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.

To investigate effects of low-level laser therapy in managing lymphedema

Women were randomly assigned to laser treatment or usual care. Subjects in the laser group received low-level laser therapy (LLLT) three times a week for four weeks to the axillary region. Outcome measures were assessed at baseline, after four weeks of treatment and again at a four-week follow-up.

• The study sample (N = 21) was comprised of female patients. 
• Mean age range was 50.9–51.3 years.
• Patients had undergone unilateral mastectomy for breast cancer and clinically manifested lymphedema of the arm. 
• Patients were not receiving any concurrent cancer treatment.

The study took place in an outpatient setting in China.

The study used a single-blind, randomized controlled trial design.

• Arm volume was measured using a tank volumeter.
• Tissue pressure resistance was measured using a tonometer.
• Patients took the Disability of Arm Shoulder and Hand (DASH) questionnaire.

In the laser group, arm volume decreased significantly (p = 0.000), whereas those in the control group had a significant increase at the four-week follow-up. Group differences were significant (p = 0.044) at the four-week follow-up time point. For the first month, there were no significant differences between groups. Over time, the laser group showed a significant increase in tonomety readings at some sites (p = 0.000), indicating less tissue hardness, while there were no changes in the control group. Mean DASH scorers decreased significantly from baseline in the laser group (p = 0.04). There were no significant changes in DASH scores in the control group.

Low-level laser treatment in the study appeared to improve subjective pain and disability, improve tissue tone, and reduce lymphedema.

• The study sample was small, with less than 30 participants.
• Although authors state the study was single blinded, patients would have known if they were or were not receiving laser treatment because no sham control was used.
• No information was obtained or reported about other patient activities and behaviors that are known to potentially affect lymphedema development

Low-level laser therapy is promising for management of lymphedema postmastectomy.

To analyze the evidence on complete decongestive therapy (CDT) as a bundled intervention for the treatment of lymphedema

• Databases searched were PubMed, CINAHL, Cochrane Collaboration, PapersFirst, ProceedingsFirst, PEDro, National Guidelines Clearing House, DARE, and ACP Journal Club databases.
• Studies were included in the review if they sampled more than 10 people. Gray literature was excluded.

A total of 5,927 references were found and evaluated using the Oncology Nursing Society (ONS) Putting Evidence Into Practice (PEP) Levels of Evidence.

The final review involved 27 studies, 14 reviews, and 2 consensus documents.

Patients were undergoing multiple treatment phases of care.

Most studies considered CDT as a bundled intervention. Follow-up studies showed that pain decreased with longer length of treatment as well as patient adherence. Results of one long-term study in 356 patients after one year correlated with adherence in using compression sleeves by day or bandaging at least three nights per week. Findings regarding the effect of MLD as a component of CDT were contradictory. Discrepancies may be because of differences in lymphedema measurement and variations in how MLD was applied by both technique and dosage. Studies of compression bandaging showed that no differences were found between high- and low-pressure bandaging and that low pressure was better tolerated. One study showed that up to 48% of pressure loss under the bandage because of limb volume reduction. Adherence to compression bandage use has a direct correlation with reduction in volumes.

CDT is effective in the management of lymphedema; however, the relative roles of the components of CDT are unclear. Levels of evidence in this area are seen to be weak. The role of patient adherence requires further examination.

• Inconsistencies exist in defining and measuring lymphedema.
• Lack of blinding in research studies and small sample sizes are prone to type 2 errors. 
• Little research has been conducted regarding management of truncal and lower-extremity lymphedema.

CDT as a bundled intervention for lymphedema management appears to be effective. Patient adherence is a key component of treatment. Nurses need to educate and assist patients to maintain the use of compression garments and bandaging as prescribed to achieve effective lymphedema management. The evidence in this area is relatively weak, and further research continues to be needed. Research could benefit from more consistent definition and measurement approaches and examination of techniques for facial, breast, truncal, and genital lymphedema as well as effective risk reduction strategies. More standardization of treatment protocols would be helpful.

To raise awareness of constipation in palliative care; to provide guidance on the assessment, diagnosis, and management of constipation; and to encourage research in this area.

Databases searched were PubMed and the Cochrane Library (2001-2006).

Search keywords were constipation, laxatives, palliative care, terminal care, terminally ill, hospice, guidelines, recommendations, ​and systematic reviews.

Four publications were found for consideration. They were graded according to the UK National Service Framework for Long Term Conditions and the Oxford Quality Scale. A pan-European work group of healthcare professionals with experience in management of constipation in palliative care was assembled to debate and reach consensus on best practice.

• Constipation was defined as “passage of small, hard feces infrequently and with difficulty.”
• Estimates of the prevalence of constipation in palliative care range from 32% to 87%.
• The costs of constipation are as follows.
  • The cost of laxatives per year in England among older adults is 43 million pounds.
  • An economic study of US nursing homes identified costs of $2,253 per long-term resident annually.
  • A UK study found that 80% of community nurses spend up to half a day per week treating patients with constipation.
  • A study reported that 5.5% of calls to a UK district nursing service were directly related to constipation.
• Pharmacologic agents, metabolic factors, neurologic disorders, structural physical abnormalities, and function factors such as diet and environment contribute to constipation.

Key approaches to the prevention of constipation include

• Ensuring privacy and comfort
• Increasing fluid and fiber intake
• Encouraging activity and increasing mobility
• Anticipating constipating effects of agents such as opioids and providing laxatives prophylactically.

Principles of treatment include

• Oral laxatives should be used in preference to rectal treatments.
• Arachis oil is derived from peanut oil, and allergy may prevent its use.
• A combination of a softener and stimulant is recommended. A comprehensive table with types of laxatives, dosage, mechanism of action, speed of action, possible side effects, contraindications, and starting dose is provided.
• An algorithm for management is provided for
  • First-line treatment: oral combination of a softener (e.g., polyethylene glycol, lactulose, electrolytes) and stimulant (e.g., senna, sodium picosulfate)
  • Second-line treatment: rectal suppositories, enemas, and consideration of opioid antagonist if patient is taking opioids
  • Third-line treatment: manual evaluation and consideration of opioid antagonists if patient is taking opioids
  • Ongoing monitoring and patient education.

• Little evidence was found in this area, current research is poor, and additional research is needed on many aspects of assessment, diagnosis, and management in palliative care.
• Although the authors suggest prophylactic approaches, the algorithm provided begins only at patient complaint of constipation.

This guideline provides a practical algorithm for constipation management based on consensus, rather than actual evidence. Specific choices of oral laxatives are not recommended; however, substantial evidence-based information for comparison of available oral laxatives agents is given.