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.

STUDY PURPOSE: To review the published evidence on non-pharmacologic interventions for fatigue in men with prostate cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: PubMed, PsycINFO, CINAHL, Cochrane Central Trials Register and Embase, PsychExtra, SIGLE, Australian New Zealand Clinical Trials Registry, ClinicalTrials.gov, World Health Organisation International Clinical Trials Registry Platform, EU Clinical Trials Register, MedNar, and reference lists of articles included in review

KEYWORDS: key concepts of prostate cancer, fatigue, non-pharmacological and nursing management, and various interventions; detailed search for PubMed included as appendix

INCLUSION CRITERIA: Adult men older than 18 years with prostate cancer at any stage of treatment; non-pharmacologic interventions including exercise, exercise with diet and lifestyle modification, education, and cognitive behavioral therapy; comparison to other non-pharmacologic interventions or usual care; experimental studies; fatigue as primary outcome of interest using existing validated tools to measure

EXCLUSION CRITERIA: Not stated

TOTAL REFERENCES RETRIEVED = 1,480

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two independent reviewers appraised studies; validity assessed with Johanna Briggs Institute Critical Appraisal Checklist for Randomised and Pseudo-Randomised Studies

• FINAL NUMBER STUDIES INCLUDED = 8
• SAMPLE RANGE ACROSS STUDIES: 21–240
• TOTAL PATIENTS INCLUDED IN REVIEW = 600
• KEY SAMPLE CHARACTERISTICS: Undergoing treatment for prostate cancer or completed treatment within past 12 months; age range 46–86 years

PHASE OF CARE: Multiple phases of care     

APPLICATIONS: Elder care

All studies were of high methodologic quality. Four out of five studies measuring physical activity found statistically significant fatigue reduction; the other study showed a trend toward fatigue reduction. Two studies concluded that cognitive behavioral therapy was effective in managing cancer-related fatigue. Two studies looking at education had mixed results. Brief nursing education was not significant in reducing fatigue, but intensive prostate-specific education was significant.

This report supports physical activity for managing cancer-related fatigue. Cognitive behavioral therapy and intensive focused education are also likely to be effective.

• Only eight studies included
• Variety in delivery of interventions and measurement of fatigue

Nurses should continue to recommend physical activity for management of cancer-related fatigue. Cognitive behavioral therapy and intensive education may be considered.

To compare a meditative movement practice, Qigong/Tai Chi Easy (QG/TCE), with sham Qigong (SQG), testing the effects of the meditation/breath aspects of QG/TCE on breast cancer survivors’ persistent fatigue and other symptoms

Hour-long sessions held twice weekly taught breast cancer survivors QE/TCE or SQG for 12 weeks measuring the effect on fatigue, depression, and sleep. Participants were asked to practice at home at least 30 minutes per day.

• N = 87  
• AGE RANGE = 40–75 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Stages 0–III; the majority of participants were educated at the level of at least some college and were at higher income levels. 90% were white and non-Latino.

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Mayo Clinic Cancer Center, Scottsdale, AZ

• PHASE OF CARE: Late effects and survivorship

This was a double-blinded, randomized, controlled trial. Fatigue was the primary outcome and sleep quality and depression were secondary outcomes.

• Fatigue Symptom Inventory (FSI)
• The Pittsburgh Sleep Quality Index (PSQI)
• Beck Depression Inventory (BDI)

Fatigue decreased in the QG/TCE group compared to the SQG group at postintervention and at the three-month follow-up (p = .024). However, fatigue declined significantly in both groups. Depression and sleep quality did not demonstrate improvement in the QG/TCE group compared to the SQG group at the post-intervention and at the three-month follow-up.

QG/TCE showed significant improvement over time compared to SQG for fatigue. Both groups showed improvement for fatigue, depression, and sleep dysfunction

• Small sample (< 100)
• Findings not generalizable
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Blinding of the session instructors is identified as a limitation. The instructors could have unintentionally made a difference in the delivery of the interventions and outcomes. There is a concern that the contrast between the two interventions may have not been enough. The sham intervention is not described fully. There was a greater than 15% drop-out rate with no intent to treat analysis.

Low-intensity exercise may be beneficial in reducing a number of symptoms and improving the well-being of cancer survivors. This study demonstrates that QG/TCE’s focus on meditative movement with a focus on breath appears to have an advantage for improving breast cancer survivors' persistent fatigue. A larger sample and longer intervention time is needed.

