To assess the effects of an informational leaflet about delirium on family-perceived distress, the need for improvement in professional care for delirium, and the knowledge about the causes of delirium in patients during the end of life

Palliative care practitioners distributed an informational leaflet on delirium as part of their routine care of patients. Families of patients who experienced delirium at the end of life were then contacted by mail six months after the patient had died to complete a questionnaire about their experience.

• N = 113   
• MEAN AGE = 74 years
• MALES: 61%, FEMALES: 39%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Predominately spouse of patient (42%) or child of patient (36%)

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Japan

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

Single-arm, historical control

A questionnaire was developed for the study that measured family distress (single item), the need for improvements in professional care for delirium (single item), and knowledge of the causes of delirium (single item). A Likert-type scale was used for each question.

The intervention group had a better understanding of certain aspects of the causes of delirium (p < 0.001). No difference was reported between the historical control and intervention groups in terms of the levels of family-perceived distress or the need for improvement in professional care for delirium.

An educational leaflet may improve family members' knowledge and understanding about some of the causes of delirium at the end of life.

• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Low return rate
• Potential for recall bias among both groups surveyed

Written information about expected symptoms, such as delirium, may be helpful in increasing family members' knowledge.

To explore the potential efficacy of duloxetine for use against chemotherapy-induced peripheral neuropathy (CIPN) among patients with gynecologic cancers receiving paclitaxel

The medical records of patients being treated with duloxetine were evaluated retrospectively. The severity of symptoms before and after duloxetine administration was evaluated according to documented patient responses as either responders (symptoms dropped more than 1 grade) or non-responders (patients had a stable or worsening grade of neuropathy). A maintenance dose of duloxetine at 20 mg per day was given in 18 cases, and 40 mg per day was given in seven cases. In 12 cases, duloxetine administration began during chemotherapy. In 13 cases, it was started after chemotherapy (in four of these cases, one year after the completion of chemotherapy).

• N = 25  
• MEDIAN AGE = 62 years (range = 40–77 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Ovarian, corpus, and cervical cancers; all were receiving paclitaxel and carboplatin with or without epirubicin; median accumulated dose of paclitaxel was 1,805 mg per body; accumulated median dose of carboplatin was 3,368 mg
• OTHER KEY SAMPLE CHARACTERISTICS: Prior to duloxetine, medications used in some patients included goshajinkigan, pregaabalin, vitamin B12, and SSRIs.

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Japan

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

Retrospective, observational trial

• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 4.0

56% of patients responded to duloxetine and 44% did not respond. An analysis of demographic, disease, and treatment-related variables showed no significant association between any of these factors and the effectiveness of duloxetine. Adverse events were mild, and duloxetine generally was well tolerated. Overall, older patients tended to be less responsive to duloxetine.

The majority of patients responded to duloxetine, suggesting that in some patients, it can be helpful in managing the symptoms of CIPN.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement validity/reliability questionable

The findings of this study suggest that duloxetine may be helpful for some patients for the prevention and management of CIPN. However, it was not effective in all cases. The study's findings were limited by its design. Additional research studies exploring effective dosages, the types of CIPN that respond to duloxetine, appropriate timing, and effects of duloxetine on the full range of CIPN symptoms rather than just pain are needed.

To assess the effectiveness of pyridoxine for the prevention of hand-foot syndrome in patients receiving capecitabine

Patients were randomized to receive pyridoxine or not. Pyridoxine 30 mg was given three times daily during chemotherapy. The primary study endpoint was hand-foot syndrome of grade 2 or higher.

• N = 60   
• MEAN AGE = 62.1 years
• MALES: Not provided, FEMALES: Not provided
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Colorectal cancer

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Japan

PHASE OF CARE: Active antitumor treatment

Open-label, randomized, controlled trial

Common Terminology Criteria for Adverse Events (CTCAE)

Sixty percent of patients had at least grade 2 hand-foot syndrome. No differences existed between study groups.

Pyridoxine was not shown to have an effect for the prevention of hand-foot syndrome.

• Small sample (< 100)
• Risk of bias (no blinding)

Pyridoxine was not shown to have a preventive effect on the development of hand-foot syndrome. There are few interventions studied or shown to be effective for the prevention of this complication of cancer treatment. Ongoing research is needed to determine the effective approaches for the management of skin and nail toxicities.

To measure the technical success of therapeutic bronchoscopy and its impact in improving dyspnea and quality of life among patients with malignant central airway obstruction

Data from the AQuIRE (American College of Chest Physicians Quality Improvement Registry) for 1,115 procedures on 947 patients undergoing therapeutic bronchoscopy from January 2009–February 2013 were used for this study. Primary outcome data were defined as greater than a 50% opening of airway lumen. A smaller subset (N = 187) of centers collected pre- and postprocedure (30 days) secondary outcome data looking at dyspnea improvement after bronchoscopy as measured via Borg scores and health-related quality of life (HRQOL) measured via the SF-6D.

