The intervention included twelve 90-minute meetings of a supportive-expressive group therapy led by a licensed clinical social worker; participants discussed problems, coping, treatment, mood, self-efficacy, relationships, pain, sleep, body image, and sexuality. Outcomes were emotional distress, mood, self-efficacy, body image, sexuality, social support, quality of life (QOL), pain, and sleep.

• The sample comprised 20 patients with stage I to IIIA breast cancer.
• Mean age was 47 years.
• Patients were post surgery.

Three community settings in Northern California

Patients were undergoing the active treatment phase of care.

The study used a one-group, pre-/posttest design.

Brief questionnaire based on the Structured Insomnia Interview to assess quality and quantity of sleep and daytime sleepiness

Patients undergoing 12 weeks of supportive group therapy showed statistically significant improvement in sleep (less waking during the night).

• The study had a small sample size and lacked a control group.
• Training is required to observe for unstable emotional status.
• A licensed clinical social worker familiar with supportive-expressive group therapy is needed.
• Cost is incurred for a space for the class and the instructor.

To evaluate the effectiveness of concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) in improving symptoms of xerosis in patients receiving chemotherapy.

• The study reported on a sample of 30 adult patients.
• Patients had gastrointestinal, breast, prostate, and lung cancers, and lymphoma; were receiving chemotherapy; and were experiencing dry, sensitive skin.

This study was conducted at Friedrich-Schiller University in Jena, Germany, and at Istituto Dermatologico San Gallicano in Rome, Italy.

This was a controlled, monocentric, three-week treatment trial.

• Patients were assessed on days 0, 7, 14, and 21 with four electronic devices.
  • Skin pH-Meter^® PH 900 to assess skin pH
  • Tewameter^® TM 300 to measure transepidermal water loss (TEWL)
  • Corneometer^® CM 825 to measure capecitabine-based skin hydration
  • Sebumeter^® SM 815 to measure casual surface sebum content
• Physician clinical assessment included the following.
  • Estimation of dryness symptoms with an original scale from 0 to 4
  • Visual assessment of perceived skin change with a 10-point scale
  • Physicians and patients gave subjective assessment on a questionnaire about the tolerability of both products.

• A significant reduction in TEWL (p < 0.007) was noted over time on the treated forearm.
• Compared to baseline, sebum content hydration values increased significantly until the end of the study (p < 0.001).
• Casual skin surface lipids increased significantly on the treated forearm (p < 0.03).
• No significant difference existed in pH values on both the treated and untreated forearms.
• For the physicians' clinical assessment, a progressive improvement of all skin symptoms was recorded in the course of treatment, whereas the lowest values (e.g., the best results) were obtained on the last examination day (p < 0.001).
• The visual assessment of the perceived change in skin state showed a significant improvement over the course of the study.
• Both the physicians and patients considered the application of the treatment tolerable enough with a good cleansing effect, leaving a nice sensation after use.

Concomitant treatment with a cleanser (slight acidic washing) and a slightly acidic emollient (both pH 5.5) was effective in improving symptoms of xerosis in patients receiving chemotherapy.

• The study was not randomized or double blinded.
• The study was funded by Sebapharma, whose products were used.

The purpose of the study was to compare the use of pegfilgratim in all chemotherapy cycles with pegfilgrastim use at the clinician’s discretion for the reduction of febrile neutropenia, grade 3 or 4 neutropenia, dose delay, dose reduction, hospitalization, antibiotic use, and infections in older adults with cancer.

Study period was June 2002 to Nov 2004.

Older adults with cancer of the breast, ovary, lung, or aggressive non-Hodgkin lymphoma (NHL) were randomized to pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring with cycle one) or secondary prophylaxis with pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring after cycle one at physician’s discretion [discretion may be in response to severe neutropenia, netropenia-related events during chemotherapy, dose delays, dose reductions, or no changes in dose or timing]).

