To test the effectiveness of major depression treatment using add-on therapy methylphenidate to mirtazapine compared with the addition of placebo to mirtazapine in terminally ill patients with cancer (prognosis of living less than three months)

• N = 88   
• AGE RANGE = 44.39–70.82 years, no significant difference between groups
• MALES: 10 males (23%) in one group and 20 males (46%) in one group, FEMALES: Not reported
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: The study excluded patients who were already being treated with antidepressants and who had existing psychiatric comorbidities. Cancer diseases were not significantly different between groups, and the study included patients with breast, upper gastrointestinal, colorectal, renal, pancreatic, bone, urinary tract, prostate, uterine-cervical-ovarian (grouped), and other cancers.
• OTHER KEY SAMPLE CHARACTERISTICS: Breast cancer occurrence was the only significant difference between groups.

• SITE: Single site   
• SETTING TYPE: Multiple settings    
• LOCATION: University of Malaya Medical Centre in Kuala Lumpur, Malaysia

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care

Four-week, randomized, double-blind, placebo-controlled trial

• Montgomery-Åsberg Depression Rating Scale (MADRS): 10-item measure of appearance of depression symptoms. One item is by self-report, and nine items are rated by clinicians.
• Clinical Global Impression-Severity (CGI-S): single-item measure of clinicians' impression of illness severity

Symptom relief by day 3 was noted among patients with the add-on therapy. Scores on the depression scale and severity of illness were improved by day 3 and day 14, respectively.

• Small sample (< 100)
• Measurement validity/reliability questionable
• Subject withdrawals ≥ 10%
• Discontinuation rate above 26% because of death and 11% because of adverse events

Early patient screening for depression among patients in palliative care is highlighted. Improved depression scores were noted by day 3 and improved the severity of illness by day 14. Consider add-on therapy with a fixed dose of mirtazapine and adding methylphenidate as described for patients with cancer with major depressive disorders in palliative care. Whether or not the rapid antidepressant effect of methylphenidate outweighs the potential for significant adverse effects needs to be individually determined for each patient.

To evaluate the effect of music in children with cancer who undergo lumbar puncture (LP)

Children were randomized to use either earphones with music (intervention group ) or earphones without music (control group) using iPods. The researcher and physician were blinded to participant group assignment. Immediately prior to the LP procedure, heart rate, blood pressure, oxygen saturation, and respiratory rate were obtained, and pain and anxiety scores were recorded. Directly after the procedure was finished, anxiety was remeasured. Self-reported pain was obtained before, during, and after LP. Physiologic parameters were recorded throughout the procedure. No local anesthetics or other analgesics were administered, which was usual care. Ten children in each group were chosen to be interviewed as well immediately after the LP procedure.

• The study reported on a sample of 40 pediatric patients.
• Patient age ranged from 7 to 12 years.
• The sample was 37.5% female and 32.5% male.
• All children had leukemia and were to have a lumbar puncture procedure.

• Single site
• Outpatient setting
• Hanoi, Vietnam

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for pediatrics.

A double-blind, randomized controlled trial design was used.

• Pain Numeric Rating Scale (NRS): Pain intensity self-reported from 0 (no pain) to 10 (worst pain)
• Spielberger State-Trait Anxiety Inventory (STAI)–short form
• Physiologic measures of heart rate, blood pressure, etc.
• Brief semi-structured interview

Pain scores during LP were significantly lower for the music group (p < 0.001), 2.35 compared to 5.65 in controls. Pain scores after the procedure were also lower for the music group (p < 0.003). Anxiety scores after 10 minutes of music before LP were lower for children in the music group (p < 0.001). Anxiety after LP was also lower in the music group (p < 0.001) compared to controls; however, pre- and post-differences in anxiety in both intervention and control groups were minimal. Heart rate and respiratory rate were significantly different between the two groups, with lowered heart (p = 0.012) and respiratory rate (p = 0.009) during the procedure. In interviews, most of the children in the music group indicated that listening to their favorite music helped them feel calm and took their minds off the procedure.

Use of music as a distraction may be helpful to reduce pain and anxiety in children undergoing lumbar puncture.

• The study had a small sample, with less than 100 participants.
• The STAI was developed for and generally used in adults, and has not been validated in children.
• The children themselves could not be blinded to the intervention, and because the children in the control group were entered into the study with the knowledge that they might be given the intervention, but were then assigned to control, they may have felt they were missing something. This could have influenced findings.
• Potential risks with reuse of earphones for providing the music may be present.
• Post-anxiety between groups was reported, but no pre-post change in anxiety was reported. The music group also had lower anxiety at baseline, so it is not clear whether any post difference was due to the intervention.

