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Smith, C.A., Pirotta, M., & Kilbreath, S. (2014). A feasibility study to examine the role of acupuncture to reduce symptoms of lymphoedema after breast cancer: A randomised controlled trial. Acupuncture in Medicine. Advance online publication. 

Study Purpose

To determine the feasibility, acceptability, and safety of acupuncture to treat arm lymphedema in women following treatment for breast cancer

Intervention Characteristics/Basic Study Process

This was a randomized, controlled trial of acupuncture compared to usual treatment. Twenty women with stable, unilateral, intransient lymphedema that was present for at least six months prior were recruited. Ten participants were in the control group. The remaining 10 received 12 acupuncture treatments administered to body and arm points on the nonlymphedematous limb over eight weeks, twice weekly for four weeks then once weekly for four weeks. Clinical outcomes were assessed at baseline and again after eight weeks.

Sample Characteristics

  • N = 17  
  • MEAN AGE = 57 years (control, SD = 8.4 years), 63.4 years (acupuncture, SD = 7.4 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer-related lymphedema
  • OTHER KEY SAMPLE CHARACTERISTICS: Had lymphedema for at least six months

Setting

  • SITE: Single-site    
  • SETTING TYPE: Outpatient    
  • LOCATION: Clinic in Sydney, Australia

Phase of Care and Clinical Applications

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

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • Bioimpedance spectroscopy (BIS) and arm circumference measure (SFB7 instrument)
  • Lymphoedema Symptom Intensity and Distress Survey–Arm and Trunk (LSIDS-AT)
  • Measure Yourself Medical Outcome Profile (MYMOP)

Results

Compliance with the treatment protocol was high; 37 women were recruited and 20 were included in the trial. Three women withdrew from the trial. Participants reported an average of two symptoms associated with treatment. Acupuncture did not worsen lymphedema in the intervention group. The change in BIS measurements ranged from a 0.01 increase to a 0.3 decrease in the control group. The intervention group’s BIS measurements saw an increase of 0.28 and a decrease or 0.43. No increases in swelling greater than 10% occurred. No changes in quality of life or other patient-reported outcome measures related to lymphedema were reported.

Conclusions

Acupuncture did not cause any significant changes in limb volume for women with arm lymphedema. It may stabilize lymphedema symptoms. No major safety concerns were identified.

Limitations

  • Small sample (< 30)
  • Key sample group differences that could influence results
  • Subject withdrawals ≥ 10%
  • Other limitations/explanation: The control and intervention groups were chosen randomly, but the women in the acupuncture group had symptoms for a significantly longer period of time.

Nursing Implications

Acupuncture did not improve or exacerbate lymphedema in women who were breast cancer survivors. At this time, there is not enough research to promote the use of acupuncture as an effective intervention for the reduction of arm volume in this population.

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Smith, T.J., Bohlke, K., Lyman, G.H., Carson, K.R., Crawford, J., Cross, S.J., . . . American Society of Clinical Oncology. (2015). Recommendations for the use of WBC growth factors: American Society of Clinical Oncology clinical practice guideline update. Journal of Clinical Oncology, 33, 3199–3212. 

Purpose & Patient Population

PURPOSE: To update prior 2006 guidelines for the use of white blood cell (WBC) growth factors
 
TYPES OF PATIENTS ADDRESSED: Adults or children with solid tumor or lymphoma treatment with chemotherapy

Type of Resource/Evidence-Based Process

RESOURCE TYPE: Evidence-based guideline

PROCESS OF DEVELOPMENT: American Society of Clinical Oncology (ASCO) committee members and guidelines staff monitor medical literature to determine update needs, and update committee-drafted guidelines based on results from selected trials and clinical experience.  
 
INCLUSION CRITERIA: Phase-II, randomized controlled trials; systematic reviews; meta-analyses

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Results Provided in the Reference

Sixty-six publications formed the evidence base for the recommendations. Forty-one were randomized, controlled trials.

Guidelines & Recommendations

Primary colony-stimulating factor (CSF) prophylaxis starting with the first cycle and continuing in subsequent cycles is recommended for those who have about a 20% or higher risk for febrile neutropenia.
  • Secondary CSF prophylaxis is recommended for patients who have a neutropenic complication from a prior cycle of chemotherapy.
  • CSFs should be administered after an autologous HCT (strong recommendation) and may be administered after allogeneic hematopoietic cell transplantation (HCT) (weak recommendation).
  • The use of CSFs as primary prophylaxis in children is reasonable.
  • Prophylactic CSF for patients with aggressive lymphoma aged 65 and older undergoing curative treatment should be provided (moderate strength recommendation).
The guidelines also suggest that various CSFs and biosimilars are clinically equivalent.

