To determine whether cover gowns in addition to gloves decrease the nosocomial transmission of vancomycin-resistant enterococci (VRE) in an intensive care unit.

• Current practice studied first: gown and nonsterile, disposable gloves. Change in practice studied: gloves only.
• Private rooms and hand washing signs
• Equipment, such as blood pressure cuffs, thermometers, and stethoscope, dedicated to the patient

• Mean patient age was 54.6 years (SD = 16.2).
• Patients with at least two perirectal cultures
• For the gown and gloves study period, 141 patients (with 64 patients colonized on admission) were enrolled for 895 days.
• For the gloves only group, mean age was 55 years (SD = 15.1), and 173 patients (with 71 colonized) were enrolled for 945 days.

Medical intensive care unit (teaching hospital)

This was a prospective study.

Gown and Gloves

• 22% (11 of 49) of patients at risk developed VRE
• Acquisition rate: 1.80 cases per 100 days
• 23% of patients’ admission cultures grew VRE

Gloves Only

• 22% (21 of 51) of patients at risk developed VRE
• Acquisition rate: 3.78 cases per 100 days
• 20% of patients' admission cultures grew VRE

• Length of stay was a risk factor.
• No conceptual model was described.

The purpose of this article is to evaluate the safety, clinical response, and pharmacokinetics of pegfilgrastim compared to filgrastim in pediatric patients with sarcoma receiving dose-intensive vincristine-doxorubicin-cyclophosphamide/ifosfamide-etoposide (VDC/IE) chemotherapy.

Pediatric patients with biopsy-proven sarcomas scheduled to receive four cycles of VDC (cycles 1 and 3) / IE (cycles 2 and 4) chemotherapy in three-week intervals were randomized in a 6:1 ratio (pegfilgrastim to filgrastim). Pegfilgrastim group received one subcutaneous injection of 100 mcg/kg and filgrastim group received daily subcutaneous injections 5 mg/kg daily. Both groups received injections starting about 24 hours after completion of week 1 chemotherapy with continuation until a post-nadir absolute neutrophil count (ANC) greater than 10 x 10⁹/L achieved or until 24 hours prior to the next chemotherapy cycle. ANC greater than 1 x 10⁹/L and platelets greater than 100 x 10⁹/L were the minimum acceptable levels for chemotherapy. Chemotherapy modifications were made for infections requiring intensive care or for typhlitis, meningitis, or O₂-dependent pneumonia.

• 35 patients were in the sample.
• The age range was 0–21 years.
• 36.4% of the sample were female, 63.6% were male
• Diagnoses were ewing sarcoma family, rhabdomyosarcoma, and other soft-tissue sarcoma.
• 35 patients were White; 3 were Black, 5 were Hispanic, and  one was classified as Other.

10 outpatient settings in the United States and Australia

• The phase of care was active treatment
• Applications was for pediatrics

Phase II randomized, controlled trial (RCT), open-label.

• Duration of grade 4 neutropenia (ANC of 0.5 x 10⁹/L or lower) during cycles 1 and 3.
• Time to ANC recovery to 0.5 x 10⁹/L or greater in cycles 1 and 3
• Rate of febrile neutropenia (defined as ANC less than 0.5 x 10⁹/L) and an oral or oral-equivalent temperature of 38.2°C or greater on the same day.
   

85% of patients in the filgrastim group had febrile neutropenia compared to 68% in the pegfilgrastim group. The duration of grade 4 neutropenia was about equal in both groups with a median duration of 1 day less in the pegfilgrastim group during cycle 1. The median recovery to ANC time was also the same in both groups. One patient in the pegfilgrastim group in cycle 1 and three in cycle 3 failed to have neutrophil recovery. All patients in the filgrastim group had neutrophil recovery. The pharmacokinetics were similar for pegfilgrastim and filgrastim. In the pegfilgrastim group, duration of grade 4 neutropenia was inversely related to age (i.e., the younger the patient, the longer the duration). Adverse events were statistically equivalent between the groups; however, more types of events occurred in the pegfilgrastim group.

