To compare the efficacy and safety of two filgrastim formulations for controlling chemotherapy-induced neutropenia and to evaluate the noninferiority of the test drug against the original

Patients with grade 4 neutropenia were randomized 1:1 to Eurofarma filgrastim or Roche filgrastim. Doses were administered subcutaneously daily 5 mg/kg until absolute neutrophil count was 10,000/mm³ or greater or until the 15th day of the chemotherapy cycle (V14). Only a single event of febrile neutropenia was considered during the study period per patient. Neutrophil counts were drawn every two days.

• N = 219   
• AGE = 49–51 years
• MALES: Not specified
• FEMALES: Not specified
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer stages II–IV
• OTHER KEY SAMPLE CHARACTERISTICS: Full dose of TAC or AT chemotherapy

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Brazil

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

Phase III, open-label, noninferiority, randomized, two-group trial

• Kolmogorov-Smirnov test with Lilliefors correction used to evaluate standard distribution of the outcome variables
• Lillifors correction also used to adjust the estimated population parameters (mean and variance, standard deviation)

To assess the noninferiority of the test drug to the original the 90% confidence interval for the difference in the rates of grade 4 neutropenia between the two groups were initially calculated.

No significant difference (p = 0.9971) in the rate of grade 4 neutropenia existed in the total number of patients in each group during the first chemotherapy cycle.

Risk of bias (no blinding)

The increased surveillance of patients’ neutrophils may have produced better outcomes. The difference between the two drugs was negligible. Strong patient teaching is warranted, regardless of the process of events during the chemotherapy cycle.

To see if topical aloe vera gel would be beneficial in reducing the skin side effects of radiation therapy (RT).

Participants were stratified according to bra cup size, history of lymphocele drainage, and smoking. Participants were randomized to use of aloe vera or an aqueous cream for control.

• The sample was comprised of 208 participants with breast cancer.
• Median age was 57.5 years (range 28–89).
• Patients had undergone lumpectomy or partial mastectomy.
• Median radiation dose was 60.15 Gy.

Mater Centre, Australia, and the Royal Brisbane Hospital Centre, Australia

The study was a randomized, controlled, double-blind trial.

• Weekly assessment form based on Dische’s Morbidity Rating Scale was used to record skin reactions.
• Researchers observed for erythema, itching, pain, and extent of treatment area affected by dry or moist desquamation. The areas affected by moist desquamation were identified according to site.
• Weight, skin type, tumor stage, and previous skin cancer were also recorded.
• Weekly assessments were performed using the Radiation Therapy Oncology Group (RTOG) scale.
• Skin changes recorded were itching, skin texture, tanning, erythema, time to skin change, and dose at first skin change.

Aqueous cream was significantly better than aloe vera gel in reducing the incidence of dry desquamation and moderate or higher pain (p < 0.001). Participants with cup size D or more in either treatment arm experienced a significantly greater incidence of moderate or higher erythema compared with smaller-breasted women (p < 0.02). For non-chemotherapy participants, the aloe vera arm experienced a significantly reduced incidence of moderate or higher erythema (p = 0.02). The control group arm experienced a significantly reduced incidence of moderate or higher pain (p = 0.03). The most important predictors of development of skin reaction were radiation dose, breast size, patient smoking, and damage to the lymphatic system manifested by one or more lymphocele drainage. Cumulative dose was greater than 2,700 cGy, and there was a delay to onset of erythema (p = 0.013).

Aqueous cream is superior to aloe vera in reducing the acute RT skin reactions of dry desquamation and pain.

• The consistency and appearance of the two study preparations were quite dissimilar, so participants may have guessed the identity of their study preparation.
• Ninety percent of the final skin assessments were conducted over the telephone, so the research nurse was not able to view the participant’s skin and had to rely on the subjective assessment.

To clinically evaluate the use of a polymeric membrane for the management of radiodermatitis in terms of skin integrity, management of desquamation, relief of pain and inflammation, and healing time

Patients with Radiation Therapy Oncology Group (RTOG) scores of 1–3 and early signs of skin reactions were followed for four weeks during treatment. Study data and patient assessments were obtained weekly. The polymeric dressing provided a mild cleansing agent activated by exudate that supported natural debridement. The dressing also contained glycerine, which provided moisture, and surfactant, which has been reported to reduce tension between healthy and unhealthy tissue.

