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Pignol, J.P., Olivotto, I., Rakovitch, E., Gardner, S., Sixel, K., Beckham, W., . . . Paszat, L. (2008). A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. Journal of Clinical Oncology, 26, 2085–2092.

Study Purpose

To determine if breast intensity-modulated radiation therapy (IMRT) can lead to significant reduction in radiation-induced skin toxicity

Intervention Characteristics/Basic Study Process

Participants randomly assigned to receive 50 Gy in 25 fractions to the whole breast using either standard RT or breast IMRT. Random assignment was stratified for use of boost and breast size. Standard skin care during the radiation treatment was similar between groups. Patients were assessed weekly during and up to six weeks after RT.

Sample Characteristics

  • The sample was comprised of 331 female patients receiving either IMRT (n = 170) or conventional RT (CRT) (n = 161).
  • Mean age in the IMRT group was 57.1 years, with a standard deviation (SD) of 10.7 years.
  • Mean age in the CRT group was 56.4 years, with a SD of 10.5 years.
  • All patients had early-stage breast cancer treated by breast conserving surgery with three or fewer involved lymph nodes.

Setting

The study too place at two cancer centers in Canada.

Study Design

The study used a phase III, double-blind, randomized, controlled trial design.

Measurement Instruments/Methods

  • Acute skin reaction or pain was measured using the National Cancer Institute Common Toxicity Criteria (NCI CTC) scale and ccurrence of moist desquamation.
  • Quality-of-life (QOL) data was coded using the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire C-30 general module and the BR-23 module self-assessment questionnaires.
  • Breast size was defined as small (bra sizes 32A or 32B, 34A or 34B, and 36A), medium (bra sizes 32C, 34C, 36B, or 36C and 38A, 38B, or 38C), or large (larger bra sizes).

Results

A lower proportion of patients experienced moist desquamation during or up to six weeks after radiation treatment with IMRT (31.2%) compared to 47.8% with standard treatment (p = 0.002). Multivariate analysis found IMRT (p = 0.003) and smaller breast size (p = 0.001) significantly associated with a decreased risk of moist desquamation. Breast IMRT (31.2%) significantly reduced the occurrence of moist desquamation compared to a standard wedged technique (47.8%) (p = 0.002).

Conclusions

IMRT was associated with reduced risk and prevalence of moist desquamation.

Limitations

No information was given on what the standard skin care was during the radiation treatments, just that it was similar between sites.

Print

Piet, J., Würtzen, H., & Zachariae, R. (2012). The effect of mindfulness-based therapy on symptoms of anxiety and depression in adult cancer patients and survivors: A systematic review and meta-analysis. Journal of Consulting and Clinical Psychology, 80, 1007–1020.

Purpose

To evaluate current evidence regarding the effect of mindfulness-based therapy (MBT) on symptoms of anxiety and depression in patients with cancer

Search Strategy

  • Databases used in the search were EMBASE, PubMed, PsycINFO, Web of Science, Scopus, and Cochrane Collaboration.
  • Search keywords were mindfulness, MBT, MBSR, and cancer.
  • Inclusion criteria were English-language studies reporting on adult patients with a current or former diagnosis of cancer who were receiving MBT or mindfulness-based stress reduction (MBSR) as an intervention. Studies included pre- and postintervention valid continuous measures of anxiety or depression symptoms.
  • Exclusion criteria were unspecified.

Literature Evaluated

  • The study included 670 references.
  • Authors used the Jadad scale to evaluate and comment on the literature.

Sample Characteristics

  • A final number of 22 studies were included in the review.   
  • Sample range across studies was 1,409 participants, with a range of 12–287.
  • Mean participant age was 55 years.
  • Women with breast cancer represented 86% of the sample.

Phase of Care and Clinical Applications

Multiple phases of care

Results

Among nonrandomized studies, overall effect size for anxiety was 0.60 (Hedges’s g, p < 0.001) and 0.42 (p < 0.001) for depression. Among randomized controlled trials, effect size for anxiety was 0.37 and 0.44 (p < 0.001) for depression. Most studies used the Profile of Mood States scale or the State-Trait Anxiety Inventory. The range of Jadad quality scores was 0–4, with only six studies having scores greater than 2. This score indicates low quality. Heterogeneity among studies was moderate.

