To determine the effects of a spiritual care and support program on levels of depression in patients with leukemia

Patients in intensive care randomly were assigned to the spiritual care or control groups. Patients in the control group could receive the spiritual care program after the completion of the study. The program encouraged a supportive presence through the expression of feelings, needs, and concerns, and provided education regarding disease, treatment, and supportive touch. To support religious rituals, patients were provided a prayer rug, rosary, and a veil for women. Participants also had access to an MP3 player and earphones to listen to prayers and passages from the Quran. Readings of prayers and the Quran at the bedside were implemented by a clergyman. Study measures were obtained at baseline and on day 3 by an individual blinded to study group assignment.

• N = 64  
• MEAN AGE = 41.68 years
• MALES: 60.5%, FEMALES: 39.5%
• KEY DISEASE CHARACTERISTICS: All participants were diagnosed with leukemia, and most participants had acute myeloid leukemia.
• OTHER KEY SAMPLE CHARACTERISTICS: About 50% of participants had a high school education. The mean time since diagnosis was 24.32 months in the experimental group and 18.08 months in the control group.

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

• PHASE OF CARE: Active antitumor treatment

Single-blinded, randomized, controlled trial

• Depression Anxiety and Stress Scale (DASS)

The mean postintervention score in the experimental group was lower than that of the control group (p < .001), and the change in depression scores in the intervention group was marginally significant (p < .07). Baseline data and changes for both groups were not provided.

This intervention, which included support and psychoeducational components along with spiritual support, was associated with reduced depression scores.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Other limitations/explanation: Findings may not be applicable to other cultural groups and individuals. The study had a very short duration. The treatment involved was not described, so it is not clear whether some patients were more acutely ill than others.

Supportive and psychoeducational interventions that include a component of spiritual support may be beneficial for hospitalized patients with leukemia. The provision of holistic supportive care is a principle of nursing care. These findings provide marginal support for the efficacy of these interventions during short-term hospitalization. There were several study limitations.

The objective of the study was to retrospectively examine whether recurrent malignant pleural effusions (MPEs) could be managed on an outpatient basis using small-bore tunneled pleural catheters (PCs) and without the use of sclerosing agents.

The study was a retrospective analysis of 24 patients who underwent placement of PCs to manage recurrent dyspnea symptoms due to MPEs.

Patients chosen were experiencing symptomatic MPEs and

• Had an advanced primary malignancy
• Had a predicted life expectancy of at least three months
• Had prior experience with dyspnea symptom relief post-thoracentesis
• Had radiographic evidence of an accessible, free-flowing pleural effusion.

PC placement took place in an outpatient clinic under local anesthesia or conscious sedation. Written and oral instructions were given to the patients and caregivers, including details on how to care for the catheter and perform drainage at home. Patients and their caregivers also received home visits from a home health nurse to reinforce these instructions. Patients were evaluated in the outpatient center weekly for the first two weeks and then as needed clinically. In each post-placement visit, patients were evaluated for subjective findings such as dyspnea, chest discomfort, and exercise intolerance. Objective evaluations included pulse oximetry, blood pressure, heart rate, respiratory rate, and weight measurement. In addition, patients were evaluated for pulmonary and/or catheter complications, including chest radiographs and computed tomography scans (if indicated).

Once the PC output was less than 50 mL on three consecutive days, the PC was removed using only local anesthesia in the Pulmonary Outpatient Center, and patients were periodically followed by the Interventional Pulmonology outpatient practice for evaluation of symptom recurrence or effusion.

• The study reported on a sample of 24 patients aged 47–89 years.
• Of the sample, 33% were males and 67% were females.
• Key disease characteristics were breast (11), lung (5), colon (1), mesothelioma (3), renal (1), melanoma (1), and adenocarcinoma of unknown primary (2).
• Patients who were extremely ill and had the potential to be admitted for the treatment of MPEs were excluded from this study.
   

This single-site study was conducted in an outpatient clinic in Philadelphia, PA, for both insertion and removal of the PC catheter.

• Patients were undergoing multiple phases of care.
• The study has clinical applicability for end of life, palliative care, and quality of life . 
   

The study was a retrospective chart analysis.

The dyspnea assessment instrument was not identified, but the presence and absence of dyspnea was implied.

