To compare hydrogel dressing to gentian violet (GV) for healing moist desquamation

Patients were referred after a nurse or radiographer identified moist desquamation. They were randomly assigned to GV or hydrogel. Patients were given instruction on how to apply GV or hydrogel at home and were assessed by radiographers on alternate days until the healing occurred. Tracing of the moist desquamation area on to polythene sheets was done randomly on different days with different patients.

• The study sample (N = 30) was comprised of male (6.3%) and female (93.7%) patients with head and neck or breast cancer.
• Mean age was 61.2 years for the GV group and 57.4 years hydrogel group.
• Median dose was 50 Gy, with a range of 40–64.7 Gy.

The study took place at a single site in the United Kingdom.

The study used a randomized controlled trial design.

• The end point was the time to healing.
• The secondary end point was “area under the curve” of the plot of the median area of moist desquamation against time.
• Tracing of the area of moist desquamation was used as the measure.

• Median healing time was 12 days in the hydrogel group and 30 days in GV group.
• Ten of the 16 patients withdrew from the GV group, citing nonhealing and stinging.
• Three of the 14 patients in the hydrogel group withdrew because of stinging and noncompliance.
• Over the first seven days, there were no differences in the area of moist desquamation.
• Over 14 days, the hydrogel group had a smaller area (p = 0.003), but the area of moist desquamation increased from baseline in both groups.

The study could not support or refute the value of hydrogel dressings.

• The sample size was small, with less than 50 patients.
• There is no standard system to identify moist desquamation.
• Many patients withdrew from the study.
• The study was stopped because of the benefit seen in hydrogel.
• The study had a risk of bias because it was unblinded.
• There was no standard amount of GV applications (several times a day).
• Patients with head and neck cancer often were not nutritionally sound, and patients with breast cancer may not have as many comorbidities.
• No subgroup analysis was done.
• The report did not mention if chemotherapy given.
• Although time to healing was the main end point, no statistical analysis of differences in time to healing could be done.
• There were no standard time points of skin evaluations.

To evaluate the efficacy of primary prophylactic pegfilgrastim compared to on-demand daily G-CSF after treatment with cladribine in patients with hairy-cell leukemia (HCL)

This was a retrospective chart review of 40 patients with HCL (1991–2012) treated with cladribine (0.1 mg/kg per day) for five to seven days either subcutaneously (SC) or IV, receiving a total of 40 courses of therapy treated with filgrastim (300 mcg per day) on demand until the patients' absolute neutrophil counts (ANCs) were > 2.0 x 10⁹ compared to nine courses of therapy with primary pegfilgrastim prophylaxis (6 mg SC for 24 hours after the completion of chemotherapy).

• N = 40 (on-demand filgrastim arm had 31 patients; primary pegfilgrastim prophylaxis arm had nine patients)   
• RANGE AGE = 23–76 years  
• MALES: 80%, FEMALES: 20%
• KEY DISEASE CHARACTERISTICS: HCL diagnosis confirmed by bone marrow biopsy and additional flow cytometry confirmation (after 2004); no significant difference in clinical and laboratory parameters between study populations before therapy including cytopenias, spleen size, ANC, platelet count, hemoglobin count, nadir duration, infections requiring hospitalization, and duration of hospitalization
• OTHER KEY SAMPLE CHARACTERISTICS: The on-demand filgrastim arm included two patients who received three cycles because of relapsed disease, seven patients who were treated with two cycles, and 31 patients who received only one course of therapy. In the primary prophylaxis pegfilgrastim arm, nine consecutive courses were given to nine patients 24 hours after the completion of chemotherapy.

• SITE: Medical centers
• SETTING TYPE: Inpatient  
• LOCATION: Haifa, Israel

• PHASE OF CARE: Active treatment

Retrospective, historical control study of patients with HCL prescribed cladribine determining the effect of IV pegfilgrastim versus filgrastim on neutropenia, hospitalization, 2⁰ FN, severity of infection, and ANC nadir

• The incidence of neutropenia (defined as an ANC < 1.0 x 10⁹ /L)
• Fever (defined as a temperature > 38.2 ^oC)
• Number of days of hospitalization because of FN
• Details of severity of infection
• Number days from the last day of therapy until ANC recovery (defined as an ANC > 1.0 x 10⁹ /L)

The median follow-up was 94 months (range = 12–312 months). No significant difference was found between primary prophylaxis with pegfilgrastim versus on-demand filgrastim for patients with HCL treated with cladribine for the variables of incidence of neutropenia, number days of hospitalization because of FN, severity of infection, or the number of days from the last day therapy till ANC recovery.

