To evaluate the efficacy and safety of transdermal fentanyl in the treatment of mucositis pain associated with chemotherapy

Transdermal fentanyl (TF) was administered at a rate of 25 mcg/hour for adult patients, including those who were opioid naive. In pediatric patients, TF was administered at 12.5 mcg/hour. Because of the delayed effect of TF, patients received IV or subcutaneous morphine to relieve pain during the 8–12 hours after application of the patch. The dose of TF was adjusted after the first 24 hours, according to pain score, until pain was controlled. (Control was defined as a score of 3 or less on the rating scale.) The dose of TF was increased in 25 mcg/hour increments or 12.5 mcg/hour increments, according to age group. Severe breakthrough pain was managed with IV or subcutaneous morphine. All subjects were routinely treated with oral hygiene and antiviral, antibacterial, or antifungal oral agents. The same clinician evaluated patients on the first day of chemotherapy and daily for approximately three weeks. The patient reported pain daily by citing a score on a numeric scale. Mucositis was evaluated, on a daily basis, in terms of National Cancer Institute (NCI) Common Toxicity Criteria (CTC). Study questionnaires were sent to all patients. Questionnaire data were recorded before treatment with TF and 2, 6, and 10 days later.

• The sample was composed of 32 patients.
• Median patient age was 40 years. Age range was 4–76 years.
• Of all patients, 56.3% were female and 43.7% were male.
• The most common diagnoses were non-Hodgkin lymphoma, neuroblastoma, nasopharyngeal cancer, breast cancer, and small-cell lung cancer. Other diagnoses were included in the sample. All patients had a pain score of 4 or higher at study entry. All patients were receiving chemotherapy.

• Multisite
• Outpatient
• China

Open-label prospective trial

• Numeric rating scale (NRS), to measure pain intensity
• NCI CTC, to measure mucositis and adverse events
• European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ-C30), to measure quality of life

• After chemotherapy, median time to onset of moderate oral mucositis was five days (range of days to onset was 1–16). 
• Prior to use of TF, median NRS pain score was 6. By day 3 and at days 5, 7, 10, and 15, NRS scores had improved significantly (p < 0.001), compared to NRS scores at baseline. By day 3 median NRS was 4; by day 10, median NRS was 2. Pain disappeared in 65.6% of subjects.
• Results as measured by the EORTC QLQ-C30 improved significantly (p < 0.001) in regard to appetite, mental status, sleep, fatigue, and daily life.
• A dose of 25 mcg/hour was sufficient to control mucositis pain in 75% of the sample. Of all patients, 18.8% developed nausea and vomiting, 15.6% reported dizziness, 15.6% reported stomach discomfort, 6.3% reported constipation, and 6.3% reported patch-related itching.
• No patients discontinued the drug because of toxicity.

In this study, transdermal fentanyl was effective in reducing pain and improving quality-of-life parameters in the sample specified. Transdermal fentanyl was associated with a relatively low prevalence of adverse effects.

• The study had a small sample, with fewer than 100 patients.
• Authors did not state whether any patients required use of medication for breakthrough pain.
• Authors did not report the prevalence of adverse effects by severity.
• The number of pediatric patients versus adult patients was not stated. The means by which authors measured the pain and quality of life of very young patients (some as young as 4 years old) was not reported.
• Other mechanisms for the management of oral mucositis, which could be expected to influence pain, were not controlled or fully described.

Authors noted the delay of onset with TF opioid use. This delay suggests that TF therapy begin before onset of significant levels of pain. Further well-designed studies of TF, in adults and children, are needed.