A total of 27 PCs were placed. Three patients had bilateral PC placement, and one patient had two ipsilateral catheter placements (accounting for the extra catheter placements). All catheters were placed in an outpatient setting, and patients were sent home on the same day without any immediate complications. Five patients died during the study; four of these patients had fully functioning and patent catheters. The fifth patient developed cardiac tamponade, and the PC was removed and replaced by a chest tube. The indwelling time for these five patients prior to passing was 26.3 days.

Complications related to catheter placement included cellulitis, bacterial super-infection, and incisional tumor growth. These complications were managed with antibiotics, removal of the PC, and increases in anti-neoplastic medication.

Nineteen patients survived to catheter removal or to the time the analysis took place. Out of the 19 patients, 10 patients reached spontaneous pleurodesis after using daily PC drainage over a median time of 39 days. One patient achieved pleurodesis in 15 days after PC placement for a total of 11 out of 19 (58%) patients achieving either complete or partial pleurodesis without chest tubes or the use of sclerosing agents.

Small-bore tunneled pleural catheters are offered as an alternative, more palliative, less invasive treatment for MPEs. The number of patients in this study that reported relief of dyspnea symptoms and were able to achieve complete or partial pleurodesis after PC placement is comparable to those who undergo more invasive procedures.

•  The study had no appropriate control group
•  The study had a small sample size.
• The authors themselves recognized the potential bias of the study by excluding those patients who were extremely ill with a significant risk of being admitted for the management of MPEs.

The outpatient small-bore tunneled catheter method does not seem to be an appropriate method for patients with recurrent, symptomatic MPEs  who have weeks or days to live.

STUDY PURPOSE: To evaluate the current literature related to the efficacy and safety of tranexamic acid in craniomaxillofacial, head and neck, breast, aesthetic, burns, and plastic surgery

• FINAL NUMBER STUDIES INCLUDED = 14 studies included, 7 for meta-analysis (head and neck and breast not included in meta-analysis)
• TOTAL PATIENTS INCLUDED IN REVIEW = 288 for meta-analysis
• SAMPLE RANGE ACROSS STUDIES: Of the total studies considered, 14, including 908 patients, met inclusion criteria. Of those in this group, subspecialties included craniofacial, orthognathic, head and neck, breast, and aesthetic surgery.
• KEY SAMPLE CHARACTERISTICS: Four trials for craniofacial and three trials for orthognathic surgery

PHASE OF CARE: Active antitumor treatment

APPLICATIONS: Pediatrics

In the craniofacial studies, tranexamic acid use led to reduced blood loss (p = 0.00001) and a reduction in transfusion requirements (p = 0.00001). In the orthognathic studies, tranexamic acid use led to reduced blood loss (p = 0.01). In the head and neck trial, tranexamic acid led to a reduction in mean volume of drainage (p = 0.041). In the breast trial, tranexamic acid led to a reduction in drainage volume (p < 0.001). No complications were reported with the use of tranexamic acid in any of the included trials.

Tranexamic acid reduces blood loss and reduces the need for blood transfusions in craniofacial surgery. It reduces blood loss in orthognathic surgery and may reduce the drainage volumes in head and neck and breast surgeries.

• Limited number of studies included
• Mostly low quality/high risk of bias studies
• The head and neck study was underpowered.
• The breast trial’s protocol was not described well, with risk of bias.  
• Other agents used (ESA), other management strategies (blood pressure control, positional strategies), dosing differences, and so forth

Nurses involved in the surgical management of patients with cancer could consider the benefits of tranexamic acid in reducing drainage volumes in patients with head and neck or breast cancer. However, the articles did not draw clear correlations with the type of surgery and the presence of cancer. No significant finding was reported in these two populations related to the prevention of bleeding during or following surgical procedures.

To study the effectiveness of psyllium fiber (Metamucil^®) taken during pelvic radiation treatment for prostate or gynecological cancer

The experimental group received 1–2 teaspoons psyllium fiber. The control group did not receive any psyllium fiber. Patients in both groups were given a booklet titled “Nutritional Guidelines to Help Control Diarrhea.” Patients kept diaries from day 1 of recruitment through 28 days post-treatment, recording the number of bowel movements per day, consistency of stools, amount of antidiarrhea medication taken, and daily dose of psyllium fiber (for the experimental group).

