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Chay, WY., Tan, SH., Lo, YL, Ong, S.Y., Ng., H.C., Gao, F., . . . Choo, S.P. (2010). Use of calcium and magnesium infusions in prevention of oxaliplatin induced sensory neuropathy. Asia Pacific Journal of Clinical Oncology, 6, 270–277.

Study Purpose

The purpose of the study was to evaluate the neuropathy-protective effects of calcium and magnesium infusions in patients receiving oxaliplatin.

Intervention Characteristics/Basic Study Process

Patients were randomized to a treatment group with calcium gluconate 1 g plus 1 g of magnesium sulfate in 100 ml normal saline infused before and after oxaliplatin, or a placebo group with infusions of normal saline.

Sample Characteristics

  • The sample consisted of 19 participants with a mean age of 54 years.
  • The amount of men (52%) slightly outnumbered the amount of women (48%).
  • All of the participants had colorectal cancer and were receiving oxaliplatin-based chemotherapy with a life expectancy of more than three months.
  • Exclusion criteria included previous treatment with platinum-based chemotherapy and/or a preexisting neurologic disease or metastases.
  • Seventy-eight percent of the patients received 600 mg/m² of oxaliplatin.
  • The median follow-up was 8.7 months.

Setting

The study was conducted in a single-site location in Singapore.

Phase of Care and Clinical Applications

  • Active treatment
  • Late effects

Study Design

The study was a blinded, placebo-controlled, randomized phase II design.

Measurement Instruments/Methods

Measurements included the National Cancer Institute Common Terminology Criteria for Adverse Events [version 3.0] and oxaliplatin-specific toxicity scale nerve conduction studies.

Results

Incidence of grade 1 and 2 neurotoxicity was higher in the placebo group, but there was a higher proportion of grade 3 cumulative numbness in the treatment group. No differences were noted between groups for tingling and cold sensitivity. In addition, no difference was noted in time to onset of symptoms. Conduction studies showed lower median score at the end of the study in the treatment arm (p = 0.02). Of note, the study was ended prematurely.

Conclusions

This study does not provide strong evidence regarding the efficacy of calcium and magnesium infusion for the reduction of chemotherapy-associated peripheral neuropathy.

Limitations

  • A small sample size (less than 30 participants).
  • Findings and reported conclusions can be confusing since median end of study nerve conduction scores suggested increased abnormal conduction in the treatment group, as noted by the authors.
  • A correlation between nerve conduction findings and subjective patient symptoms are unclear.
  • No information was provided regarding chemotherapy treatment delays or dose reductions.
  • Given the question of cumulative effects, it may be more useful to look at symptoms at oxaliplatin dose levels rather than time.

Nursing Implications

Because of a small sample size, this current study does not provide strong evidence regarding use of calcium and magnesium infusions. Neuropathic symptom effects appear to be mixed, with higher prevalence of grade 3 with treatment, but overall prevalence lower with treatment. Some symptoms appear to be affected and some do not, and the relationship between nerve conduction findings and symptoms are unclear. Additional research in this area is needed to clarify the actual impact of calcium and magnesium for protective effects with neurotoxic treatment.

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Chasen, M., Urban, L., Schnadig, I., Rapoport, B., Powers, D., Arora, S., . . . Gridelli, C. (2017). Rolapitant improves quality of life of patients receiving highly or moderately emetogenic chemotherapy. Supportive Care in Cancer, 25, 85–92. 

Study Purpose

To assess the impact of adding rolapitant to standard antiemetics (5-HT3 receptor antagonists and dexamethasone) on the daily lives of patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC)

Intervention Characteristics/Basic Study Process

This is a secondary analysis study of three clinical trials (phase III experimental studies). Patients were stratified by sex and randomly assigned (1:1) to either single oral dose rolapitant 180 mg or placebo 1–2 hours prior to chemotherapy. All patients received 5-HT3 receptor antagonists and dexamethasone. Quality of life was assessed by patients by completing the 18-item Functional Living Index-Emesis (FLI-E) questionnaire on day 6 of cycle 1.