• Ifosfamide 1800 mg/m² for five days, carboplatin 400 mg/m² for two days, and etoposide 100 mg/m² for five days with recombinant human interleukin-11 (rhIL-11) subcutaneous (SC) at 25–125 mcg/kg/day on days 6–33
• Chemotherapy repeated every 21 + days or when hematologic recovery was achieved (absolute neutrophil count greater than 100z10/9 and platelet count greater than 100x10/9 for two days without platelet transfusion or a maximum of 28 days). No chemotherapy dose change was permitted in cycles one and two.
• For six cycles, until tumor progression or inadequate hematologic recovery by day 60 in cycle one or day 35 in subsequent cycles
• Select patients who received rhIL-11 with six cycles of chemotherapy and who benefited in the investigators’ opinions were able to receive subsequent doses.
• G-CSF was administered SC beginning day six and until post nadir
• Primary endpoints for safety were AE, lab, and radiologic findings.
   

• N = 47
• MEDIAN AGE = 10.5 years
• AGE RANGE = 8 months–24 years
• MALES: 30, FEMALES: 17
• KEY DISEASE CHARACTERISTICS: Children, adolescents, and young adults with solid tumors or lymphoma
• OTHER KEY SAMPLE CHARACTERISTICS: 53% white; three weeks since last chemotherapy and six weeks since last nitrosourea chemotherapy. Excluded primary/mets intracranial tumors greater than 50% infiltration of tumor into bone marrow, craniospinal xRT or xRT greater than 50% of bone marrow space
   

• Phase I/II dose escalation study

• Dose-limiting toxicities include grade 4 nonhematologic toxicity or papilloedema.
• Tolerated dose defined as dose level at which no more than 1 of 10 patients experienced dose-limiting toxicity
• Serum IL-11 concentrations measured at genetic institute
• Blood collected at 0 (predose),1, 2, 2.5, 3, 4, 6, 8,10,12, and 14 hours after IL-11
• Pharmacokinetic measures done
• Progenerator cells evaluated by colony formation assays as well as flow
• Cytokine receptor expression measured by flow
• Primary endpoints for safety were AE, lab, and radiologic findings.
• Secondary objectives to evaluate and estimate hematologic responses

Three of 47 patients withdrew. Also, 24 of 44 discontinued before receiving two cycles (9 because of disease progression; 3 for adverse events [papilloedema]; 2 for therapy changes; 10 for other reasons; 1 died). Twenty patients completed two cycles of therapy. Median time to platelet recovery was reduced (24.5–20 days in similar historical cohort). One patient developed incidence of anti-IL-11 antibody formation. Number of platelet transfusions was three versus six in historical controls. IL-11 was well-tolerated at doses less than 50; the maximum tolerated dose is 50 mcg/kg/day. Doses above this increased side effects of papilloedema in 6 of 26 patients, periosteal bone changes in 4 of 26 patients, and cardiomegaly.

• Dose-limiting side effects at greater than or equal to 75 mc
• Tachycardia—45%
• Conjunctival infection—45%
• Edema—29%
• Pain—23%
• Rhinitis—20.5%
• Diarrhea—20.5%
• Cardiomegaly—20.5%
• Papilloedema—16%
• Periosteal bone changes—11%
• Small N
• Follow-up one year out
• Large range in age/size
• Not randomized—compared to historic controls

To compare the efficacy and safety of a two-drug combination (including nutraceuticals) with carnitine and celecoxib (arm 1) versus megestrol acetate (arm 2) for the treatment of cancer anorexia and cachexia syndrome

No dietary restrictions were placed on participants. Polyphenols (2 tabs, 300 mg/day), lipoic acid (300 mg/day), carbocystine (400 mg/day), vitamin A (30,000 IU/day), and vitamin C (500 mg/day) were administered orally to all patients. Patients were then randomized to treatment arms: arm 1, L-carnitine (4 g/day) + celecoxib, or arm 2, l-carnitine (4 g/day) + celecoxib + megestrol acetate (MA) (320 mg/day). Treatment duration was four months. Measurements were obtained at 4, 8, and 16 weeks. Analysis focused on differences from baseline to 16 weeks. Data were collected from 2009 to 2010. No placebo arm was included for ethical reasons and based on previous research. Planned study duration was four months.

