To compare the pain relief achieved by one injection of alcohol versus two injections of alcohol during endoscopic ultrasound–guided (EUS) celiac plexus neurolysis (CPN); to compare the safety associated with the one- and two-injection techniques; to determine the extent to which the number of injections affects the onset and duration of pain associated with pancreatic cancer

Each CPN procedure involved injecting 20 ml 0.75% bupivacaine and 10 ml 98% alcohol into either one or two sites at the celiac trunk. The total sample was composed of 50 patients. Investigators conducted follow-up interviews by telephone to evaluate onset and duration of pain relief and complications. Interviews occurred at 24 hours after the procedure and then weekly.

• The sample was composed of 50 patients.
• Mean patient age was 63 years.
• Of all patients, 48% were male and 52% were female.
• All patients had pancreatic cancer.

• Single site
• Outpatient
• Indiana University Medical Center, Indianapolis, Indiana
   

• Phases of care: multiple
• Clinical applications: end of life, palliative care, late effects, survivorship
   

Prospective single-blinded randomized parallel-group study

• Pain relief: Chi-square–measured difference in proportion of pain relief, subjective pain relief, and reduction in the use of pain medication.    
• Onset of pain relief: Time from date of injection until 30% reduction of the pain reported at baseline. Investigators used Kaplan-Meier estimate of median time. Log rank test measured time until pain relief between groups. Mann-Whitney test compared time until pain relief in responders.
• Duration of pain relief: Time from date of injection to the date the pain returned to within 30% of the baseline value. Investigators used Kaplan-Meier estimate of median duration of pain relief. Log rank test compared duration of pain relief between groups and between those who achieved pain relief.
• Predictors of pain relief: Two-sample t tests were used to compare baseline pain score, days until onset of pain relief, and total reduction in pain relief between groups.
• Survival: Survival was calculated from date of injection to date of death.
   

Fifty patients were enrolled and randomized. Pain relief was observed in 37 patients (74%): 20 (69%) in the one-injection group and 17 (81%) in the two-injection group. Median onset of pain relief in both groups was one day. Median duration of pain relief in the one-injection and two-injection groups was 11 weeks and 14 weeks, respectively. Complete pain relief was achieved in four patients (8%), two in each group. No long-term complications occurred.

The two techniques were not associated with any significant difference in patients' experience of pain.

• The study had a small sample, with fewer than 100 patients.
• The study was a single-blinded test.

Authors observed no difference in the safety associated with the two techniques or the survival rate. Nurses would be justified in advocating for the single-injection technique, to minimize patients' discomfort.

To determine the effectiveness of glutathione for the prevention of taxol/carboplatin-induced peripheral neuropathy

One hundred eighty-five patients were randomized to receive either placebo or glutathione 1.5 mgm/m² while receiving paclitaxel and carboplatin therapy over 15 minutes immediately before chemotherapy.

• N = 185  
• MEDIAN AGE = 63 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with ovarian cancer, lung cancer, or other
• OTHER KEY SAMPLE CHARACTERISTICS: Some patients received weekly taxol, whereas others received taxol every three to four weeks. Patients with diabetes were also included.

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: U.S. 

PHASE OF CARE: Active antitumor treatment

Placebo-controlled, randomized, controlled trial

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life
• Chemotherapy-induced peripheral neuropathy–specific sensory subscale
• National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE)
• Functional Assessment of Cancer Therapy-Ovarian (FACT-O)

No differences were reported in neurotoxic symptoms between the groups the week following taxol infusion. In addition, no differences were reported between the groups receiving taxol every three to four weeks. Time to development of at least grade 2 neurotoxicity was higher in the placebo group (p = 0.039).

The results indicated that this was a negative trial and do not support the use of glutathione for neurotoxic symptoms from taxol/carboplatin therapy.

The results of this negative trial showed that glutathione was not effective in patients receiving taxol/carboplatin. Very limited evidence supports effective interventions for preventing or minimizing chemotherapy-induced peripheral neuropathy. Ongoing research is needed in this area.