• N = 23  
• MEAN AGE = 63.6 years (range = 38–82 years)
• MALES: 32%, FEMALES: 68%
• KEY DISEASE CHARACTERISTICS: Various tumor types including breast, head and neck, and prostate
• OTHER KEY SAMPLE CHARACTERISTICS: Highest radiotherapy dosage was 74 Gy in 37 fractions

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

• PHASE OF CARE: Active antitumor treatment

Observational

• Numeric pain scale
• Wong and Baker FACES^® scale
• Patient diary
• RTOG skin rating

From baseline to week 3, RTOG scores improved. Diary pain scoring showed an overall reduction in pain from an average of 6.5 to 1.6. Fixation of the dressing was a challenge, particularly among patients with breast and gynecologic cancers. Themes from a qualitative analysis of patient diaries identified skin improvement, a cooling effect of the dressing, and pain reduction.

Polymeric dressing use may be helpful for the prevention and treatment of radiodermatitis.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: The frequency and timing of dressing changes was not described. The way in which data were presented did not enable the reader to determine how many patients had a significant improvement or decline in skin condition, though group trends were shown. Who measured skin condition and how it was measured was not clear.

Polymeric dressings may be helpful for the prevention and treatment of radiodermatitis. Additional, well designed, clearly reported studies are warranted. Keeping this specific dressing in place was found to be a challenge for some patients.

Investigate the effects of meditation on the symptoms of anxiety, depression, and fatigue in women who were receiving radiation therapy for breast cancer

The intervention group received a total of 12 meditation therapy sessions during its six-week radiation therapy period. The control group received only conventional radiation therapy. The meditation intervention was Brain Wave Vibration meditation, which is based on a Korean traditional exercise, simple movements, music, and positive messages (changing weekly). This focuses on the senses of the body, relaxing the body and mind and relieving negative thoughts through natural rhythmic movements.

• N = 83    
• MEAN AGE = 47 years
• MALES: 0%, FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Female patients with breast cancer undergoing breast conservation and radiation therapy with curative intent
• OTHER KEY SAMPLE CHARACTERISTICS: Primarily married, primarily financially stable, primarily HER-2/neu negative

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Asan Cancer Center, Seoul, Korea

• PHASE OF CARE: Active anti-tumor treatment
• APPLICATIONS: Elder care

Randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Revised Piper Fatigue Scale
• The European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30

Patients who received meditation therapy saw mild improvements, with a reduction in anxiety and fatigue. Patients in the control group also showed significant reduction in fatigue and anxiety, and post-intervention scores actually were lower for both of these in the control group. No effect was seen for depression.

The study states that an “affirmation” can be made that meditation can be used as a non-invasive intervention for improving fatigue and anxiety. However, results showed significant reductions in these symptoms for patients in the control group as well. This provides minimal support for effectiveness of the approach used here.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%
• Korean study, using a Korean meditation technique; likely not generalizable to the United States
• Big impact on time
• Not a billable service; great staff time and training involved
• Unclear whether the meditation was in a group setting or individual; what relation did group dynamics play in a group of patients who may have met together 12 times and formed an effective peer-to-peer support group?
• The study was underpowered by the author's calculations.
• An intent to treat analysis was used, but how this was applied was not stated.

Nurses likely would not have any options of referral to meditation resources. Something more generalizable, like relaxation or mindfulness, would have been a better option for a study. The study is Korean; typically educated Korean women may have had previous exposure to meditation, and the intervention would be more acceptable to them than to American women.

To compare two common prophylactic platelet transfusion thresholds for patients receiving induction chemotherapy for acute leukemia

Patients were divided into four groups: new diagnosis of leukemia in patients aged less than 60 years; new diagnosis in patients 60 years or greater; relapsed disease in patients aged less than 60 years; and relapsed disease in patients aged 60 years or greater. Patients were randomized by selecting cards from an envelope to receive platelets when their morning platelet counts were either 10,000 microliters or 20,000 microliters. All platelet apheresis product transfusions were given according to the same transfusion orders. Controls for failure to respond to platelet transfusion for all participants were included in the study as well as guidelines for removing patients if warranted. For serious and life threatening bleeding, and as otherwise directed by the treating physician, therapeutic platelets were administered to study participants.