Nursing Implications

The guidelines provide general recommendations for the primary and secondary prophylactic use of CSFs in patients being treated for cancer, and also outlines concerns regarding cost and the potential overuse of CSFs. The determination of a 20% risk for febrile neutropenia was not straightforward given patient variation and regimen alterations according to individual patient responses. Further work is needed to develop and evaluate clear individualized risk-based models for CSF use in a variety of patients with cancer.

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Smith, C., Carmady, B., Thornton, C., Perz, J., & Ussher, J. M. (2013). The effect of acupuncture on post-cancer fatigue and well-being for women recovering from breast cancer: a pilot randomised controlled trial. Acupuncture in Medicine, 31, 9–15.

Study Purpose

To evaluate the feasibility and acceptability of acupuncture in managing fatigue and well-being in women with breast cancer.

Intervention Characteristics/Basic Study Process

Patients were randomized to acupuncture, sham control, or wait-list control groups. Six acupuncturists provided the interventions. All needles were inserted with a Park device for both the sham and actual groups. Treatments were performed twice weekly for three weeks and then weekly for another three weeks. Acupuncture was administered at five points, and the needles were stimulated manually. Needles were retained for a maximum of 20 minutes, and sessions lasted 45 minutes. Women in the wait-list control were contacted every four days during the study. Women in the acupuncture group were also interviewed to explore the perceived impact of the intervention.

Sample Characteristics

  • In total, 30 patients (100% female) were included.
  • Mean age was 55 years.
  • All patients had breast cancer.
  • No patients were receiving treatment during the study.
  • Prior treatments received were not described.
  • All patients had fatigue scores between 4 and 6, which were considered moderate levels at baseline.

Setting

  • Single site  
  • Outpatient 
  • Australia

Phase of Care and Clinical Applications

  • Patients were undergoing the transition phase after active treatment.
  • The study has clinical applicability for palliative care.

Study Design

The study used a randomized, sham-controlled trial, with a mixed method.

Measurement Instruments/Methods

  • Brief Fatigue Inventory (BFI)
  • Well-Being Questionnaire (W-BQ12)
  • Measure Yourself Concerns and Wellbeing Questionnaire (MyCaW)

Results

Fatigue declined over time in all three groups. It was reported that fatigue declined significantly in the acupuncture group after two weeks; however, no statistical results were provided. Almost half of the women recruited declined participation, mainly due to the travel distance required. Well-being scores improved in all women, with no differences between groups. Findings from interviews showed that women who received acupuncture experienced improved sleep and relaxation with treatments and improved mood.

Conclusions

Findings suggested that acupuncture treatment is feasible in this group of patients and may be of benefit in improving fatigue.

Limitations

The study had a small sample size, with less than 100 patients.

Nursing Implications

The study suggested that acupuncture was feasible as provided and might have benefit in the management of fatigue; however, the study did not provide strong evidence to support the efficacy of acupuncture to improve fatigue.

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Smith, L.A., Azariah, F., Lavender, V.T., Stoner, N.S., & Bettiol, S. (2015). Cannabinoids for nausea and vomiting in adults with cancer receiving chemotherapy. Cochrane Database of Systematic Reviews, 11, CD009464. 

Purpose

STUDY PURPOSE: To evaluate the effectiveness and side effects of cannabinoids for chemotherapy-induced nausea and vomiting (CINV) in adults with cancer

TYPE OF STUDY: Meta-analysis and systematic review

Search Strategy

  • DATABASES USED: MEDLINE, EMBASE, LILACS, PsycINFO, and Cochrane  Collaboartion 
  • KEYWORDS: Search term details are provided .
  • INCLUSION CRITERIA: Randomized controlled trails comparing cannabinoid with either placebo or an antiemetic medication.

Literature Evaluated

TOTAL REFERENCES RETRIEVED = 441
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: The Cochrane risk of bias tool was used to evaluated study quality.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 23

Results

Nine trials compared cannabis with placebo. Two trials showed no difference between groups in complete absence of nausea, three trials showed likelihood of absence of vomiting with cannabinoids compared to placebo (RR = 5.7, 95% CI [2.6, 13]), and three trials showed more chance of complete absence of nausea and vomiting with cannabinoids (RR = 2.9, 95% CI [1.8, 4.7]).  Patients tended prefer cannabis to placebo. Cannabinoids versus prochlorperazine: nine trials with 1,221 patients compared these two. No significant differences in risk of CINV were found. Patients preferred cannabis in seven trials. Few very small trials of other drug comparisons were reviewed. Overall analysis of comparison with other antiemetic drugs showed the effectiveness of cannabis; however, the quality of the evidence was low to moderate level.