This retrospective study demonstrated no difference in the clinical effectiveness of primary pegfilgrastim versus on-demand filgrastim after cladribine therapy for patients with HCL.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Findings not generalizable
• Questionable protocol fidelity
• Other limitations/explanation: The majority of patients were in the filgrastim group (n = 31) compared to the pegfilgrastim group (n = 9). There may have been differences between the sites that were not disclosed. The grade of neutropenia not described. There were differences between the study groups (relapsed patients in the filgrastim on-demand arm). There were unknown comorbities in study population. Previous patient chemotherapy exposure was unknown. The details of the types and severity of infections post-treatment were not well-reported or described.

This study demonstrated no difference in the incidence of neutropenia, FN, or infections requiring hospitalization between the use of pegfilgrastim versus filgrastim after treatment with cladribine. Large, prospective, randomized trials need to be conducted to validate this study's results. Nurse-sensitive interventions remain critical in the prevention of infection for patients with HCL and prolonged neutropenia caused by disease and treatment.

The study evaluated transdermal clonidine for alleviating tamoxifen-induced hot flashes in women with a history of breast cancer.

Four weeks of transdermal clonidine (equivalent to a daily oral dose of 0.1mg) was followed by four weeks of placebo patches or vice versa. Patches were changed weekly.

The study enrolled 116 women with a mean age of 54 years who were receiving tamoxifen for breast cancer experiencing hot flashes and requesting intervention; experiencing hot flashes for longer than one month and at least seven per week. One hundred ten (110) of the 116 completed the study. Participants were stratified by age, duration of hot flash symptoms, and the average frequency and severity of hot flashes.

This was a randomized, double-blind, crossover prospective study.

The study employed the following measures:

• Daily self-administered patient questionnaires
• Weekly questionnaires
• Nurse assessment every two to three weeks for compliance, toxicity profile, and standard questions
• Hot flash severity and frequency measures and combined hot flash score

The study showed a statistically significant decrease in hot flashes (frequency and severity) (p < .0001), and clinically moderate decreases in frequency (20%) and severity (10%). Toxicities included dry mouth (p < .001) and constipation (p < .02).

Small study size limited the value of the outcomes.

To provide a systematic review of institutional interventions designed to improve management of pain in hospitalized patients with cancer

Databases searched were MEDLINE, Cochrane Library, and authors’ personal libraries.

Search keywords were pain, pain measurement, outcomes assessment, or quality assurance.

Inclusion criteria was not specifically stated, other than that studies involved patients with cancer.

Exclusion criteria was not specifically stated.

Total number of studies retrieved or initially evaluated is not provided.

Articles were reviewed and independently summarized by the authors, and any disagreements were discussed until consensus was achieved.

Studies were not exclusively for patients with cancer, but all did involve some cancer care cases.

• Four studies involving the effect of educational interventions for care providers, encompassing 939 nurses
• Two studies involving patient education, encompassing 343 patients
• Ten studies of interventions to improve assessment and documentation of pain, involving more than 2,876 cases
• Three studies involving the use of auditing and feedback, involving more than 4,662 patients
• Two studies and one meta-analysis involving use of pain specialty consultation
• One study involving the use of a computerized decision support system (CDSS) to enhance physician prescribing and treatment of pain

Nursing educational interventions improve knowledge and correct misconceptions but have not shown improved pain or patient satisfaction.

Studies suggest that patient education and tailored counseling sessions directed at patients can improve pain scores and negative beliefs and misconceptions.

Routine pain assessment has been shown to improve staff and patient satisfaction; however, interventions have not been shown to improve overall pain scores or pain severity.

Provision of audit and feedback of patient pain scores to nursing  staff improved pain assessment rates but had no effect on pain severity.

The study involving CDSS showed some improvement in prescribing practices, predominantly reducing use of meperidine, but did not demonstrate improved pain scores.

