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Hiramatsu, Y., Maeda, Y., Fujii, N., Saito, T., Nawa, Y., Hara, M., . . . West-Japan Hematology and Oncology Group. (2008). Use of micafungin versus fluconazole for antifungal prophylaxis in neutropenic patients receiving hematopoietic stem cell transplantation. International Journal of Hematology, 88, 588–595.

Study Purpose

The hypothesis was that micafungin (150 mg) is a safe and effective alternative to fluconazole (400 mg) for the use of antifungal prophylaxis during neutropenia.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to receive either micafungin or fluconazole treatment using a 1:1 schedule.  Randomization was stratified according to the risk or transplant-related mortality.  High risk included acute leukemia in relapse or in complete remission for at least the third time, chronic myelogenous leukemia other than the first chronic phase, Hodgkin lymphoma or non-Hodgkin lymphoma in relapse or greater than or equal to the second complete or partial remission, myelodysplastic syndrome, or myeloproliferative syndrome.  Low risk included all factors not classified as high risk and any type of transplant (i.e., autologous, allogeneic using peripheral blood stem cells or bone marrow, or allogeneic using cord blood).  Groups received either 150 mg of micafungin or 400 mg of fluconazole daily by infusion until the earliest of: (1) absolute neutrophil count (ANC) of 500 cells/mmor greater, (2) 42 days after hematopoietic stem cell transplantation (HSCT), (3) development of proven, probable, or suspected invasive fungal infection, (4) development of unacceptable drug toxicity, or (5) other reason for withdrawal or discontinuation of treatment.  Antifungals were given within 48 hours of initiation of the transplant conditioning treatment.

Sample Characteristics

  • One hundred four patients were evaluable (52 patients in each arm).  
  • Mean age was 46.5 years (range 16–67) in the micafungin arm and 47.3 years (range 18–65) in the fluconazole arm.
  • In the micafungin arm, 64% of patients were male and 36% were female.  In the fluconazole arm, 68% of patients were male and 32% were female.
  • Key disease characteristics were malignant lymphoma (46% in the micafungin arm, 44% in the fluconazole arm), multiple myeloma (18% in the micafungin arm, 26% in the fluconazole arm), acute myeloid leukemia (AML) (14% in the micafungin arm, 12% in the fluconazole arm); myelodysplastic syndrome (MDS) (10% in the micafungin arm, 8% in the fluconazole arm); acute lymphoblastic leukemia (ALL) (6% in both arms), and other hematologic malignancy/nonmalignant disease (6% in the micafungin arm, 4% in the fluconazole arm).  
  • Transplant type included autologous HSCT in 48% of patients in both arms and allogeneic HSCT in 52% of patients in both arms.  Peripheral blood was used in all autologous HSCTs, allogeneic bone marrow or peripheral blood was used in 38% of patients in the micafungin arm and 44% in the fluconazole arm, and cord blood was used in 14% of patients in the micafungin arm and 8% in the fluconazole arm.

Setting

  • Mutli-site  
  • Inpatient
  • Patients were hospitalized at the hematology departments of six study sites in Japan.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

This was a prospective, randomized, open-label comparative trial.

Measurement Instruments/Methods

  • Treatment success was defined as an absence of proven, probable, or suspected systemic fungal infection through a four-week period.     
  • Definitions of the Fungal Infections Cooperative Group of the Suropena Organization for Research and Treatment of Cancer, National Institute of Allergy and Infectious Diseases Mycoses Study Group were used.
     

Results

Neutrophil recovery was seen in an average of 13.7 days in both arms.  Graft-versus-host disease was present in 24% of patients in the micafungin arm and 30% in the fluconazole arm.  Overall treatment success, defined as the absence of proven, probable, or suspected systemic fungal infection through the end of prophylaxis therapy and as the absence of a proven or probable systemic fungal infection through the end of the four-week posttreatment period, was comparable in both arms, with 94% in the micafungin arm and 88% in the fluconazole arm.  This was not a significant difference.

Conclusions

The study showed that another class of medications, the echinocandins, can be effective in preventing fungal infections.  Its effectiveness is comparable to that of fluconazole, which is considered the gold standard for antifungal prophylaxis.  Neither drug had significant side effects, although the incidence was slightly higher with the use of micafungin.