Conclusions

Findings demonstrate a low to moderately significant effect of MBT in reducing anxiety and symptoms of depression among patients with cancer. Heterogeneity among studies suggests that findings be viewed with caution.

Limitations

  • Most participants were women with breast cancer. Findings may not be generalizable to males and to other diseases.
  • The quality of many of the assessed studies was low. 
  • Most studies did not include patients with clinically significant levels of anxiety or depression at baseline.
  • Studies were done at various phases in the cancer trajectory, so how the phase of care may have influenced findings is unclear. 
  • In general, anxiety and depression symptoms improve over time with no intervention. The research did not consider this fact.

Nursing Implications

MBT may benefit patients with cancer by reducing anxiety and symptoms of depression. The use of MBT appears to be feasible in cancer care. The low quality of studies in this analysis points to the need for well-designed research on the effects of MBT.

Print

Pielichowski, W., Barzal, J., Gawronski, K., Mlot, B., Oborska, S., Wasko-Grabowska, A., & Rzepecki, P. (2011). A triple-drug combination to prevent nausea and vomiting following BEAM chemotherapy before autologous hematopoietic stem cell transplantation. Transplantation Proceedings, 43(8), 3107–3110.

Study Purpose

To evaluate the efficacy of a triple-drug combination (palonosetron + aprepitant + dexamethasone) to prevent acute and delayed emesis after high-dose chemotherapy with BEAM (carmustine + etoposide + cytarabine + melphalan) before hematopoietic stem cell transplantation (HSCT) by comparison with historical control of patients treated with dexamethasone + ondansetron or dexamethasone + palonosetron

Intervention Characteristics/Basic Study Process

Triple drug antiemetic regimen (aprepitant 1 hour before chemotherapy [125 mg on day one and 80 mg on days 2 & 3] + 0.25 mg IV palonosetron 30 minutes before chemotherapy and 20 mg IV dexamtheasone 15 minutes before chemotherapy for day 1 and 12 mg daily for rest of chemotherapy regimen) was compared to data from historical control patients that received 32 mg ondansetron and IV dexamethasone daily during chemotherapy or palonosetron and dexamethasone (dexamethasone given as 20 mg IV day 1 and 12 mg daily for rest of chemotherapy regimen in all cases). Acute phase was defined as the first 24 hours after receiving chemotherapy, and delayed phase was definied as days 2–5.

Sample Characteristics

  • The study consisted of 96 participants.
  • The age and gender of patients was not provided.
  • The study group sample consisted of 54 patients with non-Hodgkin lymphoma and 42 patients with Hodgkin lymphoma for patients receiving “triple drug regimen.” Historical controls were described as “comparable in terms of numbers, age, sex, weight and underlying diseases.\"
  • Historical control patients received ondansetron (32 mg IV daily during HDC) or palonosetron (assumed to be daily). Both regimens included dexamethasone.

Setting

The study was conducted at a single inpatient setting in Warsaw, Poland.

Phase of Care and Clinical Applications

All patients were in active treatment.

Study Design

This was a descriptive study with comparison to historical controls.

Measurement Instruments/Methods

  • Severity of nausea was measured on a 4-point scale with none = no nausea; mild = slight nausea but no disruption to daily activities; moderate = nausea and some disruption to daily activities; and severe = extreme nausea and severe disruption to daily activities. 
  • Emetic response rate was evaluated using the following criteria: complete response = no emetic episodes; major response = 1-2 episodes; minor response = 3-5 episodes; and treatment failure = more than 5 episodes.
  • Response to study drugs was measured on 4-point scale based on the relief of nausea and vomiting: highly effective, moderately effective, slightly effective, and not effective.

Results

Patients treated with the triple-drug antiemetic combination showed higher response rates than those receiving palonosetron or ondansetron (+ dexamethasone) during both the acute and delayed phases in reduction of chemotherapy-induced nausea and vomiting (CINV).

Conclusions

Drawing conclusions based on the information provided in the study is difficult.

Limitations

  • The sample size was small with fewer than 100 participants.
  • The researchers did not use validated tools to measure response.
  • The article does not clearly indicate whether the study was observation or self-report. 
  • The authors did not provide clear descriptions of the patients in the historical controls (e.g., number of patients, diagnosis, ages, sex). 
  • The authors did not describe the statistical analysis process.
  • The method of describing the results was confusing and difficult to interpret.

