To compare effects of patient-controlled epidural analgesia (PCEA) and patient-controlled IV analgesia (PCIA) after surgery for gastric cancer

Patients undergoing radical gastrectomy were randomized to receive either PCEA or PCIA. Patients receiving PCEA had a catheter inserted at T8–9 before anesthesia induction and postoperatively received an infusion of .05% bupivacaine and 100 mcg/ml morphine at a basal rate of 4 ml per hour for 48 hours, supplemented with rescue boluses of 4 ml with a 30-minute block-out period. The PCIA group received morphine at a basal rate of 1 mg per hour with rescue boluses of 1 mg every 10 minutes as needed. The primary outcome was postoperative pain at rest on day 1 after surgery.

• N = 60
• MEAN AGE = 60.35 years
• MALES: 53.3%, FEMALES: 46.7%
• KEY DISEASE CHARACTERISTICS: 11.7% had total gastrectomy. Others had distal gastrectomy with Billroth I or II. 66.7% had stage 3 disease.

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

• PHASE OF CARE: Active antitumor treatment

• Randomized parallel group

• Visual analog scale for pain

The mean pain scores in the PCEA group on days 1 and 2 were 2.9 (p < .01) and 2.3 (p < .05), respectively, compared to scores of 3.8 and 3.3, respectively, in the PCIA group. Pain on coughing was also significantly lower in the PCEA group (p < .05). Time to passage of flatus was lower in the PCEA group (p < .05), with 0.8 days' difference on average. Patients receiving PCEA had an average 10.7-day hospital stay, compared to 11.9 days in the PCIA group (p < .05). No differences were seen in post-operative complications between groups.

Findings show that post-operative analgesia with PCEA resulted in better pain control and lower hospital stay compared to analgesia with PCIA.

• Small sample of less than 100
• Risk of bias (no blinding)

Epidural analgesia may provide better post-operative pain management than IV analgesia. Nurses need to know how to care for and monitor potential complications with the use of epidural catheters.

To study the effects of music therapy on depression in female patients with breast cancer after radical mastectomy; to study how music therapy affects duration of hospital stay  

Subjects were randomly assigned to a music or usual-care group (control). Investigators collected data on the day before radical mastectomy (pretest), the day before hospital discharge (first post-test), and at the second and third hospital admissions for chemotherapy (second and third post-tests). Different chemo intervals meant that the second and third post-tests were between 14 and 28 days; the mean time was 18.6 days (SD = 7.4 days). Total intervention time involved the hospital stay after radical mastectomy (mean 13.6 days [SD = 2 days]) and the two chemotherapy periods (the mean time of each period was 8.9 days (SD = 7.1 days). The experimental group received an introduction to music, and participants selected preferred music. Each participant listened to his or her choice of music through headphones connected to an MP3 player. Participants listened to music twice a day, 30 minutes each time. Investigators did not offer music to the control group.

• The sample was composed of 120 participants, 60 in each group.
• The age range of participants was 25–65 years.
• All the participants were female.
• All the participants had breast cancer that required radical mastectomy.
   

• Single site
• Medical college
• Xi’an, Shaanxi, China
   

• Phase of care: active treatment
• Clinical applications: late effects and survivorship
   

Randomized controlled trial with repeated measures

• Chinese version of the Zung Self-Rating Depression Scale (ZSDS)   
• General questionnaire, for the collection of demographic data

• Investigators retrieved 450 validated questionnaires. The rate lost to follow-up was 12.5%.
• Clinical data and demographic data about age, education, income, marital status, and quality of spousal relationship revealed no significant baseline differences between the two groups (P > 0.05).
• Before radical mastectomy, the mean depression score of all participants was 37.19 (SD = 6.30); 36 participants (30%) suffered from depression symptoms. At baseline, data revealed no statistical difference in depression between groups. Post-test depression scores did demonstrate significant differences between the two groups (F = 39.13, P < 0.001; F = 82.09, P < 0.001).
• The depression scores of both groups trended downward during follow-up periods, but the score curve of the experimental group was lower than that of the control group (p < 0.001).
• Postradical mastectomy, the mean duration of hospitalization, experimental group, was 13.62 days (SD = 2.04 days); mean duration of hospitalization, control group, was 15.53 days (SD = 2.75 days). This difference was significant (P < 0.001).

