Kampshoff, C.S., Chinapaw, M.J., Brug, J., Twisk, J.W., Schep, G., Nijziel, M.R., . . . Buffart, L.M. (2015). Randomized controlled trial of the effects of high intensity and low-to-moderate intensity exercise on physical fitness and fatigue in cancer survivors: Results of the Resistance and Endurance Exercise After ChemoTherapy (REACT) study. BMC Medicine, 13, 275-015-0513-2.
To evaluate the effectiveness of a high-intensity (HI) and low-to-moderate–intensity (LMI) resistance and endurance exercise program compared with a wait-list control (WLC) group on physical fitness and fatigue in a mixed group of cancer survivors who completed primary cancer treatment, including chemotherapy
The HI (β = 2.2, 95% confidence interval [CI] [1.2, 3.1]) and LMI (β = 1.3, 95% CI [0.3, 2.3]) groups showed significantly larger improvements in peak VO2 compared to the WLC group. Improvement in peak VO2 was larger for the HI group than the LMI group (β = 0.9, 95% CI [−0.1, 1.9]), but the difference was not statistically significant (p = 0.08). Relative improvements in peak VO2 were 20% and 15% for the HI and LMI groups, respectively, which is in line with the relative improvements in healthy adults after a 12-week exercise program. No significant intervention effects were found for grip strength and 30-second chair-stand tests. Compared to the WLC group, both the HI and LMI groups showed significant improvements in general fatigue (HI: β = −1.3, 95% CI [−2.2, −0.4] and LMI: β = −1.1, 95% CI [−2, −0.2]), physical fatigue (HI: β = −2, 95% CI [−2.9, −1.1] and LMI: β = −1.4, 95% CI [−2.3, −0.5]), and reduced activity (HI: β = −1.1, 95% CI [−1.9, −0.2] and LMI: β = −1.2, 95% CI [−2.1, −0.3]), with no significant differences between both interventions. The HI group showed a beneficial effect on motivation compared to the LMI group (β = −0.8, 95% CI [−1.5, −0.03]) and WLC group (β = −1.2, 95% CI [−1.9, −0.4]), with no significant differences between the LMI and WLC groups. Furthermore, the HI group showed a significant reduction in mental fatigue compared to the WLC group (β = −0.9, 95% CI [−1.7, −0.2]). The effects on peak VO2 were modified by age (HI: βinteraction = −0.2, 95% CI [−0.3, −0.1], p = 0 and LMI: βinteraction = −0.1, 95% CI [−0.2, −0.01], p = 0.03), indicating larger effects for younger participants. No significant interaction effects for gender or diagnosis were found for physical fitness or fatigue.
Supervised HI exercise can be safely recommended to cancer survivors shortly after their completion of cancer treatment. HI and LMI exercise were equally beneficial in counteracting general and physical fatigue.
Advising patients to exercise or referring them to exercise specialists to exercise under supervision is beneficial when possible.
Kampe, S., Wolter, K., Warm, M., Dagtekin, O., Shaheen, S., & Landwehr, S. (2009). Clinical equivalence of controlled-release oxycodone 20 mg and controlled-release tramadol 200 mg after surgery for breast cancer. Pharmacology, 84(5), 276–281.
To assess clinical equivalence pain at rest of 20 mg controlled-release oxycodone and 200 mg controlled-release tramadol over 24 hours
Patients were premedicated with midazolam 7.5 mg and continuous-release oxycodone 20 mg or tramadol 200 mg. Patients received the same medication 12 hours later. After surgery, patients had access to rescue medications (paracetamol [acetaminophen]). Postoperative assessments were performed at 8, 16, and 24 hours after premedication.
Randomized double-blinded study
There was no significant difference between treatment groups with regard to adverse effects. The cumulative amount of IV paracetamol given during the first 24 hours after the operation did not differ significantly between the two groups. Postoperative pain management and patient satisfaction were equal in both groups.
There were no significant differences in pain control or incidence of adverse effects between the two groups.
Findings suggest effectiveness of continuous-release tramadol for the treatment of acute pain.
Kamboj, M., Blair, R., Bell, N., Son, C., Huang, Y.T., Dowling, M., . . . Sepkowitz, K. (2015). Use of disinfection cap to reduce central-line–associated bloodstream infection and blood culture contamination among hematology-oncology patients. Infection Control and Hospital Epidemiology, 36, 1401–1408.
To evaluate the impact of the routine use of a passive disinfection cap for catheter hub decontamination
Prior to the use of disinfection caps, the organization followed Centers for Disease Control and Prevention (CDC) recommendations for catheter care and routinely used chlorhexidine-impregnated dressings. The intervention was the routine use of disinfection caps with each central venous catheter (CVC) access rather than manual scrubbing of catheter hubs. The caps were changed after each access or every seven days on high-risk units. After implementation on high-risk units for six months, disinfection caps were introduced for routine use in general oncology units. Central line–associated bloodstream infection (CLABSI) rates were compared across all phases, preimplementation to full implementation. Data were compared to that from clinical units that did not use disinfection caps.