Sample Characteristics

  • N = 2,402 (1,070 patients in the pooled HEC studies and 1,332 patients in the MEC/AC)   
  • AGE: Between 18–90 years
  • MALES: 39.1% (938 patients), FEMALES: 60.9% (1,464 patients)
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Various malignancies; a Karnofsky performance score of 60 or greater; a predicted life expectancy of four months or greater; and adequate bone marrow, kidney, and liver function
  • OTHER KEY SAMPLE CHARACTERISTICS: Aged older than 18 years, naïve to their scheduled HEC/MEC

Setting

  • SITE: Multi-site   
  • SETTING TYPE: Not specified    
  • LOCATION: Canada

Phase of Care and Clinical Applications

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

Study Design

Three double-blind, phase III, randomized, controlled longitudinal trials (specified analyses [MEC/AC study]), and pooled post hoc analyses (HEC studies)

Measurement Instruments/Methods

Treatment comparisons were performed between the FLI-E questionnaire total score and nausea and vomiting domain scores, in addition to the end point of no impact on daily life.

Results

Data were analyzed for all randomized patients in the modified intent-to-treat population. Patients in the rolapitant group reported a significantly higher FLI-E total score than patients in the control group in the pooled HEC studies (confidence interval [CI] [2.6, 7.9], p < 0.001) and in the MEC/AC study (CI [1.7, 6.5], p < 0.001). A significant improvement in the nausea domain score was observed with rolapitant versus control in the pooled HEC studies (CI [0.2, 3.4], p = 0.02) and the MEC/AC study (CI [0.3, 3.3], p = 0.019), as well as the vomiting domain score in the pooled HEC studies (CI [2.1, 4.7], p < 0.001) and the MEC/AC study (CI [1.1, 3.4], p < 0.001).

Conclusions

This secondary analysis study demonstrated the efficacy of adding rolapitant to standard antiemetics in reducing the negative delayed impact of CINV on the daily lives of patients receiving HEC or MEC.

Limitations

  • Baseline sample/group differences of import
  • Secondary analysis data from three experimental clinical trials
  • Included patient with various cancers

Nursing Implications

Nurses should be aware of the additional benefit of adding an NK1 receptor antagonist to the treatment of patients with cancer receiving HEC and MEC.

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Chasen, M., Hirschman, S.Z., & Bhargava, R. (2011). Phase II study of the novel peptide-nucleic acid OHR118 in the management of cancer-related anorexia/cachexia. Journal of the American Medical Directors Association, 12, 62–67.

Study Purpose

To determine the effect of OHR118 on appetite, early satiety, and nutritional intake in patients with advanced cancer experiencing anorexia or anorexia-cachexia syndrome

Intervention Characteristics/Basic Study Process

Patients received 4.0 ml of OHR118 via subcutaneous injection daily for 28 days. Patients who benefited were offered the option to continue for a total of 56 days.

Sample Characteristics

  • The study reported on a sample of 11 patients with cancer experiencing anorexia or anorexia-cachexia syndrome.
  • Mean patient age was 63 years, with a range of 18–80 years.
  • The sample was 71% male and 29% female.
  • Patients were diagnosed with lung, pancreatic, colorectal, gastric, prostate, or head and neck cancer.
  • Of the sample, 27% of patients had stage III disease and 73% had stage IV disease.

Setting

  • The study site was not specified, but the authors were from the Division of Palliative Care at the University of Ottawa, so it appears that the study was Canadian and done at a single site.
  • The nature of the intervention would suggest an outpatient setting.

Phase of Care and Clinical Applications

  • Patients were undergoing the active treatment, end-of-life, or long-term follow-up phase of care.
  • The study has clinical applicability for late effects and survivorship, and end-of-life and palliative care.

Study Design

  • A prospective, observational study design was used.
  • Patients were not randomized, nor was there a control group.
  • Neither patients nor researchers were blinded.