• N = 121   
• AGE = 50.5 years (SD = 8.7 years)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer 
• OTHER KEY SAMPLE CHARACTERISTICS: All participants were diagnosed with breast cancer and were currently undergoing or were within three months of completing chemotherapy.

• SITE: Single site   
• SETTING TYPE: Other    
• LOCATION: Community program operates within the Health and Wellness Lab at the University of Calgary in Alberta, Canada

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Elder care

Pre-post design

• Physical health outcomes
• Health-related quality of life, fatigue, cognitive function, and depressive symptoms
• The physical well-being (PWB) subscale score
• Functional Assessment of Cancer Therapy-Breast (FACT-B) total score
• The FACT-B Breast Cancer Subscale (BCS) score
• FACT-General (FACT-G)
• The FACT-G physical well-being (PWB) subscale score
• The FACT-G emotional well-being (EWB) subscale score
• Center for Epidemiological Studies Depression Scale (CESD)
• FACT-Cognitive Function (FACT-Cog)

• Body mass index increased from baseline to 12 weeks by 0.5 kg/m² (p = 0.01). No significant differences were reported in participant-reported quality of life, fatigue, cognitive function, or depressive symptoms from baseline to 12 weeks.
• For the 24-week intervention, many of the physical health outcome measures improved significantly.
• The FACT-B total score at 24 weeks improved by 7.4 points compared to both (p = 0.002).
• The FACT-G score at 24 weeks improved by 5.9 and 5.6, respectively, compared to baseline (p = 0.003) and 12 weeks (p = 0.001). The FACT-B Breast Cancer Subscale (BCS) score at 24 weeks improved by 1.4 (p > 0.05) compared to baseline and by 1.8 compared to 12 weeks (p = 0.038).
• The physical well-being (PWB) subscale score at 24 weeks improved by 1.8 and 2.8 compared to baseline (p = 0.015) and 12 weeks (p = 0.002), respectively. The emotional well-being (EWB) subscale score at 24 weeks improved by 1.6 compared to baseline (p = 0.029) and by 0.7 compared to 12 weeks (p > 0.05). The functional well-being (FWB) subscale score at 24 weeks improved by 2.1 and 1.7 compared to baseline (p = 0.017) and 12 weeks (p = 0.01), respectively. No significant differences in social well-being (SWB) subscale scores existed at 24 weeks. Participant-reported fatigue measured by the Functional Assessment of Chronic Illness-Fatigue (FACIT-F) questionnaire improved 5.1 at 24 weeks compared to 12 weeks (p = 0.002).
• No significant differences in cognitive function measured by the FACT-Cog were reported. 
• Depressive symptoms measured by the CESD improved (decreased) at 24 weeks by 2.8 and 2.9 compared to baseline (p = 0.05) and 12 weeks (p = 0.009), respectively.

• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)

To compare the analgesic efficacy and safety, and quality of life of oxycodone (OXY) compared with oxycodone/naloxone (OXN) combination in treating opioid-naïve patients

Patients were seen at three or four different times when starting long-acting oxycodone products.

• N = 131   
• AGE = 62 years
• MALES: 52.1%, FEMALES: 47.9%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Solid tumor
• OTHER KEY SAMPLE CHARACTERISTICS: Pain

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Rome, Italy

PHASE OF CARE: Multiple phases of care

Retrospective, observational, three data collection time periods—T0, T30, and T60. T15 available for patients who needed closer monitoring.

• Pain intensity
• Neuropathic pain using Douleur Neuropathique 4 questionnaire
• Daily dose of medications
• Dose increments
• Quality of life
• Chronic Pain Sleep Inventory
• Physical and Mental Component Summary scores of the Short Form-12 Health Survey Questionnaire
• Bowel Function Index
• Safety evaluations

The patients who received OXN had better early improvement in bowel function than the patients who received OXY (p < 0.001).

OXN and OXY have similar analgesic effects, but OXN seems to have better bowel outcomes.

• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results 
• Measurement/methods not well described
• Subject withdrawals ≥ 10%

OXN may have better bowel function outcomes compared with OXY in patients starting analgesics.