Conclusions

Analysis showed that cannabinoids were more effective than placebo and were similar to a few antiemetics for the management of CINV.

Limitations

The study quality was low overall. Comparison antiemetics in included trials were not the most current and highly effective medications.

Nursing Implications

Cannabis-based medicines may be useful adjuncts for the management of CINV. More current research comparing cannabinoid efficacy alone or as adjunctive treatment with agents such as NK1 and 5HT3 would be useful. Some of the cannabis-related research has suggested effectiveness with nausea, which has not been managed as well as vomiting with current regimens.

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Smile, T.D., Tendulkar, R., Schwarz, G., Arthur, D., Grobmyer, S., Valente, S., . . . Shah, C. (2016). A review of treatment for breast cancer-related lymphedema: Paradigms for clinical practice. American Journal of Clinical Oncology. Advance online publication. 

Purpose

STUDY PURPOSE: To evaluate breast cancer–related lymphedema treatment options to provide guidance to clinicians

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed and associated article reference lists
 
INCLUSION CRITERIA: Interventions included complete decongestive therapy (CDT), manual lymphatic drainage (MLD), compression, and invasive approaches, such as surgical interventions or liposuction
 
EXCLUSION CRITERIA: Not specified

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 149
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Not specified, included case studies and retrospective studies, 12 were randomized.

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 45 
  • TOTAL PATIENTS INCLUDED IN REVIEW = 1,838: 758 for CDT, 383 for MLD and compression, and 597 for invasive procedures
  • SAMPLE RANGE ACROSS STUDIES: 2–139
  • KEY SAMPLE CHARACTERISTICS: All had breast cancer.

Phase of Care and Clinical Applications

PHASE OF CARE: Late effects and survivorship

Results

  • CDT: Studies showed a consistent finding of volume reduction.  
  • MLD: 12 studies reported MLD with or without compression. The role of MLD as a single intervention is limited—it may have benefit incorporated into CDT.
  • Compression: Seven studies showed that compression was associated with consistent volume reduction. Kinesio taping was included with bandaging and intermittent pneumatic compression.
  • Invasive treatments: There were few studies of liposuction. Surgical interventions such as lymphatic bypass and node transplantation were associated with complications.

Conclusions

CDT is the most studied and consistently beneficial intervention.

Limitations

  • Limited search
  • Limited number of studies included
  • No quality evaluation
  • Mostly low quality/high risk of bias studies
  • Low sample sizes
  • Very limited number of studies and only one database used

Nursing Implications

This review adds to the body of evidence showing that the use of compression bandaging and CDT are shown to be effective for managing breast cancer–related lymphedema. Nurses can recommend these interventions. Additional research is needed in the area of invasive interventions.

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Sloman, R. (2002). Relaxation and imagery for anxiety and depression control in community patients with advanced cancer. Cancer Nursing, 25, 432–435.

Study Purpose

To determine the efficacy of relaxation and imagery for control of depression and anxiety

Intervention Characteristics/Basic Study Process

Patients were assigned to one of four treatment conditions:

  • progressive muscle relaxation (PMR) training
  • guided imagery training
  • both PMR and guided imagery training
  • control group

 A trained nurse taught patients the techniques in their homes, left a tape recorder and cassette, and asked subjects to practice the technique(s) twice daily. The nurse visited twice weekly to repeat the sessions.

In the control group, the nurse spent an equal amount of time with subjects, discussing general health and treatment concerns.

Investigators conducted pretesting. Post-testing occurred, for all subjects, three weeks after the initial session.

Sample Characteristics

The sample was composed of 26 men and 30 women. All participants had advanced cancer and were receiving palliative care.

Setting

  • Home
  • Sydney, New South Wales, Australia

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS), to measure anxiety and depression
  • Functional Living Index-Cancer (FLIC), to measure quality of life

Results

All three treatment groups showed significant reduction in depression, compared to the control group. No one treatment proved to be significantly superior, and none of the three treatments produced a significant reduction in anxiety.

Limitations

  • The study had a small sample size, with fewer than 56 participants.
  • Authors did not provide a clear description of the PMR and guided imagery techniques, so replication would be difficult.
  • The study occurred in one site, with one nurse conducting the interventions.
  • Post-testing at three weeks showed a short-term benefit; long-term benefits were not addressed.
Print

Sloman, R. (2002). Relaxation and imagery for anxiety and depression control in community patients with advanced cancer. Cancer Nursing, 25, 432–435.