Measurement Instruments/Methods

  • Patient-Generated Subjective Global Assessment (PG-SGA)
  • Edmonton Symptom Assessment Scale (ESAS)
  • Dyspepsia Symptom Severity Index (DSSI)
  • Simmonds Functional Assessment (SFA)
  • Bodystat 1500 (lean body mass and body composition measurement)
  • Harpenden Skinfold Caliper (skinfold thickness measurement)

Results

Eleven patients completed the first 28 days of the study, and 6 completed the second 28 days. Results from the first 28 days demonstrated a statistically significant improvement of appetite (p = 0.01) and depression (p = 0.05) on the ESAS. All other ESAS items did not show a statistically significant improvement. The overall PG-SGA score measuring nutrition (weight loss, nutrition impact symptoms, intake, and functional capacity) was significantly reduced (p = 0.01). The DSSI showed statistically significant results for the items of frequent burping or belching (p = 0.02), feeling full after meals (p = 0.04), and abdominal distention (p = 0.03). The sit-to-stand item on the SFA was statistically significant (p = 0.01) for deterioration of ability.

The authors concluded that OHR118 showed improvements consistent with previous work done in a \"very positive\" larger study in the AIDS population, and that this translates to \"improved patient comfort and quality of life.\"

Conclusions

Of the many values measured with the multiple measurement tools, only the general PG-SGA score, appetite, frequent belching, feeling full after meals, and abdominal distention showed statistically significant improvement. The study did not meet the secondary endpoints of changes in performance status, lean muscle mass, or quality of life.

Limitations

  • The authors concluded that the depression item on the ESAS was significant with a p value of 0.05; however, their preanalysis value of significance had been determined to be less than 0.05. They then went on to state in their discussion that improving appetite would improve depression, which their study demonstrated. The significant findings of decreased depression were challenging to interpret because of the statistical methods used in analysis and should be interpreted with caution.
  • Of the initial 21 patients recruited, 10 dropped out, 5 had disease progression or died, 2 had abdominal pain, 1 had a phobia of needles, and 2 refused to continue citing no reason. There was no control group, and it is not clear from the study how patients were recruited.
  • The abstract states that eight patients continued to 56 days; however, the manuscript analysis says that six completed the 56 days.
  • It is not clear if OHR118 is an approved agent.

Nursing Implications

This study should be interpreted with caution because it was small, with limited statistically significant results to support the research objective.

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Charles, M. A., Reymond, L., & Israel, F. (2008). Relief of incident dyspnea in palliative cancer patients: a pilot, randomized, controlled trial comparing nebulized hydromorphone, systemic hydromorphone, and nebulized saline. Journal of Pain and Symptom Management, 36, 29–38.

Study Purpose

To compare the efficacy of nebulized hydromorphone, systemic hydromorphone, and nebulized saline for incident dyspnea in patients with advanced cancer.

Intervention Characteristics/Basic Study Process

On three occasions when patients requested treatment for incident breathlessness, they randomly received one of the following:

  • 5 mg of nebulized hydromorphone
  • A systemic breakthrough dose of hydromorphone
  • 3 mL of nebulized saline and an agent to maintain double blinding.

If patients felt the intervention was not effective, they could ask for additional pharmaceutical interventions. Patients scored breathlessness at 10, 20, 30, and 60 minutes from completion of treatment. Treatment order was randomized.

Sample Characteristics

  • The sample was comprised of 20 patients (11 men, 9 women) receiving palliative care.
  • Mean age was 69 years (range 48–83). 
  • Diagnoses included primary lung cancer or secondary lung pathology, including lung metastases, pleural effusion, or pulmonary emboli.
  • To be eligible, patients had to have Mini Mental State Exam (MMSE) results of at least 24 out of 30.
  • Thirteen patients were on continuous oxygen.
  • Mean baseline total opioid dose in morphine equivalent mg was 82 (range 10–540).

Setting

  • Inpatient- and community-based hospice service in Brisbane, Australia
  • Single site

Phase of Care and Clinical Applications

Patients were undergoing the palliative and end of life phases of care.

Study Design

The study was a pilot, double-blind, randomized, crossover, controlled trial.