To examine the effects of a one-hour art-making session during bone marrow transplantation (BMT) treatment

Interested patients were randomly assigned to the sequence to receive either the art-making session or the control condition first and were then crossed over to the other condition. Art-making sessions were 40–60 minutes. Patients were provided with a ceramic tile, brushes, and paint to create a tile at no cost. Measurements were obtained pre- and postintervention. Patients waited an average of 6.8 days between the treatment and control conditions.

• The study reported on a sample of 20 patients undergoing BMT.
• Mean patient age was 38.5 years, with a range of 20–68 years.
• The sample was 50% male and 50% female.

• Single site
• Inpatient setting
• Kansas

Patients were undergoing active antitumor treatment.

 A crossover pre/post-test design was used.

• Therapy-Related Symptom Checklist
• State-Trait Anxiety Inventory
• Salivary cortisol measurements collected between 9 am and noon

Symptoms declined in post-test measures in both conditions, with significant decline post art making (p = 0.01). There was no significant change in anxiety scores. Salivary cortisol levels declined significantly in both conditions. Time between conditions ranged from 1 to 28 days.

Art making appeared to reduce treatment-related symptoms but had no apparent effect on anxiety.

• The study had a small sample, with less than 30 participants.
• The study had risk of bias due to no blinding, no random assignment, and no appropriate attentional control condition.
• The timing of postintervention measures for each condition is not stated; it is not clear whether these were done immediately after the art-making session, or at what time points they were measured in the control condition. Time between cortisol level measurements also was not stated. In some cases, the time between conditions was only one day, which seems too brief to avoid contamination of effect. 
• Patients self-selected to participate.

This pilot study showed that the art-making session appeared to have an effect in reducing treatment-related symptoms; it is not clear if the art making specifically was effective, or if any diversional activity would have the same result. Findings do not support an effect of art making on anxiety.

To evaluate the feasibility of taking daily donepezil, an acetylcholinesterase inhibitor, to improve cognitive function in women who report cognitive impairment one to five years after completing adjuvant chemotherapy for breast cancer

This study evaluated the feasibility of a randomized, controlled trial of 24 weeks of donepezil (5 mg/day for 6 weeks, then 10 mg/day for 18 weeks) versus placebo. Potential participants were prescreened for moderate-to-severe self-reported cognitive impairment, and those enrolled were stratified by menopausal status and time since chemotherapy. Self-reported cognitive function, co-occurring symptoms, and quality of life were measured before the trial, halfway through the trial (i.e., 12 weeks), and at the completion of the trial (i.e., 24 weeks). Neuropsychological testing was conducted at baseline and 24 weeks.

• N = 47   
• MEDIAN AGE = 56 years
• AGE RANGE = 39–79 years
• FEMALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Nonmetastatic invasive breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Of the patients, 90% were Caucasian, 71% were married, 98% had completed high school, 95% were perimenopausal or postmenopausal, and 68% were on hormonal therapy (primarily an aromatase inhibitor). All patients had completed adjuvant chemotherapy one to five years (X = 2.5 years) before enrollment. Excluded current poor performance status, severe fatigue, and untreated major depressive disorder, as well as a history of major neurological or psychological disorders

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: A university medical center and 15 community clinical oncology programs in the Southeastern United States

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care

Double-blind, randomized, controlled trial of donepezil versus placebo with repeated measures

Donepezil may have some benefit for patients related to changes in cognitive function. Further research is needed to provide strong evidence.

• Small sample (< 100)
• Findings not generalizable
• Subject withdrawals ≥ 10%  
• This feasibility study of a randomized, controlled trial was not powered to detect group differences.

This study primarily showed that future large studies of donepezil in women with breast cancer are feasible. The findings suggest that donepezil may improve memory in breast cancer survivors who report moderate-to-severe cognitive problems. Executive function may improve for some women. Anxiety and insomnia are potential side effects.