To evaluate the effects of a structured, in-person, group multidisciplinary approach on several domains of quality of life (QOL) for patients with advanced cancer and their caregivers

The four-week intervention, tested previously in eight sessions, included six 90-minute sessions. Patients were invited to all six sessions, and caregivers were invited to four. Structured sessions targeted emotional, cognitive, physical, spiritual, and social domains of QOL. Every session opened with 15 minutes of physical therapy and closed with 15 minutes of relaxation therapy. Weekly topics included strategies to deal with health behavior and mood changes, radiation and chemotherapy effects, spirituality, social needs, record keeping, coping, exercise, quality of life, spiritual dimensions of disease, and communication with healthcare and support teams. Healthcare providers with diverse roles delivered the intervention. Ten brief telephone counseling sessions over a period of 20 weeks followed the four-week intervention. Patient/caregiver dyads were evaluated at baseline, four weeks postintervention, 27 weeks postintervention, and 52 weeks postintervention.

• N = 131  
• AGE = Not stated
• MALES: Not stated, FEMALES: Not stated
• KEY DISEASE CHARACTERISTICS: Caregivers and patients with newly diagnosed (within past 12 months) advanced cancer receiving radiation therapy.  
• OTHER KEY SAMPLE CHARACTERISTICS: In total, 88% of caregivers were married, 75% were spouses, 62% were employed, and 66% or more had some college education.

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Suburban cancer center in Minnesota

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

Randomized, controlled trial

• Caregiver Quality of Life Index–Cancer (CQQOL)
• Linear Analog Self-Assessment (LASA)
• Profile of Mood States (POMS)

At four weeks postintervention, statistically significant differences in favor of the intervention arm were found for the LASA spiritual well-being domain (p = 0.0.048), the POMS vigor and activity subscale (p = 0.02), the POMS fatigue and inertia subscale (p = 0.02), the POMS total score (p = 0.02), and the CQOLC adaptation domain (p = 0.02). Durability was found at 27 weeks only for improvements in the POMS fatigue and inertia subscale (p = 0.01). At 27 weeks postintervention, the intervention group showed improvement over the standard care group in the CQOLC disruptiveness domain (p = 0.049) and the CQOLC financial concerns domain (p = 0.02). Although levels of significance did not appear, study results were similar at 52 weeks.

Although caregivers showed improvements in a few specific QOL domains assessed in this study, this comprehensive multidisciplinary intervention did not affect overall ​caregiver QOL. Continued study to identify and evaluate specific, tailored interventions focused on improving cancer caregiver QOL is needed.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Subject withdrawals ≥ 10% 
• Other limitations/explanation: The results at 52 weeks postintervention were not provided. Limited information was listed about caregiver demographics, which may have influenced study findings.  Recruitment methods and phone call intervention specifics did not appear to interpret study findings. There was a lack of information on the usefulness of intervention for improving caregiver QOL.  

Continued research focused on dyadic (patient/caregiver) versus individualized caregiver interventions may offer insight into optimal ways to meet caregiver QOL needs. Conceptually defined and structured mixed methods approaches (qualitative and quantitative) could define components of tailored interventions to minimize caregiver burden and emotional distress that affect caregiver well-being.

To quantify the overall effect of antidepressants in the treatment of depressive symptoms in patients with cancer

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: PubMed and Cochrane library

KEYWORDS: Depressive or depression and cancer

INCLUSION CRITERIA: Double-blind randomized trials, presence of depression or depressive symptoms in patients with cancer determined by diagnostic criteria or depression rating scale, primary outcome was reduction in severity of depressive symptoms, published between 1980–2010

EXCLUSION CRITERIA: Not specified

TOTAL REFERENCES RETRIEVED: N = 5,959

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane collaboration tool for risk of bias

• N (studies) = 9
• SAMPLE RANGE ACROSS STUDIES: 35–177
• TOTAL PATIENTS INCLUDED IN REVIEW: 722

Six trials compared antidepressants to placebo. In head-to-head comparison trials, fluoxetine was not superior to desipramine, no difference was seen between paroxetine and amitryptiline, and mirtazapine had a greater effect than imipramine. Overall effect size in meta-analysis was RR = 1.56 (95% CI 1.07 = 2.28, p = .021) in favor of antidepressants. Only three studies reported the number of patients with side effects, and many studies had a lot of missing data and high dropout rates or low samples.

Findings suggest that antidepressants are beneficial for depression and depressive symptoms in patients with cancer. However, the strength of this finding is limited due to limitations in studies included in this meta-analysis.

A low volume of studies was included. Average risk of study bias was unclear. Differing depression scales and criteria for depression response were used across studies. Most studies had small sample sizes for analysis. Study duration ranged from five weeks to six months.

This analysis provides some support for effectiveness of antidepressants in treatment of depression and depressive symptoms in patients with cancer. Nurses need to be aware of adverse side effects of antidepressants that may make other symptoms worse, such as nausea and cognitive impairment. Most studies reviewed did not analyze antidepressant side effects, so the real tolerability of antidepressants in patients with cancer is not clear. Patients may benefit from antidepressants but need to be monitored for side effects of this treatment.