• N = 78  
• AGE RANGE = 19–82 years
• MALES: 64%, FEMALES: 36%
• KEY DISEASE CHARACTERISTICS: Patients were treated with one of three commonly used induction therapies. These included cytarabine x 7 days and daunorubicin x 3 days; cytarabine 2–3 Gm/m2 every 12 hours x 12 doses; or mitoxantrone 12 mg/m2 x 3 days with etoposide 150 mg/m2 CI x 5 days. 
• OTHER KEY SAMPLE CHARACTERISTICS: None

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: University of Iowa Hospital

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care, and palliative care 

Prospective, randomized trial

• Bleeding toxicity scale
• Number of bleeding episodes (calculated by documentation in patient chart or observation by investigator) 

The study found that there was no statistical difference in the total number of bleeding episodes between the two groups of patients (p = .12). Of note, there was a significant increase in platelet reactions in the platelet group receiving ≤ 20,000 microliters (p = 0.005).

Administration of prophylactic platelets at a threshold of 10,000 microliters can cut back the utilization of platelets and reduce the incidence of viral exposure without a statistically significant effect on morbidity.

• Small sample (< 100)
• Risk of bias (no control group)
• Findings not generalizable

Nurses need to be familiar with professional guidelines and institutional policies regarding platelet transfusions. This would include the use of premedications, post-transfusion blood drawing, and reporting of platelet reactions. For those institutions that use platelet thresholds higher than 10,000 microliters, it may be time to revisit practice based on the findings of this study.

To assess the combined and comparative effect of cognitive behavioral therapy (CBT) and armodafinil to improve sleep and daytime functioning in survivors of cancer.

Participants were randomized to (a) CBT-I and placebo, (b) CBT-I and armodafinil 50 mg b.i.d., (c) placebo BID, or (d) armodafinil 50 mg BID. All received written sleep hygiene guidelines. Participants had CBT-I in 30–60-minute individual, in-person sessions during weeks 1, 2, and 4; and had 15–30-minute phone sessions during weeks 3, 5, and 7. Study medicine was taken for 47 days from 7 am to 9 am and 12 pm to 2 pm.

• N = 88  
• MEAN AGE = 56 years 
• MALES: 12%, FEMALES: 88%
• KEY DISEASE CHARACTERISTICS: Patients with any cancer who completed chemotherapy and/or radiation not less than one month prior and had no measurable disease
• OTHER KEY SAMPLE CHARACTERISTICS: Patients discontinued any prescribed or OTC sleep medications one week prior to the study and for the duration of the study

• SITE: Not stated/unknown    
• SETTING TYPE: Not specified  
• LOCATION: United States and Canada

• PHASE OF CARE: Transition phase after active treatment

• Four am factorial
• Randomized and blinded trials for medications but not for CBT-I

• Quantitative data of fatigue assessment using brief fatigue inventory (BFT)
• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) scale

Improvement in fatigue was noted with CBT for insomnia (p = 0.002 on BFI;  p < 0.001 on FACIT-F). No improvement in fatigue was noted with placebo, on armodafinil alone, or on armodafinil with CBT-I.

CBT for insomnia appears to improve fatigue in patients with insomnia, and armodafinil was not shown to improve fatigue in patients with insomnia and fatigue.

• Small sample (less than 100)
• Study was a secondary aim of a previous trial.

This study shows that CBT for insomnia may be beneficial to patients with fatigue and that armodafinil does not improve fatigue.

The purpose of this study is to evaluate whether prophylactic pegfilgrastim administered with first- or second-line chemotherapy was feasible and reduced the incidence of grade 3/4 neutropenia and neutropenia-related complications in patients receiving 14-day oxaliplatin- or irinotecan-containing 5-FU–based chemotherapy regimens for advanced or metastatic colorectal cancer (CRC). 

One of three chemotherapy regimens (FOLFOX 4, FOLFIRI, or FOIL) was selected by physician discretion. Patients were randomized to receive either pegfilgrastim 6 mg or placebo on day 4 of each 14-day regimen. During the study period (the first four cycles of chemotherapy), the incidence of grade 3/4 neutropenia and febrile neutropenia were compared between the pegfilgrastim and placebo groups.

• The sample size was 241 at baseline; 135 completed the study.  
• All were adults aged 18 years or older.
• Men made up 67% of the sample; women made up 33%.
• A key disease characteristic was locally advanced or metastatic CRC not curable by surgery and not amenable to curative radiation therapy

• Multi-site (54 sites) 
• Outpatient settings  
• United States
   

Active treatment

Randomized, controlled trial, double-blinded. The control group received placebo.