The use of pegfilgrastim is as safe and effective to use as filgrastim in pediatric patients with sarcomas and requires just one dose compared to daily doses of filgrastim.

• Small sample (less than 100)
• No blinding with risk of bias
• The 6:1 ratio of patients receiving pegfilgrastim versus filgrastim makes the comparisons between groups more challenging in determining the efficacy of outcomes.
   

The administration of pegfilgratim as a one-time dose can be as effective as daily doses of filgrastim against neutropenia in pediatric patients being treated with myelosuppressive chemotherapy for sarcomas. Nurses can advocate for the use of pefgilgrastim to decrease the burden of number of injections in pediatric patients with sarcomas.

To assess the effect of home-based exercise on sleep quality and proinflammatory cytokines in patients with breast and prostate cancer receiving radiation therapy

Patients randomly were assigned to the home-based exercise or control group. Patients in the control group received standard care and were encouraged to remain only as active as they were prior to study inclusion. Patients in the intervention group were given 45 minutes of instruction by an exercise physiologist and given an exercise kit that contained written instructions, a pedometer, and resistance bands. The exercise prescription followed the American College of Sports Medicine guidelines for progressive walking at moderate intensity. Resistance band use was designed for low to moderate intensity, focusing on upper extremities. Patients wore pedometers during the first week. All patients were followed weekly for four weeks. Study measures were obtained at baseline and after the intervention.

• N = 38
• MEAN AGE = 60.1 years (SD = 12.1 years)
• MALES: 29%, FEMALES: 71%
• KEY DISEASE CHARACTERISTICS: All had breast or prostate cancer and were in treatment with radiation therapy; none had recurrent disease or distant metastases.
• OTHER KEY SAMPLE CHARACTERISTICS: 61% were married, 90% were Caucasian, 50% had previous chemotherapy, and 74% had at least some college education. Inclusion criteria included a sedentary lifestyle.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Canada

• PHASE OF CARE: Active antitumor treatment

• RCT
  • This report is a secondary analysis of the initial RCT.

• Pittsburgh Sleep Quality Index
• ELISA for IL-6, TNF–α, and s-TNF-R

Fifteen of the 19 patients in the exercise group reported increased daily steps walked and at follow-up at three months walked significantly more than patients in the control group (p < .05). Twelve of the 19 patients in the intervention group reported doing resistance training for an average of 17 minutes three days per week. Overall sleep quality improved over time in both groups, and no significant difference was seen between groups. Post-intervention levels of IL-6 and TNF-α increased slightly in both groups. Both of these were lower in the exercise group, but the difference was not significant.

These findings do not demonstrate an impact of a home-based exercise program on sleep quality.

• Small sample (less than 30)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Other limitations/explanation: Although use of sleep medications is mentioned in the report, no data are provided regarding this or differences in other interventions between groups.

Findings show that patients being provided with training and materials to do a home-based exercise program was associated with good adherence by patients. However, findings did not show an effect of this exercise on sleep quality. Exercise is beneficial and should be encouraged but does not appear to have a beneficial effect on sleep-wake disturbance.

To analyze the effects of a four-week yoga intervention on cancer-related fatigue and the burden of overall side effects in older cancer survivors

This report is a secondary analysis of a previously published multi-site, randomized, controlled trial to assess the effects of yoga on fatigue and sleep problems among patients with cancer who completed initial treatment. Participants aged 60 years or older who had completed fatigue measures were included in this analysis. Group yoga sessions were provided two days per week for four weeks. The program included breathing exercises, postures, and mindfulness exercises involving meditation, visualization, and affirmation. Random sessions were independently observed by study coordinators to verify the content.