Limitations

This was an open-label study and was not powered to measure success rate differences.

Nursing Implications

Patients should be educated regarding the use, effectiveness, side effects of the medications, and need for continued antifungal prophylaxis based on risk.

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Hiramatsu, T., Sugiyama, M., Kuwabara, S., Tachimori, Y., & Nishioka, M. (2014). Effectiveness of an outpatient preoperative care bundle in preventing postoperative pneumonia among esophageal cancer patients. American Journal of Infection Control, 42, 385–388.

Study Purpose

To determine the effectiveness of a care bundle completed by patients with esophageal cancer before surgery to reduce the risk of postoperative pneumonia

Intervention Characteristics/Basic Study Process

Two groups of patients undergoing subtotal esophagectomy were compared based on their use of a daily care bundle intervention before surgery. The intervention included seven different activities: 1) deep breathing, 2) breathing exercises with an incentive spirometer, 3) respiratory muscle stretching, 4) professional oral cleaning by a dental hygienist, 5) thorough cleaning of the teeth and tongue, 6) adherence to nutrition guidelines, and 7) smoking cessation. 
 
Retrospective data were collected for patients who did not use the care bundle (precare bundle implementation). This group was compared to patients who used the care bundle. Patients who used the care bundle received instructions on each activity during a 30–60 minute outpatient session. Patients were instructed to complete the seven activities every day beginning on day 1 of instruction until the day of surgery, and they recorded adherence to each activity daily. The time from instruction until surgery ranged from 4–42 days, and the mean was 11 days.

Sample Characteristics

  • N = 240  
  • MEDIAN AGE = 64 years (range = 36–86 years)
  • MALES: 83.3%, FEMALES: 16.7%
  • KEY DISEASE CHARACTERISTICS: Esophageal cancer
  • OTHER KEY SAMPLE CHARACTERISTICS: The comparison groups were significantly different based types of surgery. The care bundle group was 65.4% thoracotomy and 34.6% thoracoscopic versus the non-care bundle group, which was 96.7% thoracotomy and 3.3% thoracoscopic.

Setting

  • SITE: Single site    
  • SETTING TYPE: Multiple settings  
  • LOCATION: Japan

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Retrospective, case-controlled study comparing two groups of patients, each from a different time period in the past.

Measurement Instruments/Methods

The definition of postoperative pneumonia was based on the Centers for Disease Control and Prevention criteria. The detection of postoperative pneumonia was based on bacteria collected from a bronchoscope within 30 days of surgery. An analysis between groups was completed using logistic regression.

Results

The control group (no care bundle) included 216 patients, and the case group (care bundle) included 26 patients. In the case group, compliance with the seven care bundle activities varied. All patients received professional oral cleaning by a dental hygienist and achieved smoking cessation. Respiratory muscle stretching, adherence to nutrition guidelines, and breathing exercises using an incentive spirometer were the activities most often missed with 62%, 69%, and 73% of patients reporting 100% adherence, respectively. 
 
In total, 20.4% of patients developed postoperative pneumonia. In the control group, 22.4% of patients developed postoperative pneumonia, and in the case group, 3.8% of patients developed postoperative pneumonia. The median day to developing pneumonia was postoperative day 5. Care bundle activities were significantly associated with a decreased incidence of postoperative pneumonia (OR = 0.16; CI = 95%; 0.01–0.94). Recurrent laryngeal nerve palsy was significantly associated with an increased incidence of postoperative pneumonia (OR = 3.18; CI = 95%, 1.44–7.11).

Conclusions

Completing daily care bundle activities before surgery for esophageal cancer may lower the risk of postoperative pneumonia. The study design and underadherence to care bundle activities limit stronger conclusions. However, most care bundle activities were inexpensive with little risk to patients, so the use of this intervention may still be warranted.