• The study reported on 84 patients (72 males and 12 females).
• Patients had prostate or gynecologic cancer and were undergoing radiotherapy to the pelvis of at least 4,000 cGy in 20 fractions. 
• Patients with gastrointestinal (GI) disease, tumors of the GI tract, or regularly using laxatives or antidiarrheal medications were excluded from the study.

This was a nonblinded, randomized controlled trial.

• Diarrhea was assessed using the Murphy Diarrhea Scale, which is a scale that has not yet been validated but is based on preexisting scales.
• A day with diarrhea was defined as any one of the following.
  • 4–6 bowel movements (BMs) more than normal limits for the patient
  • One or more watery BMs
  • 2-3 loose BMs more than normal limits for the patient
  • Use of antidiarrhea medications
• Severity rankings were as follows.
  • Mild: Less than 11% of days with diarrhea
  • Moderate: 11%–20% of days with diarrhea
  • Severe: More than 20% of days with diarrhea
• Researchers identified the mean severity score for diarrhea, incidence of diarrhea, mean time to onset of diarrhea, mean duration of diarrhea (in days), and the mean percentage of days in which patients took antidiarrhea medication.

• Psyllium fiber was effective in reducing the incidence and severity of radiation-induced diarrhea.
• A statistically significant difference was found in severity (p = 0.030) and incidence (p = 0.049) of diarrhea.
• No statistical difference was found in mean time to onset of diarrhea, duration of diarrhea, or percentage of days in which patients took antidiarrhea medications.
• Psyllium fiber was well-tolerated, and patients had no complaints of GI side effects.
• The cost of psyllium fiber is low.

Psyllium fiber is a well-tolerated, low-cost, effective intervention for reducing the incidence and severity of radiation-induced diarrhea in patients undergoing pelvic radiation treatment for prostate or gynecologic cancer. 

• Because this was a pilot study, it was limited in scope.
• The study had a high attrition rate (60 out of 84 patients completed the study, 30 in each group; patients with inaccurate or incomplete diaries and patients in the non-psyllium fiber group who used psyllium fiber were excluded from final analysis).
• Proctor and Gamble, manufacturer of Metamucil^®, provided partial funding for the study via a research grant.

To determine the effectiveness of palonosetron when compared to granisetron in controlling nausea and vomiting in people with gastrointestinal cancer who were receiving moderately emetogenic chemotherapy

Patients with gastrointestinal cancer receiving their initial dose of induction chemotherapy (moderately emetogenic) either received 3 mg of granisetron or 0.75 mg of palonosetron on day 1 of treatment in addition to standard treatment (6.6 mg IV dexamethasone on day 1 and 8 mg oral dexamethasone on days 2 and 3). Effectiveness of the antiemetics was evaluated on day 5 by comparing occurrence of acute and delayed nausea and vomiting between the two groups.

• N = 92  
• MEAN AGE (whole sample) = 67.25 years (range = 37–86 years) 
• MALES: 69.5%, FEMALES: 30.4%
• KEY DISEASE CHARACTERISTICS: Gastrointestinal cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Receiving moderately emetogenic chemotherapy

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Large cancer clinic in Japan

• PHASE OF CARE: Active antitumor treatment

Prospective observational design, no random assignment of conditions, and no blinding of conditions

The Multinational Association of Supportive Care in Cancer's (MASCC's) Antiemesis Tool (MAT) with additional items about anorexia added. The MAT contains eight items assessing acute and delayed nausea and vomiting and one item assessing anorexia. Participants were asked to complete this measure five days after receiving chemotherapy.

Overall nausea and delayed nausea were significantly lower in the palonosetron group as compared to the granisetron group (p  <  0.01). The differences between acute nausea, overall vomiting, delayed vomiting, and acute vomiting were not statistically significant.

Palonosetron effectively controls delayed nausea caused by moderately emetogenic chemotherapy as compared to granisetron in patients with gastrointestinal cancer.

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

Palonosetron appears to be effective in controlling delayed nausea and would be a useful antiemetic to prescribe for those receiving regimens consisting of moderately emetogenic chemotherapy.

The purpose of the study was to facilitate practice based on clinical evidence by establishing practice guidelines on the use of myeloid growth factors. Adults in hematology and oncology were studied.
 

The resource type was evidence-based guideline. The process of development included a review of the meta-analysis, systematic Cochrane review, and a review of several randomized clinical trials.