• The total sample size was 852.
• All participants were aged 65 years and older.
• The amount of women was 548; the amount of men was 304.
• Key disease characteristics were lung, breast, or ovarian cancer or aggressive NHL.
• In the solid tumor and NHL groups, each of the following age groups were comprised of 33% of the patients: 65–69 years old, 70–74 years old, and 75 years and older.
• 90% were Caucasian and 90% had an ECOG score of 0 or 1.
• The majority of all patients were diagnosed with disease stage III or IV.

• Multi-site  
• Outpatient setting  
• Community cancer centers nationwide

• The phase of care was active treatment
• Application was for elderly care

Phase IV, open-label, randomized, multicenter, community-based trial

• Febrile neutropenia 
• Grade 3 neutropenia
• Chemotherapy regimen
• Solid tumor type
• Pegfilgrastin administered
• Dose delay, dose reduction, hospitalization, and antibiotic use

701 patients with solid tumors. Fifteen were excluded, making the sample size 686 (343 in the pegfilgrastim arm, 343 in the physician discretion arm). Those who completed the study in each arm was 198 in the pegfilgrastim arm  and 175 in the physician discretion arm. Forty-two percent of patients in the discretion arm received pegfilgrastim, most often for grade 3 or 4 neutropenia. There were 151 patients with NHL. Five were excluded, making the sample size 146 (73 in the pegfilgrastim arm, 73 in the physician discretion arm). Thirty-eight patients in each arm completed the study. In the discretion arm, 64% received pegfilgratim.
 

Febrile neutropenia was lower in the all-cycle pegfilgrastim arm compared to the discretion arm, with a 60% reduction in incidence of febrile neutropenia for patients with solid tumors (p = 0.001) and 59% reduction of febrile neutropenia for patients with NHL (p = 0.004). Grade 4 febrile neutropenia was 22% for patients with solid tumors and 75% for patients with NHL in the all-cycle pegfilgrastim arm compared to 58% for patients with solid tumors and 86% for patients with NHL in the discretion arm. Rates of febrile neutropenia in the first cycle for patients with solid tumors were 3%, and 7% for NHL patients in the all-cycle pegfilgrastim arm compared to 7% for solid tumors and 25% for NHL patients in the discretion arm.

Overall, for patients with solid tumors, the all-cycle pegfilgrastim arm had lower rates of grade 3 or 4 neutropenia, dose delays, dose reductions, decreased hospitalizations, and decreased antibiotic use compared to the discretion arm; and similarly for patients with NHL with the exceptions of higher rates of dose delay and dose reductions in the all-cycle pegfilgrastim arm. None of these findings were statistically significant.
 

The most serious adverse event related to pegfilgrastim use was bone pain (12%) in the solid tumor group and in the NHL group (9%) for those receiving all-cycle pegfilgrastim compared to 5% and 4%, respectively, for the discretion arm.

Pegfilgrastin use in older adults undergoing chemotherapy for cancer of the lung, breast, or ovary, or for NHL is safe and effective with use starting in the first cycle for the reduction of febrile neutropenia, grade 3 or 4 neutropenia, febrile neutropenia-related hospitalizations, and antibiotic use. Dose delay and dose reduction were shown to be increased for patients with NHL who received pegfilgrastin at all cycles compared to physician discretion, which may be due to increased use of pegfilgrastin through physician discretion in this population. In addition, due to the use of pegfilgrastin by physician discretion as the comparison group and the unknown information about frequency of dosing in the discretion arm outside of the majority beginning pegfilgrastin treatment following a grade 3 or 4 febrile neutropenic event, coupled with limited statistically significant outcomes, it is difficult to have a definitive conclusion based on these findings. Clinically, however, the outcomes do appear favorable towards use of pegfilgrastin beginning with the first cycle.

• This study was funded by Amgen, the manufacturer of pegfilgrastim, and the study was not blinded. 
• The use of pegfilgrastim for neutropenia and related adverse events in patients with other types of malignancies were not evaluated in this study.
• Fewer patients with NHL were able to be randomized to the discretion arm since physicians often wanted pegfilgrastim started early in these patients due to known neutropenic outcomes.
• In addition, this article was a replication of the article by Balducci et al. (2007), which was the original report of the findings; therefore, this article published two years after the original does not add to the knowledge of efficacy of use of pegfilgrastim.