Limitations

  • Small sample (< 30): Not for study as a whole, but for the intervention group
  • Baseline sample/group differences of import: Significant difference in surgical approach (p < 0.001) and operative time (p = 0.002) between the comparison groups; variation in adherence to care bundles
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)
  • Other limitations/explanation: Although compliance rates with the care bundle activities reflect real-world applications, it makes the conclusions based on care bundle activities difficult to discern. Also, it was unclear how many days preoperatively a patient should complete the care bundle activities.

Nursing Implications

Preoperative nursing interventions and patient education may influence postoperative health outcomes. Nurses can promote smoking cessation, deep breathing, breathing exercises, oral care, and adherence to nutritional guidelines before surgery for esophageal cancer as a potential strategy to decrease the risk of postoperative pneumonia.

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Hirai, K., Motooka, H., Ito, N., Wada, N., Yoshizaki, A., Shiozaki, M., . . . Akechi, T. (2012). Problem-solving therapy for psychological distress in Japanese early-stage breast cancer patients. Japanese Journal of Clinical Oncology, 42, 1168–1174.

Study Purpose

To examine the feasibility and effectiveness of problem-solving therapy for psychological distress among patients with early-stage breast cancer

Intervention Characteristics/Basic Study Process

The problem-solving therapy involved five weekly sessions aimed at assessing problems, setting goals, generating solutions, choosing a solution, and implementing the solution and evaluating results. The therapy included a manual and worksheet for patients to use. Authors collected self-report data prior to the intervention, after the final sessions, and three months after the final sessions.

Sample Characteristics

  • Mean patient age was 50.21 years (SD = 11.09 years).
  • The sample was 100% female.
  • The majority of participants had stage II disease. All had had prior surgery; 89% were on hormone therapy.
  • Of all participants, 43% were employed full- or part-time, 79% were married, and 21% had a college education.

Setting

  • Single site
  • Outpatient setting
  • Japan

Phase of Care and Clinical Applications

Patients were undergoing active antitumor treatment.

Study Design

A pre/post-test design was used.

Measurement Instruments/Methods

  • Two-item 11-point Likert-type distress scale
  • Hospital Anxiety and Depression Scale (HADS), Japanese version
  • Scale that measured self-efficacy of patients with advanced cancer
  • Brief Cancer-Related Worry Inventory
  • European Organization for Research and Treatment Cancer Core Quality-of-Life Questionnaire (QLC-C30), Japanese version

Results

Four patients dropped out of the study after starting treatment. Analysis showed a significant effect of time on anxiety and depression scores (p < 0.01).  Over time scores for global health status, physical functioning, emotional functioning, and role functioning improved significantly.

Conclusions

The study shows that symptoms of anxiety and depression and some aspects of quality of life improved over time. The effect of the intervention cannot be evaluated from these study results. Though authors state that the intervention was feasible, the fact that 17% of the initial sample did not complete the study suggests that the intervention was not of interest to a substantial proportion of the patients.

Limitations

  • The study had a small sample size, with fewer than 30 participants.
  • The study had risks of bias due to the lack of a control group, blinding, and random assignment.

Nursing Implications

Study results are insufficient to allow evaluation of the acceptability and efficacy of the problem-solving intervention.

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Hingmire, S., & Raut, N. (2015). Open-label observational study to assess the efficacy and safety of aprepitant for chemotherapy-induced nausea and vomiting prophylaxis in Indian patients receiving chemotherapy with highly emetogenic chemotherapy/moderately emetogenic chemotherapy regimens. South Asian Journal of Cancer, 4, 7–10. 

Study Purpose

To assess the safety and efficacy of aprepitant for chemotherapy-induced nausea and vomiting (CINV) prophylaxis with highly emetogenic cheomtherapy (HEC) or moderately emetogenic chemotherapy (MEC) regimens

Intervention Characteristics/Basic Study Process

Patients received 125 mg aprepitant on day 1 and 80 mg along with palonosetron and dexamethasone

Sample Characteristics

  • N = 75   
  • AGE RANGE = 18-71 years
  • MALES: 10.3%, FEMALES: 89.7%
  • CURRENT TREATMENT: Chemotherapy
  • KEY DISEASE CHARACTERISTICS: Multiple tumor types 
  • OTHER KEY SAMPLE CHARACTERISTICS: Sixty percent were receiving HEC therapy.