Nursing Implications

Although the study appeared to support the use of established CINV guidelines established by the National Comprehenaive Cancer Network (NCCN) and the American Society of Clinical Oncology (ASCO), the data in this study were of questionable significance because of the information provided and poor quality of the study.

Print

Phillips, R.S., Friend, A.J., Gibson, F., Houghton, E., Gopaul, S., Craig, J.V., & Pizer, B. (2016). Antiemetic medication for prevention and treatment of chemotherapy-induced nausea and vomiting in childhood. Cochrane Database of Systematic Reviews, 2, CD007786. 

Purpose

STUDY PURPOSE: To update a previous systematic review regarding the effectiveness and adverse events of pharmacologic interventions used to control anticipatory, acute, and delayed nausea and vomiting in children younger than 18 years who are preparing to receive chemotherapy

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Studies were identified by searching CENTRAL, MEDLINE, EMBASE, LILACS, and PsycINFO. Conference proceedings from ASCO, the International Society of Pediatric Oncology, Multinational Association of Supportive Care in Cancer, and ISSI Science and Technology Proceedings Index dating to December 16, 2014 were also used. Trial registries dating to to December 2014 were used, and reference lists from other studies were screened for additional studies.  
 
INCLUSION CRITERIA: Study abstracts were screened for randomized controlled trials (RCTs) that compared a pharmacological antiemetic, cannabinoid, or benzodiazepine with placebo or any alternative active intervention in children younger than 18 years who had a diagnosis of cancer and were scheduled to receive chemotherapy.
 
EXCLUSION CRITERIA: No specific exclusion criteria were stated.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: Eight hundred forty-four potentially useful articles were originally identified. Of these, 67 were included for detailed screening (described below). 
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two authors independently extracted quality data from each RCT according to the criteria of concealment of treatment allocation, blinding of the care provider, blinding of the participants, blinding of the outcome assessor, random sequence generation, and incomplete outcome data. The potential for selective reporting of outcomes was partially assessed by checking the reported outcomes against the study methods stating where outcomes were collected. The reviewers assessed for other potential bias, such as those associated with publication, funding, researcher role, and drop-out rates for cross-over, multiphase trials. Discrepancies between review authors were resolved by consensus.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 34 studies were included—28 original reviews and 6 updates.
  • TOTAL PATIENTS INCLUDED IN REVIEW: 1,719 participants and 2,226 episodes
  • SAMPLE RANGE ACROSS STUDIES: Median sample: 30 with a range of 12–428 patients; episode range = 50.5 with a range of 20–428 patients
  • KEY SAMPLE CHARACTERISTICS: Not reported

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Pediatrics

Results

Thirty-four studies using a range of antiemetic regimens produced a variety of outcomes. The majority of quantitative data related to the complete control (CC) of acute vomiting (27 studies). Adverse events were reported in 29 studies and nausea outcomes in 16 studies. Two studies assessed the use of dexamethasone with 5-HT3 antagonists for CC of vomiting (pooled risk ratio [RR] = 2.03, 95% confidence interval [CI] [1.35, 3.04]). Three studies compared 20 mcg/kg granisetron with 40 mcg/kg for CC of vomiting (pooled RR = 0.93, 95% CI [0.8, 1.07]). Three studies compared granisetron and ondansetron for CC of acute nausea (pooled RR = 1.05, 95% CI [0.94, 1.17], two studies), acute vomiting (pooled RR = 2.26, 95% CI [2.04, 2.51], three studies), delayed nausea (pooled RR = 1.13, 95% CI [0.93, 1.38], two studies), and delayed vomiting (pooled RR = 1.13, 95% CI [0.98, 1.29], two studies). Narrative synthesis suggests that 5-HT3 antagonists are more effective than older antiemetic agents, even when these agents are combined with a steroid. Cannabinoids are probably effective but produce frequent side effects.

Conclusions

This review provides evidence that knowledge of the most effective antiemetics to prevent chemotherapy-induced nausea and vomiting in pediatrics is incomplete and additional research is needed. This review also indicates that 5-HT3 antagonists are effective in patients receiving emetogenic chemotherapy and that granisetron or palonosetron may be better than ondansetron. Adding dexamethasone improves control of vomiting, although the risk-benefit profile of adjunctive steroid remains uncertain.