Measurement Instruments/Methods

  • Perceived intensity of breathlessness was measured on a vertical 100-mm visual analog scale (VAS).
  • Pulse rate and peripheral oxygen saturation were measured with a pulse oximeter.
  • Respiratory rate was counted by the research nurse over two 30-second intervals.

Results

There were no differences between treatments in improvement scores. Improvement in breathlessness at 10 minutes post intervention completion was seen in each of the treatment conditions. Improvement considered to be clinically significant (≥1 cm on the VAS) was only seen with the nebulized hydromorphone. Respiratory rate improved over time from 10 to 60 minutes (p < 0.05), with no difference between treatments. There were no clear, consistent preferences among patients for any particular intervention.

Conclusions

The results suggest that nebulized saline provides relief of incident breathlessness; its effect is ongoing and does not differ significantly from the effects of nebulized opioid treatments.

Limitations

  • The study was appropriately powered to answer the study questions, but the study had a small sample size.
  • A change of 1 cm on the VAS was used as a clinically significant symptom change, in concert with the work of others.
  • Further research to define clinically significant differences in patient perception would be beneficial.
  • It is not clear if higher doses of hydromorphone might yield differences across groups.
  • The authors suggested that improvements in respiratory rates and peripheral oxygen over time likely represent Type I error in this study because the patients had a background of irreversible baseline dyspnea.
  • The presence of the research nurse, to specifically administer this protocol, may have had an effect in terms of reassuring patients and confounded the overall results. Similar research having patients self-administer treatments might address this aspect.
  • It is unclear if findings represent placebo effects.
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Charalambous, A., Giannakopoulou, M., Bozas, E., & Paikousis, L. (2015). A randomized controlled trial for the effectiveness of progressive muscle relaxation and guided imagery as anxiety reducing interventions in breast and prostate cancer patients undergoing chemotherapy. Evidence-Based Complementary and Alternative Medicine, 2015, 270876. 

Study Purpose

To test the effectiveness of progressive muscle relaxation (PMR) and guided imagery as stress-reducing interventions

Intervention Characteristics/Basic Study Process

Patients randomized to usual care had weekly meetings with psychologists. Those randomized to PMR and guided imagery had four supervised sessions and daily self-practice for three weeks. To stimulate imagery, the guided imagery component included auditory, tactile, and olfactory images. The imagery script was accompanied by music. The intervention was tested and measured with biofeedback prior to study use.  Both groups were assessed at baseline and at the end of three weeks. Daily text message reminders were sent to the intervention group to remind them to practice PMR.

Sample Characteristics

  • N = 208  
  • AGE RANGE: 40-60 years
  • MALES: 50%, FEMALES: 50%
  • KEY DISEASE CHARACTERISTICS: Breast and prostate cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: 49% had university education; 71% were married

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Home    
  • LOCATION: Cyprus

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

  • Single, blind. randomized, controlled trial

Measurement Instruments/Methods

  • Zung self-rating anxiety scale
  • Beck Depression Inventory
  • Salivary a-amylase and cortisol levels

Results

The group had a decrease in mean anxiety score whereas the control group had an increase in anxiety at three weeks compared to baseline. The difference between groups of this change was significant (p < 0.001).  The same pattern of change between groups was shown for depression (p < 0.001). Salivary amylase and cortisol levels were directly related to anxiety and depression scores (p < 0.001).

Conclusions

PMR and guided imagery were associated with reduced anxiety and depression among patients with breast and prostate cancer during chemotherapy.

Limitations

  • Risk of bias (no appropriate attentional control condition)
  • Other limitations/explanation: No information was provided regarding patient adherence to daily PMR practice. No information was provided regarding any medications for anxiety or depression or chemotherapy regimens involved. Very limited demographic information is provided. The manner in which the imagery scenarios and music were provided were not described.

Nursing Implications

Findings here showed that progressive muscle relaxation and guided imagery were effective in reducing anxiety and depression during chemotherapy treatment. These are very low-risk interventions that can be helpful and can be readily incorporated into standard patient care.