• N = 947   
• AGE = 62.8 years
• MALES: 55.6%, FEMALES: 44.4%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Of all participants, 71.7% had primary lung cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: The sample size for clinical outcome data was 187.

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Cleveland Clinic Foundation, Cleveland, OH; the Penn State Cancer Institute, Hershey, PA; the University of Illinois Hospital and Health Sciences Center, Chicago, IL; the Department of Pulmonary and Critical Care Medicine, Boston University, Boston, MA; the Department of Interventional Pulmonology, Chicago Chest Center, Chicago, IL; the Department of Pulmonary and Critical Care, Baylor College of Medicine, Houston, TX; the Department of Internal Medicine, Division of Pulmonary, Allergy, and Critical Care Medicine, Duke University Medical Center, Durham, NC; the Department of Pulmonary and Critical Care Medicine, Johns Hopkins Hospital, Baltimore, MD; the Department of Pulmonary, Critical Care, and Sleep Medicine, University of Cincinnati, Cincinnati, OH; and the Department of Pulmonary and Critical Care Medicine, University of Calgary, Calgary, AB, Canada

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

• Retrospective data analysis for technical outcomes
• Prospective trial to evaluate clinical outcomes

• SF-6D
• Borg Rating of Perceived Exertion Scale score 
• Technical success was based on anatomic criteria defined as a brochoscopically reopening of the airway lumen to greater than 50% of the normal diameter, and the airway had to connect to a viable area of distal lung. All clinical outcomes were assessed by the attending physician using standardized definitions from a code book developed by the American College of Chest Physicians Quality Improvement Registry, Evaluation and Education (AQuIRE) program, to evaluate therapeutic bronchoscopy for malignant central airway obstruction.

The use of therapeutic bronchoscopy for the treatment of malignant central airway obstruction had a high technical success rate. More importantly, patients showed significant improvement in their subjective rating of dyspnea and in HRQOL. Having clinical outcome data assists in the process of weighing potential risks versus benefits of this procedure. Given that some of the patients with the worst dyspnea at baseline ultimately had the greatest benefit, these patients should be considered for therapeutic bronchoscopy and not assumed to be too sick to benefit.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Findings not generalizable
• No standard method of patient selection or standardization of procedure, as all clinical decisions were at the discretion of the individual performing the therapeutic bronchoscopy
• Significant variations in practice patterns existed in different centers and locations of care.
• Technical success rates were determined by the individual performing the procedure, and bias may have existed.

To educate and advocate for patients undergoing therapeutic bronchoscopies, nurses must be knowledgeable about the different types, purpose, indications, and potential risks and benefits of each. The technical success of the procedure is not sufficient enough in measuring the overall benefit to the patient; quality of life and palliation of dyspnea outcomes must also be considered.

• FINAL NUMBER STUDIES INCLUDED = 21, and 19 in meta-analysis
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,007
• SAMPLE RANGE ACROSS STUDIES: 19-549
• KEY SAMPLE CHARACTERISTICS: Varied tumor types, ages ranged from 18-89 years

Antidepressants were effective in reducing distressing symptoms (SMD = -0.229, p = 0.018) and major depression or depressive symptoms (SMD = -0.285, p = 0.001).  All types of antidepressants showed some efficacy, although tricyclic antidepressants did not show efficacy across two small studies. SSRIs and manserin were effective. Quality of life measures were also improved. There was significant heterogeneity. Analysis showed significant efficacy was correlated with length of follow up (p < 0.001). Antidepressants did not differ from placebo in terms of acceptability, using drop-out rate as a proxy of acceptability.

Antidepressants of all types demonstrated overall efficacy for improvement in depressive symptoms as well as other distressing symptoms. SSRIs and manserin showed the best results

Overall quality of reports was graded as low to moderate. Several studies included funding by drug companies, suggesting sponsorship bias as the funder role was not described.  There was significant heterogeneity

Findings from this analysis show that antidepressants, particularly SSRIs and manserin, were tolerable and effective in reducing depressive symptoms in patients with cancer. Findings also suggest that efficacy may increase over time, pointing to the potential need for sufficient duration of treatment. It is important that nurses screen for symptoms of depression among patients with cancer, and facilitate relevant treatment.

STUDY PURPOSE: Assess effects of antidepressants among people with cancer for treatment of depression

There was no differences between antidepressants as a class and placebo in five RCTs, no difference between groups comparing different antidepressants, and no difference in drop-out rates between placebo and antidepressants

The findings did not provide strong evidence for efficacy of antidepressants.