No significant decrease in CLABSI rates occurred when disinfection caps were used in high-risk units. CLABSI rates declined significantly when the caps were introduced among general oncology units that were at high-risk (p < 0.001); however, CLABSI rates did not change significantly within general oncology units that were not high-risk. The proportion of contaminated blood cultures from high-risk units declined after introducing the disinfection caps (p < 0.01). Substantial cost savings with reduction in CLABSI rates and contaminated specimens was estimated, assuming hospitalwide implementation results.
The use of catheter disinfection caps may help reduce CLABSI rates in high-risk patient groups and reduce the contamination of blood culture specimens obtained via catheters.
The findings suggest that the routine use of disinfection caps for CVCs may be helpful in reducing CLABSI rates among patients undergoing hematopoietic cell transplantation (HCT) and those with hematologic malignancies deemed to be at high-risk for infection. This is a relatively low-cost intervention that may be beneficial; however, this study does not provide strong evidence in support of this effect. Given the findings here, further research on the effects of this approach is warranted.
Kamath, J., Feinn, R., & Winokur, A. (2012). Thyrotropin-releasing hormone as a treatment for cancer-related fatigue: a randomized controlled study. Supportive Care in Cancer, 20, 1745–1753.
To evaluate the efficacy and safety of thyrotropin-releasing hormone (TRH) compared with placebo to treat idiopathic cancer-related fatigue (CRF).
Patients received four study medication bolus infusions, once a week, over a four-week period. The infusions were separated by one week (plus/minus one day). Two of the infusions were TRH at doses of 0.5 and 1.5 mg (lower dose given first), and the other two infusions were placebo. Fatigue assessments were obtained at baseline.
Patients were undergoing the transition phase after active treatment.
The study used a pilot, phase II trial, double-blind, placebo-controlled, crossover design with two randomizations.
Improvements in energy level (p = 0.004 for 0.5 mg TRH and p = 0.002 for 1.5 mg TRH), vigor and fatigue, and sleep disturbance were markedly higher for both TRH doses compared with placebo (saline infusion) throughout the interval from baseline through 72 hours postinfusion. No significant difference existed in energy level between the two doses. The walking test scores and the anxiety and depression symptoms showed no statistically significant difference between TRH and placebo. Side effects included modest increases in blood pressure, heart rate, nausea, flushing, and bladder sensation or urge to urinate.
TRH was safe and well tolerated by the patients. The results suggested significant beneficial effects of intravenous TRH in the treatment of CRF.
More data are needed to confirm these findings with a larger population. Nurses can encourage patients with prominent fatigue symptoms to enter a clinical trial testing the efficacy of TRH.
Kaltenbaugh, D.J., Klem, M.L., Hu, L., Turi, E., Haines, A.J., & Hagerty Lingler, J. (2015). Using web-based interventions to support caregivers of patients with cancer: A systematic review. Oncology Nursing Forum, 42, 156–164.
STUDY PURPOSE: To survey literature focused on social, psychological, financial, technology, and nursing topics for evidence supporting web-based informational and supportive interventions to improve the health of the caregivers of patients with cancer
TYPE OF STUDY: Systematic review
PHASE OF CARE: Early-stage (breast cancer) to stage 4 (lung cancer)
Three of the five articles used in the systematic review showed that web-based interventions decreased caregiver negative mood. One of the three studies showed that a multifaceted CHESS intervention had a moderate effect size (d = 0.387) to decrease caregiver burden and negative mood (d = 0.436) at six months. Another study using CHESS with a clinical report showed small to moderate effect reducing caregiver negative mood at six months and at one year (d = -0.592). A third study describing an informational intervention showed a large effect size (d = 0.88) on this variable. Two multifaceted interventions and one single-faceted intervention supported lower levels of caregiver stress and perceptions of broad social support. Only two of six studies presented usability score outcomes, and only one study addressed the feasibility of the web-based intervention.
Although only six of 581 initial literacy citations met the systematic review study criteria, those six indicated the successful use of web-based cancer caregiver interventions to meet social and psychological needs. The effect sizes of the six studies compared favorably to traditional interventions focused on caregiver burden, self-efficacy, and quality of life. The limited numbers of articles on web-based interventions that positively affected diverse groups of caregivers’ social, financial, and psychological outcomes support future exploration of the usefulness and feasibility of such interventions for cancer caregiver health.