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Open-label, prospective, observational

Measurement Instruments/Methods

  • Complete response (CR) defined as no emesis and no use of rescue medicatiton
  • Common Terminology Criteria for Adverse Events (CTCAE), version 4

Results

For all regimens, CR rates were 96.8%, 93.7%, and 92% for acute, delayed, and overall phases. Nine percent reported side effects; the most common was hiccoughs.

Conclusions

Triple drug antiemetic prophylaxis was effective to manage CINV in most patients.

Limitations

  • Small sample (< 100)
  • Risk of bias (no control group)
  • Risk of bias (no blinding)
  • Risk of bias (no random assignment)

 

Nursing Implications

This study adds to the substantial body of evidence for the efficacy of triple drug antiemetic regimens for the prevention of CINV.

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Hines, S., Ramis, M.A., Pike, S., & Chang, A.M. (2014). The effectiveness of psychosocial interventions for cognitive dysfunction in cancer patients who have received chemotherapy: A systematic review. Worldviews on Evidence-Based Nursing, 11, 187–193. 

Purpose

STUDY PURPOSE: To determine the effectiveness of psychosocial interventions for chemotherapy-related cognitive dysfunction (CRCD)
 
TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

DATABASES USED: Published literature including Cochrane Central, PsycInfo, PsycArticles, CINAHL, PubMed, Biomed, APAIS Health (Informit), Academic Search Elite, and EMBASE; unpublished studies including ProQuest Dissertations and Theses, Grey Literature Report, PsycEXTRA, Mednar, and direct communication with researchers
 
KEYWORDS: Search terms were not iterated in this article but were specified in the JBL Library of Systematic Reviews as (a) cancer or neoplasm or tumor and cognition or memory or concentration and antineoplastic agent or chemo or drug and psychosocial, and (b) neoplasms and cognition or cognition disorders and antineoplastic agent and psychology, social.
 
INCLUSION CRITERIA: Studies were included if participants were ≥ 18 years of age, diagnosed with any type of cancer, and received chemotherapy as a component of treatment either during or before the intervention. Interventions included cognitive behavioral training, psychological counseling, and education on compensatory techniques. Published and unpublished studies between 1985 and 2010 were included. Studies were determined to meet quality criteria if they were randomized, contained blinded participants or outcome assessors, used intention-to-treat analyses, and reported data for all measured outcomes.
 
EXCLUSION CRITERIA: Studies with ill-described or absent methods were not included in this review.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 122
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The authors assessed articles for inclusion using a form based on Cochrane Collaboration recommendations. They assessed the articles chosen for inclusion for quality with standardized appraisal instruments (i.e., the Joanna Briggs Institute Meta-Analysis of Statistics Assessment and Review Instrument [JBI-MAStARI]). No articles were included that ranked as having poor quality. Data were extracted with tools from the JBI-MAStARI. Results from two of the articles were pooled in a statistic meta-analysis (Review Manager 5.1, The Nordic Cochrane Centre, and The Cochrane Collaboration). Weighted mean differences and 95% confidence intervals were calculated for the continuous variables. A Chi-square test was used to assess heterogeneity. Narrative form was used when statistic pooling was not possible.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 6
  • TOTAL PATIENTS INCLUDED IN REVIEW = 812
  • KEY SAMPLE CHARACTERISTICS: Five studies (two ongoing at the time of publication) were designed to investigate cognitive behavioral training (CBT). One study involved an intervention based on CBT. A meta-analyses was conducted for two of the studies for which the authors provided additional data. Participants were primarily female, and the mean age range was 49.2–60.4 years.
 

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

Six studies were included. Five investigated CBT (two ongoing at the time of publication), and one involved a CBT-based neuropsychological intervention. CBT interventions were examined for concentration (n = 3) and memory (n = 4) in the systematic review. Low heterogeneity was noted (X2 = 0.00) for pooling trial results.  
 
Concentration: The meta-analysis included two studies (Doorenbos et al., 2005; Given et al., 2004) indicating that CBT significantly reduced concentration problems at 20 weeks for intervention groups (p = 0.004). Only one study included 32-week assessment. Concentration results were not sustained (Doorenbos et al., 2005). The third CBT trial (Poppelreuter et al., 2009) demonstrated a significant improvement in concentration across two intervention groups and healthy controls at the completion of therapy (p < 0.001), but no sustained intervention effects were seen at a six-month follow-up (p = 0.09).  
 