• Laboratory results (complete blood count with five-part differential)    
• Patient temperatures, either reported or taken by healthcare provider
• Adverse events (nausea, diarrhea, fatigue, anemia, vomiting, anorexia, dehydration, abdominal pain, asthenia, pyrexia, decreased weight, hypokalemia, insomnia, neutropenia, constipation, alopecia, bone pain, dyspnea, pain, and febrile neutropenia)
   

Patients treated with pegfilgrastim were significantly less likely (13%) to develop grade 3/4 neutropenia than those who received a placebo (43%) (p < 0.05). The pegfilgrastim group also experienced significantly fewer dose delays or dose reductions (33.4% versus 45%) (p < 0.05).

The study compares pegfilgrastim versus placebo, but does not consider pegfilgrastim versus filgrastim, which may have similar efficacy at reduced expense. Additional study is warranted, including a cost-benefit analysis.

•  The study authors disclosed potential conflicts of interest, including owning stock in Amgen, the company that produces pegfilgrastim.
•  Amgen also provided writing assistance for this article, which raises questions of bias.

Patients with CRC receiving every-two-week chemotherapy regimens may benefit from supportive medications to stimulate neutrophil production.

To develop a question prompt sheet (QPS) for use by physicians and family members of seriously ill patients

1. QPS development: Caregivers (n = 33) and palliative care healthcare providers (HCPs) (n = 15) with at least two years’ experience in end-of-life care were interviewed and asked to discuss questions that family caregivers of seriously ill patients have. Caregivers were interviewed separately, and HCPs were interviewed in two separate focus groups. The researcher audiotaped and transcribed the interviews. Data analyses were iterative and conducted until no additional topics were raised. Inter-rater agreement was ≥ 0.80, indicating excellent agreement. The QPS consisting of 25 questions was recommended with no modifications.
2. QPS pilot study: Informed consent was obtained, and family caregivers were given the QPS and asked to check questions they wanted to discuss with the physician. Caregivers then gave the QPS to the physician. Following the appointment, family caregivers were asked whether the QPS was acceptable and feasible for use, and whether it should be modified.

• The QPS development sample included 33 caregivers (27 females [82%] and 6 males [18%]) and 15 HCPs of diverse disciplines.
• Content validity was established with 10 current family caregivers.
• The QPS pilot testing sample was comprised of 56 caregivers (41 females [73%] and 15 males [27%]).
• The age range of caregivers in QPS development was 20–70+ years; mean age in pilot testing was 53.7 years.
• Patients at end-of-life phase had multiple primary tumor types.

QPS development: HCPs from various disciplines including medicine, nursing, psychology, social work, clergy, and ethics who had at least two years of experience in end-of-life care helped define the QPS. Family caregivers used a large community-based hospice consult service for care of a seriously ill family member who had a life expectancy of less than six months. Bereaved caregivers included those who had lost a family member within the past year. Bereaved caregivers were either African American (n = 15; 45%) or Caucasian (n = 18; 55%). Primary patient illnesses (n = 23) were cancer (n = 10; 82%) and cardiovascular disease (n = 6; 26%).

QPS pilot testing: Caregivers were Caucasian (95%), African American (2%), or other (2%). The relationship to the patient was spouse (55%) or nonspouse (45%). The mean number of months providing care to the patient was 28 months. The mean hours per week providing care was 132 hours. Patients mainly had a diagnosis of cancer.

• QPS development: University-based inpatient palliative-care consult service and a large, community-based hospice serving western Pennsylvania
• QPS pilot testing: Outpatient palliative care clinic at a National Cancer Institute–designated center at the University of Pittsburgh in Pennsylvania

Prospective tool development and a feasibility pilot study were used.

• Family caregivers were asked whether they thought the QPS was acceptable and feasible to use in the clinic using a five-point Likert scale (pilot testing).
• Family caregivers were asked whether they thought the QPS should be modified or if the QPS added too much time to the visit (pilot testing).

The QPS, which encompasses medical, practical, psychological, and religious/spiritual informal caregiver concerns, had high content validity (> 0.80) and appeared in a satisfactory structure and layout based on caregiver feedback. Caregivers noted 17 of 25 questions as important for caregiver–physician discussion, including patient medication effects (46%), what to expect in the future (45%), patient depression (39%), who to call for help (32%), addiction (30%), hospice (25%), home-health services (23%), treatment risk (23%), whether the patient will have pain (21%), nutrition and anorexia (21%), suffering (21%), what to expect when the patient is dying (21%), recovery from illness and life expectancy (20%), and bereavement support (20%). Caregivers found the QPS easy to understand and felt comfortable completing the form in the clinic. Physicians involved in the study believed the QPS was valuable and nondistracting to clinical work. Family caregivers (70%–75%) reported that the QPS made it easier to ask questions in front of the family.