Nursing Implications

Overall, the evidence related to the treatment of chemotherapy-induced nausea and vomiting in pediatric populations receiving emetogenic chemotherapy is lacking and requires additional research, and 5-HT3 medications have been shown to be effective in small studies.

Print

Phillips, R., Hancock, B., Graham, J., Bromham, N., Jin, H., & Berendse, S. (2012). Prevention and management of neutropenic sepsis in patients with cancer: Summary of NICE guidance. BMJ, 345, e5368.

 

Purpose & Patient Population

The purpose of the article was to assess systemic reviews of best available evidence, including consideration of cost, management of neutropenic sepsis leading to avoidable deaths, and the lack of systems for urgent assessment and lack of institutional policies for managing neutropenic sepsis. Adults (aged 18 or older) with acute leukaemias, stem cell transplantations or solid tumors with expected neutropenia of 0.5 x 109/L or less post-chemotherapy were assessed.

Type of Resource/Evidence-Based Process

This was an evidence-based guideline with a guideline summary process of development.

Inclusion criteria included adult patients receiving chemotherapy. Exclusion criteria included being younger than age 18 and a diagnosis of lymphoma.

Phase of Care and Clinical Applications

The phase of care was active anti-tumor treatment

Results Provided in the Reference

High-quality evidence based on systematic reviews/meta-analyses of randomized, controlled trials (RCTs), moderate quality evidence based on systematic reviews, experienced opinion of Guideline Development Group (GDG), and National Cancer Action Team referenced as experience and opinion sources. Low-level evidence includes observational studies.

Guidelines & Recommendations

High-quality evidence (systematic reviews/meta-analysies of RCTs):

  • Initiate monotherapy antibiotics when neutropenic sepsis suspected as acute emergency
  • No routine prophylaxis with G-CSFs
  • Monotherapy for first-line empirical antibiotic

Moderate quality evidence (systematic reviews):

  • Outpatient antibiotics considered for low-risk patients after screening
  • Oncology-trained professional assessment of septic risk complications during first 24 hours using tool validated for risk score

Experienced opinion of Guideline Development Group (GDG):

  • Inform caregiver/ patients before chemotherapy about neutropenia risk and management.  Provide verbal and written information before and throughout treatment.
  • Train healthcare professionals to identify and manage potential or actual neutropenic sepsis.
  • Monitor antibiotic resistance for flouroquinolones used prophylactically for neutropenic sepsis.
  • Assess when to begin or continue empirical antibiotic therapy.

Low level evidence (observational studies):

  • Chest x-ray, removal of vascular access device (plus GDG guideline) only when clinically indicated
  • Temperature greater than 38⁰C and neutrophil count of 0.5 x 109/L as a neutropenic sepsis diagnosis

Limitations

  • Cannot be applied to children, patients younger than 18 years, or anyone with lymphoma. 
  • No external peer review.

Nursing Implications

High-quality evidence exists for practice recommendations:  

  • Initiate monotherapy antibiotics when neutropenic sepsis is suspected as acute emergency
  • No routine prophylaxis with granulocyte colony stimulating factors differs from other professional guideline recommendations regarding primary and secondary prophylaxis for at-risk patients.
  • Monotherapy for first-line empirical antibiotic
Print

Phillips, R.S., Gopaul, S., Gibson, F., Houghton, E., Craig, J.V., Light, K., & Pizer, B. (2010). Antiemetic medication for prevention and treatment of chemotherapy induced nausea and vomiting in childhood. Cochrane Database of Systematic Reviews (Online), 9, CD007786.

Purpose

To assess effectiveness, adverse events, and quality of life associated with pharmacologic interventions for control of anticipatory nausea and vomiting in children about to receive chemotherapy and for control of acute and delayed nausea and vomiting in children receiving chemotherapy

Search Strategy

Databases searched were MEDLINE, Embase, LILACS, and Cochrane CENTRAL register of clinical trials to February or March 2008.