Postmastectomy, depression scores of the experimental group were lower than those of the control group, and duration of hospital stay was shorter for patients receiving music therapy. However, lack of data regarding actual use of music therapy by patients and lack of information regarding patients’ health status and other types of treatment preclude recommendation of music therapy without further study.

• Data were self-reported.
• Double-blind methodology was not used because of the specificity of the intervention.
• Investigation was from a quantitative aspect only; subjective experiences were not studied.
• Subjects with extensive radical mastectomy played a small part in this trial.
• The percentage lost to follow-up was high. 
• The study had a potential testing effect as a result of repeated measurement.

When caring for patients with breast cancer who are suffering from mood disturbance, nurses should select interventions whose evidence of mood-disturbance reduction is greater than the evidence of effect that listening to music presents. However, listening to music is a low-risk, low-cost intervention that might be helpful to some patients.

• FINAL NUMBER STUDIES INCLUDED: 5 
• TOTAL PATIENTS INCLUDED IN REVIEW = 793
• KEY SAMPLE CHARACTERISTICS: Multiple types of cancer including colon, breast, stomach, biliary tract, and duodenum. Pyridoxine dose ranged from 50 mg/day to 600 mg/day.

PHASE OF CARE: Active antitumor treatment

Prophylactic pyridoxine did not reduce the incidence of capecitabine-induced HFS of any grade (OR = 0.91; 95% CI: 0.67–1.24), of ≥ grade 2 HFS (OR = 1.17; 95% CI: 0.82–1.67), or ≥ grade 3 HFS (OR = 1.05; 95% CI: 0.60–1.85).

Pyridoxine is not effective at preventing HFS associated with capecitabine.

• The dose of pyridoxine varied greatly from 50 mg/day to 600 mg/day.
• The optimal dose of pyridoxine has not been established. 
• Two included studies were retrospective studies. 
• Authors noted a publication bias in severe HFS.

Prophylactic pyridoxine is not an effective intervention to prevent HFS in patients receiving capecitabine.

• FINAL NUMBER STUDIES INCLUDED = 6 
• TOTAL PATIENTS INCLUDED IN REVIEW = 78
• SAMPLE RANGE ACROSS STUDIES: 74–227 patients

APPLICATIONS: Palliative care

Four studies included reported pain intensity, and the meta-analysis did not show a significant impact on pain intensity. Two of the four studies looking at patient attitudes showed decreased patient barriers to analgesic use. The studies reported improved patient knowledge.

Nurse-led psychoeducational interventions improved patient knowledge for pain management, reduced barriers to analgesic use, and may have reduced pain intensity.

• High heterogeneity
• Very few studies included in the review

This review did not add substantially to the current body of evidence regarding the effects of psychoeducational interventions on pain management. It did show that psychoeducational interventions can be beneficial in improving patient knowledge, reducing patient barriers to analgesic use, and possibly reducing pain intensity.

To determine if mecapegfilgrastim, a biosimilar, is as effective as pegfilgrastim in preventing febrile neutropenia (FN) in patients with advanced non-small cell lung cancer

One hundred fifty-one patients were split into three groups—two with two different doses of mecapegfilgrastim and one with normal saline (control). After the initial cycle, the control group received recombinant human granulocyte–colony-stimulating factor (rhG-CSF), while the other two groups continued their doses of mecapegfilgrastim.

• N = 146 
• MEAN AGE = 55.89 years 
• MALES: 69.2%, FEMALES: 30.8% 
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Non-small cell lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Patients receiving platinum-based chemotherapy

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

• PHASE OF CARE: Active antitumor treatment

• Double-blind, three-group, randomized trial followed by an open-label

• Neutropenia grade 3 or 4 (absolute neutrophil count [ANC] 1–0.5 x 10⁹/l)
• FN temperature of 38.5 degrees with neutropenia as above
• Duration of neutropenia from nadir to ANC 2 x10⁹/L
• Depth of ANC nadir

For the first phase of the study, both mecapegfilgrastim arms showed a lower incidence of grade 3 or greater neutropenia (p < 0.0001 and p = 0.0001). For the second phase, which was unblinded, the incidence of FN was lower across all cycles with both doses of the biosimilar (p < 0.023 and p < 0.0001) compared to placebo. No significant differences existed in FN incidence in those cycles when compared to G-CSF. Time to ANC recovery was significantly lower with the biosimilar compared to placebo and no different from the time to recovery with G-CSF.

