To examine the effects of a collaborative care intervention for reducing depression, pain, and fatigue in patients and stress and depression in caregivers

Patients and their caregivers were randomized to receive a web-based stepped intervention or enhanced usual care. The web-based intervention included access to a psychoeducational web site and a care coordinator who contacted participants by telephone every two weeks and in-person during clinic or hospital visits about every two months. The care coordinator communicated with the medical team or primary care physician for recommended interventions. In addition to the psychoeducation, the website provided an area where patients could record and monitor their own symptoms, a library of relaxation and educational videos, a participant chat room, and a general resource library. Care coordinators were trained in cognitive behavioral therapy and used an intervention manual. Weekly supervision of care coordinator adherence to the study protocol was provided. In the enhanced usual care group, if a patient had high depression or pain scores, he or she was contacted by a care coordinator and was provided with education and referrals for symptom management interventions as needed.

• N = 188   
• MEAN AGE = 61 years (SD = 11)
• MALES: 73%, FEMALES: 27%
• KEY DISEASE CHARACTERISTICS: Hepatic cancer or cancers with liver metastases

• SITE: Single site   
• SETTING TYPE: Home    
• LOCATION: Pittsburgh

PHASE OF CARE: Late effects and survivorship

Randomized, controlled trial

• Caregivers: Center for Epidemiological Studies Depression Scale (CES-D), Caregiver Quality of Life Index-Cancer (CQLI-C) scale
• Patients: CES-D, Brief Pain Inventory (BPI), Functional Assessment of Cancer Therapy-Fatigue (FACT-F), FACT-General (FACT-G), FACT-Hepatobiliary (FACT-Hep)

There were 84 page views by caregivers. Most frequently viewed areas were living with cancer, diagnosis and treatment, and managing symptoms. For patients, no differences existed between groups in fatigue or pain. An effect size of 0.748 for caregiver stress was seen at the six-month follow-up. An effect size of 0.372 was seen for caregiver depression.

The web-based psychoeducational intervention did not show significant benefit for patient symptoms compared to enhanced usual care. This intervention aimed at patients but may have had some benefit for caregivers of those patients with significant symptoms.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• The number of caregivers involved in the analysis of impact on stress, etc., was not stated, and no statistical analysis of differences between caregiver groups was provided.  
• The enhanced usual care group had many of the same features as the experimental group—the main difference was the website use.  
• There may not have been enough difference between interventions to show significant effects.

This study looked at the effects of a web-based system for psychoeducation and support of patients on patient symptoms and associated caregiver stress and depression scores. No significant difference in patient symptoms compared to the usual care study group was seen. This intervention, aimed at management of patient symptoms, may have had some positive benefit for caregivers.

RESOURCE TYPE: Consensus statement

PROCESS OF DEVELOPMENT: Panel members included pain management physicians, neurosurgeons, medical oncologists, radiation oncologists, and palliative care physicians.

DATABASES USED: No search engines were identified.

No level of evidence tables were submitted.

The adoption of intrathecal therapy for pain management by physicians broadens their ability to control pain and limit side effects and supports the use of intrathecal therapy for cancer pain management.

• A lack of RCTs for intrathecal pain therapy is noted
• An RCT evaluating polyanalgesia is suggested
• Studies in efficacy and safety of various agents in the spinal space
• Comparative studies of conventional medical management versus intrathecal drug delivery in patients with cancer
• Studies on cost-effectiveness

The study assessed the  efficacy of paroxetine compared to placebo in reducing hot flashes in women with or without history of breast cancer.

There were four study arms:

• Arm A: four weeks of paroxetine 10 mg/day followed by four weeks of placebo 
• Arm B: four weeks of paroxetine 20 mg/day followed by four weeks of placebo
• Arm C: four weeks of placebo followed by four weeks of paroxetine 10 mg/day
• Arm D: four weeks of placebo followed by four weeks of paroxetine 20 mg/day

Women with or without history of breast cancer having at least 14 hot flashes per week were eligible, of whom 279 women were screened, and 151 were randomly assigned. 107 patients completed study. Mean age was 53 years. More than 80% had prior history of breast cancer, and 60% were taking an antiestrogen.