Search keywords included the specific names of all drugs used for nausea and vomiting, including cannabinoids. Extensive listing of terms and Medical Subject Heading (MeSH) terms were provided in appendices. Multiple terms were included for pediatric cases. MeSH Nausea, MeSH Vomiting and anticipatory vomiting, Cancer and associated terms, and Chemotherapy. Manual reference screening and author contact for further information also was used.

Studies were included in the review if they 

  • Were randomized controlled trials (RCTs) where an antiemetic, cannabinoid, or benzodiazepine was compared to either a placebo or an alternative intervention.
  • Involved participants under age 18 with a cancer diagnosis receiving chemotherapy and a pharmacologic antiemetic.

Studies were excluded if they 

  • Incorporated neurokinin 1 (NK1) receptor antagonists (RAs).
  • Used nonpharmacologic approaches.

Literature Evaluated

Initial searching provided 844 references. Of these, 67 were identified for detailed screening. A final sample of 27 articles reporting on 28 trials was included. Evaluation included assessment of study quality and risk of bias.

Sample Characteristics

  • Across all studies, 1,719 patients were included. Sample sizes of included studies ranged from 12 to 428 participants, with a median of 30 participants.
  • Quantitative synthesis incorporated findings from five trials in which pooled analyses were done for different doses of granisetron and for the addition of dexamethasone to 5-HT3 RAs.

Results

  • No data were available on anticipatory nausea and vomiting or for any valid quality-of-life measures.
  • Data on outcomes beyond the first 24 hours of chemotherapy often were found.
  • Data on nausea were inconsistently reported, and they were most often reported using measurement scales that were not validated.
  • Most results were for acute emesis only.
  • Effects of interventions were as follows.
    • Cannabinoids
      • Four studies compared cannabinoids with alternative antiemetics. These demonstrated different results.
      • Two studies showed benefits of tetrahydrocannabinol over prochlorperazine and metoclopramide for control of nausea and vomiting.
      • Two other studies showed no benefit in comparison with domperidone and prochlorperazine.
    • Corticosteroids:
      • Steroids as a sole intervention were used in two studies compared to metoclopramide. Results of these two studies were completely different.
      • Two studies examined addition of steroids to 5-HT3 RAs. Addition of steroids showed good benefit in pooled results for complete control of vomiting (RR = 2.10, CI = 95%, 1.62–2.72)
    • 5-HT3 receptor antagonists:
      • Three studies looked at the effectiveness of 5-HT3 RAs in comparison to concurrent dexamethasone and either metoclopramide or chlorpromazine. One study found no differences among groups, and two studies found ondansetron and granisetron to be more effective.
      • Seven studies compared doses of granisetron, ondansetron, and tropisetron. Higher dosages and differing schedules did not demonstrate any advantage for reducing acute vomiting.
      • One study compared oral ondansetron versus IV dexamethasone. No differences were found between these groups.
    • Other agents: Three studies examined chlorpromazine versus metoclopramide and a cocktail of lorazepam, dexamethasone, metoclopramide, and benztropine (LDMB).
      • Chlorpromazine was more effective than a similar dose of metoclopramide in terms of duration of nausea.
      • Domperidone was more effective than metoclopramide regarding duration of nausea.
      • The LDMB cocktail was more effective than chlorpromazine for complete control of vomiting.

A broad range of adverse events were reported for 5-HT3 RAs. Those reported most frequently were headache, sedation/somnolence, and abdominal pain. The main side effects reported with cannabinoids were drowsiness, dizziness, mood alteration, and increased appetite. Only a few studies reported side effects with metoclopramide or chlorpromazine.

Conclusions

This review concluded that knowledge of the most effective antiemetics to prevent chemotherapy induced nausea and vomiting in children is incomplete and imprecise. Nausea often was reported with different methods that were not validated. No information was available about delayed or anticipatory nausea. Conclusions from these trials were that 5-HT3 RAs appear to be more effective than older antiemetic agents, even when those agents are combined with steroids. Additionally, 5-HT3 RAs with dexamethasone were effective in patients who were to receive highly emetogenic chemotherapy, although the addition of steroids was unclear. Cannabinoids were found to probably be effective. Related side effects may be experienced as adverse by some patients but not others.