The administration of pegfilgrastin starting with the first cycle of chemotherapy may reduce neutropenic events and related complications in older adults with cancer. Nurses can be at the forefront of advocating for this therapy, administering it, and monitoring patients for effective outcomes and/or adverse events.

Patients receiving 250 mg/m² IV irinotecan over 90 minutes every two weeks were given 500 mg levofloxacin tablets once at 8 pm and 4 g cholestyramine three times per day (not together with other medications) beginning the day before chemotherapy to day +1. Patients with acute cholinergic syndrome, abdominal cramping, and early diarrhea, were given 0.25-1 mg IV atropine. Patients experiencing delayed diarrhea were offered loperaminde.

• The study reported on 51 patients with metastatic colorectal cancer (CRC) in second-line treatment.
• Mean age was 64 with a range of 41–81.
• Patients had not received prior irinotecan therapy and were refractory or resistant to 5-fluorouracil (5-FU).

This was a phase II trial.

• Patients recorded diarrhea incidence and severity in diaries following each chemotherapy dose.
• Diarrhea severity was measured using World Health Organization (WHO) grading.

• Forty patients (78%) did not develop diarrhea, 11 patients (22%) reported WHO grade 1–2 diarrhea, and only one patient (2%) reported WHO grade 3 diarrhea.
• No patients reported grade 4 diarrhea. 
• Reported incidence of diarrhea without prophylaxis in the literature is up to 40%.

• The study sample was small.
• This was a phase II study.
• Investigators did not conduct pharmacokinetic analyses of the active metabolites SN-38 and SN-38G in plasma.
• No information was provided on the effect of cholestyramine on the efficacy of irinotecan efficacy. If cholestyramine decreases the effects of irinotecan, this could account for a decreased incidence of diarrhea.

Combination cholestyramine and levofloxacin is a promising option for prevention of delayed diarrhea caused by irinotecan and may help to escalate the dose of irinotecan in the future.

To determine the effectiveness of ABH gel (containing Ativan^®, Benadryl^®, and Haldol^®) on chemotherapy-induced nausea and vomiting (CINV) in patients with cancer

• N = 22  
• MEAN AGE = 47.1 years (range = 18–72 years)
• MALES: 6 (27.3%), FEMALES: 16 (72.7%)
• KEY DISEASE CHARACTERISTICS: The majority of the enrolled patients were status post–bone marrow transplant and other types of cancer, but the types of cancer were not specified.  
• OTHER KEY SAMPLE CHARACTERISTICS: Twenty patients had Hispanic or Latino background, 16 patients were Caucasian, and six were African American.

• SITE: Single-site    
• SETTING TYPE: Multi-site  
• LOCATION: An outpatient bone marrow transplant clinic and an inpatient palliative care unit at the Virginia Commonwealth University Massey Cancer Center in Richmond, United States

• APPLICATIONS: Palliative care

A randomized, double-blind, placebo-controlled, crossover, noninferiority clinical trail

• The Condensed Memorial Symptom Assessment Scale (CMSAS) was used to assess the symptoms of nausea.

In total, 22 patients enrolled in the study. However, 20 patients completed both arms (treatment and placebo) as a crossover. In the results section, the researcher listed three important findings: the mean change in the nausea score from baseline to 60 minutes post-treatment in both groups was not statistically significant; the ABH gel was not topically absorbed well even four hours after application; and almost 67% of the study patients stated that treatment was not effective in relieving symptoms.

The researchers concluded that the ABH gel in its current formulation should not be used for patients with cancer.

• Small sample (< 30)

The same authors also demonstrated similar results in healthy volunteers in their previously published study in the May 2012 issue of the same journal titled “ABH Gel is not Absorbed From the Skin of Normal Volunteers,” which found that ABH gel is not absorbed well topically. In that study, lorazepam and Haldol^® were almost undetectable in the blood samples of healthy study subjects; in other words, the plasma samples indicated that ABH gel was clinically or therapeutically insignificant. Therefore, ABH gel in its current formulation should not be used in patients with cancer.

