To evaluate the efficacy and feasibility of music imagery.

The intervention involved 45-minute sessions with a music therapist occurring twice weekly during a four-week hospital stay. The intervention consisted of education about how to use music imagery exercises together with the opportunity to practice music imagery techniques and experience a successful music imagery encounter. The music therapist chose music for each specific patient based on an assessment of the patient’s musical preferences, current emotional state, and energy level. After the session, the patient was provided with equipment to play CDs containing music imagery exercises, and patients were encouraged to use the CDs at least daily during their hospital stay.

• To be included in the study, patients had to 18 years or older, receiving at least three radiotherapy treatments, and able to read English.
• Patients were excluded if they had a documented psychiatric illness, cognitive impairment, or current treatment for a brain tumor or were not cognitively able to participate in the intervention or answer the self-report questionnaires. 
• Patients were admitted to the Hematology-Oncology Unit at Indiana University Hospital for the treatment of acute leukemia or high-grade non-Hodgkin lymphoma.
• Forty-nine patients were hospitalized for induction chemotherapy for acute leukemia or high-grade lymphoma (24 in standard care and 25 in standard care with music imagery).

Patients were undergoing the active treatment phase of care.

This was a randomized, controlled trial.

• Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) scale
• Patients also were asked to record how many exercises were used between meetings with the therapist, as well as the perceived effectiveness of the music imagery exercises; however, the authors reported that no patient recorded that information.

The intervention showed no effect on fatigue.

• The study had a small sample size.
• The intervention may have been too weak, despite the high rate of music imagery intervention completion, to produce significant benefits on fatigue outcomes.
• The intervention required referral to a music therapist.

The intervention was lower-body aerobic exercise three times a week for 10 weeks in groups. The three groups were low-intensity exercise, moderate-intensity exercise, and control.

The study reported on a sample of 18 patients with cancer recovering from treatment.

A randomized controlled trial design was used.

• Linear Analog Self-Assessment (includes anxiety)
• Quality of Life Index for patients with cancer
• Physiologic capacity measures

There was significant decrease in anxiety pre- and post-study (p = 0.011) but not compared to the control group versus findings of decreased anxiety in the exercise group.

• The study had a small sample.
• No reliability for the instrument measuring anxiety was provided.
• Group interactions may have influenced anxiety.

To compare lymphedema-related outcomes between women receiving complete decongestive therapy (CDT) and a home program versus those receiving manual drainage and compression garments

Patients were divided into two groups. One group received manual drainage, compression garments, glenohumeral mobilization, and deep breathing exercises. The other received CDT including manual drainage, compression garments, and a home self-massage and exercise program. Participants received initial training for the home program to be completed daily. Both groups received treatment from a therapist five days per week for six weeks. Study assessments were done a baseline, week 4, and week 6.

• N = 60
• MEAN AGE = 56.2 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All participants had breast cancer, and 51% received a radical mastectomy.

• SITE: Single site  
• SETTING TYPE: Multiple settings  
• LOCATION: Saudi Arabia

• PHASE OF CARE: Late effects and survivorship

Pre- and post-test design

• Arm circumference measurements
• Visual Analog Scale (VAS) for pain
• Disabilities of the Arm Shoulder and Hand (DASH) questionnaire

Subjects in both groups had significant reductions in arm volume, pain, and DASH scores.

Both CDT with a home program of manual drainage and exercise and standard manual lymphatic drainage with compression garments resulted in significant improvements in arm volume, associated pain, and disability scores.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: The type of pain measured was not clear. The results reporting was unclear in the tables provided. It was not clear if patients were randomly assigned to groups.

Both the combination of manual lymphatic drainage with compression garment use and CDT with a daily home program were associated with significant improvements in lymphedema symptoms.

