakis, N., Papageorgiou, M., . . . Roilides, E. (2018). Voriconazole antifungal prophylaxis in children with malignancies: A nationwide study. Journal of Pediatric Hematology/Oncology, 40, 22-26.
To determine the safety of voriconazole (VRC) as antifungal prophylaxis (AFP) in pediatric hematology/oncology patients.
Patients received IV VRC 5-7 mg/kg every 12 hours as AFP, not as empiric treatment. Dosing and duration of VRC therapy was at the discretion of the treating physician. Median VRC dose = 7 mg/kg. Median duration of VRC = 17 days (range = 1-31 days). Median number of AFP courses = 1.7 (range = 1-6) per patient.
Retrospective chart review
Researchers assessed the rate of breakthrough IFIs during AFP and tabulated the incidence, time of onset, and severity of all AEs related to VRC.
Only one breakthrough IFI was found in the 429 courses of VRC given to 249 unique patients. Median duration of AFP with VRC was 17 days (range = 1-31 days). Median number of courses of VRC was 1.7 (range = 1-6) per patient. Females required more courses of VRC (median = 2, range = 1-4) than males (median = 1, range = 1-6) (p > 0.05). The underlying malignancy had a significant effect on the number of courses of VRC, with patients with leukemia receiving a median of 2 courses (range = 1-6). Patients without leukemia required a median of one course (range = 1-4) (odds ratio = 0.47; 95% CI [0.047, 0.5]; p = 0.019).
Seventy AEs of any grade were reported (a rate of 16.3%). There was no significant correlation between age, sex, and type of AEs. Of the 70 AEs, 38.5% were grade I, 48.4% were grade II, and 12.8% were grade III. Severity of AEs was not impacted by sex (p = 0.745), age (p = 0.78), and type of AE (p = 0.365). None of the AEs was severe enough to warrant discontinuation of VRC.
VRC provides effective prophylaxis in pediatric hematology/oncology patients at risk for IFIs. AEs were tolerable and manageable. However, the pediatric population may not be able to report subjective AEs, which could result in underdiagnosis of AEs. The risk of long-term AEs remains unknown.
Risk of bias (no control group)
Although AFP with VRC is effective, safe, and fairly well-tolerated, nurses should monitor their patients for early signs of AEs.