Inclusion criteria:

• Adult women with and without a prior history of breast cancer who could not or did not wish to take hormone therapy
• History of troublesome hot flashes occurring at least 14 times per week lasting 1 month or longe
• ECOG performance status of 0–2
• Creatinine and bilirubin less than two times normal level
• Vitamin E use for at least one month prior to study entry and continued through study period 
• Antiestrogen use for at least one month prior to study entry and continued through study period

Exclusion criteria: Concomitant use of cytotoxic chemotherapy, radiation therapy, estrogen or progesterone use, antidepressants, monoamine oxidase inhibitors, or treatments for hot flashes

The study was conducted in multi-institutional out-patient oncology clinics.

The trial was stratified, randomized, double-blind, cross-over, and placebo-controlled . Participants were stratified by age group (younger than 60 or older than 60) and antiestrogen use (yes or no).

Measures included:

• Hot flash daily diary
• QOL tools:
  • The Center for Epidemiologic Studies Depression Scale
  • Hospital Anxiety and Depression Scale (seven anxiety items)
  • Medical Outcomes Study (MOS)
    • Sleep Problems Index
    • Sexual Problems Index 
    • Overall health-related QOL questionnaire

Paroxetine 10 mg significantly reduced hot flash frequency and composite score by 40.6% and 45.6%, respectively compared to 13.7% and 13.7% for placebo (p = .0006 and p = .0008, respectively). Paroxetine 20 mg significantly reduced hot flash frequency and composite score by 51.7% and 56.1%, respectively compared to 26.6% and 28.8% for placebo (p = .002 and p = .004, respectively). Efficacy was similar between the two doses but women were less likely to discontinue low-dose paroxetine. Paroxetine 10 mg was associated with a significant improvement in sleep compared to placebo (p = .01).

Study attrition was a limitation: 39 women did not complete 9 weeks of therapy; 26 women did not return diaries.

To determine the optimal use of prophylactic platelet transfusion for the prevention of hemorrhage after chemotherapy and stem cell transplantation

• FINAL NUMBER STUDIES INCLUDED = 8  
• TOTAL PATIENTS INCLUDED IN REVIEW = 390 in the intervention group and 362 in the control group  
• KEY SAMPLE CHARACTERISTICS: Three trials compared prophylactic platelet transfusions to therapeutic platelet transfusions. Three trials compared prophylactic platelet transfusions with different transfusion trigger levels. Two trials compared prophylactic platelet transfusion with varying dose schedules.

• Studies included few patients, and it was not clear whether a lack of difference in studies was a reflection of the lack of power.
• Even with combined studies, analysis is underpowered.
• Literature is dated, with the majority of studies undertaken more than 25 years ago.
   

The studies provide no indication to change the current practice guidelines recommending prophylactic platelet thresholds of 10 x 10⁹/liter, but uncertainty with this body of literature should be recognized. There is a need for trials with adequate power that compare prophylactic to therapeutic platelet transfusion.
 

To determine whether or not having a prophylactic platelet policy was as safe and effective as giving prophylactic platelet transfusions

If their platelet count was less than 10, patients were randomly assigned to one of two groups. One group would receive prophylactic platelet transfusions on the same day of count less than 10. The other group would not receive prophylactic transfusion. The patients would continue the treatment arm for 30 days post-randomization. All patients were given platelet transfusion if bleeding occurred at World Health Organization (WHO) grade 2, before an invasive procedure, or at the discretion of the clinician. If WHO grade 3 or 4 bleeding occurred, patients were treated with platelets and no longer remained on the treatment arm but were still monitored per the protocol.

• N = 598
• MEDIAN AGE = 55.5 years
• MALES: 65%, FEMALES: 35%
• KEY DISEASE CHARACTERISTICS: AML, ALL, CML, lymphoma, and multiple myeloma
• OTHER KEY SAMPLE CHARACTERISTICS: Patients who were receiving chemotherapy or stem cell transplants (70%) and were expected to be thrombocytopenic for at least five days.