To assess the feasibility of instituting a multicenter effort to standardize central line (CL) care and CL-associated bloodstream infection (CLABSI) tracking while quantifying the impact of standardizing these processes on CLABSI rates among pediatric patients

A CL maintenance bundle was developed using Centers for Disease control and Prevention guidelines and recommendations as well as best practices from previous pediatric CLABSI efforts. These guidelines included (a) a reduction in the number of CL manipulations and entries, (b) the maintenance of a sterile entry to CL (hand hygiene and sterilization of port), (c) and standardized CL care practices (date and time cap, tubing/dressing/needle changes, standardized procedure). Tubing changes were every 96 hours and every 24 hours for blood products and lipids. Staff members audited the CLABSI bundle practice monthly using a standard form and submitted unit profile information. Teams met in two-day learning sessions annually and interacted monthly via webinars.

• N = 28 separate units  
• KEY DISEASE CHARACTERISTICS: 50% hematology or oncology and transplant; 36% hematology or oncology; 7.1% oncology and transplant; and 7.1% transplant only
• OTHER KEY SAMPLE CHARACTERISTICS: Units varied in size (8–48 beds); two thirds of teams were Magnet hospitals; 93% of patients were afebrile, neutropenic, postintensive chemotherapy patients with acute myeloid leukemia in inpatient settings waiting for count recovery; none of the units used antimicrobial impregnated catheters; a third used chlorhexidine gluconate baths in at least some patients; half involved patients and families in daily rounds

• SITE: Multi-site    
• SETTING TYPE: Inpatient    
• LOCATION: United States

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

Cohort comparison study

Teams reported baseline data regarding CLABSI from January 2006 and October 2009. These data were compared to the intervention period from November 2009 to August 2012. CLABSIs were tracked as number per 1,000 CL days per month. CLABSIs occurring more than 48 hours after hospital admission and less than 48 hours prior to hospital discharge were deemed inpatient events and included in measurements.

Across 46 months, precollaborative effort CLABSI rates were 2.85 per 1,000 CL days. During the first 34 months after the intervention, that rate was 2.04 per 1,000 CL days (p = 0.05). The odds for having no CLABSIs per unit per month was 2.59 higher during the collaborative intervention (p = 0.01). The compliance with recommended CL maintenance increased rapidly over the first year from 38% at baseline to 79% by the end of the first year. It remained at a rate of 81%–86% during the remainder of the intervention period.

The 28% reduction during the first 2.5 years suggested the elimination of about 290 CLABSIs over that period with an estimated reported cost savings of about $11 million. It was feasible to implement a standardized CL maintenance care bundle, track CL infections with standardized definitions, and generate benchmark data across a large network of centers. The implementation of a standardized catheter care bundle in a multi-instutituional collaborative effort was associated with reduced CLABSI rates.

• Risk of bias (no control group)
• Measurement validity/reliability questionable
• Other limitations/explanation: Retrospective study design; reliability of self-reported adherence to all aspects of the care protocol was not examined; patient characteristics in terms of infection risk were not described

Nurses are on the front lines when it comes to CLABSI prevention. This report demonstrated the effectiveness of a multisite collaborative initiative to reduce CLABSI rates. The implementation of a specific care bundle, monthly practice auditing, monthly webinars, and annual education of care teams involved was reported to be effective. This report provides suggested approaches for such initiatives and demonstrates associated improvement in quality and cost reduction.

To determine safety and efficacy of fixed doses of methylnaltrexone (MNTX) in patients with advanced disease

After participation in a two-week placebo randomized controlled trial (RCT), patients were eligible to enroll in a 10-week open-label extension study to evaluate the use of MNTX at a fixed dose based on weight using as-needed dosing. Patients were dosed at 8 mg SC for weight of 38 kg to less than 62 kg or, if 62 kg or greater, at a dose of 12 mg. Doses were administered as needed but not more often than daily. Rescue doses of other bowel medications were permitted if the MNTX was not effective. Patients were taking stable laxative regimens and a stable dose of opioids.

• N = 230  
• MEAN AGE = 65.9 years
• MALES: 50.9%-51.7%, FEMALES: 48.3%-49.1%
• KEY DISEASE CHARACTERISTICS: Advanced illness, with 57%-66% having a cancer diagnosis

• SITE: Multi-site    
• SETTING TYPE: Multiple settings  
• LOCATION: United States

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

• Open-label extension study following a prior clinical trial using MNTX for the management of opioid-induced constipation

• Diary of bowel function
• Clinic visits

MNTX was effective in the management of opioid-induced constipation in both the RCT and the open-label extension study. The results were based on rescue free bowel movements after doses of MNTX. For the MNTX arm in the RCT component, 62.9% of patients had bowel function compared with 9.6% of the placebo control group (p < 0.0001). Weight did not have an effect on outcome. Secondary end points were all in favor of MNTX, including time to bowel function after first dose. The most common side effects were abdominal pain and nausea.