Study quality was generally low with unclear risk of bias in multiple aspects of the study design and implementation. In five studies, risk of bias due to conflict of interest was questionable. There was no difference found between SSRIs and tricyclic antidepressants. Studies included were all conducted prior to 2009.

This particular analysis did not demonstrate efficacy of antidepressants in patients with cancer for management of depressive symptoms. There were multiple limitations in this analysis due to the low quality of the studies included.

To assess the effect of Lactobacillus and fiber supplementation on tolerability of treatment with chemotherapy containing 5-fluorouracil (5-FU) and to compare the tolerability and frequency of diarrhea with the Mayo regimen (bolus 5-FU) to that of the simplified de Gramont regiment (bolus plus continuous 5-FU)

Postoperative colorectal cancer (CRC) patients were randomly assigned to receive adjuvant chemotherapy monthly (Mayo regimen) or twice monthly (simplified de Gramont regimen) for 24 weeks. Further randomization determined whether patients received the probiotic Lactobacillus rhamnosus GG gelatin capsules twice daily and daily fiber on cycle days 7–14 for 8 days per month during the 24 weeks of chemotherapy. All patients received dietary counseling and kept nutrition diaries. Treatment-related adverse effects were assessed at every cycle.

• The study reported on 148 patients.
• Median age was 60 years, with a range of 31–75.
• The sample was 49% female and 51% male.
• Patients were scheduled to receive adjuvant chemotherapy after surgery for Dukes’ B or C CRC or chemotherapy following surgery for Dukes’ D CRC who were rendered free from metastases by the surgery.

The study was conducted at a single-site, outpatient setting in Finland.

All patients were undergoing the active treatment phase of care.

This was a prospective, randomized trial.

The National Cancer Institute of Canada Common Toxicity Criteria, version 2, was used.

• Less grade 3-4 diarrhea occurred in patients receiving Lactobacillus supplementation than in those not receiving it (22% versus 37%; p = 0.027). 
• Less abdominal discomfort (flatulence, borborygmi, or abdominal distention) of any grade occurred in patients receiving Lactobacillus than in those not receiving it (59% versus 75%; p = 0.058). 
• Only 21% of the patients receiving Lactobacillus had chemotherapy dose reductions due to bowel toxicity as compared to 47% of those who did not receive this supplement (p = 0.0008). 
• Lactobacillus supplementation had no significant effects on overall treatment toxicity or on the frequency of stomatitis or neutropenia.
• Fiber supplementation did not affect overall gastrointestinal (GI) toxicity (p = 0.13).

The frequency of grade 3 or 4 diarrhea and the frequency of abdominal discomfort may be decreased with the use of Lactobacillus rhamnosus supplementation for patients receiving 5-FU-based chemotherapy.

• Adjuvant chemotherapy for CRC now commonly includes irinotecan, capecitabine, or oxaliplatin.  5-FU was the only adjuvant chemotherapy given in this study.
• The study was neither placebo-controlled nor blinded to the administration of the fiber or Lactobacillus.
• Metoclopramide and 5-HT₃ inhibitors were used to treat nausea and vomiting. These medications could possibly have effected reported bowel toxicity.
• No mention was made regarding whether patients were instructed to avoid yogurts and other dairy products produced by fermentation.
• Use of antimicrobials was not mentioned as an exclusion criterion.

The administration of Lactobacilus rhamnosus GG may decrease the frequency and severity of diarrhea and abdominal discomfort with 5-FU-based chemotherapy. Further placebo-controlled, blinded studies are needed.

To determine the cumulative incidence of varicella-zoster virus (VZV) two years after transplant.

Following allogeneic hematopoietic stem cell transplant (HSCT), patients received low-dose valacyclovir (VCV) for prophylaxis against VZV.  Up to day 35, patients received oral acyclovir (ACV) 1,000 mg/day, and then from days 36 to 365, they received oral VCV 500 mg/day three days a week.  Patients were monitored for VZV for two years after HSCT.

• Forty adult patients (57% male, 43% female) were included.
• Median age was 43 years (range 18–61).    
• Diagnosis for transplant: ten patients had acute myeloblastic leukemia, eight had acute lymphoblastic leukemia, four had chronic myelogeneous leukemia, five had myelodysplastic syndrome, nine had Hodgkin lymphoma, one had multiple myeloma, and three had severe aplastic anemia.
• Patients were excluded if they had renal or liver dysfunction, antithymocyte globulin, T cell-depleted graft, cord blood, or a hematologic malignancy and were not in remission prior to HSCT.
• Patients from ages 16 to 70 who were seropositive for VZV-IgG antibody prior to allogeneic HSCT.  Those enrolled were not necessarily as young or as old as the eligibility criteria.