The QPS was evaluated by informal caregivers who found the tool acceptable and feasible for use in an outpatient palliative care setting. A QPS used in caregiver–physician clinical discussions can facilitate informal caregivers’ ability to ask important questions that increase their comfort during end-of-life care of a loved one.

• The study had a small sample, with less than 100 participants.
• The QPS was tested during only one visit with physicians.

The QPS or a similar tool outlines possible informal caregiver questions that nurses could address in care delivery. The main questions that caregivers chose to use in the study, such as those pertaining to medication side effects, what to expect in the future, or patient depression, highlight and provide guidance for discussion with family caregivers.

Inclusion of caregivers in conversations with the nurse may build rapport and trust that may facilitate initiation of discussion regarding end-of-life concerns and caregiver coping and health promotion issues. An interdisciplinary approach, including nursing involvement, allows meeting of complex patient–caregiver needs throughout the trajectory of care of a serious illness, including cancer.

Further refinement and testing of the QPS is important since it addresses the need to improve communication and stimulate discussions between informal caregivers and HCPs about an ill patient. Areas for further development include the unique perspective of the woman caregiver, literacy level of the QPS user, and testing in other populations.

The questions this study raises regarding good communication for future study are important. The QPS, although providing a structure for question asking, does not address the caregiver–physician relationship aspect that supports understandable and comfortable delivery of information between both parties. The QPS questions seem to focus on the patient’s needs and how the caregiver can respond to those needs. Few focus on caregiver needs as a result of caregiving to support continued care or recovery from bereavement. Continued work must address ways, including use of appropriate screening tools, to facilitate optimal caregiver and physician communication throughout the care cycle of a seriously ill family member to increase quality of life for carers.

STUDY PURPOSE: To evaluate the auxiliary effectiveness of acupuncture and moxibustion in the treatment of cancer-related fatigue (CRF)

TYPE OF STUDY: Systematic review and meta analysis

• FINAL NUMBER STUDIES INCLUDED =  7 prospective RCT
• TOTAL PATIENTS INCLUDED IN REVIEW = 804
• KEY SAMPLE CHARACTERISTICS: Patients with cancer, mean age 55 years in five trials; mean age 70 years in two trials. Two studies concentrated on breast cancer; for other studies, the cancers varied.

PHASE OF CARE: Active anti-tumor treatment

Fatigue declined over time for all groups: true acupuncture, sham acupuncture, and controls. However, no significant difference between groups was noted. Three studies looked at moxibustion lacking information on adverse effects and inadequate methodology.

The authors concluded that data is currently insufficient to recommend as an intervention for CRF other than when traditional interventions fail. No data exist to recommend this over conventional interventions, which are not described in this article.

• The article did not describe enhanced/routine care.
• The authors described patient’s interest in interventions but never described physiology of effect for acupressure/puncture or moxibustion in CRF.

Insufficient date to recommend.

• FINAL NUMBER STUDIES INCLUDED = 15 (There was a meta-analysis of six studies.)
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,926
• SAMPLE RANGE ACROSS STUDIES: 20–598 patients
• KEY SAMPLE CHARACTERISTICS: Small sample sizes

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care

Studies included were of steroids used as a treatment with pain assessed as an outcome. Dexamethasone was used in eight studies. Nine of the studies were designed with pain as an outcome. Six were placebo-controlled studies, one was a crossover study with a placebo, five had active controls, one was an open-label study, and two were low- versus high-dose studies. There did not appear to be a statistic benefit to the use of corticosteroids for all patients with cancer-related pain. Studies compared corticosteroids to standard therapy. A meta-analysis was done of six studies, and the others were not included because of missing data. There was insufficient data to do a subgroup analysis. A data point of one week was used as a standardization point for the interventions of the six studies in the meta-analysis. The meta-analysis showed an overall mean difference of –0.84 (p = 0.002) in favor of corticosteroids. There was insufficient evidence to evaluate side effects.

Evidence appeared to be weak in regard to the efficacy of corticosteroids for pain relief in patients with cancer. Although the meta-analysis suggested some benefit, the confidence interval was wide, and the quality of the studies included was low.

• Ability to assess effectiveness limited by small sample size
• High risk of bias
• Low quality of evidence

There was limited evidence to support the use of corticosteroids for chronic pain. If used, their benefit should be evaluated frequently and discontinued if none is found. Corticosteroids have numerous side effects, and the benefits versus harms must be weighed before their use in patients with cancer-related pain.