• The study reported on 60 patients.
• Mean patient age was 65.2 years (SD = 8.7), with a range of 46–82 years.
• The sample was 58.6% male and 41.4% female.
• Most patients (96.6%) had stage IV disease, and one patient was stage IIIB.
• Patients had a variety of diagnoses, including head and neck, lung, colorectal, stomach, ovarian, and pancreatic cancers. One patient had esophageal cancer.
• Seventy-six percent of patients were receiving concomitant palliative chemotherapy.

• Single site
• Setting not specified
• Medical oncology, Cagliari, Italy

• Patients were undergoing long-term follow-up care.
• The study has clinical applicability for end-of-life and palliative care, and late effects and survivorship.

A phase III, randomized, two-group, non-inferiority trial design was used.

• Lean body mass (LBM): bioelectrical impedance analysis (BIA), dual-energy x-ray absorptiometry (DEXA), and regional computed tomography (CT) at L3    
• Total daily physical activity and resting energy expenditure (REE): electronic armband
• Secondary endpoints: grip strength, six-minute walking test, fatigue, REE < body weight, appetite (measured by visual analog scale), interleukin 6 (IL-6), c-reactive protein (CRP), tumor necrosis factor (serum blood marker), and quality of life (European Organization for Research and Treatment Cancer Core Quality of Life questionnaire [EORTC QLQ-C30])
• Safety: adverse events classified by the National Cancer Institute Common Terminology Criteria for Adverse Events
• Multidimensional Fatigue Symptom Inventory–Short Form

Primary endpoints: There was no significant difference (based on t test) between arms for LBM and physical activity. DEXA and CT of L3 significantly increased at 16 weeks from baseline in both arms. BIA did not change in either arm. There were no significant changes in physical activity in either arm. The six-minute walking test improved in both arms, and grip strength did not change significantly in either arm. REE, fatigue, Eastern Cooperative Oncology Group score, and prognostic score decreased significantly in both arms. Body weight did not change significantly in arm 1 but did increase in arm 2 (p = 0.052, which was not significant but on the border and trending). Appetite was reported as improved significantly in both arms (p < 0.05). Fatigue scores were improved significantly in arm 1 after treatment  (p = 0.036). Survival measurements did not change and were not significantly different between groups. Two patients reported grade 3 diarrhea.

No significant differences were found in patients based on the intervention arm.

• The study had a small sample size, with less than 100 patients.
• Adherence to treatment, patient-reported outcomes, and impact of each individual drug were not reported. Therefore, it was difficult to know which medication had the impact.
• This was a small, single-site study. Although significant improvements in appetite were reported, there is no description of how this was measured.
• The report states a planned follow-up of four months but does not state how long the follow-up actually was.

A multimodal approach may help to improve anorexia and cachexia in patients with cancer. More work focused on patient-reported outcomes, safety, and adherence is needed. Specific description of how appetite is assessed should be included in studies reporting this outcome measure.

PHASE OF CARE: Multiple phases of care

No information is provided regarding literature retrieved, quality of evidence, or how the evidence was used to develop the guidelines provided.

Outlines relevant healthcare provider roles. Identified the following assessment tools for use: Edmonton Symptom Assessment Scale, the NCCN's Distress Thermometer, and the Hospital Anxiety and Depression Scale. Provides a stepped path of interventions based on ongoing monitoring of symptoms and effectiveness of previous interventions. Recommendations for initial intervention are patient education (in-person or online) and brief emotional support. Ongoing interventions for those with cancer-related anxiety and depression include coping skills training, relaxation skills, communication skills, mindfulness, and a variety or psychological therapies.

Despite an extensive review process for guidelines, as well as input from stakeholders, there is little information on the evidence base for the recommendations provided.

This guideline outlines recommended providers, and nurses are not specifically outlined as recommended providers in the written pathway other than as “other appropriately trained staff,” although nurses are identified as having roles in screening, assessment, and educational and counseling types of roles. This guideline provides no new information and does not directly provide the evidence base on which recommendations are based. The guideline suggests more limited roles for nurses than has been demonstrated in relevant research.

