To examine the effects of live saxophone music in patients with cancer

Patients were randomly assigned to music or control groups. A holistic nurse played the saxophone music for patients in a hospital room with the patient lying in bed and the door closed. Sound could not be heard in other rooms. Patients chose five or six musical pieces of different styles from a large playlist. The patient listened for about 30 minutes, then returned to the regular hospital room. The intervention was given weekly for four weeks. Control group patients had a 30-minute rest period. Physiologic parameters and mood and pain data were obtained after the intervention or rest period weekly. Patients were receiving chemotherapy in an inpatient setting.

• N = 52
• MEAN AGE = 64.9 years (SD = 12.7 years)
• MALES: 17.3%, FEMALES: 82.7%
• KEY DISEASE CHARACTERISTICS: Disease types not described; 86.6% had metastatic disease
• OTHER KEY SAMPLE CHARACTERISTICS: Overall, 98% of participants listened to music regularly and 61.5% were receiving analgesics.

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: Italy

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

Single-blinded, randomized, controlled trial

• Physiologic parameters including systolic and diastolic blood pressure, pulse rate, glycemia, and oxygen saturation
• Visual Analog Scale (VAS) for pain (0–10)
• VAS for mood from (0 = great mood, and 10 = worst possible mood)

Oxygen saturation in the experimental group increased from an average of 98 to 99 postintervention. Pain levels in the experimental group decreased on average from 1.8 (SD = 1.9) to 0.7 (SD = 1.1, p = 0.001). Mood changed from a 5 on average to 2.2 in the experimental group (p = 0.000). There were no significant changes in the control group. Differences between the groups were not significant for pain or mood.

The findings of this study did not show a significant effect on pain from live music compared to usual care. Listening to live music was associated with improved mood.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: More patients in the experimental group were receiving analgesics at baseline. The types of analgesics or any change in analgesics were not discussed. Baseline pain levels were low, suggesting potential floor effects. The mood measurement was not a validated tool. Measures were taken immediately after the intervention, and it was not clear what value from the weekly measures was used in the final analysis. No description of the types of pain was given.

The findings of this study suggest that listening to live music can improve patients’ moods. This study did not provide strong evidence for the effects of music on pain, and the study report had multiple limitations. Music interventions are low-risk and may be helpful for some patients. The intervention can be provided in multiple ways in multiple settings although the use of live music therapy can be more limiting because of available settings.

To determine the feasibility and possible benefits of a music imagery intervention for hospitalized patients with acute leukemia or high-grade non-Hodgkin lymphoma

Study patients completed baseline self-report instruments to assess affect, anxiety, and fatigue. Participants were then randomized to receive standard care or standard care plus music imagery. Standard care was hospitalization in a HEPA-filtered room with restricted visitor access and supportive medical care. A board-certified music therapist provided music imagery sessions. Sessions included relaxation and music imagery and were designed to provide participants with an opportunity to practice music imagery techniques, provide a successful music imagery experience, and answer any questions. When the initial session was complete, the therapist provided a CD with four 20-minute music imagery exercises as well as a CD player. Participants were encouraged to use the exercises at least once a day, and more frequently if they could. Participants used a journal to record how many exercises were used and their perceived effectiveness of the music therapy exercises. During therapist visits, patients could ask questions, change music imagery selections, and experience a therapist-led music imagery session. Music for the study included light classical and new age music chosen by the therapist based on assessment of the patients’ musical preferences and current emotional state and energy level. Sessions by the therapist occurred within three days of admission and twice a week during the hospital stay, up to four weeks.

• The study reported on a sample of 30 patients; 19 patients withdrew early from the study.
• Mean patient age was 52.47 years +/- 15.36 in the music imagery group and 55.53 years +/- 15.88 in the control group.
• The sample was 61% female and 39% male.
• Patients were hospitalized in a protective environment; all had either acute leukemia or non-Hodgkin lymphoma.
• Sixty-five percent of patients were married.

• Single site
• Inpatient setting
• Hematology oncology unit of Indiana University Hospital

Patients were undergoing the active treatment phase of care.

A randomized controlled trial design was used.

• Functional Assessment of Chronic Illness Therapy–Fatigue scale (FACIT-F)
• Spielberger State Anxiety Inventory (STAI-S)
• Music Imagery Journal
• Feasibility was assessed by rate of consent to participate, percent of completed music imagery sessions, and completion of measurement instruments.

Overall, 72% of therapy sessions were completed when accounting for study dropouts. No one completed the music imagery journal, due to feeling too sick or not remembering. Forty-nine percent completed an average of 60% of the measurement instruments. Analysis of mean scores over time, using repeated measures ANOVA, showed that both study groups improved in terms of greater positive affect, less negative affect, less fatigue, and less anxiety (p < 0.001). There were no differences in these results between study groups. Within those patients with low negative affect at baseline, those who received the therapy had lower anxiety at week 4 or hospital discharge than those in the control group.

Music imagery therapy is feasible in this population. Only those patients who had low initial negative affect demonstrated a potential benefit of the intervention in terms of lower anxiety at the end of the study period. Anxiety and fatigue declined over time in all patients.

• The study reported on a small sample, with less than 30 participants.
• The study design lacked an attentional control.
• The authors interpreted findings regarding apparent benefit only in those with lower initial negative affect scores to reflect an inability on the part of more negative patients to engage in the intervention. This suggests that patients who may need help for anxiety reduction the most would be those who are least able to benefit from this type of intervention.
• There was no way to evaluate actual use of therapy exercises because patients did not maintain the journals provided. This suggests that patients who are this severely ill may not be able to attend to this type of data collection.
• It cannot be determined whether patients used these exercises in between therapist-led sessions or not, and how this affected findings.
• The study had a high drop-out rate, with 10 patients (20% of the initial sample) withdrawing due to being too sick to carry out the intervention or voluntary withdrawal.

Results suggest that this type of intervention may only be of benefit in a select group of patients who are not as severely ill and do not have a high negative affect. The drop-out rate also suggests that this is a type of intervention for which participation and effect are highly dependent upon the patients’ preferences and interest in involvement. Findings suggest that once patients acclimate to the hospital environment, anxiety, fatigue, and negative affect decline, suggesting that nursing attention to helping patients with this acclimation may be most important in addressing these patient problems.

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.