• N = 97  
• MEAN AGE = 65.96 years
• MALES: 6%, FEMALES: 94%
• KEY DISEASE CHARACTERISTICS: Multiple tumor types; breast cancer most prevalent (65%)

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: New York

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care 

Single, blinded, randomized, controlled trial

• Multidimensional Fatigue Symptom Inventory-Short Form (MFSI-SF)
• Clinical symptom inventory 11-point rating scale (Global symptom burden was calculated as the sum of all individual symptom scores ranging from 0–120.)

Participants attended an average of 6.2 of the eight yoga sessions. After the intervention, yoga participants reported a significantly lower level of fatigue compared to the standard care patients (p = 0.03) and a significantly lower global side effect burden (p < 0.01). Significant results were only in the physical and mental components of fatigue.

The findings of this study showed that yoga improved fatigue.

• Small sample (< 100)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Other limitations/explanation: There was high variability among the sample in the time since initial treatment ended, this ranged from 2–24 months. The sample included very few men, and the majority of participants were white and well-educated. The duration of follow-up was only four weeks. Participants were aware of the study outcomes of interest, so there was an associated potential threat to the internal validity of the study

The findings of this study suggest that yoga may be beneficial to older cancer survivors for the reduction and management of cancer-related fatigue. Studies of yoga have tended to be done in women and individuals with relatively high formal education. Additional research is needed to examine the effectiveness and acceptance of this type of intervention in more diverse patient groups.

GM-CSF topically (Leukomax mouthwash)
Given in 250 ml 400 mcg recombinant Escherichia coli GMCSF once daily as soon as erythema was diagnosed, ordered to swish and swallow over period of 1 hr.
Control arm – conventional mouthwash (Hydrocortisone, Pantocain)
Patients also told to maintain strict oral hygiene using a soft toothbrush and fluoride toothpaste, and to avoid tobacco, alcoholic beverages, very hot and cold food, and spicy food.

Stratified for RT chem. Combination or RT alone.
All patients had daily rinses at least 3x/day. GM-CSF versus pantocain, hydrocortisone, cional kreussler, and bepathen (European product).

 

The study was comprised of 59 patients, recruited, 14 not randomized, patients = 45.
GMCSF group = 23,  21 control
18 and 17 completed trial

Jan 1997 – Oct 1998

Prospective, randomized, parallel grouped phase II clinical trial (non-blinded)

WHO scale for mucositis
 

No statistically significant evidence was reached in the grade of oral mucositis or the patient’s perception of oral pain.

Unable to determine therapeutic benefit of control arm product versus lack of effect of GM-CSF versus benefit of strict oral hygiene.

Authors conclude the agent cannot be recommended.
 

Intervention not effective
 

• Sample size small
• Selection of control arm agent
• \"Tremendous cost\" of agent

IV palifermin (recombinant human keratinocyte growth factor) 60 mg/kg was given for three consecutive days immediately before a conditioning regimen (total body irradiation [TBI] plus high-dose [HD] chemo). Additional doses administered on days 0, 1, and 2.

• The study reported on 212 patients with a median age of 48.5 years and an age range of 18–69 years.
• Patients were stratified according to the center and type of cancer; 106 were given palifermin and 106 received placebo.
• All patients had hematologic cancers and were receiving autologous stem cell transplant (SCT).

The study was conducted in a multisite setting.

This was a placebo-controlled, double-blind, phase 3, randomized trial.

• The World Health Organization (WHO) oral toxicity scale was used.
• The Radiation Therapy Oncology Group (RTOG) acute radiation-morbidity scoring criteria for mucous membranes was used.
• The Western Consortium for Cancer Nursing Research (WCCNR) revised staging system for oral mucositis was used.
• Use of analgesia and total parenteral nutrition (TPN) was recorded.
• Duration of mucositis was recorded.
• Incidence of mucositis was recorded.
• Mucositis was evaluated for 28 days.