A fixed dose of MNTX is safe and effective in the management of opioid-induced constipation in patients with advanced disease.

• Risk of bias (no blinding)
• Patients under 38 kg were not eligible
• Short study duration

This study adds support to the data that MNTX is safe and effective for opioid-induced constipation.

To evaluate the effect of musical therapy on anxiety in patients with breast cancer receiving conventional treatment

Patients were randomly assigned to the music or control group. While in the waiting room for 30 minutes prior to chemotherapy treatment, those assigned to the music group had the opportunity to choose and listen to pretaped musical themes with a Walkman and earphones for 15 minutes. Control patients received standard care. Anxiety levels were measured at baseline and after 15 minutes.

• The study reported on a sample of 60 female patients (30 in each study group).
• Mean patient age was 49.2 years +/- 6.9 in the experimental group and 52.7 years +/- 6.1 in the control group.
• All patients had stage I or II breast cancer and were receiving adjuvant chemotherapy.
• All patients had social support persons or family members present at the time of study.

• Single site
• Italy

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

Speilberger State and Trait Anxiety Inventories

There were no differences between groups in pretreatment anxiety levels. Both groups demonstrated moderate pretreatment anxiety levels. Pretreatment state anxiety levels were higher than trait anxiety levels in both groups (p < 0.05). Post-test anxiety scores in the experimental group decreased by 9.9 (p < 0.001). In the control group, there was no significant change, although anxiety increased slightly after 15 minutes. There were no significant relationships between anxiety scores and demographic variables.

Listening to music may reduce anxiety related to chemotherapy administration. The levels of state anxiety compared to trait anxiety indicates that chemotherapy treatment is a stressful situation for patients.

• The study reported on a small sample, with less than 100 participants.
• The study was a single brief intervention, and it is not clear if listening to music would always have an effect of reducing anxiety before treatment.
• The study was limited to women with breast cancer and may not be readily applicable to patients with more advanced disease, those receiving treatments other than adjuvant chemotherapy, males, or those with other types of cancer.
• Other potential symptoms were not evaluated, so it is unclear how music would impact anxiety in the setting of additional patient symptoms.

Chemotherapy administration can be stressful for patients, and listening to music prior to treatment may be helpful to them. Providing the opportunity to listen to music is a simple intervention that has no inherent risks to patients and could easily be incorporated into practice in healthcare settings.

To explore the safety and effectiveness of omega-3 poly-unsaturated fatty acid (PUFA) added to parenteral nutrition in protecting patients with leukemia from severe enterocolitis

Fourteen patients with acute myeloid leukemia (AML) who received omega-3 PUFA in a phase II trial were compared with 66 consecutive control patients not getting this intervention. Total parenteral nutrition (TPN) was given as a standard emulsion containing the full supply of carbohydrates, amino acids, and lipids, with a total energy content of 2,215 kcal in a 1,875 mL volume via central venous catheter over 24 hours. Patients included in the phase II study additionally were administered 100 mL/d of a commercially available IV omega-3 PUFA formulation over four hours. TPN and omega-3 PUFA were given up to duration of four weeks.

• N = 14  
• AGE: Unknown
• MALES, FEMALES: Unknown
• KEY DISEASE CHARACTERISTICS: De novo AML or high-risk myelodysplastic syndrome (MDS); planning to undergo chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Eligible participants were any adults with cyto- or histopathologically confirmed de novo diagnosis of either AML or high-risk MDS (IPSS score of higher than 1.5). All participants had been considered for TPN and had an Eastern Cooperative Oncology Group performance status of 2 or less and were about to undergo myeloablative induction chemotherapy.