• SITE: Multi-site  
• SETTING TYPE: Multiple settings  
• LOCATION: United Kingdom and Australia

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care 

Randomized, controlled trial

• Daily bleeding assessment forms were completed by trained staff when patients were inpatient.  
• Bleeding diaries were kept by patients when in an outpatient setting.

In relation to frequency of bleeding events of WHO grades 2, 3, or 4, the prophylactic group was superior to the no prophylactic group (p = 0.04). The number of days with bleeding events of WHO grades 2, 3, or 4 was higher in the no prophylactic group (p = 0.004). The length of time it took until a patient’s first bleeding event was shorter for the no prophylactic group (p = 0.02). Six patients in the no prophylactic group, as compared to one in the prophylactic group, had a WHO grade 3 or 4 bleeding event although the difference was not significant. The prophylactic group received more transfusions overall. Serious adverse events between the two groups were not significant.

The results of this study support the need for prophylactic platelet transfusions policies at cancer centers to reduce bleeding, although the authors note that their study cannot validate what is safe or effective practice.

• Risk of bias (no blinding)
• Measurement/methods not well described
• Measurement validity/reliability questionable

Nurses need to become familiar with the WHO grading criteria for bleeding episodes in order to help educate patients on the bleeding risks of low platelet counts. Nurses also need to know the policy of their own institution about what platelet threshold is used for prophylaxis, if such a policy exists. For those nurses who treat hematologic malignancies and/or stem cell transplant patients, the results of this trial could be the basis for an internal PI project.

This document provides a summary guide of infection prevention recommendations for outpatient settings.

Guidelines  

Administrative recommendations:

• Provide job- or task-specific infection prevention education and training to all healthcare providers (HCPs), including those employed by outside agencies and those available by contract or on a volunteer basis to the positions. 
• Use soap and water when hands are visibly soiled (e.g., blood, bodily fluids) or after caring for patients with known or suspected infectious diarrhea (e.g., Clostridium difficile, norovirus). Otherwise, the preferred method of hand decontamination is with an alcohol-based hand rub.
• Use personal protective equipment.
• Clean, disinfect, and/or sterilize medical equipment. 
• Implement measures to contain respiratory secretions in patients and accompanying individuals who have signs and symptoms of a respiratory infection, beginning at the point of entry to the facility and continuing throughout the duration of the visit.

The guidelines represent the absolute minimum expectations for safe care. They are not all-encompassing, and organizations should refer to original source documents for detailed guidance and references.

To determine if group-based cognitive behavioral therapy (CBT) following surgery for breast cancer had long-term benefits for depressive symptoms

Women who previously participated in a single-blind RCT of 10 weeks of a group-based cognitive behavioral intervention versus a one-day psychoeducational control condition were contacted five years later for follow-up assessment. Patients were mailed a questionnaire to complete.

• N = 130
• MEAN AGE: 62.5 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: 88.4% were disease free at follow-up.

• SITE: Single site  
• SETTING TYPE: Home  
• LOCATION: Miami, FL

• PHASE OF CARE: Late effects and survivorship

• Follow up post-RCT

• Center for Epidemiological Studies Depression Scale (CES-D)

Women who had participated in the CBT intervention reported fewer depressive symptoms (d = 0.32, p = 0.03). The power to detect this difference was 0.93.

Findings suggest that CBT-approach interventions had long-term benefit in reducing depressive symptoms among women with breast cancer.

• The measure for depression was different from what was used in the initial study, and it is unclear whether patients had clinically relevant depression to begin with.

Cognitive behavioral interventions have been shown to be effective interventions for depression. This study suggests that CBT benefits can be long lasting. Alhough most nurses do not provide full CBT, principles of the CBT approach can be readily incorporated into nursing care and psychoeducational interventions. This approach can be recommended for use.

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.