To describe the use of methylnaltrexone (MNTX) in pediatric patients with cancer in both inpatient and outpatient settings

A retrospective chart review was conducted on all children, adolescents, and young adults with incurable cancer treated at St. Jude Hospital from May 2008 to June 2013. Pharmacy data and chart data were reviewed for inclusion data. Patients had documented OIC and the administration of enteral preparations and/or suppositories to treat OIC. After standard therapy for OIC was not successful, MNTX was administered subcutaneously at 0.15 mg/kg per dose.

• N = 9  
• AGE RANGE = 17 months-21 years
• MALES: 44%, FEMALES: 56%
• KEY DISEASE CHARACTERISTICS: Progressive, incurable cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Children, adolescent, and young adult

• SITE: Single site  
• SETTING TYPE: Multiple settings    
• LOCATION: Memphis, TN

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Pediatrics and palliative care 

• Retrospective chart review (RCR)

• Data collection tool specific to this study was used.

MNTX administration produced bowel function in seven (78%) of the patients in one hour and with five (71%) of the patients having a response to first dose. With repeated dosing, 71% had continued response. There were no side effects documented. Two patients responded to repeated doses. The drug was effective in four of five patients with intra-abdominal disease.

The study revealed that MNTX can be safe and effective in children, adolescents, and young adults with OIC and end-of-life disease.

• Small sample (less than 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable

OIC is a distressing side effect of opioid pain management. The use of MNTX in pediatric patients with cancer with progressive disease appears to be an effective and safe in this retrospective audit, but prospective randomized clinical trials are required.

• To examine the context of the use of morphine to manage cancer-related pain
• To establish how the views of healthcare professionals, patients, caregivers, and prescribers affect the use of morphine in practice
• To provide a case study and critique of critical interpretive synthesis (CIS) to synthesize a diverse body of evidence

• Databases searched were MEDLINE on OvidSP (1950–2008), CINAHL (1982–2008), EMBASE (1980–2008), PsycINFO (1967–2008), Health Management Information Consortium, and Social Sciences Citation Index accessed via Web of Science (1956–2008).
• Authors designed a search strategy that combined recognized search terms related to morphine (predominantly, terms used by the Cochrane Pain, Palliative and Supportive Care Group for oral morphine for cancer pain) with terms to identify qualitative research. Authors supplemented electronic searching with manual searches and contact with experts.
• Studies were included if they
  • Described results of original qualitative research.
  • Referred to the use of opioids for cancer pain.
  • Were published in English.
• Authors did not cite exclusion criteria.

Electronic searches retrieved a total of 2,886 records. After screening by title, 255 abstracts were retrieved for initial review. Of these the author obtained 30 articles for full review. Reference chaining yielded another 10 articles. A final sample of 19 resources met criteria and were analyzed. The author used a quality-appraisal checklist. Findings from each qualitative report were identified and compared with recommendations regarding effectiveness. Two resources provided the framework of comparison: Cochrane Systematic Review of Oral Morphine for Cancer Pain and the European Association for Palliative Care recommendations regarding use of opioids for cancer pain.

• The sample, across studies, included 465 patients.
• Study samples included male and female patients and self-identified African Americans.
• Samples included caregivers, nurses, patient and caregiver triads, and nursing and medical students. Patients included those who adhered and did not adhere to prescribed regimens, reluctant opioid takers, and older individuals in the community.

The study resulted in the synthesis of four arguments.