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Chapell, R., & Aapro, M.S. (2013). Efficacy of aprepitant among patients aged 65 and over receiving moderately to highly emetogenic chemotherapy: A meta-analysis of unpublished data from previously published studies. Journal of Geriatric Oncology, 4(1), 78–83. 

Purpose

STUDY PURPOSE: To review the evidence related to efficacy of aprepitant in patients over age 65
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Merck & Company's internal records
 
KEYWORDS: No search terms. Looked for randomized, double-blind, placebo-controlled, parallel-group studies.
 
INCLUSION CRITERIA: Studies included patients both under and over age 65, results were stratified by age, and standard therapy was compared to antiemetic regimen including aprepitant.  
 
EXCLUSION CRITERIA: None listed

Literature Evaluated

TOTAL REFERENCES RETRIEVED = Article does not say
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: A comprehensive meta-analysis was used to combine results from all four studies for a fixed-effects model. Relative risk was calculated across studies in different age groups and were compared using the Q test of heterogeneity. 

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 4 
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not reported
  • SAMPLE RANGE ACROSS STUDIES: Not reported
  • KEY SAMPLE CHARACTERISTICS: Three studies included patients with solid tumors; one study included breast cancer only.

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care

Results

The relative risk of complete response for patients under 65 is 1.30 (95% CI: 1.19–1.42; p < 0.0001). It is not significantly different from patients over 65 (Q = 0.281, p = 0.596). The relative risk for a complete response for patients over 75 is 1.42 (95% CI: 1.07–1.89; p = 0.02). It is not significantly different from the relative risk for patients under the age of 75 (1.28, 95% CI: 1.19–1.37; Q = 0.49, p = 0.78). The relative risk of a complete response to regimens including aprepitant for patients over 75 is not different for patients under 65 (Q = 0.42, p = 0.81). There was no statistically significant difference in heterogeneity among studies.

Conclusions

Aprepitant is beneficial for patients both over and under age 65.

Limitations

  • Included studies did not use the same chemotherapy regimen.
  • Extremely limited demographic data were presented.
  • Search did not include major databases.
  • No year limits were described in the study.
  • Authors did not state how many studies were retrieved.

Nursing Implications

The addition of aprepitant should be considered in patients, regardless of age, for the management of chemotherapy-induced nausea and vomiting associated with moderate and highly emetogenic chemotherapy.

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Chao, L.F., Zhang, A.L., Liu, H.E., Cheng, M.H., Lam, H.B., & Lo, S.K. (2009). The efficacy of acupoint stimulation for the management of therapy-related adverse events in patients with breast cancer: A systematic review. Breast Cancer Research and Treatment, 118, 255–267.

Purpose

To scrutinize the evidence of using acupoint stimulation (APS) by any modality on managing adverse events related to anticancer therapies in patients with breast cancer

Search Strategy

English databases searched were PubMed, Cochrane library, Embase, the Cumulative Index to Nursing and Allied Health, and PsycINFO.

Chinese databases searched were CNKI, CEPS, and WanFang as well as manual searching.

Search keywords were medical terms of breast cancer (e.g., breast neoplasm, breast carcinoma, breast tumor) combined separately with at least one of the following: acupuncture, acupressure, auricular acupuncture, ear acupuncture, acupuncture points, electroacupuncture, acupoint, transcutaneous electric nerve stimulation,  moxibustion.

Studies were included if they

  • Were in English or Chinese language.
  • Reported on adults diagnosed with breast cancer at any stage and undergoing treatments such as surgery, radiotherapy, chemotherapy, hormonal therapy, or palliative treatment and experiencing treatment-induced adverse events.
  • Utilized an intervention that involved stimulation of acupuncture points by any modality.
  • Had at least one clinically related outcome variable, as well as condition-specific outcomes or generic health status outcomes.

Studies were excluded if they were

  • Animal studies.
  • Case reports and anecdotal evidence.
  • Qualitative studies or descriptive surveys.
  • Reports available only in abstract form.
  • Trials that included diagnosis other than breast cancer unless separate data was available for the breast cancer group.