The Cochrane database was reviewed. Keywords included  neutropenia, febrile neutropenia, myeloid growth factors, G-CSF, clinical practice guidelines, filgrastim, and pegfilgrastim
 

Active antitumor treatment

This article did not discuss the specific evidence, but outlined benefits of treatment with colony-stimulating factor (CSF) and its use in chemotherapy regimens. Distinguished use as secondary or therapeutic and reviewed the different types of CSFs to be used with which tumor types. The volume of citations was 35.

The use of CSF for primary prophylaxis should be based on the risk of an episode of febrile neutropenia based on disease and chemotherapy regimen. Chemotherapy regimens with risk of febrile neutropenia greater than 20% of primary prophylaxis with CSF is recommended; 10%–20% febrile neutropenia CSF should be considered and less than 10% risk CSF is not recommended. Secondary prophylaxis following an episode of febrile neutropenia or dose-limiting neutropenia, CSF should be considered if not given previously or in cases in which a reduction or delay of the dose is associated with poor prognosis.  Therapeutic use when patients present with febrile neutropenia is recommended based on the existing risk factors for poor clinical outcomes or for developing infection-associated complications.

Risk factors are older than age 65 years, sepsis syndrome, severe neutropenia, absolute neutrophil count (ANC) less than 100 mcl or prolonged duration of more than 10 days, pneumonia, invasive fungal infection or other clinically documented infections, hospitalization at time of fever, and prior episode of febrile neutropenia.

Provides professional evidence-based guidelines for use of CSFs for prophylaxis and treatment of febrile neutropenia. Recommendations here are consistent with those of past versions, and are consistent with those of the National Comprehensive Cancer Network and other relevant professional groups.

To evaluate the efficacy of olanzapine in the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving platinum-based chemotherapy and prophylactic palonosetron and dexamethasone

• N = 100   
• MEAN AGE = Control group: 55.04 years (SD = 1.5); test group: 53.66 years (SD = 1.55)
• MALES: 58%, FEMALES: 42%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Head and neck cancer, cervical cancer, esophageal cancer, ovarian cancer

• SITE: Single site   
• SETTING TYPE: Not specified
• LOCATION: Hospital in northwest India

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

This was a randomized, controlled, assessor-blind study.

Patients recorded the frequency and time of emetic episodes and the frequency and time of rescue antiemetics for the first five days. Patients also used the Multinational Association for Supportive Care in Cancer (MASCC) Antiemesis Tool (MAT) to record the control of nausea and vomiting and intensity of symptoms from days 1–5. Patients also recorded any adverse effects on days 1, 3, and 8–10 and as needed, as well as the duration and severity of the adverse effect. A trained nurse assessed all patients between day 8–10. At this time, the patients' overall quality of life was assessed using the European Organization for Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-C30), version 3, questionnaire.

For patients receiving platinum-based chemotherapy, olanzapine is an effective addition for the prevention of CINV. The only side effect listed is more sedation.

Findings not generalizable

Olanazpine is effective for the prevention of CINV in this sample with few adverse effects. It may not be generalizable, but more studies are supporting its use.

To evaluate the effectiveness of sodium picosulfate for constipation.

Patients were randomized to receive either sodium picosulfate or matching placebo drops as treatment. If the study treatment was not effective, 10 mg bisacodyl was used as rescue medication. Patients were allowed to titrate the number of study drug drops to best meet their bowel function needs.

• The study reported on a sample of 202 women.
• Mean patient age was 50.8 years in the treatment group and 51.9 years in the placebo group.
• The sample comprised healthy patients with functional constipation.
• Mean duration of constipation was 13.2 years.

• Multi-site
• Outpatient
• 45 general practices in Germany

This was a double-blind, placebo-controlled, parallel-group, randomized clinical trial.

• Diary to record bowel symptoms
• SF-36^®, version 2
• Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire
• Rome III diagnostic criteria

• The mean number of complete spontaneous bowel movements (BMs) increased from 0.9 to 3.4 in the sodium picosulfate group, compared to an increase from 1.1 to 1.7 in the placebo group (p < 0.0001).
• The mean number of complete spontaneous BMs per week compared to baseline increased by more than one in 65.5% of patients (p < 0.0001).
• After 24 hours, more patients in the intervention group had a complete spontaneous BM compared to the control group (69% versus 53%).