• SITE: Single site   
• SETTING TYPE: Inpatient   
• LOCATION: Bern, Switzerland

• PHASE OF CARE: Active antitumor treatment

• Phase II trial with a historical control group of consecutive patients with AML

• Common Terminology Criteria for Adverse Events (CTCAE) v3.0

Two out of 14 patients included in the phase II trial experienced grade 3 colitis after initiation of chemotherapy (14%), and none experienced grades 4 or 5. Conversely, 16 out of 66 control patients experienced grade 3 colitis (24%), 3 experienced grade 4 (5%), and 2 died of grade 5 colitis (3%). According to blind assessments, 3 out of 14 patients included in the phase II trial experienced grade 3 colitis after initiation of chemotherapy (21%), and 1 had grade 4 colitis (7%), whereas 7 out of 66 control patients experienced grade 3 colitis (11%), 4 experienced grade 4 (6%), and 4 died of grade 5 colitis (6%). Among the 13 patients who actually received omega-3 PUFA, two were deemed to have grade 3 colitis (15%) according to open assessment, whereas three were deemed to have grade 3 colitis (23%) and one was deemed to have grade 4 colitis (8%) according to blind assessment. Odds ratios of colitis were grades 3 and above. The benefit of omega-3 PUFA was more pronounced in adjusted as compared with crude analyses and more pronounced according to open as compared with blind assessments. Formal statistical significance at the conventional α level of 0.05 was reached only for the adjusted analyses of colitis grades as determined by the open assessor, with an odds ratio of 0.27 (95% CI 0.11–0.65). The IPT weighted analysis according to blind assessments yielded a non-significant odds ratio of 0.79 (95% CI 0.35–1.78).

The study showed little evidence to suggest that the addition of omega-3 PUFA to TPN in patients with AML undergoing myeloablative chemotherapy is effective in reducing the incidence of severe neutropenic enterocolitis. Results depended on the approach chosen in assessing colitis grades (open versus blind assessment), and the nature of the analysis (crude or adjusted using inverse probability of treatment weighting).

• Small sample (less than 30)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Questionable protocol fidelity
• Other limitations/explanation: The original study design was not carried out because of accrual problems.

Therapeutic interventions remain limited in neutropenic colitis. To truly answer the question of whether this intervention would benefit patients, trials should be centrally randomized with adequate placebo controls to blind patients, blind adjudication of colitis grades, and an intention-to-treat analysis.

Comparison of venlafaxine versus clonidine for the treatment of hot flashes with regard to side effects, efficacy, QOL, and sexual functioning in patients with breast cancer.

Patients randomly assigned to receive venlafaxine for eight weeks, followed by a wash-out period of two weeks, then eight weeks of clonidine or vice versa

N = 60 (30 assigned to venlafaxine and 30 to clonidine). Patients with a primary or metastatic breast cancer age 60 years or younger, allowed antitumor hormonal treatment if started one month prior and continued taking throughout treatment period.

Double-blind, randomized, cross-over study.

Assessment took place before the start of each drug, then at 2, 8, 12, 18 weeks after treatment began. Six questionnaires were used to compare the drugs' effects on adverse events, efficacy, QOL, and sexual functioning: daily diary on hot flashes, hot flash–related daily interface questionnaire, Medical Outcomes Study Short Form (SF-36), sexual activity questionnaire, and Zung Self-Rating Depression Scale.

Forty patients completed all treatments, 12 patients only one treatment, 8 patients neither. Dropout rates during venlafaxine were 15 out of 59, versus clonidine, 5 out of 53. Withdrawal rateswere not affected by sequence of treatment. Efficacy: After eight weeks, no difference was seen between the two drugs in reduction of hot flash scores: median 49% for venlafaxine and 55% for clonidine. The drug that the patient received first caused the greatest reduction in hot flash score.

Statistics: based on the testing used to calculate the number of patients needed to detect differences, the sample size was too small to detect difference, which may be the reason no statistical difference was  found between the interventions.