This study does not provide convincing support for effectiveness of listening to music to reduce anxiety, but it appeared to reduce pain during the procedure. Music provision is a potentially low-risk and low-cost intervention that may be helpful to reduce pain and anxiety in children who are undergoing uncomfortable procedures. Further study of the use of music in combination with other forms of distractions and methods to combat pain are indicated. It is not clear if providing music via use of iPod and earphones is the best approach, as children in this study did indicate that the earphones were somewhat uncomfortable, and use of earphones for multiple patients could be a potential source for transmission of infection.

To evaluate possible differences between the severity and duration of oral mucositis (OM) and other clinical end points previously found to be associated with OM in patients who received palifermin compared to those who did not

A retrospective chart review of 99 consecutive patients who received an allogeneic hematopoietic stem cell transplantation (AHSCT) with palifermin from December 2006 to December 2009 was conducted, and 30 patients who received AHSCT from January to December 2005 served as control group (this group was treated before palifermin became standard of practice). Palifermin was administered for three consecutive days with the third dose 24 hours before the initiation of fractionated total body irradiation and three additional doses after the completion of the conditioning regimen (days 0–2). All patients received a comprehensive oral care regimen, and oral assessments were conducted every three days by a certified respiratory therapist.

• N = 129  
• AGE RANGE = 18–59.2 years
• MALES: 51%, FEMALES: 49%
• KEY DISEASE CHARACTERISTICS: Hematologic malignancies (acute lymphoblastic leukemia and acute myeloid leukemia)
• OTHER KEY SAMPLE CHARACTERISTICS: Conditioned with fractionated total body irradiation and etoposide

• SITE: Single site    
• SETTING TYPE: Not specified    
• LOCATION: Cancer center

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

• Retrospective chart review

• National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v2.0
• OM grades 1 and 2 were categorized as mild, and grades 3 and 4 were categorized as severe.

OM developed in 95% of patients in the palifermin group and all 30 patients in the control group. Severe OM developed in 34% of the palifermin group and 80% of the control group (p < 0.0001) with the median duration of OM 13 days with palifermin and 18 days with the control. The median duration of sever OM was not found to be different between groups. The median duration patient-controlled analgesia use was shorter in the palifermin group as was the use of opioids. No significant difference in the duration of total parenteral nutrition use was found.

Palifermin reduced the incidence of severe OM and the overall duration of OM in this study. This supported the use of palifermin.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)

This study supported palifermin use in this population. However, additional studies providing evidence on quality of life and patient-reported outcomes are needed.

To evaluate whether adding methylphenidate to mirtazapine in the treatment of depression in terminally ill patients with cancer will cause an earlier antidepressant response compared to patients receiving mirtazapine and a placebo

Patients initially were interviewed by a psychiatrist to confirm the diagnosis of major depressive symptoms using the Mini-International Neuropsychiatric Inventory. Patients were randomized and double-blinded (1:1) to receive either methylphenidate (MPH) or a placebo with mirtazapine (MTZ). Patients taking MTZ received a fixed dosage while MPH was first dosed at 5 mg BID then increased, if needed, after day 3. Outcomes were assessed at baseline and at six subsequent follow-up visits during the double-blind treatment on days 3, 6, 9, 14, 21, and 28. Assessments included the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression–Severity scale.

• N = 88  
• MEAN AGE = 59.52 years (group 1), 55.89 years (group 2 [placebo])
• MALES: 78%, FEMALES: 22%
• KEY DISEASE CHARACTERISTICS: Patients diagnosed with a major depressive disorder in the terminal disease stage of any type of cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving palliative care with a life expectancy less than three months; oncology or surgery departments or palliative care units; Malay, Chinese, Indian, and other ethnicities were included; 84% were inpatient in both groups

• SITE: Single-site    
• SETTING TYPE: Multiple settings    
• LOCATION: University Malaya Medical Centre, Kuala Lumpur, Malaysia

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

Randomized, double-blinded, placebo-controlled study

• Montgomery-Asberg Depression Rating Scale (MADRS): A clinician-rated scale for the assessment of depression that includes 10 items (nine are patient-reported and one is based on observation). 
• Clinical Global Impression–Severity Scale (CGI-S): A single-item, clinician-rated scale that reflects the global severity of illness at time of assessment.

Although this was a small-scale study and the dropout rate was high, this study has implications for a small subset of patients. The addition of MPH to the standard treatment of depression may improve the response rates of terminally ill patients with cancer, beginning as early as three days after starting treatment. MPH must be used with caution due to side effects.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: The percentage of males was higher in the placebo group. There was a high dropout rate, mostly because of death, but side effects and personal reasons also were mentioned. Well-designed, larger studies need to be done. A study using MPH alone would be useful. Some of the symptoms could be related to the disease rather than depression.