• Fewer patients in the palifermin group had WHO grades 3 or 4 (63%) than in the control group (98%) (p < 0.001).
• Fewer patients in the palifermin group had WHO grades 4 (20%) than in the control group (62%) (p < 0.001).
• Patients in the palifermin group had a lower median duration of mucositis at 6 days versus 9 days in the control group (p < 0.001).
• Fewer patient in the palifermin group reported soreness of mouth and throat (29%) than in the control group (46.8%) (p < 0.001).
• Patients in the palifermin group reported lower use of opioids (212 mg morphine equivalents) compared to the control group (535 mg morphine equivalents) (p < 0.001).
• Incidence of TPN was lower in the palifermin group (31%) than the control group (55%) (p < 0.001).
• Adverse events were rash, pruritus, erythema, mouth and tongue disorders, and taste alteration.

Patients in the palifermin group experienced statistically significant decreases in incidence and duration of mucositis.

• One or more of the study researchers had a relationship with AMGEN, which manufactures palifermin.
• The study only looked at a hemotologic autologous SCT population.
• The trial only studied the IV formulation.
• Palifermin costs may be a limitation.

Patients in the study group received 910 mg/m² IV amifostine 15–30 minutes prior to  200 mg/m² melphalan prior to autotransplant for multiple myeloma (MM). 

• The study reported on a sample of 90 patients; 43 patients received amifostine, and 47 did not.
• The age range was 31–69 years with a median age of 54 years.

This was a multicenter study conducted between May 1999 and November 2000.

This was an open label, randomized study.

The World Health Organization (WHO) scale for mucositis, median duration of mucositis, duration of total parenteral nutrition (TPN), and duration of narcotics use were recorded.

• Patients in the amifostine group experienced a reduction in median grade of maximal mucositis and incidence of grades 2–4 mucositis compared to the control group. 
• Patients in the amifostine group were more likely to experience no mucositis than patients in the control group, although the difference was not significant.
• Median duration of maximal severity was 3 days in the control group and 4 days in the amifostine group (p = 0.18).
• The control group was more likely to experience severe delayed emesis compared to the amifostine group, although this difference was not significant. 
• No significant differences were found in the requirement for or duration of TPN or narcotics.

This study provided weak statistical evidence for the use of amifostine.

• This study was supported by Schering Plough, which also manufactured amifostine, and Amgen.
• Amifostine infusion toxicities were common in this study.

• FINAL NUMBER STUDIES INCLUDED = 102 (However, data from 82 studies were abstracted, WMES were calculated from 66 high quality studies, and a systematic level of evidence criteria was applied to evaluate 60 outcomes.)
• TOTAL PATIENTS INCLUDED IN REVIEW = 41 (control), 42 (intervention)
• SAMPLE RANGE ACROSS STUDIES: 4–322 patients
• KEY SAMPLE CHARACTERISTICS: 40% during treatment, 60% after treatment, 83% breast cancer, 90% randomized controlled trials, 80% aerobic (either alone or combined with another modality), 76% did not adequately describe their sample, and 57% described the intervention

PHASE OF CARE: Multiple phases of care

The majority of studies demonstrated a positive effect on upper and lower body strength and self-esteem with physical activity during treatment. The majority of studies also demonstrated a positive effect on aerobic fitness, lower body flexibility, lean body mass, quality of life, trial outcome index, breast cancer subscale, vigor and vitality, fatigue, immune parameters, pain, symptoms, and side effects post-treatment. Twenty-nine of 36 studies reporting on aerobic exercises reported no side effects from physical activity. Significant WMES were found post-treatment for fatigue (-0.54, p = 0.003).

In general, physical activity is well-tolerated during and after cancer treatment. More studies are needed on specific kinds of exercise and the structure of delivery. Physical activity studies with fatigue as an outcome have increased from five to 14 since 2005 for post-treatment interventions with 93% of studies showing positive results and 50% of them being statistically significant.