Meta-analysis of eight studies in the effect of a hospital-based palliative care team suggests that referral to such programs results in small but positive effects on pain, other symptoms, satisfaction, and reduction in length of stay compared to conventional care.

The major types of institution-wide interventions aimed at improving pain management include education, inclusion of pain assessment as a vital sign, auditing and staff feedback of pain scores, use of CDSS, and referral to palliative care specialists. Improved knowledge, assessment, and process of care measures have been demonstrated; however, no substantial effects on actual pain scores and severity have been demonstrated as a result of these interventions. From this review, the most promising interventions related to actual pain outcomes appear to be patient education and counseling and referral to palliative care specialists. The authors conclude that no generalizable interventions were identified.

• Findings are limited by the fact that studies had numerous methodological flaws and, in some cases, very small samples.
• The search strategy was limited and not well-reported and may have missed reports of some quality improvement efforts that may have not been published or identified in this review.

Findings point to the difficulty of being able to demonstrate the effects of institutional interventions on patients’ measurable pain outcomes other than satisfaction with pain management. Most of these efforts are not necessarily appropriate in a randomized controlled trial type of design, leading to questions of methodological rigor in findings, and suggest that the patient’s experience of pain is complex and not readily determined by standardized processes.

Findings suggest that individual patient interventions including counseling and education are worth further investigation in order to have an effect on pain outcomes.

Involvement of palliative care specialists appears to be somewhat effective to improve pain outcomes; however, it is not clear that universal referrals to such groups for all pain management are practical. This raises the question of how such specialized knowledge, focus, and expertise might be shared and utilized in new ways to impact all patients. It is not clear that educational interventions for staff that have been studied are sufficient to improve knowledge of providers to the extent required to impact pain-related results.

To determine if healing touch can benefit women undergoing diagnostic procedures for breast cancer

Patients were randomized to receive healing touch or to a control group receiving usual care by the day of the week after completing baseline surveys. Those in the experimental group were placed in a treatment room and placed on a massage table. Healing touch was provided by a trained practitioner for 15 minutes. Surveys were again completed after the breast biopsy procedure in both study groups. Participants were given a third set of surveys to return via mail the following day.

• N = 53   
• MEAN AGE = 52.59 (SD = 12.67 years)
• FEMALES: 100%
• CURRENT TREATMENT: Not applicable
• KEY DISEASE CHARACTERISTICS: Undergoing breast biopsy
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty-two percent indicated that their baseline stress level was high or very high.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: Minnesota

PHASE OF CARE: Diagnostic

Randomized, controlled trial

• State-Trait Anxiety Inventory (STAI)
• Coping Resources Inventory
• Heart and respiratory rate
• Blood pressure

State anxiety levels declined significantly immediately after the biopsy in both groups. On the next day, anxiety remained lower in the therapeutic touch group, but the difference between groups was only marginally significant (p = 0.06). Physiologic measures showed that the intervention groups respiratory rate and heart rate decreased, but differences between groups were not significant.

The findings suggest that healing touch may be helpful to reduce anxiety associated with undergoing a breast biopsy. Further study is needed to demonstrate efficacy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• The assignment was not truly random.  
• No information is given regarding the number of participants who actually returned mailed surveys, and the sample size for the follow-up data is not stated.
• The findings for women undergoing breast biopsy may not be applicable to other patient groups.

Therapeutic touch is a noninvasive intervention that may be helpful for some individuals undergoing periods of stress and anxiety related to diagnostic procedures. Further research is needed to determine the effectiveness of this intervention compared to usual care. Future studies should incorporate comparison to a sham intervention.

Patients were randomized, in double-blind fashion, to pentoxifylline 400 mg by mouth three times daily or placebo three times daily. If patients lost 5% of their on-study weight, the bind was broken and patients could cross over to the pentoxifylline arm.