Memory: Differences between interventions and measurement outcomes prevented a meta-analysis (Ferguson et al., 2007; Ferguson et al., 2010; Given et al., 2008; Poppelreuter et al., 2009). Differences in initial memory were observed at the intervention's completion but were not sustained (​Ferguson et al., 2010; Poppelreuter et al., 2009). Mixed results were seen for subjects receiving symptom advice for cognitive concerns through personal versus automated intervention approaches (Given et al., 2004), and no results were observed in a more rigorous second study by Ferguson et al. (2010).

Conclusions

The authors indicated that there was insufficient evidence to recommend these interventions and concluded that future research involving CBT interventions for CRCD are unlikely to yield different findings. However, this systematic review and meta-analysis is limited because CBT and neuropsychological interventions and instruments differed, resulting in the inability to pool results.

Limitations

  • The meta-analysis was conducted on only two studies.
  • More studies with long-term follow-up periods are needed to draw conclusions about the efficacy of CBT. Additional information regarding intervention descriptions, subject characteristics, and the instruments used for outcome measures are necessary to complete this review for comparison.

Nursing Implications

The authors indicated that additional research using CBT for CRCD is unlikely to indicate efficacy. However, this review was limited by the limited number of studies reviewed, its lack of longitudinal timepoints, and the differences between the CRCD interventions.  

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Hindley, A., Zain, Z., Wood, L., Whitehead, A., Sanneh, A., Barber, D., & Hornsby, R. (2014). Mometasone furoate cream reduces acute radiation dermatitis in patients receiving breast radiation therapy: Results of a randomized trial. International Journal of Radiation Oncology, Biology, Physics, 90, 748–755.

Study Purpose

To demonstrate the potential benefits of topical mometasone furoate (MF) for the prevention of acute radiation reactions with a primary measure/endpoint being the mean modified Radiation Therapy Oncology Group (RTOG) score

Intervention Characteristics/Basic Study Process

Cream application
  • MF and diprobase were applied daily to the irradiated sites from day 1 for five weeks during breast radiation therapy (three weeks radiation therapy [RT], two weeks post-RT).
Radiation
  • Patients received 40 Gy of radiation therapy in 15 fractions in three weeks.
  • Some patients received an electron boost of 10 Gy in five fractions.
Randomization was stratified according to radiation site and whether the patient was a smoker. Patients were randomized to use MF or diprobase. Diprobase, an aqueous cream, was used as the control arm.
 
Assessments
  • Assessments occurred at baseline and on days 8, 15, 21, 29, 36, and 43.

Sample Characteristics

  • N = 99
  • MEAN AGE = 59.5 years
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: All patients had breast cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Included nonsmokers, ex-smokers, and smokers; bra cup sizes A–E were included; 72% also received chemotherapy

Setting

  • SITE: Multi-site
  • SETTING TYPE: Outpatient
  • LOCATION: United Kingdom

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment

Study Design

Double-blinded, randomized, controlled trial

Measurement Instruments/Methods

  • Modified RTOG for skin dermatitis
  • Dermatology Life Quality Index (DLQI)
  • Hospital Anxiety and Depression Scale (HADS)
  • Erythema measurement by reflectance spectrophotometry

Results

RTOG
  • Mean RTOG scores were lower for patients using MF than for those using diprobase (p = 0.046).
  • Patients using MF experienced lower scores than those using diprobase for the time till maximum RTOG score (statistically insignificant).
  • 4.8% of the patients using MF reached an RTOG of 2.5 versus the 15.5% of patients using diprobase who reached the same score. On a week-to-week basis, the difference in average scores between the groups in was not significantly different.
  • The odds ratio of having a lower RTOG score associated with MF use was 2.38 (p = 0.18).
Erythema
  • Higher erythema values were seen in patients using diprobase versus MF. Over the course of the study period, the average treatment difference between groups was significantly better for those using MF (p = 0.012).
HAD
  • Patients in the MF group experienced higher anxiety and depression scores at baseline than those in the diprobase group.
DLQI
  • Diprobase was associated with increased DLQI scores between weeks 2 and 3, but these scores gradually fell.
  • MF was associated with increased DLQI scores till week 5, but this score fell thereafter.
  • DLQI scores were worse for those using diprobase.