To examine the efficacy of celiac plexus neurolysis on pain in patients receiving surgical resection for locally advanced disease

Patients who were identified as having unresectable disease underwent open biopsies if indicated and palliative biliary or gastrointestinal bypasses as deemed appropriate. Once it was determined that resection was appropriate, patients were randomly assigned to receive the study intervention or a placebo of normal saline injections. Postoperative pain control consisted of intravenous patient-controlled analgesia. For the analysis, patients were grouped according to resectability and the presence of pain at baseline. Patients were followed for 24 months. Pain was evaluated via patient surveys done every three months. Celiac plexus neurolysis has been shown to reduce pain in patients with advanced pancreatic cancer.  

• N = 467  
• MEAN AGE = 76.5 years
• MALES: 54%, FEMALES: 44%
• KEY DISEASE CHARACTERISTICS: Pancreatic cancer

• SITE: Single site  
• SETTING TYPE: Not specified    
• LOCATION: Thomas Jefferson University Hospital

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

Double-blinded, placebo-controlled, randomized, controlled trial

• Brief Pain Inventory (BPI)
• Functional Assessment of Cancer Therapy (FACT) hepatobiliary

There were no significant differences in postoperative complications between groups. There were no overall significant differences in pain scores over time between groups. A subgroup analysis showed a reduction in pain at three to nine months among patients with pain at baseline who received surgical resection. There were no differences in pain results from the addition of neurolysis.

This study showed that palliative surgical resection reduced pain as many as nine months after surgery, and that there was no added benefit from celiac neurolysis.

• Subject withdrawals ≥ 10% 
• Other limitations/explanation: No information about the use of analgesics or other interventions for pain during the study period was provided. Low survey response rates were reported at various time points; however, it was difficult to find the actual number of respondents at various measurement points.

A number of studies have shown that celiac neurolysis is effective in reducing pain among patients with chronic pain associated with unresectable pancreatic cancer. This study suggested that, for those patients where palliative resection is possible, that resection is more effective than neurolysis and that neurolysis in addition to resection did not appear to have additional benefit. There were a number of important limitations in this study. However, it pointed to the value of additional research in this area to determine the most beneficial approaches for long-term pain control in this group of patients.

To compare the efficacy of gabapentin 300 mg and 900 mg for controlling anxiety symptoms among breast cancer survivors

Patients were randomly assigned to receive 300 mg or 900 mg of gabapentin or placebo daily. Outcomes were assessed at baseline, four weeks, and eight weeks.

• The study reported on a sample of 420 female patients with breast cancer.
• Mean patient age was 55 years.
• All patients had completed initial therapy.
• More than 75% of patients were married, and about 70% were on tamoxifen.
• All patients had at least two hot flashes per day for seven days prior to enrollment.

• Single site
• Outpatient setting
• Rochester Cancer Center

Patients were undergoing the transition phase of care after initial treatment.

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

• Strait-Trait Anxiety Inventory
• MD Anderson Symptom Inventory

At four weeks, patients on gabapentin showed significant reduction in anxiety scores (p = 0.005). Patients with the highest baseline anxiety scores had the greatest improvement, and those with low anxiety levels had little change. These patterns were maintained at the eight-week follow-up. The greatest improvement in anxiety was seen in those getting 300 mg of gabapentin. Anxiety scores of those on placebo also declined, but changes were not significant.

 Gabapentin 300 mg daily was effective in reducing symptoms of anxiety in these breast cancer survivors.

• Findings are not generalizable.
• The sample was women who also had hot flash symptoms; the mechanism of action of gabapentin has been associated with mechanisms causing hot flashes, so this may not have the same effect in women who do not have hot flash symptoms.

This study demonstrated that 300 mg of gabapentin daily was effective in controlling anxiety symptoms among breast cancer survivors who had been experiencing hot flashes and had relatively high baseline anxiety. Gabapentin is currently off label in psychiatry to treat anxiety symptoms and commonly used to treat hot flashes and neuropathic pain in breast cancer survivors. As shown in other research, improvement in anxiety symptoms tends to be found in patients who have clinically relevant levels of anxiety to begin with. Nurses can consider and advocate for use of gabapentin to manage anxiety in these patients.