• N = 70 patients (randomized, 35 in each arm)
• ELIGIBILITY CRITERIA: Older than 18 years of age, Eastern Cooperative Oncology Group (ECOG) performance status 0–2, life expectancy greater than three months, weight loss greater than five pounds over two months, estimated calorie intake of less than 20 kcal/kg/d
• EXCLUSION CRITERIA: Parenteral or tube feeding; edema or ascites; use of corticosteroids, androgens, progestational agents, or hydrazine sulfate within one month; mechanical gastrointestinal (GI) obstruction; more than five episodes of emesis per week; primary or metastatic brain tumors; hemoptysis, GI hemorrhage, or Sr. Cr more than two times normal
• Patients were stratified by
  • Primary tumor site
  • Amount of weight loss
  • Use of chemotherapy (CDDP versus non-CDDP)
  • Sex, ECOG performance status, and MD estimate of survival.

Patients were randomized in a double-blind fashion.

• Objective evidence of weight change (excluded if patient had edema or ascites)
• Questionnaires to evaluate appetite and perceived food intake

No significant difference was seen between cohorts in weight gain (P = .43). According to the questionnaires, there was no evidence that pentoxifylline is more effective than placebo in enhancing appetite. Toxicity data were similar for both groups for nausea and vomiting, fluid retention, and abdominal pain. The study was closed after the planned interim analysis, and it was concluded that pentoxifylline is not an effective treatment for cancer anorexia and cachexia.

The 95% confidence interval for the difference in the percentage of weight gain for pentoxifylline minus placebo ranged from a loss of 3.3% to a gain of 1.9%; this confidence interval suggests that the percentage of weight gain for pentoxifylline-treated patients is about the same for patients receiving placebo.

• Heterogeneous group of patients with cancers arising from a variety of primary sites

To evaluate the effectiveness of a self-managed, home-based walking program of moderate intensity

Prior to randomization, patients completed baseline questionnaires before beginning chemotherapy and after completing two of six cycles of chemotherapy. Patients were then randomized to usual care control or usual care plus exercise groups. Patients in the exercise group were given an intervention booklet with recommendations to ensure adherence, tips, guidance, and a diary to keep a log of walking duration and intensity. Self-management strategies used for guidance were based on the theory of planned behavior, including setting weekly goals, reflecting by writing achievements and shortfalls, and modifying goals. Pedometers were provided to the walking group. The intervention lasted 12 weeks.

• N = 50   
• MEAN AGE = 53.7 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had breast cancer, and most were grade 2 or 3; 72% were postmenopausal.
• OTHER KEY SAMPLE CHARACTERISTICS: Sixty percent were reported to be inactive at baseline.

• SITE: Single site   
• SETTING TYPE: Home    
• LOCATION: United Kingdom

PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Functional Assessment of Cancer Therapy (FACT)-Fatigue scale
• Self-Esteem Scale
• Profile of Mood States (POMS) short form
• Borg Rating of Perceived Exertion (RPE) scale
• Pedometer measures of steps taken each day
• General Practice Physical Activity Questionnaire

Eighty percent adhered to the intervention based on walking diaries. Group by time analysis showed that the intervention had a positive effect on fatigue (p = 0.02). No effects on anxiety or depression as measured by HADS were reported.

The self-managed, home-based walking program had a positive effect on fatigue.

• Small sample (< 100)
• Risk of bias (no blinding)

This study adds to the body of evidence showing that exercise has a positive effect on fatigue. A self-managed, home-based walking program is a practical approach to incorporating activity during active treatment. 

The purpose of this systematic review was to evaluate studies conducted with various antifungal agents to determine whether or not commonly used antifungals decrease mortality in patients with cancer.

The search strategy used databases such as the Cochrane Central Register of Controlled Trials (CENTRAL) and PubMed, as well as the reference lists of articles attached to the publications identified. Also reviewed were the proceedings of the ICAAC (from 1990–2007), General Meeting of the ASM (from 1990–2007), and the European Congress of Clinical Microbiology and Infectious Diseases (1995–2007). The authors also contacted expert researchers in the field.

Key words included random,  control,  blind,  nystatin,  amphotericin,  fluconazole, itraconazol,  ketoconazole,  miconazol,  voriconazol,  bone-marrow, cancer, fungemia, hematologic, fumalignan, neoplasm, neutropenia,  granulocytopenia,  leukemia,  or lymphoma

Randomized trials of antifungal treatments that were experimental in nature for patients with cancer were included. Studies that applied to treatment or prevention of oral candidiasis were excluded, as well as any non-randomized trials or randomized trials with noncancer patients.
 