Conclusions

This study demonstrated that MF cream may be beneficial in reducing the severity of acute radiation skin reactions when compared to diprobase cream applied daily to the irradiated area on the breast during three weeks of RT and two weeks post-RT.

Limitations

  • Small sample (< 100)
  • Baseline sample/group differences of import
  • Measurement validity/reliability questionable
  • Intervention expensive, impractical, or training needs
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: It is not clear whether intensity-modulated radiation therapy was used, which impacts the development of radiodermatitis. A slightly higher percentage of participants in the diprobase group also received chemotherapy, which could have affected the results in this group negatively. The chemotherapy agents that participants received were not described.

Nursing Implications

The findings of this study demonstrated that the use of MF cream was more effective than an aqueous cream for the prevention of severe radiodermatitis in women receiving radiation therapy for breast cancer. Mixed results have been seen in various studies using different topical corticosteroids, suggesting that specific steroid selection is important. Overall findings suggest that it may be important to begin topical treatment use prior to radiation rather than using steroids for the treatment of radiodermatitis after it has developed. The optimal schedule for the use of such treatments has not been determined, and it has varied across studies.

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Hilpert, F., Stahle, A., Tome, O., Burges, A., Rossner, D., Spatke, K., . . . du Bois, A. (2005). Neuroprotection with amifostine in the first-line treatment of advanced ovarian cancer with carboplatin/paclitaxel-based chemotherapy—A double-blind, placebo-controlled, randomized phase II study from the Arbeitsgemeinschaft Gynäkologische Onkologoie (AGO) Ovarian Cancer Study Group. Supportive Care in Cancer, 13, 797–805.

Intervention Characteristics/Basic Study Process

Women with ovarian cancer scheduled for treatment with carboplatin or paclitaxel-based chemotherapy were randomized to receive either IV premedication with amifostine 740 mg/m2 or placebo for 30 minutes. Data were collected at baseline, after each cycle of chemotherapy, and at three and six months after completion of chemotherapy.

Sample Characteristics

The sample consisted of 71 women with advanced ovarian cancer.

Study Design

The study was a double-blind, randomized, placebo-controlled study.

Measurement Instruments/Methods

  • Measurements included vibration perception thresholds and vibration disappearance thresholds before cycle 4 and after the end of treatment. Secondary objectives were patella and Achilles tendon reflexes and two-point discrimination.
  • Sensory symptoms, fine global motor activities, and quality of life were collected via questionnaire.
  • Toxicity was reported according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE).

Results

Thirty-seven women received amifostine and 34 received the placebo infusion. A significant protective effect of amifostine was found in vibration, two-point discrimination, and deep tendon reflexes. No significant differences were observed for single sensory or motor symptoms; however, amifostine improved sensory neuropathy according to the NCI-CTCAE criteria. Inconsistent results were reported in regard to quality of life.

Limitations

  • The study sample size may have been too small to detect group differences.
  • Inconsistencies were present regarding the assessment of sensory neurotoxicity, the neurologic assessment of vibration thresholds, and quality of life.
  • There were inter-observer variances with vibration sense measurement.
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Higginson, I.J., Bausewein, C., Reilly, C.C., Gao, W., Gysels, M., Dzingina, M., . . . Moxham, J. (2014). An integrated palliative and respiratory care service for patients with advanced disease and refractory breathlessness: A randomised controlled trial. The Lancet. Respiratory Medicine, 2, 979–987. 

Study Purpose

To assess the effectiveness of a short-term breathlessness support service in facilitating breathlessness mastery in patients with advanced disease

Intervention Characteristics/Basic Study Process

Participants were randomly assigned at a 1:1 ratio by a computer-based system to the intervention group (immediate access to the breathlessness support service plus standard care) or the control group (standard best practice and access to the breathlessness service after six weeks). 
 