Studies showing significant effects of web-based cancer caregiver interventions may appear more often in the literature to affect article capturing for this systematic review. The lack of identification of caregiver ethnicity in 80% of the cited studies leaves a gap in understanding how non-Caucasian samples or male caregivers may respond to web-based interventions. Published studies after February 1, 2014 were absent from the review. Only six studies met the criteria for the review.
Increasing the use and success of technology to deliver health-related consumer interventions currently support initial evidence for web-based programs, aligned with traditional cancer care, to improve quality of life of patients with cancer and their caregivers. Additional research identify the dosing of Internet interventions and evidence of the efficacy of various forms of interventions is needed.
Kahl, C., Sayer, H. G., Hinke, A., Freund, M., & Casper, J. (2012). Early versus late administration of pegfilgrastim after high-dose chemotherapy and autologous hematopoietic stem cell transplantation. Journal of Cancer Research and Clinical Oncology, 138, 513–517.
To evaluate the optimal application time for pegfilgrastim in autologous hematopoietic stem cell transplant (AHSCT) recipients.
Within two institutions, patients were assigned to either receive pefilgrastim 6 mg subcutaneously on day 1 (Peg1) or pegfilgrastim 6 mg subcutaneously on day 4 (Peg4). Primary study endpoint was time between transplant and neutrophil recovery to greater than 500/µl. A difference of less than 1 day was not considered clinically significant.
Patients were undergoing the active antitumor treatment phase of care.
This was an open-label, phase II study.
Both groups had a median of 10 days to neutrophil engraftment >500 µl and granulocyte engraftment greater than 1,000 µl, with no difference between groups. There were no differences between groups in time to platelet engraftment, incidence of febrile neutropenia, incidence or duration of IV antibiotics, or transfusion requirements.
Early administration of pegfilgrastim demonstrated no benefit versus administration on day 4 after AHSCT. No clear recommendation can be made with respect to an optimal time for pegfilgrastim use.
The study findings suggest that early and late administration of pegfilgrastim are equally effective in terms of time to neutrophil, granulocyte, and platelet recovery after AHSCT, need for IV antibiotics, transfusion, and incidence of febrile neutropenia.
Kahler, K.C., Hassel, J.C., Heinzerling, L., Loquai, C., Mossner, R., Ugurel, S., . . . \"Cutaneous Side Effects\" Committee of the Work Group Dermatological Oncology (ADO). (2016). Management of side effects of immune checkpoint blockade by anti-CTLA-4 and anti-PD-1 antibodies in metastatic melanoma. Journal of the German Society of Dermatology, 14, 662–681.
RESOURCE TYPE: Expert opinion
PROCESS OF DEVELOPMENT: Clinical review
This article provides an overview of the mechanisms of action of immune checkpoint blockade and clinical effects in metastatic melanoma. The focus is the adverse effect profile and therapeutic management. The side effect profile includes a review of a meta-analysis of 1,265 patients from 22 clinical trials who received ipilimumab. Eighty-two to ninety-five percent of patients experienced treatment-related side effects. Incidence tables are provided as well as a checklist for important questions during patient visits, blood test recommendations, and organ-specific side effects. Diarrhea and colitis are described with a table of trade, treatment, and follow-up. Other organ-specific side effects are also reviewed. Recommendations for management algorithms are discussed.
Comprehensive clinical studies have shown a major benefit of anti-CTLA-4 antibody ipilimumab and two anti-PD-1 antibodies nivolumab and pembrolizumab in various tumors, including melanoma. These agents enhance an autoimmune phenomenon that affects various organs. Persistent diarrhea and colitis are evidenced early in treatment and can be serious adverse effects. The clinical significance is the debilitating effect they have on patients, with electrolyte disturbances and protracted weight loss. Intestinal perforation is a serious risk. Grade 1–2 diarrhea is treated with loperamide and electrolyte replacement. An endoscopy should be considered with persistent low-grade diarrhea because it diagnoses the true extent of the colitis. For grade 3–4 diarrhea/colitis, immunotherapy should be discontinued and high-dose corticosteroids initiated. Symptoms improve markedly with this regimen. Treatment with infliximab (5 mg/kg) is used in rare cases in which steroids do not induce a response. Colitis is associated with ocular inflammation, and observing for this side effect is imperative. Comprehensive study data identify that the timely and consistent use of corticosteroids allows for control and regression of symptoms in the majority of cases.
This is an overview of a complex multidisciplinary side-effect management concern with new checkpoint inhibitors. Further study would be necessary for a nurse to acquire in-depth knowledge for patient care.
Immuno-oncology is becoming a mainstay of pharmacological cancer treatment. Knowledge of side effects of these checkpoint inhibitors, especially diarrhea and colitis, is essential to their prevention, treatment, and management. Early recognition and intervention can reduce sequelae for patients.
