Evaluate the efficacy of Traumeel S in management of oral mucositis in patients receiving radiation for head and neck cancer.

Patient were matched and assigned to either mouth rinses with sage tea or with Traumeel S solution in alcohol. Participants were to rinse with the solution for 30 seconds before swallowing. Analgesics were prescribed according to stated individual patient requirements. Patients were assessed weekly.

The study was comprised of 20 patients, with a mean age of 58.8 years.
MALES 75%, FEMALES 25%
KEY DISEASE CHARACTERISTICS: All had head and neck cancer and were receiving 60-70 Gy median radiation dosage. 12 patient were also receiving Cisplatin. 75% had tumors of the oropharynx.

SITE: Single site

SETTING TYPE: Outpatient

LOCATION: Germany

PHASE OF CARE: Active antitumor treatment

Matched pairs design – non random

• CTC for adverse events v 3.0
• EORT-QOL–C30 questionnaire
• Head and neck, 35 questionnaire
• Patient diary of symptoms

No significant differences between groups in oral pain or occurrence of mucositis. Oral pain, pain on swallowing, and taste disturbances were lower in the Traumeel S group; however, this difference was not statistically significant, and patients on Traumeel S also received more frequent analgesics.

The study shows no effect of Traumeel S on mucositis or oral pain.

Small sample (<30)

Risk of bias (no blinding) 

Risk of bias (no random assignment)

Unintended interventions or applicable interventions not described that would influence results

Key sample group differences that could influence results

Measurement/methods not well described

Other limitations/*explanation:  Diary measurement of symptoms was not described. There was no control or description of other analgesics used. Frequency of mouthrinses was not stated, and there is no information about patient adherence to rinses. Samples differed in tumor location and radiation delivery site somewhat. More patients in the experimental group were receiving analgesics prior to beginning radiation.

Findings of this small study do not show that Traumeel S is effective in the prevention or management of oral mucositis in patients receiving radiation for head and neck cancers.

To evaluate the efficacy of resistance training to treat fatigue

• N = 155  
• MEAN AGE = 56 years (range = 29–75 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer stages I–III; received lumpectomy or mastectomy and scheduled for radiotherapy; majority did not receive chemotherapy; study occurred an average of 67 days after surgery
• OTHER KEY SAMPLE CHARACTERISTICS: Age ≥ 18 years; body mass index ≥ 18 kg/m²

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

• PHASE OF CARE: Active antitumor treatment

Single, blinded, randomized, controlled trial

• Fatigue was assessed with the Fatigue Assessment Questionnaire (FAQ), a 20-item self-assessment questionnaire validated for a German-speaking population. 
• Center for Epidemiologic Studies Depression Scale (CES-D)
• Quality of life was assessed with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30 BR23) for breast cancer.
• Trail Making Test (TMT)

• Other limitations/explanation: Patients were blinded, but investigators were not.

This study adds to the already extensive evidence supporting that exercise improves fatigue. This study showed this to be the case for patients receiving radiation therapy treatment and demonstrated that group interaction and attention alone were not responsible for the changes seen by including an attention control group in the study design. Nurses should recommend that patients participate in exercise to combat fatigue during cancer treatment.

To determine whether a phytotherapeutic agent is effective for the prevention of radiodermatitis

Patients were entered into the study prospectively. Patients used the same modalities as historical controls for skin care and also Capilen^® cream. Patients were evaluated weekly and at four weeks after treatment concluded. The cream was applied twice daily beginning two weeks before radiation therapy (RT) and during RT. A topical steroid was used at the first sign of skin alterations (erythema) every day until skin returned to its baseline state. The experimental cream contained extracts form calendula and multiple other plants with antioxidative and anti-inflammatory properties.

• N = 30 (30 historical controls)
• MEAN AGE = 61.6 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Median dose of 50 Gy in 25 fractions to the whole breast; skin-sparing radiotherapy was planned

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: Italy

• PHASE OF CARE: Active antitumor treatment

Observational with historical controls

• Radiation Therapy Oncology Group (RTOG) skin toxicity scale

A larger proportion of experimental patients experienced no toxicity. Lower percentages of patients in the experimental group were seen with all toxicity grades. There was no statistically significant difference between groups in toxicity level distributions. The percentage of patients who were toxicity-free at the end of treatment was 53.3% in the experimental group and 36.7% in the historical controls (p = 0.041).

Fewer patients using physiotherapy cream had radiodermatitis at the end of study evaluations, suggesting that it may be useful for the prevention of radiodermatitis. As this study had several limitations, additional well designed research is warranted.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Other limitations/explanation: The skin care used by historical controls and included in the care of study patients is not described; it appears that a variety of other topical creams were used. As topical steroids were used at the first sign of erythema, it is not clear what effects the steroid had versus the experimental intervention.

The findings of this study suggested that the cream tested here might be useful; however, because of multiple study limitations, this evidence is not strong. Additional research is warranted as there are few interventions that have been effective in the prevention and management of radiodermatitis.

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.