Intervention Characteristics/Basic Study Process

The intervention involved progressive muscle relaxation (PMR) and guided imagery (GI). Patients were visited by a community RN who was trained in the use of relaxation and imaging technique. Tape recorders with cassettes were used to teach PMR and GI, with instructions provided by a clinical psychologist guiding the techniques.

Patients were randomized to one of four treatment groups:

  1. PMR training
  2. GI training
  3. Both PMR and GI training
  4. Control group (pre/post-test)

Sample Characteristics

  • The study reported on a sample of 56 patients with advanced cancer who were experiencing anxiety and depression.
  • All patients were receiving palliative care in their own homes, and all were on pain medication.

Setting

  • Community nursing setting
  • Sydney, Australia

Study Design

A randomized controlled trial design was used.

Measurement Instruments/Methods

  • Hospital Anxiety and Depression Scale (HADS): Used to measure anxiety and depression
  • Functional Living Index–Cancer Scale: Used to measure quality of life (QOL)

Results

  • None of the three treatments produced a significant reduction in anxiety (failed to reach significance [p = 0.057]).
  • All three treatments produced a significant reduction in depression.
  • All three treatments had improved QOL as measured by the index.

Limitations

The study had a small sample size.

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Slichter, S.J., Kaufman, R.M., Assmann, S.F., McCullough, J., Triulzi, D.J., Strauss, R.G., . . . Granger, S. (2010). Dose of prophylactic platelet transfusions and prevention of hemorrhage. New England Journal of Medicine, 362(7), 600–613. 

Study Purpose

To determine the effect of the dose of platelets (high, medium, or low) on bleeding with secondary aims to determine the effect of this dose upon grade of bleeding, number of platelets transfused, and number of transfusions

Intervention Characteristics/Basic Study Process

Hospitalized patients were randomly assigned by a computer at a 1:1:1 ratio to receive prophylactic platelet transfusion at either a low dose, a medium dose, or a high dose (1.1 × 1011, 2.2 × 1011, or 4.4 × 1011 platelets per square meter of body-surface area) when morning platelet counts were 10,000 per cubic millimeter or lower for five days or more. Site staff was not told the patients' specific assigned dose; however, complete blindness was prevented because of differences in transfusion volume. A blood transfusion service provided the assigned dose within the allowable range of ± 25% for this study. Treating physicians could change the trigger threshold for a patient if clinically indicated. The patient would return to the study protocol trigger as soon as possible. Site-specific guidelines were used to determine red cell infusions. Patients were assessed daily for 30 days after the first infusion, at a 10-day period without a platelet transfusion, at discharge, at death, or at withdrawal from the study.

Sample Characteristics

N = 1272

MEDIAN AGE: 47 years (low-dose), 50 years (medium-dose), 51 years (high-dose)

MALES: 60.4%, FEMALES: 39.6%

KEY DISEASE CHARACTERISTICS: Patients undergoing hematopoietic stem cell transplants or chemotherapy for hematologic cancers or solid tumors
 
OTHER KEY SAMPLE CHARACTERISTICS: Other required criteria were weight 10–135 kg; PT and PTT 1.3 times the upper limit of the normal range or less; fibrinogen of 100 mg per deciliter or more; and no other platelet transfusion during the current hospitalization. 

Setting

  • SITE: Multi-site 
  • SETTING TYPE: Inpatient  
  • LOCATION: All around the country

Phase of Care and Clinical Applications

  • PHASE OF CARE: Active antitumor treatment
 
 

Study Design

Randomized, controlled trial

Measurement Instruments/Methods

  • World Health Organization (WHO) criteria
  • Physical examinations
  • Interviews with patients
  • Chart reviews for bleeding events
  • Platelet counts, hematocrit values, and hemoglobin values  

Results

There was no significant difference between the percentages of patients who a received low, medium, or high dose of platelets and bleeding.

Conclusions

There is no significant difference in the volume of platelets given after the trigger of 10,000 for patients. Based on these results, using the lower volume of platelets would preserve the already decreased volume of available platelet products.

Limitations

  • Risk of bias (no blinding)

Nursing Implications

Nurses were not blinded on this study due to the fact that they were aware of the volume that was transfused; however, this would not affect the amount of volume that was delivered to the patient. Nurses are involved in the assessment of bleeding, transfusion, and monitoring of laboratory values.

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Slev, V.N., Mistiaen, P., Pasman, H.R., Verdonck-de Leeuw, I.M., Uden-Kraan, C.F., & Francke, A.L. (2016). Effects of eHealth for patients and informal caregivers confronted with cancer: A meta-review. International Journal of Medical Informatics, 87, 54–67. 