Both doses of mecapegfilgrastim were effective in reducing neutropenia within each cycle of chemotherapy compared to rhG-CSF.

• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Findings not generalizable

As more biosimilars make their way to the market, studies such as this will be important in determining the care nurses provide to their patients. Nurses need to be aware of current literature and the implications for their patients. This study showed that the biosimilar CSF was more effective than placebo and as effective as G-CSF.

To examine effects of music therapy and progressive muscle relaxation (PMR) training on depression and anxiety in Chinese patients with breast cancer 

Patients randomly were assigned to the intervention group (which received the music and PMR intervention) or a usual care group after a radical mastectomy. To avoid contamination, intervention and control patients were placed in different inpatient areas. Music therapy involved listening to music via headphones connected to an MP3 player for 30 minutes twice per day. This began within 48 hours after surgery. Patients selected their preferred music. PMR training was conducted on the second postoperative day. Training was conducted twice per day for 30 minutes until discharge. Patients were encouraged to do PMR and music listening exercises together. Patients in the control group received the usual postoperative nursing care only. Study measures were obtained the day before surgery and the day before hospital discharge. Data collectors were blinded to group assignment.

• N = 170  
• MEAN AGE = 47.01 years (SD = 9.5 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Most had modified radical mastectomy and 89% had chemotherapy immediately after surgery

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: China

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled, single-blinded trial

• Zung Self-Rating Depression Scale (SDS)
• State-Trait Anxiety Inventory (STAI)

Analysis showed that there was a significant reduction in anxiety and depression over time alone (p < .001) as well as by group (p < .001), and there was a significant interaction between group and time (p = .0009). Depression scores declined an average of 7.2 points in the intervention group and 4.6 points in the control group. Anxiety scores declined an average of 16 points in the intervention group and 11 points in the control group. Hospital stay time was significantly lower in the intervention group (p < .001). Hospital stay length was shorter in the intervention group.

The findings of this study suggest that the combination of PMR and listening to music was helpful in reducing anxiety and depression in women after mastectomies.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• Other limitations/explanation: No information was provided regarding other potential confounders such as postoperative complications, pain levels, etc. that could influence reported outcomes. Data collection was conducted via face-to-face interview, and although it was stated that data collectors were blinded, it is not clear where the data collection took place. If it took place in the hospital, data collectors could deduce group assignment because of the different locations in the hospital. This study was of Chinese women, so applicability to other groups is not known. It is not clear in the report whether all sessions of the intervention were guided by the investigators or done by the patients on their own. It is not clear how, if supervised by investigators, the patient could listen to the PMR training if they also were listening to music via headphones.

Listening to music and using progressive muscle relaxation may have a positive impact on anxiety and depression in patients postoperatively. These are low-risk, low-cost interventions that may be beneficial. The findings of this study showed that those who had the intervention also had shorter hospital stays. There is insufficient evidence to determine the real impact of this intervention on duration of hospitalization; however, these findings suggest that this area deserves further exploration.

To compare the effectiveness of Mepilex^® Lite dressings versus usual care in the time to healing of postirradiation dermatitis in patients with nasopharyngeal carcinoma

• Control arm: Routine wound care and cleansing with a saline solution
• Intervention arm: Wound cleansing followed by application of Mepilex Lite dressing
• Primary endpoint: Time to wound healing (i.e., time between recruitment and complete reepithelialization with absence of any moist desquamation)
• Signs of infection also were measured.
• Assessments were made at baseline and then every Monday, Wednesday, and Friday.