STUDY PURPOSE: Evaluate effects of yoga on physical and psychosocial symptoms
TYPE OF STUDY:  Meta Analysis & Systematic Review

DATABASES USED: AMED, CINAHL, British Nursing Index, CENTRAL, EMBASE, PEDro, psycINFO, PubMed and SPORT-Discus
KEYWORDS:  States detailed search profiles available on request
INCLUSION CRITERIA:  RCT, adults with any cancer diagnosis, yoga intervention including physical postures, control group non exercise
EXCLUSION CRITERIA:  Yoga included as part of a larger intervention such as mindfulness based stress reduction were excluded

TOTAL REFERENCES RETRIEVED : N = 1909
EVALUATION METHOD AND COMMENTS ON LITERATURE USED Study method quality evaluated using a Delphi list previously developed and tested.  Low quality defined as <50% of possible total score.

FINAL NUMBER STUDIES INCLUDED; N(studies)  =  13
SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW:  Range 18-128
KEY SAMPLE CHARACTERISTICS:  12 studies involved breast cancer patients, 1 was in lymphoma

PHASE OF CARE:  Multiple phases of care

Physical outcomes: Pain was evaluated in 4 studies, meta analysis of 2 of these showed a large effect size (d=-0.63, 95% CI -0.98, -0.31)
Psychosocial outcomes: Reduced anxiety (d=-0.77; 095% CI -1.08, -0.46) fatigue (d=-.051, 95% CI -0.79,-0.22)  Effects on sleep disturbance were small and insignificant.
Dropout rates ranged from 0-38%
Interventions ranged from planned 6 -15 sessions.  Some studies involved supervised yoga classes, and some involved home practice only.  Studies involved patients in active treatment and others involved cancer survivors who had completed treatment.

Findings suggest that yoga may be helpful to reduce anxiety and fatigue in patients with cancer.

States 3 studies included participant blinding or double blinding – it is unclear how a participant would not know they were receiving a yoga intervention.  Varied methods of measurement were used in the studies included – there is no description of how these were handled in meta analysis.  There is no report of heterogeneity findings.   Most studies were very small sample sizes.  There was a wide range of drop -out rates and no information about how this was handled in analysis.  Studies did not include attentional control conditions, so it is unclear how much effect was due to group support versus the actual yoga activity.  No differentiation was made between group session interventions versus patients who did home practice alone after instruction.

Findings do not provide strong support for effectiveness of yoga for sleep.  Findings do suggest that yoga may be helpful for patients to reduce anxiety and fatigue.  Nurses can support involvement in this type of activity for patients who are interested in participating in yoga.

To evaluate the efficacy and safety of IV amifostine during radiochemotherapy for head-and-neck cancer

Patients in the study group received 300 mg/m² IV amifostine on the days in which they received carboplatin and radiation therapy (RT). On the days in which they received only RT, they were given 200 mg/m² IV amifostine.

• The study reported on 132 patients (67 in the amifostine group and 65 in the placebo group).
• The median age of patients in the amifostine group was 57 years and the median age of patients in the placebo group was 58 years. Patients' ages ranged from 23–78 years.
• This was a randomized, double-blind, placebo-controlled, phase III, multicenter study.
• Patients had been diagnosed with stage III or IV head and neck cancer and were receiving RT and 70 mg/m² carboplatin.

The study was conducted between October 1996 and October 1999.

• Radiation Therapy Oncology Group (RTOG) scoring was used.
• The Acute/Late Radiation Morbidity Scoring Criteria were used.

• Effectiveness not established; no statistical evidence was found to indicate that mucositis was improved with the use of amifostine versus placebo.
• In the amifostine group, 39% of patients experienced grade 2 or higher xerostomia; in the placebo group, 35% of patients experienced grade 2 or higher xerostomia (p = 0.715).
• In the amifostine group, 39% of patients experienced grade 3 or higher xerostomia; in the placebo group, 22% of patients experienced grade 3 or higher xerostomia (p = 0.055).
• In the amifostine group, 47 patients completed the study; in the placebo group, 55 patients completed the study.
• The most common reactions were nausea/vomiting, hypotension, allergic reaction, and rash.
• In the amifostine group, 30% of patients discontinued treatment versus 11% in the placebo group.

The intervention was not found to be effective in the management of mucositis toxicity.

This was the first randomized and placebo-controlled study of amifostine in the head and neck cancer population.