Kahler, K.C., & Hauschild, A. (2011). Treatment and side effect management of CTLA-4 antibody therapy in metastatic melanoma. Journal of the German Society of Dermatology, 9, 277–286.
RESOURCE TYPE: Expert opinion
PHASE OF CARE: Active antitumor treatment
N/A
Expert opinion level information
Currently, limited research evidence regarding interventions for the prevention and management of various side effects associated with immunotherapies exists. Corticosteroids are suggested to treat most side effects.
Kachare, S.D., Sanders, C., Myatt, K., Fitzgerald, T.L., & Zervos, E.E. (2014). Toward eliminating catheter-associated urinary tract infections in an academic health center. The Journal of Surgical Research, 192, 280–285.
To determine if implementing two interventions would cause a reduction in catheter-associated urinary tract infections (CAUTIs) in an inpatient surgical oncology unit (The first intervention was designed to decrease the use of Foley catheters, and the second intervention was designed to initiate early removal while preventing reinsertion of the Foley catheter.)
The first intervention was the development of a hospital-wide guideline outlining the indications for Foley catheter use. There were six defined reasons for the use of a Foley catheter in a patient. If the patient did not meet one of these criteria, then Foley catheter use was not recommended. The second intervention included two measures. The first was aimed at the early removal of the catheter by designing a daily electronic query sent to the attending physician regarding continuing use of the Foley catheter, and the second was direct personal contact with the primary medical team to determine the medical necessity of continued Foley catheter use. They also focused on the prevention of catheter reinsertion by following a developed algorithm for the healthcare team.
This study design was a pre/post design with preintervention data obtained in a retrospective manner followed by the authors obtaining postintervention data.
There was a significant reduction in the use of Foley catheters after the interventions were put in place (P < 0.0001). There also was a significant reduction in CAUTI rates for patients who did require a Foley catheter after interventions were put into place, from 4.6 to 0 (P = 0.03). For patients who required a Foley catheter and had a diagnosed CAUTI during the postintervention time period, none of the Foley catheters were reinserted. The preintervention group had four patients with positive CAUTIs who had a Foley reinserted.
Even though the study was limited to one inpatient surgical oncology unit, the findings support other similar studies of best practice indicating use of Foley catheter insertion criteria as well as algorithm guidelines for care after catheter removal. Because infections can be detrimental in the oncology population, healthcare teams working with these patients should explore the literature surrounding the prevention of CAUTIs and ways of implementing best practices.
Oncology nurses need to be diligent with hand hygiene, not only among themselves but with other members of the healthcare team. They also need to adhere to Foley catheter bundles, including the daily verification of continuing need for the catheter, the use of catheter securement devices, keeping tubing below the level of the bladder, keeping the bag off of the floor, and providing perineal care at least twice per day. If the institution does not have a catheter bundle, nurses need to lead the initiative to implement one. This study demonstrated successful institutional approaches for protocol implementation and ongoing auditing and interventions with care providers.
Julião, M., Oliveira, F., Nunes, B., Vaz Carneiro, A., & Barbosa, A. (2014). Efficacy of dignity therapy on depression and anxiety in Portuguese terminally ill patients: A phase II randomized controlled trial. Journal of Palliative Medicine, 17, 688–695.
To determine the influence of dignity therapy on depression and anxiety in palliative care unit inpatients diagnosed with a terminal illness and experiencing high levels of distress
Dignity therapy (DT) is brief psychotherapy aimed at decreasing the loss of dignity for patients with a life-limiting illness. This nonblinded, phase II, randomized, controlled trial involved a control group receiving standard palliative care (SPC) and an intervention group receiving SPC plus DT. Participants received a baseline assessment of anxiety and depression, an explanation of DT, and a copy of the DT questions at T1 of the study. They were then randomized into two groups. Within two to three days, the intervention group received audio recorded 30–60-minute DT sessions that were transcribed verbatim within the next two to three days and transformed into a written narrative. The DT therapist read the narrative to the patient and received corrections, returning the final narrative to the patient. Follow-up measurements of depression and anxiety in both groups were conducted on days 4 (T2), 15 (T3), and 30 (T4).
This nonblinded, phase II, randomized, controlled trial involved a control group receiving SPC and an intervention group receiving SPC plus DT.
Terminally ill patients experience high levels of depression and anxiety. DT was suggested as a feasible offering to people with increased or severe psychological distress. Participants who received DT experienced depression and anxiety score reductions, suggesting psychological benefits at least to the 30-day measurement period.
DT can be offered to patients with terminal conditions near the end of life (six-month prognosis). DT implementation requires careful training in the practice. Additional randomized, controlled trials testing DT against other psychological interventions in other populations of severely ill or terminally ill patients are needed.