• N = 88 started, 83 completed    
• AGE = Adults aged 50 years or younger (n = 50), adults aged 50 years or older (n = 38) 
• MALES: 62.5% (n = 55), FEMALES: 37.5% (n = 33)
• KEY DISEASE CHARACTERISTICS: Nasopharyngeal carcinoma
• OTHER KEY SAMPLE CHARACTERISTICS: Concurrent chemoradiation, three cycles of neoadjuvant cisplatin and 5FU chemotherapy, Chinese patients. There was no significant difference in the participant characteristics between the treatment and control arm.  These characteristics include age, Karnofsky Performance Status Scale, initial wound size, cancer staging, or radiotherapy technique.

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: Southeast Asia

• PHASE OF CARE: Active antitumor treatment

This was a systematic, inpatient, controlled clinical trial investigating the effect of Mepilex Lite dressings on radiation-induced dermatitis in patients with nasopharyngeal cancer who were undergoing curative-intent radiotherapy.

• Modified Radiation Induced Skin Reaction Assessment Scale (RISRAS) was used to assess erythema, dry desquamation, moist desquamation, necrosis, and patient symptoms such as pruritus, burning, discomfort, and impact on daily life.
• Wound pain was measured using a visual analog scale of 0–10
• Sleep problem, neck mobility, and appearance disturbance were measured using a 10-point Likert scale of 0 (less) to 10 (more distress) 

Median time to wound healing  was 16 days (95% CI 12–19 days) in the Mepilex Lite group and 23 days (95% CI 19–27 days) in the control group (p = 0.009). Initial wound size of greater than or equal to 10 cm² (p = 0.005), lymph node classification of 3 (p < 0.001), and AJCC overall stage III and IV (p = 0.003) were associated with prolonged wound healing time. No signs of infection were identified in either group. Participants in the Mepilex Lite group had significantly less (X = 4.38) sleep problems than the control group (X = 7.23, p = 0.005). Wound pain was significantly less in the Mepilex Lite group (X = 5.31) as compared to the control group (X = 6.89, p = 0.02). There was no difference in the neck mobility and appearance disturbance between the treatment and control groups.

Mepilex Lite dressing provides a promising alternative in the treatment of radiation dermatitis in nasopharyngeal carcinoma and is worthy of further research.

• Small sample (< 100)
• Risk of bias (no blinding)
• Other limitations/explanation: It would have been impossible to blind the researchers or the participants when only one arm involved a dressing.

This was a small, randomized, controlled clinical trial that was not blinded. Mepilex Lite dressing significantly decreased the time to wound healing of radiation dermatitis among individuals being treated for nasopharyngeal carcinoma. Additional studies are needed in a large, more diverse population of patients with cancer.

• FINAL NUMBER STUDIES INCLUDED = 7 (initially reported as eight studies, but one was excluded because the Likert scale was used instead of the VAS to assess pain)
• TOTAL PATIENTS INCLUDED IN REVIEW = 403 patients with pancreatic cancer, 196 patients undergoing CPB, and 207 undergoing medical management
• KEY SAMPLE CHARACTERISTICS: Mean age of CPB patients was 57–67 years; mean age of control patients was 60–68 years; proportion of males was similar between groups among the studies; the CPB methods and the pharmaceuticals were similar; the use of ethanol concentrations varied from 30%–100%

PHASE OF CARE: Multiple phases of care
 
APPLICATIONS: Elder care and palliative care

The VAS scores of the CPB groups were lower at two, four, and eight weeks after the procedure, but not all studies found that the CPB group used fewer pharmacologic agents than the control groups. Most studies showed that the CPB groups experienced less pain although the patients in these group also used nonsteroidal anti-inflammatory drugs (NSAIDS) or morphine to control their pain.

This meta-analysis found that at four weeks, groups receiving a CPB had a lower pain score. However, these results were not sustained at eight weeks, and the trend continued to the day before death with increaseing usages of NSAIDS and morphine in both groups.

• Across the various studies, there was limited postintervention consistency in pain evaluation intervals.
• The concentrations of ethanol used in CPBs varied significantly between studies. 
• CPB techniques varied across the studies.