• Multi-site
• Hospitals participating in the Japan Hematological Oncology Clinical Study Group

• Patients were undergoing posttransplant care.
• The study has clinical applicability for antimicrobial prophylaxis in a transplant setting.

This was a prospective, nonrandomized study.

• Development of VZV    
• Dermal development of VZV (defined as generalized cutaneous distribution or characteristic vesicular skin lesions on an erythematous base within a dermatome)
• Visceral development of VZV
• Toxicities of VCV
• Postherpetic neuralgia
   

Breakthrough VZV occurred in two patients while receiving VCV.  After stopping VCV prophylaxis, an additional five patients developed VZV disease.  These seven patients had a favorable response to oral or intravenous VCV given at therapeutic doses.  Univariate analysis revealed no factors that significantly associated patients with incidence of VZV.

For patients undergoing allogeneic HSCT, one year of low-dose VCV is safe and effective for preventing VZV.

Small sample size

Patients undergoing allogeneic HSCT may benefit from the safe use of low-dose prophylactic VCV (500 mg/day three times a week) for VZV in the posttransplant setting.

To investigate the effects of cognitive behavioral therapy (CBT) and patient education on depression, anxiety, pain, physical functioning, and quality of life (QOL) in adult cancer survivors

The study involved searching MEDLINE, PsycINFO, and the Cochrane Database for the period 1993–2004.

The literature evaluated included 15 randomized controlled trials (RCTs), five of which measured depression and all of which had been published 1993–2004. Authors assessed quality of the RCTs by means of the Jadad scale.

The sample size was 1,492.

CBT is related to short-term effects on depression; individual interventions were more effective than group interventions. Neither CBT nor patient education produced significant long-term effects on depression.

To investigate the effects of cognitive behavioral therapy (CBT) and patient education (PE) on anxiety in adult cancer survivors

Databases searched were MEDLINE, PsycINFO, and the Cochrane Database (1993–2004).

Search keywords were cancer, anxiety, depression, quality of life (QOL), fatigue, stress, pain, physical function, social, self-management, evidence-based, interventions, and random/randomized.

Studies were included in the review if they

• Reported on adult patients with cancer (all types and stages)
• Had a control group, randomization, and measurable outcomes of interest (anxiety, depression, fatigue, QOL, physical function, and pain)
• Had at least one follow-up assessment beyond post-treatment, which allowed for examination of duration of effects.

Studies were excluded if they were not randomized or controlled, had a score of less than four on checklist, did not report follow-up data, or did not report data on targeted outcomes.

Dissertations were excluded.

• A total of 592 studies were evaluated, with only 19 studies meeting criteria. Comprehensive meta-analysis was used to determine effect size for each outcome.
• Quality was assessed by a modified version of Jadad’s six-item checklist (randomization, double blinding, descriptions of withdrawals and dropouts, statistical analyses, inclusion and exclusion criteria, and adverse effects).
• Longitudinal study: Times of measurement varied from one week to 14 months. Median follow-up was defined as short-term (less than eight months) and long-term (more than eight months).
• Four studies reviewed used CBT for anxiety.
  • CBT sessions varied from four weekly one-hour sessions to 55 weekly two-hour sessions.
  • CBT included stress management and problem-solving approaches.
• One study reviewed used PE for anxiety.
  • PE sessions varied from one 20-minute session to six weekly one-hour sessions.
  • PE included information about illness, symptom management, and discussion of treatment options using booklets, videos, and other educational materials.

• The review reported on 1,492 adult cancer survivors.
• All types and stages of cancer were represented.
• Survivor age range was 18–84 years.
• 790 survivors were assigned to interventions, and 702 were assigned to control (medical management only).

• CBT interventions on anxiety (four studies):
  • Large effect was noted for individual and group CBT (g = 1.99, p < 0.01; 95% CI 0.69–3.31).
  • Of these four studies, a sensitivity analysis revealed a large effect size for individual treatment (g = 2.41, p < 0.01; 95% CI 1.2–3.55) and no effect for group interventions (d = 0.03, p+0.82; 95% CI -0.20–0.25).
  • Forest plots representing the effect sizes of CBT on anxiety favor the intervention.
• The single trial using PE to decrease anxiety resulted in no short-term effect on anxiety and did not include long-term follow-up on anxiety (d= -0.02, p = 0.89; 95% CI -0.36–0.31).

• Analysis did not consider patient adherence to pharmacologic interventions, which is known to be modest in medical patients.
• No cost-benefit implications were noted.

CBT is effective for short-term management (less than 8 months) of anxiety. Individually based interventions were more effective than those delivered in a group format. Various CBT approaches provided in an individual format can assist cancer survivors in reducing the emotional distress of anxiety.