Limitations

  • No information was provided about delayed or anticipatory nausea.
  • No clear definition of preferred route or dose of antiemetics was provided in this review.
  • No information about the use of antiemetics in multiday and multiagent trials was included, and effectiveness of antiemesis following the last dose of chemotherapy was unclear.

Nursing Implications

The following areas for research were identified. 

  • Clarify if there are important differences among the 5-HT3 RAs.
  • Determine the most beneficial doses and duration of dexamethasone.
  • Study the role of new agents, such as substance-P antagonists.

Future research should incorporate the use of validated measures and examination of appropriate schedules and doses to deal with anticipatory and delayed symptoms.

Print

Philip, J., Gold, M., Milner, A., Di Iulio, J., Miller, B., & Spruyt, O. (2006). A randomized, double-blind, crossover trial of the effect of oxygen on dyspnea in patients with advanced cancer. Journal of Pain and Symptom Management, 32(6), 541–550.

Study Purpose

The objective of the study was to determine if patients preferred oxygen or air following 15-minute administration of both. Another aim of the study was to identify other factors that might impact the experience of dyspnea and the response to oxygen.

Intervention Characteristics/Basic Study Process

The study compared the response to oxygen and air in hypoxic and nonhypoxic patients. Patients were randomized to receive either oxygen or air at 4 L via nasal canula for 15 minutes. At the completion of 15 minutes, dyspnea intensity ratings and oximetry were repeated. Patients then spent 30 minutes without gas. Repeat measures were performed with a crossover to the other gas for 15 minutes. Measure of symptom intensity and oximetry were repeated, then the blinded patient and investigator designated the preferred gas.

Sample Characteristics

The study reported on a sample of 51 patients. Dyspnea was related to the cancer in 47 patients (92%). In 29 of the 47 patients, cancer was the sole cause of dyspnea. In the remaining patients, dyspnea causes were from cancer complications, such as pneumonia (five patients), and cancer treatment, such as radiation pneumonitis. Fifteen patients (29%) had unrelated dyspnea causes, including 11 patients with chronic obstructive pulmonary disease.

Patients were eligible if

  • They had a diagnosis of cancer
  • Their dyspnea was related to the cancer
  • They had a dyspnea intensity score of at least 30 mm on a 0-100 mm visual analog scale (VAS)
  • They were on stable medication doses
  • They had a normal cognitive status
  • They were aged 18 years or older
  • They had no contraindications to oxygen.

Patients were excluded if they

  • Had acute respiratory distress
  • Were oxygen dependent.

Setting

The study was conducted in two centers in Australia. Patients were recruited from inpatient and outpatient units.

Study Design

Randomized, double-blind, crossover study

Measurement Instruments/Methods

  • VAS for dyspnea
  • European Organization for Research and Treatment of Cancer (EORTC) QLQ C30, providing verbal ratings of dyspnea intensity
  • Pulse oximetry oxygen saturation
  • Qualitative descriptors of dyspnea from Dyspnea Assessment Questionnaire

Results

Twenty-seven patients (53%) were randomized to the air first arm and 24 patients (47%) to the oxygen arm. No significant difference was seen in VAS score improvement between the two types of gases (p = 0.622). No significant difference was seen in percentage of verbal ratings of improvement after first gas (p = 0.888) and after the second gas (p= 0.767). A significant difference was seen between the two gas types in mean increase in oxygen saturation (p < 0.001, air = 0.94%, oxygen = 5.43%) No significant correlation was seen between VAS score and oxygen saturation. Twenty-one patients (41%) preferred oxygen, 15 (29%) preferred air, and 15 (29%) had no preference. No significant difference (p = 0.357) was seen in patient preference for air or oxygen. In the subgroup of 17 hypoxic patients, mean change in VAS score did not differ significantly between air and oxygen (p = 0.812, air = 15.4 mm, oxygen = 13.3 mm), but mean oxygen saturation levels increased significantly more for oxygen than for air (p = 0.005, air = 2.7%, oxygen = 10.7%).

Conclusions

On average, patients improved symptomatically with both air and oxygen, and no significant difference was seen between the treatments. The subgroup of 17 hypoxic patients overall did not demonstrate a significant difference between air and oxygen, despite having improved oxygen saturations when administered oxygen. No major or minor flaws were noted in the study design. The authors designated clinically significant response to oxygen to be a preference for oxygen chosen by 60% of patients. If clinically significant improvement occurred at lower increments, this study may not have been adequately powered.