Psychosocial assessment, which includes depression, is extremely important to the nursing profession. For those who care for terminally ill patients with cancer, having options to improve quality of life for a patient suffering from depression can have significant clinical implications. Using MPH may be one option to consider when seeking quick results in treating a major depressive disorder in terminally ill patients. MPH must be used with caution due to potential side effects, and the need for further research in this population is indicated.

The objective of the study is to synthesize information regarding the effect of nebulized furosemide in managing dyspnea.

• Databases searched were MEDLINE, EMBASE, CINAHL, and the Internet (1988–2006), and a manual search of article references was done.
• Search keywords were dyspnea, breathlessness, inhaled, nebulized, and furosemide.
• Studies were included if they reported on findings of experimental or clinical trial of nebulized furosemide for management of dyspnea in adults.
• No exclusion criteria were specified.

• The initial search provided 112 citations. 
• The report states that a critical review of evidence was done. 
• No specific process or review/quality criteria are described.

The final sample included 42 articles, including 39 randomized controlled trials; 2 studies in cancer, 35 in asthma, 8 studies in health volunteers, and 1 in chronic obstructive pulmonary disease.

• Some evidence suggests that nebulized furosemide could be an option in the management of dyspnea, but sufficiently powered experimental studies are lacking to have a strong conclusion in this area.
• Data in reports regarding possible diuretic effects of nebulized furosemide are lacking.
   

• Strong evidence is lacking to draw conclusions regarding effectiveness of nebulized furosemide for dyspnea management, and reporting of any diurectic effects of this approach also is lacking.
• Research in this area has a number of methodologic limitations that preclude drawing any firm conclusions.
• As some evidence exists of symptom relief produced by nebulized furosemide, further evaluation may be warranted, with appropriate placebo-controlled research.

Dyspnea was only measured in five studies reviewed.

This review demonstrates a lack of strong evidence in the area of nebulized furosemide for dyspnea and little evidence was found in the management of dyspnea in patients with cancer.

The study involved searches of the MEDLINE, Healthplan, PsychLIT, and Allied and Complementary Medicine databases. The articles included were published prior to December 1998.

The study consisted of a critical review of psychological therapies used by patients with cancer. Authors identified 627 relevant articles reporting 329 intervention trials. Authors identified 11 papers discussing 15 trials of fair quality and exploring interventions aimed at reducing depression.

Despite increased use of RCT designs, the methodological quality was generally suboptimal.

No intervention can be recommended for depression reduction, but interventions involving group therapy, education, structured counseling, cognitive-behavioral therapy (CBT), communication-skills training, and self-esteem building warrant further exploration before recommendations can be made.

• FINAL NUMBER STUDIES INCLUDED = 10 for qualitative review (nine in meta-analysis)
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,131
• SAMPLE RANGE ACROSS STUDIES: 21–389 patients
• KEY SAMPLE CHARACTERISTICS: All patients had prostate cancer.  

PHASE OF CARE: Multiple phases of care

The meta-analysis across all studies with all types of interventions showed a positive effect of intervention (p = 0.002). In four studies using exercise, there was no significant effect. Across three studies of psychosocial interventions, including psychotherapy and peer support, the was an overall significant effect (point estimate –0.961, p = 0.003). In two studies of educational interventions, there was no statistically significant effect.

The findings of this study suggest that psychosocial interventions can be effective in reducing depressive symptoms among patients with prostate cancer.

The majority of studies included were of low quality. The authors stated that in multiple-arm studies, outcomes were only used in certain selected study arms. For each subanalysis, there were few individual studies. There were some discrepancies in the report regarding the number of studies included. Samples were mixed in terms of inclusion of patients who did or did not have clinically relevant depressive symptoms. Most studies were brief, and the long-term benefits of the interventions were not clear.

Although this analysis provides relatively limited evidence regarding the effectiveness of individual types of interventions, its findings do suggest that some intervention is more effective than doing nothing. Nurses need to identify patients with symptoms of depression and those at risk for depression and take action.

Laser energy 35 J/cm² once a day for five days after the development of chemotherapy-induced \"moderate\" mucositis.

Laser has an 830 nm wavelength with a potency of 250 mW.  
 

Each patient was informed of the oral hygiene protocol:       
Avoid spicy food acid fruits, alcohol, and food and drinks with high temperature.
Use a soft toothbrush and avoid dental floss.
Only use mouth solution provided by health personnel (3% bicarbonate).
Do not smoke.       

The study was conducted March-August 2002.

Thirteen individuals were treated. Convenience sample for chemo-induced mucositis-related pain.
Mucositis was determined using the Brown methodology. Patients determined to have moderate mucositis (score 13-18) were included in the study.