The breathlessness support service was an integrative, multidisciplinary service that included respiratory therapy, physiotherapy, occupational therapy, and palliative care. Starting with an outpatient clinic visit to respiratory medicine and palliative care, the present treatment and concerns were assessed, and patients were given a breathlessness pack that included information, management and pacing guidance, a hand-held fan or water spray, and a breath mantra or poem (to facilitate relaxation during crises). Two to three weeks after the clinic visit, a home assessment was performed by a physiotherapist or occupational therapist to determine the need for walking, home aids, reinforcement of self-management, other exercises, and a DVD when appropriate. Patients were then seen at a final clinic visit with a palliative care specialist four weeks following the first visit to determine additional interventions and discharge. 
 
Patients in the control group continued to receive optimum management according to United Kingdom best practice guidelines. After the six-week research interview, these patients were then offered the breathlessness support service. 

Sample Characteristics

  • N = 105 (53 assigned to the breathlessness support service, and 52 assigned to the standard care group)  
  • AVERAGE AGE = 67 years
  • MALES: 58%, FEMALES: 42%
  • KEY DISEASE CHARACTERISTICS: Patients were included if they experienced refractory breathlessness on exertion or rest despite optimum treatment of their underlying disease; advanced diseases including cancer, chronic obstructive pulmonary disease (COPD), chronic heart failure, interstitial lung disease, and motor neuron disease were included; willing to participate in home physiotherapy and occupational therapy; able to provide informed consent
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded if they experienced breathlessness of unknown etiology, had a primary diagnosis of chronic hyperventilation syndrome, were completely homebound despite the offer of free clinic transport, or were within two weeks of treatment for an acute exacerbation.

Setting

  • SITE: Multi-site    
  • SETTING TYPE: Multiple settings    
  • LOCATION: South London

Phase of Care and Clinical Applications

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

Study Design

This was a single-blinded, randomized, controlled trial. Research nurses and interviewers were blinded to the treatment allocation. Participants, the trial coordinator, and the trial administrator were aware of the treatment allocation.

Measurement Instruments/Methods

  • Chronic Respiratory Disease Questionnaire (CRDQ)
  • London Chest Activity of Daily Living (LCADL) scale
  • EQ-5D and EQ Visual Analog Scale (VAS)
  • Palliative Care Outcome Scale (PCOS)
  • Hospital Anxiety and Depression Scale (HADS)
  • Spirometry to assess pulmonary function
  • Pulse oximetry to assess oxygen saturation
  • Severity of breathlessness in the previous 24 hours on a numeric scale (0–10)

Results

According to the authors, participants who received the integrative palliative and respiratory support service experienced a 16% improvement in breathlessness mastery at week 6 when compared to the standard care group (p = 0.048; effect size of 0.44). 
 
There were no differences in patient-reported secondary outcomes between study groups at six weeks. However, for all measured items except anxiety, the breathlessness support service group had better scores than the control group. Significant improvements in the breathlessness support service group between baseline and six weeks were observed in seven outcomes: mastery, total quality of life score, dyspnea, emotion, average breathlessness per 24 hours, exertional breathlessness per 24 hours, and palliative care outcome scale total scores.
 
The control group demonstrated improvement in only the palliative care outcome scale between baseline and six weeks, and it showed significant deteriorations on the London Chest Activity of Daly Living questionnaire and HADS.
 
Overall, participants in the control group had a poorer survival rate (75%) when compared to participants in the treatment group (95%; p = 0.048). Of the participants with cancer, no significant difference in survival existed among those in the treatment and control arms of the study. However, among the participants without cancer (42), mostly those with COPD and interstitial lung disease, those in the breathlessness support service group were alive through the study to six months. Of the 42 control patients without cancer, 38 were alive at 90 days, and 32 were alive at 180 days. 

Conclusions

An integrative approach to managing breathlessness within a support service improves patient mastery of breathlessness.