Limitations

Air was not considered a placebo in this trial, but in fact a placebo effect may have been associated with air administration. Another possible explanation is that no differential response to either air or oxygen may be a result of mechanoreceptos stimulated by any gas administration. Patients who were dyspneic upon exertion but not dyspneic at rest were not eligible to enter the study. Eligible patients had to record a dyspnea VAS score of at least 30 mm. There may have been a different preference and response to the gases for exertional dyspnea.

Nursing Implications

Accruing 50 patients with dyspnea to this study took five years, which underscores the clinical fragility of patients who experience dyspnea and the difficulty in conducting research in this population. This evidence contradicts the findings of Bruera et al. (1993), who demonstrated that oxygen is beneficial to and preferred by patients with hypoxia.

Print

Phianmongkhol, Y., Thongubon, K., & Woottiluk, P. (2015). Effectiveness of cognitive behavioral therapy techniques for control of pain in lung cancer patients: An integrated review. Asian Pacific Journal of Cancer Prevention, 16, 6033–6038. 

Purpose

STUDY PURPOSE: To synthesize the evidence regarding effectiveness of cognitive behavioral techniques (CBT) for pain in patients with lung cancer

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PUBMED, EMBASE, CINAHL, DARE, ProQuest 5000, ScienceDirect, Centre for Reviews and Dissemination. In addition, specific journals and various sources for unpublished studies were searched.
 
INCLUSION CRITERIA: Patients spoke English or Thai, had lung cancer and a life expectancy of at least two months, were experiencing cancer-related pain requiring opioids, and had a positive response to opioid medications and an average pain between 4–7 on a 0–10 scale
 
EXCLUSION CRITERIA: Patients with major psychiatric illness who had major surgery or other intervention within 30 days of the study

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 2,009
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Joanna Briggs methodology was used to assess study quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 3
  • TOTAL PATIENTS INCLUDED IN REVIEW = 211
  • SAMPLE RANGE ACROSS STUDIES: 43–121 patients
  • KEY SAMPLE CHARACTERISTICS: Patients with lung cancer as well as other tumor types

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship
 
APPLICATIONS: Palliative care

Results

The review included two studies that involved such interventions as distraction and relaxation and imagery rather than true CBT-approach interventions. No conclusions were drawn due to the lack of substantial evidence.

Conclusions

Very limited evidence exists regarding effects of CBT-type interventions for pain among patients with lung cancer.

Limitations

  • Limited number of studies included
  • Low sample sizes
  • Results of quality evaluation are not clearly provided.

Nursing Implications

This review showed there is little evidence to determine effectiveness of CBT for pain in patients with lung cancer.

Print

Pham, H. P., Rogoza, K., Stotler, B., Duffy, D., Parker-Jones, S., Ginzburg, Y., . . . Schwartz, J. (2012). Granulocyte transfusion therapy in pediatric patients after hematopoietic stem cell transplantation: a 5-year single tertiary care center experience. Journal of Pediatric Hematology/Oncology, 34, e332–e336.

Study Purpose

To determine the efficacy of granulocyte transfusion in neutropenic pediatric patients after undergoing hematopoietic stem cell transplantation (HSCT).

Intervention Characteristics/Basic Study Process

A retrospective observational review analysis was performed on all pediatric HSCT recipients between January 2005 and and January 2010 in a single center.

Sample Characteristics

  • Sixteen patients (56% male, 44% female) were included.
  • Average patient age was 12 years.
  • All patients met the criteria for granulocyte transfusion, including an absolute neutrophil count (ANC) less than 500 cells/mm3, documented bacteria land/or fungal infections, and reasonable hope for bone marrow recovery or engraftment.

Setting

  • Single site
  • Inpatient 
  • Morgan Stanley Children’s Hospital of New York – Presbyterian – Columbia University Medical Center

Phase of Care and Clinical Applications

  • Patients were undergoing the active antitumor treatment phase of care. 
  • The study has clinical applicability for pediatrics.

Study Design

This was a retrospective observational review.

Measurement Instruments/Methods

Data were analyzed using Fisher exact test for binary outcomes and the 2-tailed t test for continuous outcomes.