Literature Evaluated

Initial review involved 843 titles and abstracts and 51 full-text articles. Of those, 26 studies were included in the report.

Study evaluation began with two independent reviewers using a modified Jadad scale, assessing 3 aspects: randomization procedure (2 points); dropout and withdrawal discussion (1 point); and blinding (2 points). Studies were classified as high quality if they attained a score of 3 or higher.

Evaluated literature included 18 randomized controlled trials (RCTs) and eight controlled clinical trials published between 1999 and 2008. Nine trials included conventional acupuncture, 6 included electroacupuncture, 5 included drug injection in acupoints, 3 included self-acupressure, and 3 included acupoint stimulation by wristbands or acumagnet. Eighteen were in English, and 8 were in Chinese.

Sample Characteristics

  • The total sample size was 1,548.
  • Age range across across studies was 28–76 years.
  • Five studies reported the participant’s body mass index, which ranged from 23.1 to 28.8.
  • Information on participants’ education, background of acupuncturists, symptom distress before management, and measurement tool reliability was reported in too few studies to provide a meaningful summary.

Results

Nine of the 26 studies were rated as high quality. Adverse effects (outcomes) of the APS included vasomotor syndrome, chemotherapy-induced nausea and vomiting (CINV), post-mastectomy pain, joint symptoms, lymphedema, leukopenia, and adverse events.

Eleven studies investigated CINV and APS with acupoints P6 and ST36. Ten of the CINV studies reported APS significantly improved emesis caused by breast cancer therapy.

Conclusions

The most common outcome evaluated by APS in the studies was CINV. APS was noted to be effective in reducing acute emesis caused by breast cancer therapy. Authors reported that APS is beneficial in the management of CINV, especially in the acute phase.

Nursing Implications

Healthcare providers should consider using APS as an option for the management of CINV.

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Chan, C. W., Richardson, A., & Richardson, J. (2011). Managing symptoms in patients with advanced lung cancer during radiotherapy: results of a psychoeducational randomized controlled trial. Journal of Pain and Symptom Management, 41, 347–357.

Study Purpose

To examine the effectiveness of a psychoeducational intervention (PEI) on the symptom cluster of anxiety, breathlessness, and fatigue compared with usual care.

Intervention Characteristics/Basic Study Process

Education on symptom management and coaching on the use of progressive muscle relaxation was delivered to patients one week prior to the start of radiotherapy (RT) and repeated three weeks after beginning RT. Symptom data were collected at four times points:  prior to the intervention and at three, six, and 12 weeks postintervention.

Sample Characteristics

  • In total, 140 patients (83% male, 17% female) with lung cancer receiving palliative RT were included.
  • Patients were 16 years or older.
  • Patients had stage III or IV lung cancer.

Setting

  • Single site
  • Outpatient
  • RT unit of a publicly funded hospital in Hong Kong

Study Design

The study was a randomized, controlled trial using a pre-/posttest design with two groups.

Measurement Instruments/Methods

  • Breathlessness was assessed using a 100-mm visual analog scale.
  • Fatigue was measured with the intensity subscale of the revised Piper Fatigue Scale (PFS), consisting of 23 items. The instrument was translated into Chinese and found to be valid and reliable.
  • Anxiety was measured using the Chinese version of the State-Trait Anxiety Inventory (STAI), consisting of 20 items for measuring immediate feelings of apprehension, nervousness, and worry.
  • Functional ability was a secondary outcome measure, using the subscale of the Chinese version of the Short Form 36 (SF-36) Health Survey.

Results

A significant difference (p = 0.003) was seen over time on the pattern of change of the symptom cluster between the PEI intervention and the usual care control group. Significant effects on patterns of changes in breathlessness (p = 0.002), fatigue (p = 0.011), anxiety (p = 0.001), and functional ability (p = 0.000) were found.

Conclusions

PEI is an effective treatment for relieving the symptom cluster of anxiety, breathlessness, and fatigue and each of the individually assessed symptoms.

Limitations

  • The study had a small sample size, with less than 100 participants.
  • A high attrition rate was due to death.