To examine the effect of supportive-expressive group therapy using hypnosis in patients with metastatic breast cancer experiencing pain and to explore the interaction between hypnotizability and pain experience in women trained to use hypnosis

Baseline pain, distress, coping, social support, physical activity, and immune and endocrine function were evaluated, and patients were randomized by the project director and a research nurse using an adaptive randomization biased coin-design method. Treatments were conducted at each of the three sites weekly for 90-minute sessions. Group size varied from 3–15 participants because of rolling recruitment and participants dying. Each supportive-expressive therapy session was co-led by two psychotherapists; among these were a psychiatrist, psychologists, and social workers. Themes emerging in these sessions were fears of dying and death, including dealing with the deaths of group members, reordering life priorities, improving support from and communication with family and friends, integrating a changed self and body image, and improving communication with physicians. A hypnosis exercise ended each session, and participants were instructed to practice this several times a day and any time the pain was noticeable or increased. The control group members were offered self-directed education and a year membership to a consumer health library in their community. Post-baseline assessments were every four months for the first year and then every six months after.

• N = 124   
• AGE: Education only group (control arm): mean = 53.1 years (SD = 10.8 years), range = 30–80 years; group therapy plus education group (intervention arm): mean = 52.7 years (SD = 2.7 years), range = 33–73 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Metastatic breast cancer, recurrent breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Participants had to be proficient in English, able to participate in a support group, living in the greater San Francisco Bay Area, and have a Karnofsky score of 70 or greater. They had to be able to care for themselves but unable to do active work or carry on normal activity. 
• EXCLUSION CRITERIA: Participants were excluded if they had positive supraclavicular lymph node as the only metastatic lesion at the time of initial diagnosis, active cancers within the past 10 years other than breast cancer, basal cell or squamous cell of the skin, in situ cancer of the cervix, melanoma with a Breslow depth below 0.76, or concurrent medical conditions likely to influence short-term survival.

• SITE: Mutli-site   
• SETTING TYPE: Outpatient setting   
• LOCATION: Stanford, San Francisco, and San Jose, CA. Patients were encouraged to use hypnosis training at home.

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Late effects and survivorship, end-of-life and palliative care
   

• Randomized clinical trial

• Pain Rating Scale     
• Hypnotic Induction Profile
• Group feedback questionnaire

Analysis of covariance on change in intensity of current pain showed statistical significance (P = .001) in those in the treatment group versus the education only group. Those who received therapy and education showed a smaller increase in the intensity of current pain than the control (education alone) (P = .034). Those who had a greater intensity of current pain and suffering at baseline experience a great decrease in intensity (P = .001), whereas those for whom baseline pain was less experienced increases in intensity. No statistically significant relationships associated with hypnotizability were found across recruitment sites, and hypnotizability did not show an interaction with treatment. The treatment effect was not significant with the baseline level of pain but still predicted a greater decrease in pain (p = .008). Those who reported the most pain at baseline showed a decrease in frequency of pain, whereas those who reported least frequent pain at baseline showed an increase in frequency (p = .001). Constant pain at baseline showed the greatest reduction in constant pain, whereas those who did not report constant pain showed an increase in constant pain (p = .001). Treatment did not have an effect on constant pain. Highly hypnotizable women reported greater use of hypnosis exercises for controlling nausea and vomiting, for management of stress and anxiety, and for comfort versus low hypnotizable women.

Hypnosis and group sessions can be successful in reducing pain and suffering—more specifically for those with high hypnotizability—and potentially could be used to help control other symptoms in metastatic breast cancer or even other cancers. Patients without constant pain or with low current pain seemed to show an increase in constant pain and frequency. Low hypnotizability was also a less desirable trait in controlling symptoms; however, these individuals were found to have used hypnosis less frequently and may not have experienced maximum benefit. This method could be utilized as an adjunctive to treat symptoms other than pain; however, this study addressed pain only.