• Concerns about opiods:
  • Morphine was the drug of choice.
  • Patients, caregivers, and professionals had deep concerns about starting and continuing morphine therapy. The introduction of morphine was perceived as an accompaniment to worsening disease and death—a last resort.
  • The addictive potential of morphine was a barrier to its use, and anxieties about addiction influenced patients, caregivers, healthcare professionals, and medical and nursing students.
• Opioid use as a balancing act and trade-off:
  • Patients grappled with wanting pain relief while wanting to maintain functionality in their lives. They thought that, if they took opioids to relieve pain, they could experience adverse effects.
  • Adverse effects were viewed as a burden and were either tolerated to achieve relief or avoided by not taking medication.
  • The adverse effect most frequently mentioned was mental clouding and sleepiness.
  • After pain was so severe that taking opioids was the only alternative, the trade-off with side effects became acceptable. This was often when death was imminent. In many cases, patients took the opioids out of concern for others who were witnessing their pain.
• Existential meaning of cancer and cancer pain: Patients identified the meanings that follow.
  • Severe pain negated patients’ will to live.
  • Pain was a reminder of the presence of the cancer.
  • Severe pain indicated worsening disease and impending death.
  • Pain was vicious and exceeded any sense of control.
  • Patients feared that pain would increase before death.
  • Pain was tied up with all the emotions, fears, and uncertainties about the cancer diagnosis.
  • Taking opioids meant the cancer was out of control.
  • Fear of pain with dying was greater than the fear of dying itself.
  • Death would be a release from pain.
  • Cancer pain is a personal and private experience that no one else can understand.
• Intersubjectivity of pain: Cancer pain affects more than just the person experiencing it; it affects health professionals, caregivers, and the patient. Themes in this area follow.
  • Role and influence of health professionals:
    • Fears and concerns about addiction and adverse effects were implicitly or explicitly communicated to patients.
    • Teamwork involving nurses, physicians, patients, and caregivers was crucial to effective pain management.
  • Role of caregivers:
    • Feelings of conflict over how much control to assume in managing analgesia and how much control to give to nurses and the patient.
    • Dose-juggling responsibilities.
    • Despite education, caregivers were skeptical about problems of addiction.
    • They experienced fear, suffering, and helplessness and futility in the setting of unrelieved pain.
  • Management of pain by the patient:
    • Patients described a parallel existence—striving to live while strategizing to have a comfortable death.
    • Use of regular analgesia did not fit with some individuals’ self-image and led to conflict and guilt.
    • Various physical and cognitive strategies to manage pain were used. Most involved input from caregivers. This was a positive benefit for both.

Patients were selective about their disclosure of pain severity. The degree of confidence and trust in providers influenced reporting about pain, treatment choices, and use of opioids. Negative feeling toward providers led to reluctance to report pain.

This review provides a wealth of powerful and meaningful information that healthcare professionals can use to improve how they work with patients and caregivers in the management of cancer-related pain. Findings suggest that many professionals still have concerns about addiction with the use of opioids in the treatment of chronic cancer pain and that these professionals intentionally or unintentionally communicate these concerns, adversely influencing patients' and caregivers' experiences. Findings point to the importance of aggressive management and prevention of adverse side effects from opioids, to have a positive effect on the patient’s sense of the trade-offs involved with opioids. Findings support the concept that a team approach involving providers, caregivers, and patients and trust among team members are crucial to effective pain management.

Nurses can use the themes to guide open discussion and to anticipate potential issues regarding the use of opioids for pain management.

RESOURCE TYPE: Consensus-based guideline

PROCESS OF DEVELOPMENT: Not fully described. Provides only search terms used

Not stated

• Identifies high-risk factors as low neutrophil counts; unrelated or mismatched HCT; a combination of systemic steroid use and low neutrophil counts; high-dose cytarabine, fludarabine, or alemtuzumab; and those with acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML)
• Recommends prophylaxis for patients undergoing allogeneic HCT until at least day 75 or for 16 weeks in patients with graft-versus-host disease
• Recommends mold active prophylaxis for high-risk patients
• Recommends anticandida prophylaxis for low-risk patients
• Provides a review of individual prophylactic medications and application with specific antitumor agents used
• Recommends secondary prophylaxis in those with previous invasive fungal disease

No quality grading of evidence

Provides information regarding risk factors for consideration in determining the specific type of prophylactic agent to be used, and provides comprehensive information regarding metabolism, etc., of individual antifungals.