Forty-four articles were retrieved. The authors reviewed the identified studies for mortality, mortality associated with a fungal infection, invasive fungal infection, colonization, use of additional antifungal therapy, and harm to patients.

The final article sample size was 32, with total subjects numbering 4,287.

Active treatment

Amphotecerin B was the only antifungal studied that showed reduced mortality significantly and consistently, used either prophylactically or empirically. Ketaconozole, fluconazole, and amhotercerin B were shown to be significant in overall effect for prophylactic administration. Itraconozole, fluconazole, and amphotecerin B all showed effectiveness in treating invasive fungal infection.

Amphotecerin B is highly effective in reducing mortality associated with fungal infection in patients with cancer. More studies should be done with large sample sizes to effectively compare amphotecerin B to other anti-fungals.

To examine the influence of psycho-oncologic intervention on the psychological condition of patients with cancer

Patients, who had self-assessed regarding anxiety and depression levels, were placed in high- or low-risk groups. Participants were then randomized to either a psycho-oncologic support group or a control group. Support involved talks with a certified psychologist, who addressed development of a therapeutic relationship, supported the patient’s personal autonomy and defense mechanisms, worked to increase hopefulness and confidence, and facilitated communication between patients and providers. Patients were randomized at the time of surgery. Study measures were obtained at hospital discharge and 12 months later. The number of support sessions varied according to the length of inpatient care. High-risk groups averaged four sessions lasting an average of 41 minutes each. Low-risk patients had two or three sessions lasting an average of 40 minutes each.

• The sample was composed of 131 participants.
• Mean patient age was 57.2 years, with a range of 27–79 years.
• The sample was 36.6% male and 63.4% female.
• All cancer types were represented.

• Single site
• Inpatient setting
• Berlin, Germany

Active treatment

Randomized controlled trial

Hospital Anxiety and Depression Scale (HADS), German version

The study showed statistically significant reduction of anxiety and depression in high-risk patients who had undergone psycho-oncologic intervention at the end of inpatient care (p = 0.001). At 12 months, anxiety and depression scores increased in all patients. Depression scores increased in all low-risk patients at the time of discharge.

Patients with cancer who have anxiety may benefit from psycho-oncologic support.

• The study sample had a higher percentage of women than men, and patients had different cancer diagnoses.
• At 12 months, only 49 patients had completed the HADS tool.

Postsurgical patients with cancer who are anxious may benefit from psycho-oncologic support services. In the study, the effect of the intervention was significant in only those patients who had high anxiety scores at baseline. Study findings are similar to those produced by other research. This fact may suggest that interventions for anxiety are most beneficial for individuals who have meaningful levels of anxiety to begin with. Psycho-oncologic support did not appear to affect depression scores; however, these scores were not high at baseline.

To study the effects of two different interventions on anxiety and depression postoperatively

The interventions that were studied included a single educational session and a single session of progressive muscle relaxation delivered between the third and sixth postoperative day to women who had surgery for gynecologic cancers. Women randomly were assigned to intervention groups. Study measures were obtained preoperatively prior to hospital discharge.

• N = 35  
• MEAN AGE = 49.4 years (range = 23–79 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Varied tumor types (ovarian and cervical were most common); most had grade-2 disease

• SITE: Single-site    
• SETTING TYPE: Inpatient    
• LOCATION: Germany

• PHASE OF CARE: Active antitumor treatment

Randomized, noncontrolled trial

• Hospital Anxiety and Depression Scale (HADS)
• Perceived-stress questionnaire
• NeXus 1 (device for measuring physiological measures, respiratory rate, heart rate, skin conductance, etc.)

Anxiety scores declined significantly in both groups (p < .005), and depression declined significantly in those receiving the educational intervention (p < .001). There were no differences between groups in self-reported stress, and there were no significant changes in physiologic measures.

The findings of this study demonstrate that the interventions tested here may have some benefit; however, the strength of the results is low due to study limitations

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: It could be expected that anxiety levels would decline between preoperative and postoperative states without any intervention. The types of surgery were not described. It could be expected that outcomes at discharge could vary according to the type of surgical procedure performed and expected prognosis. Almost one fourth of participants dropped out of the study.

This study does not provide strong evidence in support of educational and muscle relaxation interventions for the reduction of anxiety or depression.