Non-parametric study

VAS pain scale

Brown methodology for classification of mucositis.
 

Significantly lower pain (p = 0.007) after each treatment. Average pain reduction was 67%. Pain reduction across the five days of treatment was also significant (p = 0.000).

Authors note that after five days, pain is usually reduced to such an extent not to require further treatment.

 Limited sample size, short study – no control

Other factors may have contributed to pain reduction, including normal healing and placebo effect.

Optimal energy level is not determined.

Cost is high, and treatment is not available at most centers.

Main focus of study was on pain .
 

• FINAL NUMBER STUDIES INCLUDED = 6
• TOTAL PATIENTS INCLUDED IN REVIEW = 805
• SAMPLE RANGE ACROSS STUDIES: n = 19 up to n = 79 across the six studies 
• KEY SAMPLE CHARACTERISTICS: Breast cancer survivors with, or at risk for, BCRL; RET was part of the intervention or the only intervention; no restrictions on age, nationality, or ethnicity but presumed all patients were female in these six studies; control group in each study; studies not written in English excluded

PHASE OF CARE: Late effects and survivorship

• No adverse effects were reported.
• Blinding was either not conducted or was less than acceptable across all six studies.
• Five of the six studies were high quality per evaluation results.
• BCRL was not increased and triggered by RET.
• Moderate to high intensity RET was superior to moderate intensity aerobic exercise in relation to building strength safely in BCRL at-risk patients.

Performing structured RET is safe and effective in increasing muscle strength in patients with breast cancer.

• Limited search
• Limited number of studies included
• Gender of study participants not clarified (women only?)

• Nurses can—and should—encourage and reassure patients with breast cancer that moderate-intensity RET is an effective means of increasing strength and regaining physical health, without risk for BCRL or any increase of existing BCRL. 
• More research is needed to focus on and to isolate the multiple variables within the different exercise options and their effects on BCRL to further compare benefits and risks in this population.

To evaluate the efficacy of a low dose of megestrol acetate (MA) in debilitated patients with cancer experiencing cachexia

Participants received 80 mg of MA twice daily after meals. After a two-week treatment period, participants were evaluated for efficacy, side effects, and satisfaction.

Consecutive patients (convenience sample)

Patients with advanced cancer and any degree of weight loss were eligible for the study. Of the 20 patients who were evaluable,

• 12 were female and 8 were male.
• The median age was 68.
• The most common malignancy was lung cancer.
• The median ECOG performance status was 2.

Excluded from the study were patients with

• A life expectancy of less than four weeks
• An ECOG performance status of less than 3
• Breast or prostate cancer who were currently receiving hormonal or cytotoxic therapy
• The presence of pleural effusion or ascites
• Uncontrolled hypertension, diabetes mellitus, or congestive heart failure 
• A history of deep-vein thrombosis (DVT) or in treatment for DVT.

This single-site study took place in a large midwestern city at a large academic medical center with a cancer center.

The study was a phase II trial with a nonrandomized design and a descriptive, observational setup.

Outcomes included appetite, satisfaction, and side effects. Appetite and satisfaction were evaluated using a questionnaire that included one question for appetite (0 = absent, 4 = better than normal) and one yes/no question on satisfaction (Are you satisfied with the way the medication affected your appetite?). This empirical indicator appears to have been developed by the research team, although this is not clearly explicated. Side effects were measured using a “Side Effect Profile” (a list of MA side effects developed from a number of previous studies using varying doses of MA).

Fifteen out of 20 patients were deemed “responders.” Most responders had an appetite change of one degree in the categorical question, and 16 answered that they were “satisfied” with the way the medication affected their appetite. There were no significant differences in results based on gender, age, or performance status. The third outcome, side effects, was not specifically reported according to the Side Effect Profile. Researchers reported that five patients developed symptoms not present before the study; in three patients, these were considered drug-related.

The researchers concluded that a low dose of MA given twice daily was an effective appetite stimulant in patients with advanced cancer.

• The study lacked a constitutive definition of anorexia, appetite, satisfaction, and side effects. 
• Participants were considered evaluable for side effects after two doses and for efficacy after four doses. This time period (1 to 2 days) does not allow time for the drug to take effect.
• Eligibility criteria lack specificity.
• The validity and reliability of the instrument used to measure appetite and satisfaction are absent.
• Researchers indicated that appetite improvement by one degree on the categorical scale was a response, but how or why one degree constituted a response was not specified.
• The recruitment sites were listed, but these settings were not described.
• The statistical discussion was weak, with no explanation of sample-size calculation, power, or effect size.
• There was limited discussion of the statistical methods used to assess outcomes.
• Cost implications were not discussed.