The findings of this meta-analysis show consistent results in regard to the efficacy of CPB in decreasing pain for patients with pancreatic cancer short-term and overall.

STUDY PURPOSE: To evaluate caregiver outcomes related to telehealth interventions in palliative care

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 9 
• TOTAL PATIENTS INCLUDED IN REVIEW = 527
• SAMPLE RANGE ACROSS STUDIES: 8–217
• KEY SAMPLE CHARACTERISTICS: One study included patients with cancer. Four studies were of patients in hospice.

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

Four studies used videophones for communication with medical professionals, and two used telephones for counseling. Two studies showed a reduction in caregiver anxiety with the intervention. One study showed a significant reduction in caregiver burden, and one showed no difference in caregiver burden measures. Individual studies also showed improved family function, reduction in caregiver negative mood, decreased depression over time, and reduced stress over time among caregivers. Overall, 66.7% showed positive effects of the interventions. All studies concluded that the approach was feasible, and most revealed that caregivers were satisfied with the intervention.

Telehealth interventions might improve the caregiving experience. Additional research in this area is needed.

• Mostly low quality/high risk of bias studies
• Low sample sizes
• The content of interventions is not well described.

Telehealth intervention approaches may be an effective way to deliver various aspects of care and caregiver interventions. This can be a practical alternative to other approaches, particularly for caregivers in rural or underserved communities. Additional research is warranted to also identify the most effective components of these types of interventions.

To evaluate whether spore powder of Ganoderma lucidum (G. lucidum) has beneficial effects on fatigue and overall quality of life in patients with breast cancer undergoing endocrine therapy.

Patients in the experimental group received spore powder of G. lucidum 1,000 mg three times a day for four weeks (from Beijing Great Wall Pharmaceutical Factory, batch # B20050008). This is a traditional Chinese medicine that contains polysaccharides, alkaloids, enzymes, and proteins. The control group received placebo for four weeks. Outcomes were evaluated at baseline and the end of four weeks. 

• The total sample was comprised of 48 women, with 25 patients in the experiemental group and 23 in the control group.  
• Median age was 51.3 years (standard deviation [SD] = 9.8) in the experiemental group and 53.2 years (SD = 8.7) in the control group (p > 0.1).
• Patients were stage I to IIIA. 
• Multimodal treatment included surgery, radiation and/or chemotherapy, and endocrine therapy for all patients. 
• Duration of endocrine therapy varied from more than six months to up to five years. 
• No statistically significant differences existed between the groups.
• Patients received endocrine therapy for breast cancer.
   

The study was conducted at the Third Affiliated Hospital of Harbin Medical University in Harbin, China, from June 2009 to September 2010.

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

The study was a randomized, placebo-controlled trial.

• Functional Assessment of Cancer Therapy–Fatigue (FACT-F)
• Hospital Anxiety and Depression Scale (HADS)
• European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (EORTC QLQ-C30)
• Biological Markers of Fatigue:  tumor necrosis factor (TNF) and interleukin-6 (IL-6)
• Safety and toxicity tests, such as a renal function test, liver function test, and the Common Toxicity Criteria version 2.0 scale
• Fatigue was measured with a single-item numeric rating scale with possible values from 0 (a great deal of fatigue) to 10 (no fatigue).
• Energy was measured with a single item, “How much energy have you had during the past 4 weeks?,” with possible values from 0 (no energy at all) to 10 (a great deal of energy).
   

No serious adverse effects occurred. No significant changes occurred in the renal and liver function tests. Fatigue scores were improved in the experimental group at four weeks (p < 0.01), but no significant improvement occurred in the control group. At four weeks, anxiety and depression scores had improved significantly from baseline in the experimental group. No significant improvement occurred over time in the control group.

The pilot suggested that spore powder G. lucidum may have beneficial effects on cancer-related fatigue and quality of life in patients with breast cancer undergoing endocrine therapy with no significant safety concerns.

• The study had a small sample size, with less than 100 patients.
• Nonspecific aspects of the intervention (social support) may influence the study. 
• Patients were healthy (e.g., no other comorbid conditions).
• No blinding was performed.
   

Additional research should be conducted in a larger randomized, controlled trial.