Purpose

PURPOSE: To synthesize evidence regarding effects of eHealth in patients with cancer and informal caregivers from systematic reviews

TYPE OF STUDY: Systematic review

Search Strategy

DATABASES USED: PubMed, EMBASE, CINAHL, PsycINFO, and the Cochrane Collaboration
 
KEYWORDS: Multiple terms for eHealth, cancer, systematic review, and meta analysis
 
INCLUSION CRITERIA: Systematic reviews reporting the effects of eHealth were included. EHealth was defined as the provision of information and/or support for patients or caregivers. Only minor or minimal flaws existed in the review.
 
EXCLUSION CRITERIA: Studies including patients without cancer were only included if the results for cancer were reported separately.

Literature Evaluated

TOTAL REFERENCES RETRIEVED: 8,157
 
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Quality assessment checklist for reviews; studies were only included if scores were at least of moderate quality

Sample Characteristics

  • FINAL NUMBER STUDIES INCLUDED = 10
  • TOTAL PATIENTS INCLUDED IN REVIEW = Not reported
  • SAMPLE RANGE ACROSS STUDIES: Not reported
  • KEY SAMPLE CHARACTERISTICS: Varied tumor types; mostly breast, prostate, and head and neck cancers

Results

Evidence was found for positive effects of eHealth on knowledge and perceived support. The findings regarding effects on decision-making were inconsistent. Interventions had some positive effects on patient involvement in healthcare. The findings regarding the effects of Internet support groups on anxiety and depression were mixed. Most interventions were Internet-based and had multiple components of education, support, chat groups, and communications with providers. One study used smart phone applications.

Conclusions

EHealth applications have been shown to have a positive effect on knowledge. Its effects on other aspects of the patient experience are inconsistent.

Limitations

All but one study were of moderate quality. Studies of low quality were excluded. Types of programs and components varied greatly, making the synthesis of effects for discrete interventions difficult.

Nursing Implications

eHealth applications may be a useful and practical way to provide patient and caregiver education. Its effectiveness as an intervention for psychological well-being and other outcomes was not clear given the mixed evidence. Ongoing research is needed to determine the full range of potential effects, program components that are most helpful, and needed duration of use for positive effects.

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Slatkin, N.E., Rhiner, M.I., Gould, E.M., Ma, T., & Ahdieh, H. (2010). Long-term tolerability and effectiveness of oxymorphone extended release in patients with cancer. Journal of Opioid Management, 6(3), 181–191.

Study Purpose

To evaluate the long-term safety, tolerability, and effectiveness of oxymorphone, extended release (ER), used to relieve cancer-related pain

Intervention Characteristics/Basic Study Process

Patients who had been taking oxymorphone ER in a previous study continued the dose they had been taking. Patients who had been taking a comparator opioid switched to an equianalgesic dose of oxymorphone ER. All patients underwent individualized dose titration to optimize effectiveness and tolerability of the opioid.

Sample Characteristics

  • The sample was composed of 26 patients.
  • Mean patient age was 57 years.
  • Of all patients, 51.2% were females and 48.8% were males. All patients had cancer pain.

Setting

Multisite

Study Design

Post-hoc analysis of two open-label extension studies, each at least one year long

Measurement Instruments/Methods

  • Visual analog scale (VAS), 100 mm, to measure pain
  • Brief Pain Inventory-Short Form (BPI-SF)
  • Global assessment of study medication (1 = poor, 5 = excellent)

Results

Of the 80 patients who entered the extension trial, 26 completed all 52 weeks. Seven patients discontinued the trial because of loss of medication effectiveness; 20 discontinued because of adverse events, most of which were unrelated to the study drug. Authors observed no significant increase in average pain intensity. The most common adverse events were concomitant disease progression (which 28.8% of patients experienced, n = 23), nausea (22.5%, n = 18), dyspnea (16.3%, n = 13), fatigue (16.3%, n = 13), and edema of the lower limb (15%, n = 12).

Conclusions

Patients appear to tolerate oxymorphone ER well. Oxymorphone ER provided stable long-term pain control, making it a potential alternative in the management of long-term pain.

Limitations

  • The study had a small sample, with fewer than 30 patients.
  • The pooled extension trials had different designs and assessed effectiveness using different outcome measures and assessment intervals. The trials lacked diary data to confirm exposure to oxymorphone ER.

Nursing Implications

In this study oxymorphone ER was a well-tolerated opioid that provided long-term control of cancer-related pain. In appropriate contexts, clinicians may want to consider oxymorphone ER an alternative to standard medication.

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