Results

One hundred fifty-three granulocyte transfusions were administered to 16 pediatric HSCT recipients. Patients had bacterial infections (69%), fungal infections (19%), and combined infections (12%). Concurrent infections, mostly bacterial (60%), occurred. One adverse reaction of pulmonary toxicity was reported.  The ANC of the stimulated products was significantly higher compared with the unstimulated products; however, neither the average number of granulocytes transfused by weight nor the outcomes difference were noticed between groups.

Conclusions

Granulocyte transfusion is safe in neutropenic and infected pediatric patients after HSCT. There was no difference in the outcomes between the groups that received stimulated products and those that received unstimulated products.

Limitations

  • Small sample (<30)
  • Risk of bias (no control group)
  • Findings were not generalizable.
  • Time effect:  New antibiotics, along with new dosing, develop constantly, and the clinical care/treatment may have been different across the time span (2005–2010) of the study.  The authors did not look at difference in the clearing of infections or the survival between the two groups.  No information was provided regarding the prevalence of alloimmunization nor the compatibility between patients and the granulocyte units.

Nursing Implications

Recruiting pediatric patients for a randomized, controlled trial continues to be challenging.

Print

Pfeil, A.M., Allcott, K., Pettengell, R., von Minckwitz, G., Schwenkglenks, M., & Szabo, Z. (2015). Efficacy, effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer: A systematic review. Supportive Care in Cancer, 23, 525–545. 

Purpose

STUDY PURPOSE: To review the efficacy, effectiveness and safety of neutropenia prophylaxis with use of long-acting G-CSFs in patients with cancer undergoing chemotherapy
 
TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: MEDLINE, EMBASE, and Cochrane Library
 
KEYWORDS: Balugrastim, granulocyte–colony-stimulating factor, lipegfilgrastim, neutropenia, pegfilgrastim, systematic review
 
INCLUSION CRITERIA: Clinical trials and observational studies in which patients had received long-acting granulocyte–colony-stimulating factors (G-CSF) primary prophylaxis to reduce the risk of chemotherapy-induced neutropenia (CIN) during chemotherapy
 
EXCLUSION CRITERIA: Patients who underwent stem cell transplant, editorials, letters, case reports, guidelines, health technology assessment reports, economic evaluations, narrative reviews, and research protocols; studies comparing pegfilgrastim with a daily G-CSF, placebo, or no prophylaxis if there were fewer than 50 patients; studies with pegfilgrastim alone if fewer than 100 patients received pegfilgrastim; pegfilgrastim used outside of approved indication; and studies that did not report neutropenia-related outcomes

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 731 full publications and 108 Congress abstracts; duplicates were removed, leaving 700 items

Sample Characteristics

FINAL NUMBER STUDIES INCLUDED = 44 (33 full papers and 11 congress abstracts) 
 
TOTAL PATIENTS INCLUDED IN REVIEW = 58,342 patients
 
KEY SAMPLE CHARACTERISTICS: Studies in patients with breast cancer were dominant; however, the studies included a range of patient populations and cancer types and stages as well as chemotherapy regimens.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results

Pegfilgrastim did not consistently show better efficacy or effectiveness in all studies, but the vast majority showed better efficacy and effectiveness compared to daily G-CSF, no upfront pegfilgrastim, no G-CSF or placebo in regards to CIN, febrile neutropenia (FN), chemotherapy dose reductions/delays, antibiotic use, and neutropenia-related hospitalizations. It is suggested that pegfilgrastim has an acceptable safety profile with similar AEs between pegfilgrastim and filgrastim.

Conclusions

Pegfilgrastim is currently being widely used in clinical practice, showing similar efficacy/effectiveness with acceptable safety profiles.

Limitations

Limitations include the quality of the underlying studies. Some studies did not report number of patients receiving primary prophylaxis versus secondary prophylaxis, which may have led to underestimation of effectiveness. Studies were not consistent in their definitions of FN and CIN. Combined measures of effect are missing in the analysis.

Nursing Implications

Further studies in broader patient populations are needed to confirm. This review adds to the body of evidence that shows mixed findings regarding the question of whether pegfilgrastim use achieves better patient outcomes than daily filgrastim. It is also unclear if either of these has better results for primary or secondary prophylaxis.

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