Limitations

  • Findings not generalizable
  • Other limitations/explanation: One limitation of the study was a possible placebo effect because participants were not blinded to their specific treatment groups. The authors also suggested that although nurse researchers were blinded to the intervention groups, they may have been able to determine which treatment group participants were assigned based on the existence of breathlessness equipment in their homes (thereby potentially biasing their interviews). In addition, the authors noted that their inclusion and exclusion criteria prevented the inference of study results to patients in the last month of life. Finally, the authors noted that the short-term nature of outcome follow-up restricted their assessment of care costs and long-term survival.

Nursing Implications

Additional research and education on the structure and process of an integrative breathlessness support service for patients with advanced cancer is warranted.

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Higashikawa, F., Noda, M., Awaya, T., Nomura, K., Oku, H., & Sugiyama, M. (2010). Improvement of constipation and liver function by plant-derived lactic acid bacteria: A double-blind, randomized trial. Nutrition, 26, 367–374.

Study Purpose

To evaluate the effects of yogurts made with different types of lactic acid bacteria (LAB) on the gastrointestinal system.

Intervention Characteristics/Basic Study Process

Participants were recruited via advertisement. Consenting patients were assigned using stratified randomization by defecation frequencies to receive one of three types of yogurt.

  • Type A: plant-derived LAB—Lactobacillus plantarumSN35N (95%) with SN13T (5%)
  • Type B: plant-derived LAB—Lb. plantarumSN13T (98%) with SN35N (2%)
  • Type C: animal-derived LAB—Lb. lactis A6 (86.1%), Streptococcus thermophilus 510 (13.8%), and Lb. bulgaricus C6 (0.1%)

Participants consumed 100 g of yogurt daily for a six-week period. Data were collected from clinic visits at two-week intervals.

Sample Characteristics

  • The study reported on a sample of 68 patients aged 21 to 65 years.
  • The sample comprised 49 women and 19 men.
  • Patients were healthy adults with some complaints of intestinal health, such as constipation, diarrhea, abdominal pain, and bloating.

Setting

Hiroshima, Japan

Study Design

This was a randomized, double-blind study.

Measurement Instruments/Methods

Bristol Stool Form Scale

Results

  • No statistical difference existed between the study types (groups A and B) and the control (group C).
  • Total cholesterol decreased significantly in all individuals from 214.3 mg/dl at baseline to 203.2 mg/dl at six weeks (p = 0.012) in group B, but not in groups A and C.
  • No participants reported any significant adverse events resulting from yogurt intake during the trial.
  • No abnormal changes in urine analysis or serum biochemical parameters were observed during the study.

Conclusions

In healthy adults, Lb. plantarum SN13T may improve serum lipid levels and liver function. Actual effects in relieving constipation are unclear.

Limitations

  • The sample size was small (fewer than 100).
  • The study did not include patients with cancer.

Nursing Implications

Effects in relieving constipation are unclear in healthy adults. Additional studies are warranted that include a larger sample and patients with cancer.

Print

Hidderley, M., & Holt, M. (2004). A pilot randomized trial assessing the effects of autogenic training in early stage cancer patients in relation to psychological status and immune system responses. European Journal of Oncology Nursing, 8(1), 61–65.

Intervention Characteristics/Basic Study Process

The intervention was autogenic training (AT), a type of meditation, with mental exercises:

  • Heaviness of limbs
  • Warmth of limbs
  • Calm regular heartbeat
  • Easy breathing
  • Abdominal warmth
  • Cooling of forehead

Measurements were taken at baseline and at the end of two monthly periods. Patients were observed for evidence of meditative state. Group 1 (control) received one home visit, and group II (intervention) received one home visit plus two months of AT intervention.

Sample Characteristics

The study reported on a sample of 31 women with early-stage breast cancer.

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS)
  • T and B cell markers
  • Unpaired t tests
  • Calculations of blood results and HADS scores were made of mean and standard deviation.

Results

Results showed a p value of 0.0027 between groups for anxiety. T and B cell markers remained similar in both groups. The AT group reported improved HADS anxiety levels (t = 2.00, p = 0.092). There was no statistical difference in HADS scores for patients within the group.

Limitations

  • The study had a small sample of women with early-stage breast cancer.
  • Specialized education was needed to provide the AT.
  • The authors state a limitation may be that only 7 of 16 patients in the experimental group achieved a meditative state.
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