• Blinding was not possible because this was a psychotherapy trial.
• This study is limited to white, middle-to-upper class women with metastatic breast cancer.
• The benefits of hypnosis exercise cannot be determined from this study.
• This study relied on self-reported single measures of pain, potentially limiting the accuracy of pain assessments.
• This study also may be underpowered to determine relationships to treatment conditions.
• Unable to identify effects for participants throughout the intervention because of incomplete assessments, particularly related to illness and death 
• No attentional control was provided.

Nurses may want to become educated in hypnosis as an adjunctive therapy to educate patients to utilize this method in controlling pain. Additionally, nurses may want to refer those particularly having a difficult time with symptom management to a supportive-expressive therapy group rather than providing only educational material to patients with metastatic breast cancer. Nurses also must keep in mind that group intervention and hypnosis may not be successful or appealing to all patients and certain characteristics and hypnotizability impact the success of treatment.

This study was conducted to assess the effect of prophylactic d-methylphenidate HCl (d-MPH), a central nervous system stimulant, on quality of life and cognitive function in patients with brain tumors undergoing radiation therapy.

The treatment group received a starting dose of 5 mg twice daily of d-MPH; this was escalated to a maximum of 15 mg twice daily. Patients were stratified by tumor type (primary versus metastatic), treatment (radiation therapy alone versus radiation therapy plus chemotherapy), and Karnofsky Performance Status (< 90 versus 90), and were randomized within strata to one of the two treatment arms.

• The total number of participants was 68. 
• There were 34 participants in the treatment group and 34 in the placebo group.  
• The median age of the treatment group was 52, with a range of 31–79.
• The median age of the placebo group was 60, with a range of 28–83. 
• 54.4% of participants were male and 45.6% were female, distributed across each group.
• 48.5% of participants had primary brain cancer and 51.5% had metastatic brain cancer.

This was a randomized, double-blind, placebo-controlled study.

• Mini-Mental State Examination (MMSE) for global cognitive functioning
• Functional Assessment of Cancer Therapy (FACT)-Brain for cancer-related quality of life specific to patients with brain tumors
• Functional Assessment of Cancer Therapy-F for cancer-related quality of life pertaining to symptom of fatigue
• Center for Epidemiologic Studies-Depression Scale (CES-D) for depressive symptoms

There was no difference in cognitive functioning at baseline, end of radiation therapy, or at 4, 8, and 12 weeks after brain radiation therapy. No difference in fatigue or quality of life was observed. 

Prophylactic use of d-MPH in patients with brain tumors undergoing radiation therapy did not result in an improvement in cognitive functioning, quality of life, or fatigue.

• The study's primary outcome was fatigue.
• The study had limited measurement of cognitive function; the MMSE is a global indicator.
• There was a small sample size and a high dropout rate. Only 47% of participants completed the eight-week assessment.
• The study was stopped prematurely because of slow accrual and stoppage of funding by the sponsoring drug company.
• Four patients (6%) experienced side effects; two experienced nausea and vomiting, one experienced tachycardia on the placebo arm, and one went off the study due to an increase in liver enzymes.

To evaluate the effect of physical exercise on terminally ill patients with cancer.

Patients in the exercise group exercised three times a week for 20 to 30 minutes for a three- to four-week period. The schedule of exercises was individually planned by a physiotherapist. Study outcome measures were obtained at baseline, weekly, and at the end of the study. No information was provided regarding the control group procedures.

• The sample was comprised of 49 patients. 
• No age, gender, or diagnosis information was provided. 
• All patients were in hospice either at home or in an inpatient hospice setting.

• Multisite
• Inpatient and outpatient
• Poland

Patients were undergoing end of life care/end of life and palliative care phase of care.

This was a two-group comparative trial – no information was provided on whether patients were randomly assigned.