• Most of the studies involved patients with breast cancer.
• Considerations for the difficulty of making recommendations based on variations in dose response, cancer diagnosis, and stage of treatment during the intervention were acknowledged.

Patients can be educated that physical activity after a cancer diagnosis can be safe with modifications as necessary.

The mindfulness based stress reduction (MBSR) intervention was based on the main principle that purposeful management of awareness can be used repeatedly in the ongoing process of adapting to illness once experiential knowledge of key processes in the stress-response cycle is mastered. Objectives of program were to

1. Provide an opportunity to develop an understanding of one’s personal responses to stress and a means to modify them
2. Allow group member to take an active role in their healing process
3. Teach options for self-care that promote feelings of competence and mastery
4. Enhance feelings of well-being
5. Provide a safe and supportive group environment.

The intervention consisted of seven 90-minute weekly sessions. Patient outcomes were evaluated at baseline and at week 7 (end of intervention).

• N = 90 
• MEAN AGE = 51 years
• KEY DISEASE CHARACTERISTICS: Patients with cancer with multiple diagnoses and stages, with breast cancer being the most common (38%)
• OTHER KEY SAMPLE CHARACTERISTICS: Well educated with a mean of 15 years of formal education, convenience sample

• Randomized wait-list control design
  • MBSR (N = 53)
  • Wait-list control (N = 37)

• Profile of Mood States (POMS)

The MBSR intervention did not have a significant effect on improving fatigue outcomes for patients. When comparing pre- and post-test intervention scores, both the control and intervention groups experienced a decline in fatigue scores from baseline to week 7; however, this difference did not reach significance for either group.

In the initial sample of 109 patients enrolled in the study, 19 dropped out. A dropout analysis was performed, and initial POMS scores of dropouts were found to have significantly more mood disturbance on the subscales of anxiety, depression, fatigue, and total mood disturbance (p < 0.05).

• Because MBSR was a multi-component intervention, it is difficult to isolate the mechanisms of action or specific techniques they contributed to the improvements observed.
• It is possible that those assigned to the waitlist control group felt disappointment and may not have improved as much spontaneously over time as they would have otherwise.
• Because the dropout group demonstrated higher mood disturbance, the MBSR program may not be sufficient to treat patients with more serious disturbances.

To establish the safety and efficacy of modafinil for the treatment of fatigue in patients with non-small cell lung cancer

Patients were randomized to take either oral modafinil 100 mg or a matched placebo capsule. Patients took the medication on a fixed-dose titration schedule of one capsule daily for 14 days and then two capsules daily for the next 14 days. Assessments were done at baseline and on days 14 and 28.

• N = 160
• MEAN AGE = 68.9 years
• MALES: 50%, FEMALES: 50%
• KEY DISEASE CHARACTERISTICS: All patients had non-small cell lung cancer.

• SITE: Multi-site  
• SETTING TYPE: Outpatient  
• LOCATION: United Kingdom

Double-blinded, placebo-controlled, randomized, controlled trial

• Functional Assessment of Chronic Illness Treatment–Fatigue (FACIT-F) scale for fatigue
• Epworth Sleepiness Scale (ESS)
• Hospital Anxiety and Depression Scale (HADS)

Fatigue declined in all patients with no significant differences between groups. Modafinil appeared to be well-tolerated with no difference between groups in adverse events; however, more patients in the modafinil group withdrew from the study (p = .02). 42% of those receiving modafinil and 23% of those on the placebo reported that the treatment was not helpful.

Modafinil was not shown to be effective in reducing fatigue in this study.

• Subject withdrawals ≥ 10% 
• Other limitations/explanation: It is not clear what phase of care patients were in and whether receiving active treatment.  

The findings of this study do not show the efficacy of modafinil in the treatment of cancer-related fatigue. Nurses should be aware that there is insufficient evidence to support effectiveness of modafinil for fatigue and should advocate for the use of interventions that have demonstrated effectiveness.