Nursing Implications

The study provided evidence to support the symptom cluster of anxiety, breathlessness, and fatigue as interrelated, with assessment and management of those three symptoms as a cluster. Clarification of the nature of their interrelatedness is a potential area of further study. Education and counseling patients through nurses can be helpful in the management of these symptoms.

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Chan, C.W., Cheng, K.K., Lam, L.W., Li, C.K., Chik, K.W., & Cheung, J.S. (2008). Psycho-educational intervention for chemotherapy-associated nausea and vomiting in paediatric oncology patients: A pilot study. Hong Kong Medical Journal, 14(5 Suppl.), 32–35. 

Study Purpose

To assess the feasibility of using relaxation and patient education

Intervention Characteristics/Basic Study Process

Patients were placed in group 1 or 2 (no randomization information provided). Group 1 received training in progressive muscle relaxation (PMR) and guided imagery (GI) using audiotapes daily. Training was provided daily on days 0-5, then patients practiced the techniques daily for two months. Group 2 received two 30-minute patient/parent education sessions on days 0 and 2, focusing on risk assessment, antiemetic use, and meal planning. All subjects completed instruments at baseline (prior to chemotherapy) then daily for seven more days. One and two months after the intervention, anxiety, compliance with PMR and GI (group 1 only), satisfaction with care, and quality of life was assessed. Pulse and blood pressure were reported in the findings but not listed in the procedure. A third group was comprised of 10 historical control cases who matched the characteristics of group 1.

Sample Characteristics

  • The study consisted of 20 participants.
  • Mean age was 8.6 years with a range of 4–11 years.
  • Gender was not reported.
  • The majority of children had acute lymphocytic leukemia, and 12 children had osteosarcoma. Remaining diagnoses were not reported.

Setting

The study was conducted at a single site hospital in Hong Kong.

Phase of Care and Clinical Applications

All patients were pediatric and in active treatment.

Study Design

This was a clinical trial with pre- and post-test design.

Measurement Instruments/Methods

  • The following instruments were used.
    • The Morrow Assessment of Nausea and Emesis (MANE)
    • Chinese version of A-State scale of the State-Trait Anxiety Inventory
    • Play performance scale for children
    • Physiological indices of caloric intake and changes in body weight 
  • Use of antiemetics and satisfaction with care (rated on a 4-point Likert-type scale ranging from 0 = unsatisfactory to 3 = extremely satisfactory) were recorded.
  • A self-rating of intervention usefulness (rated on a 6-point Likert-type scale ranging from 0 = not at all useful to 5 = extremely useful) was obtained.
  • Health diaries were used to record PMR and Gi practice.

Results

At baseline, group 1 had significantly lower anxiety than group 2 (p = 0.032). Group 1 had less vomiting on day 3 compared to the control group (p = 0.036). No significant difference was found in antiemetic use between the intervention and control groups. No significant difference was found in body weight, CINV, antiemetic use, quality of life, or caloric intake between groups 1 and 2. Health diaries indicated that patients practiced PMR three to four times weekly at home with no significant changes in blood pressure or pulse. Patients and parents reported the interventions as moderately useful.

Conclusions

This study was poorly designed, and findings should be used cautiously. Although the authors reported that PMR and education can reduce CINV, no conclusions should be made except that further research is warranted.

Limitations

  • The sample size was small.
  • No information was provided about randomization.
  • The authors did not report how the historical control cases were identified or what information was collected.
  • No discussion was provided on how the intervention was performed in younger children.
  • No report was provided on how blood pressure, pulse, body weight, and caloric intake was measured and recorded.
  • Whether data was provided by the children or parents was not made clear.
  • Parents’ anxiety and satisfaction of care was discussed in the findings but not described in the procedure.
  • No discussion of missing data was included.

Nursing Implications

The quality of this study is too poor to provide any implications for nurses. Well-designed research in this area is needed.

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Chan, A., Leng, X.Z., Chiang, J.Y., Tao, M., Quek, R., Tay, K., & Lim, S.T. (2011). Comparison of daily filgrastim and pegfilgrastim to prevent febrile neutropenia in Asian lymphoma patients. Asia-Pacific Journal of Clinical Oncology, 7, 75–81.