• Fatigue visual analog scale (VAS) (0-10)
• Rotterdam symptom checklist
• Brief Fatigue Inventory (BFI)

There were no apparent effects on outcomes during the first two weeks. By week 3, mean VAS intensity of fatigue declined in the exercise group from 6.5 to 5.5. In the control group, fatigue increased from 6.5 to 7.5 (ANOVA; p < 0.001). Physical symptoms tended to decline slightly in the exercise group and increase slightly in the control group, with changes ranging from 0.1 to .05 (p < 0.05). There were no observable effects on quality of life scores from the symptom checklist data.

Results suggested that individualized exercise can be beneficial for fatigue in terminal patients with cancer.

• The study had a small sample size, with less than 100 participants.
• It was not clear how patients were assigned to study groups.
• No demographic or disease-related information was reported, so any relevant differences between groups that might affect findings cannot be determined.
• BFI results were not reported, and only a VAS fatigue measure analysis was given.
• Use of the symptom checklist for the single quality of life measure is questionable.
• Statistically significant outcome changes seen here were very small.
• The types of exercise provided were not described.

The study did not provide strong evidence for the effectiveness of exercise due to multiple issues in this report and the small measured changes seen. Findings suggested that exercise may be beneficial in terminally ill patients and showed that there were no apparent adverse effects from the activity provided to these patients.

The purpose of the study was to compare severe neutropenia duration and incidence of febrile neutropenia in patients getting chemotherapy with pegfilgrastim on the same day or 24 hours later.

Four studies were analyzed separately, and data were not compiled for overall analysis across cancer types. In all settings, patients were randomly assigned to either receive pegfilgrastim 6 mg on the last day of the chemotherapy cycle and placebo injection 24 hours later, or placebo on the last day of the cycle and pegfilgrastim 6 mg 24 hours later. Anti-infective prophylaxis was not allowed. Incidence of grade 4 neutropenia was the primary study endpoint, and patients were included and analyzed for one cycle. Complete blood counts were obtained weekly for each chemotherapy cycle.

• 275 participants were included.
• The mean age was 58.6 years.
• Females made up 67.6% of the sample; males made up 32.4%.
• This report is of four studies with the same design, one in breast cancer cases, one in non-Hodgkin lymphoma, one in non-small cell lung cancer, and one in ovarian cancer.
• Disease stages varied
   

• Multi-site (74 sites in the United States) 
• Setting type was not specified  

Active antitumor treatment

Randomized, double-blind placebo controlled

Not stated

In the breast study, grade 4 neutropenia was reported in 93% of same day patients and 78% of next day patients. Mean duration of severe neutropenia was 1.2 days longer in the same day group. In the lymphoma study, severe neutropenia was reported among 86% of same day pegfilgrastim patients and 64% of next day patients. Mean duration of severe neutropenia was 0.9 days longer in the same day group. Incidence of febrile neutropenia was essentially the same in both groups. In the lung cancer group, only 5% of patients experienced severe neutropenia. Analysis of the ovarian group was not done due to study closure prior to obtaining a sufficient sample. Authors report that noninferiority statistical analysis showed that next day pegfilgrastim was not inferior to same day pegilgrastim.

 Findings suggest that different timing of pegfilgrastim administration  within a two day window may not make a difference in incidence of severe neutropenia in these patient groups.

• Risk of bias(sample characteristics)
• Measurement/methods not described  
• Measurement validity/reliability questionable
• The authors note that some of the studies were underpowered to detect significant differences.
• Various samples were highly variable in terms of disease type and stage, and though data were reported by study, no further subgroup analysis was possible. 
• Method of measurement of grade of neutropenia was not described and timing of this determination not stated. 
• In some cases, it appears that analysis was done only in cycle 1 but, in other sections of the report, this is not clear.
• Chemotherapy agents used were not reported, so it is unclear how myelosuppressive they were and potential differences.

This report provides some information from four studies to examine differences in timing of administration of colony-stimulating factors. The most beneficial and cost-effective formulations, dosages, and timing have not been determined. This report has several limitations in study design and results reported.

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.