To evaluate the efficacy of palifermin, an N-terminal truncated version of endogenous keratinocyte growth factor, in the control of oral mucositis during antiblastic therapy for pediatric patients with acute lymphoblastic leukemia

Twenty patients received palifermin and other 20 patients didn’t. The palifermin group received a 60 mg/kg IV bolus per day for three consecutive days before and three consecutive days after transplant (a total of six doses). All patients were evaluated for 30 days.

• N = 40  
• MEDIAN AGE = 11 years
• MALES: 52%, FEMALES: 48%
• KEY DISEASE CHARACTERISTICS: Acute lymphoblastic leukemia
• OTHER KEY SAMPLE CHARACTERISTICS: Pediatric, allogeneic stem cell transplant

• SITE: Single-site    
• SETTING TYPE: Inpatient

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

Case-controlled study

• World Health Organization (WHO) grading scale
• Average duration of episode of oral mucositis, duration of use of total parenteral nutrition, infection rate, 100-day survival rate

This study demonstrated a statistically significant reduction in the duration of parenteral nutrition (p = .002), duration of mucositis (p = .003), and the average grade of mucositis (p = .03). Other measures were not significant. The statistical analysis showed that the drug decreased the severity of mucositis.

These data suggest that palifermin could be a valid therapeutic adjuvant to improve quality of life for pediatric patients with leukemia.

• Small sample (< 100)
• Risk of bias (no random assignment)

Palifermin decreased the duration of oral mucositis in pediatric patients being treated for leukemia. Nurses should be aware that this intervention may compliment other interventions to reduce oral mucositis in this population.

To determine if a modified cognitive behavioral stress management program would have a beneficial effect for caregivers on stress reduction

Caregivers were randomized to either the experimental intervention or usual care groups. The experimental intervention consisted of eight one on one sessions with a social worker beginning post-transplantation and continued weekly prior to evaluation at three months. Sessions were psychoeducational in nature, including coping skills training, health behaviors, improving partner communication, and relaxation as well as other components. Caregivers in the experimental group were given a biofeedback device and asked to use it four to five times weekly to facilitate relaxation. All caregivers from both study groups were encouraged to participate in programs at the facility designed to provide support for patients, families, and caregivers. Study data were obtained at baseline, one month, and three months.

• N = 122 (four weeks); 101 (12 weeks)  
• MEAN AGE = 53.5 years (range = 21–80 years)
• MALES: 23.6%, FEMALES: 75.7%
• KEY DISEASE CHARACTERISTICS: All patients were undergoing hematopoietic stem cell transplantation.
• OTHER KEY SAMPLE CHARACTERISTICS: Most caregivers were spouses or partners, and 48% were employed full-time prior to caregiving.

• SITE: Not stated
• SETTING TYPE: Multiple settings

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Perceived Stress Scale (PSS)
• Center for Epidemiological Studies (CES) depression scale
• State-Trait Anxiety Inventory (STAI)
• Caregiver Reaction Assessment (CRA)
• Profile of Mood States (POMS)
• Pittsburgh Sleep Quality Index (PSQI)
• Short Form 36 (SF-36)
• A caregiver composite distress score was created from component analysis on variables in study questions for both affective and physical well-being variables.

Baseline results showed higher than normal perceived stress, clinically relevant levels of depression, elevated anxiety, and poor sleep in caregivers. Caregivers in the intervention group had lower stress at three months (p = 0.039) and consistent declines in depression (p = 0.016) and anxiety scores (p = 0.0009) over time compared to controls. There were no differences between groups over time in measures of physical function and well-being. The composite score for caregiver distress was significantly lower among those in the intervention group (p = 0.019).

The psychoeducational intervention tested here demonstrated benefit in the reduction of caregiver psychological distress, depression, and anxiety.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)

The findings of this study demonstrated that psychoeducational interventions can be helpful to caregivers in reducing the psychological components of caregiver stress and burden. Educational and supportive interventions are low-risk and can be provided to caregivers in a variety of ways. Reducing caregiver burden can improve their well-being and permit the caregiver to be more effective in fulfilling care needs.