To explore relationships among variables and evaluate change in symptoms following cognitive behavioral therapy for insomnia (CBTI)

This paper reports a secondary analysis of a randomized controlled trial of CBTI delivered in group sessions over five weeks. Assessments done at baseline and post-treatment were analyzed.

• N = 113     
• MEAN AGE: Intervention group: 65 years, range 55–69; usual care group: 58 years, range 54–66
• MALES: 26%, FEMALES: 74%
• KEY DISEASE CHARACTERISTICS: Had breast, prostate, bowel, or gynecologic cancer and had completed initial therapy
• OTHER KEY SAMPLE CHARACTERISTICS: Had chronic insomnia defined as greater than 30 minutes for delayed sleep onset or wake time after onset, insomnia three or more nights per week for at least three months and scored five or more on the Pittsburgh Sleep Quality Index (PSQI). Most were retired and were not being treated for depression. Average fatigue severity at baseline was 5, anxiety was 7–8, and depression was 4–5.

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

PHASE OF CARE: Transition phase after active treatment

Secondary analysis of a randomized controlled trial

• 10-day sleep diary
• Hospital Anxiety and Depression Scale (HADS)
• Fatigue Symptom Inventory (FSI)

The most common symptom cluster reported was insomnia, anxiety, and fatigue (18% of patients). Clinical-level insomnia was reduced by 52% in the CBTI group compared to a 17.5% reduction in the usual care controls post-intervention (p < .001). CBTI resulted in a 10.9% reduction in rate of clinical levels of fatigue, compared with a 2.5% increase in control patients post-treatment (p = .03). Anxiety rates did not change. Most patients were not clinically depressed at baseline, and no significant differences were seen between groups in depression rates post-intervention.

The CBTI reduced prevalence of insomnia and clinically relevant fatigue.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Key sample group differences that could influence results
• At baseline, patients in the intervention group were older; no analysis was shown to determine if this difference was significant. No information is provided regarding medications or other interventions used for sleep or fatigue. Approximately 9% of the sample was lost to follow-up but from which groups is unclear.

Findings support the use of CBTI for sleep/wake disturbance and fatigue management in patients after cancer treatment. Follow-up in this report was immediately after five weeks of the intervention only, so how long-lasting any effects are is not clear.

• FINAL NUMBER STUDIES INCLUDED = 0
• TOTAL PATIENTS INCLUDED IN REVIEW = 134 pediatric patients
• KEY SAMPLE CHARACTERISTICS: A 5HT3 receptor antagonist was used as the antiemetic; age range of 0.5–18 years

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Pediatrics

Two studies addressed the comparative pediatric evidence related to the selection of a 5HT3 receptor antagonist. One study found a complete control rate of nausea and vomiting of 30% with tropisetron (8 out of 27) and 32% with granisetron (7 out of 22). The other study found a complete control rate of 61% with granisetron (20 out of 33) and 45.5% (15 out of 33) with ondansetron. Three other studies showed improved control of AINV when a corticosteroid was used with a 5HT3 receptor antagonist versus an antiemetic alone in patients receiving highly emetogenic chemotherapy (HEC). Another comparison between the use of IV versus oral 5HT3 receptor antagonists found equivalent effectiveness when used for HEC or moderately emetogenic chemotherapy (MEC).

Because of inconsistencies in the the research studies' methodologies related to pediatric AINC, there were few comparative effectiveness research (CER) examples. The evidence available to support guidelines is of low quality, and many research gaps exist. Barriers related to CER in pediatric AINV include patient factors, discrepancies related to research design, and definitions of complete control, outcomes, and outcome measures.

Insufficient evidence to develop comprehensive guidelines or for CER for AINV control in pediatric patients

Research related to pediatric AINV control is very limited and lacks in quality for comparison. The conclusions ascertained from this article were that children who used a corticosteroid with a 5HT3 receptor antagonist experienced increased efficacy of AINV control, and both IV and oral routes of these drugs have similar efficacy when used with HEC and MEC.