Study Purpose

The study aim was to compare the effectiveness of primary prophylaxis with filgrastim and pegfilgrastim to prevent the incidence of febrile neutropenia in Asian patients with cancer undergoing chemotherapy.  

Intervention Characteristics/Basic Study Process

Data analyzed on intent-to-treat basis from January 2008 and August 2009 identified from the pharmacy prescription database. The G-CSF must have been administered at least 24 hours after chemotherapy administration for primary prophylaxis against febrile neutropenia. Crossover between the two G-CSFs was allowed and the patient was assigned to the treatment group according to the G-CSF used with the first cycle.

Sample Characteristics

  • 204 total patients were examined
  • 81 received filgrastim, and 123 received pegfilgrastim
  • Mean age was 56.7 years (SD = 13.1)  in the  filgrastim group and 55.3 (SD = 14.8) years in the pegfilgrastim group.
  • Males outnumbered females, 54% to 46%, respectively
  • Patients with non-Hodgkin lymphoma  who underwent chemotherapy
  • Primary prophylaxis with filgrastim and pegfilgrastim
     

Setting

  • Single site  
  • Setting type was not specified 
  • Location was Singapore
     

Phase of Care and Clinical Applications

Active treatment

Study Design

Single-center, retrospective study

Measurement Instruments/Methods

  • Primary end point: Incidence of febrile neutropenia defined as temperature 38.3°C or greater and absolute neutrophil count (ANC) less than 500 mcl.     
  • Secondary endpoints: Dose delay of more than three days days or dose reduction of 15% or greater  in subsequent chemotherapy cycles
     

Results

During the first cycle of chemotherapy, six (7.4%) and 11 (8.9%) patients developed FN in the filgrastim and pegfilgrastim arms, respectively (p = 0.8). Across all cycles of chemotherapy treatments, the overall incidence of FN in both arms was much higher than in the first cycle. However, the incidence of FN between the filgrastim group and the pegfilgrastim group remained similar (13.6% in the filgrastim arm versus 16.3% in the pegfilgrastim arm; p = 0.69) across all cycles. More patients in the filgrastim arm experienced treatment delays (8.6%) and chemotherapy dose reductions (4.9%) compared to those who were administered pegfilgrastim (incidence of dose delay = 5.7%, p = 0.25; incidence of dose reduction = 3.3%, p = 0.45) during the first cycle. However, these differences were not statistically significant. The cumulative occurrences of dose delays or dose reductions in all cycles were higher among patients who received pegfilgrastim (absolute difference of dose delay = 2.7%, p = 0.71; absolute difference of dose reduction = 0.7%, p = 1.00). Across all cycles, for regimens that possess a FN risk below 20%, a lower incidence of FN was observed in patients who received filgrastim than those who received pegfilgrastim (12.2 versus 21.4%, respectively; p = 0.31). Similar trends also were observed with the cumulative incidence of treatment delay and chemotherapy dose reduction: patients receiving pegfilgrastim were more likely to suffer from the complications of FN. With regards to the chemotherapy regimens that possess FN risk of 20% or greater, the incidence of FN, treatment delays, and dose reductions all were  similar in both treatment arms (absolute difference in the incidence of FN = 5.6%, p = 0.52; absolute difference in the incidence of dose delays = 0.5%, p = 1.00; absolute difference in the incidence of dose reductions = 4.3%, p = 0.46).

Conclusions

There was no statistically significant difference between filgrastim and pegfilgrastim for the primary prophylaxis of febrile neutropenia in Asian patients undergoing chemotherapy. There was no statistically significant difference between filgrastim and pegfilgrastim with regard to the incidence of dose delays or dose reductions.

Limitations

Retrospective study that relied on the accuracy of the medical records reviewed.

Nursing Implications

Filgrastim and pegfilgrastim are equally effective to prevent chemotherapy-induced febrile neutropenia and to prevent dose delays and dose reductions in subsequent cycles.

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