The use of laxative with sodium picosulfate in patients with chronic constipation may improve complete spontaneous BMs.

• The study was performed on a very general population. One should be cautious in interpreting these data for patients with cancer.
• The SF-36 looks at general functional status and is not a great tool for measuring quality of life.

Nurses need to be aware of other agents for the treatment of constipation, as well as the pharmacodynamics in which these agents work.

To describe one organization’s experience and findings with the use of prophylactic and interventional granulocyte infusions.

Two different approaches with granulocyte transfusions were used: (1) as an intervention for patients with progressive life-threatening infections and (2) to prevent the recurrence of infections in patients at high risk, including those undergoing allogeneic peripheral stem cell transplant. Patients receiving prophylactic treatment were scheduled for granulocyte transfusion from the beginning of neutropenia in the treatment cycle.  As an intervention, transfusions were given to patients with an absolute neutrophil count (ANC) less than 100/mm³ if they had a life-threatening infection despite other prophylactic antimicrobial treatment or severe infections during a previous neturopenic period, with a high risk of recurrence.  Timing and frequency of granulocyte transfusions were not described, but it was stated that transfusions were stopped if the ANC was greater than 500/mm³ 48 hours after the last transfusion.  Outcomes were evaluated 30 days after the first transfusion.

• Sixty-seven patients (79% male, 21% female) were included. 
• Median age was 56 years in the prophylactic group and 52 years in the interventional group (range 21–68).
• All patients had leukemia or non-Hodgkin lymphoma; 42% were undergoing transplant, 27% were receiving consolidation chemotherapy, and 24% were receiving salvage chemotherapy. Seventy-six percent of patients had a previous underlying fungal infection.

• Single site  
• Inpatient  
• Germany

Patients were undergoing the active antitumor treatment phase of care.

 This was a descriptive observational study.

European Organization for Research and Treatment of Cancer (EORTC) criteria for the classification of fungal infections

• Twelve percent of patients died with an inability to control infection.  
• In 82% of the treatment cycles, there was a positive response, and benefit seemed to be greater in the case of fungal infections, with prophylactic use (p = 0.01).
• Transfusions were reported to be well tolerated.

This study described the use of granulocyte transfusions and findings between prophylactic and interventional use related to fungal infections.

• Small sample (<100)
• Risk of bias (no control group, no blinding, no random assignment) 
• Unintended interventions or applicable interventions that would influence results were not described.*
• Selective outcomes reporting*
• Measurement/methods were not well described.

* Results reporting provides individual case details but little analysis of results and only analysis of difference between prophylactic use and interventional use in a small subset of patients who developed fungal infections.  There was no information regarding antifungal prophylaxis or other aspects of care that can be expected to affect these outcomes.  Reporting of percentages varied between the sample percent, cycles, or episodes of transfusion.  Many of the cases reported as fungal infection were actually possible rather than actual according to the EORTC criteria used. There was no subgroup analysis between various sample groups with different infection risks.

This study provided minimal information; it described an experience in using granulocyte transfusions.

To investigate the effects of prophylactic antihistamine on colony-stimulating factor(CSF)–related bone pain

The study included observation and treatment phases. Patients receiving pegfilgrastim completed pain surveys during the observation phase. Patients who developed significant pain were randomized to loratadine 10 mg daily or a matched placebo for seven days beginning on the day of pegfilgrastim administration. Rescue analgesics were recorded. Bone pain was assessed at baseline and on day 8 during both study phases.

• N = 213 in observation phase, 46 in treatment phase   
• MEDIAN AGE = 59 years
• AGE RANGE = 22–90 years
• MALES: 33.9% (observation), FEMALES: 66.1% (observation)
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Various tumor types with breast and lung most common.
• OTHER KEY SAMPLE CHARACTERISTICS: All had baseline bone pain greater than or equal to 5 for study entry, and 25.7% were on non-NSAID analgesics at baseline.

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

• PHASE OF CARE: Active antitumor treatment

• Observation and double-blind randomized treatment trial

• Brief Pain Inventory (BPI)
• Functional Assessment of Cancer Therapy–Bone Pain (FACT-BP)

Significant bone pain occurred in 30.5% of patients and worst pain score increased on average from 1.6 to 3.6 during the eight days following pegfilgrastim (p < 0.001). Patients receiving taxanes were more likely to develop significant pain (50.8% versus 23%, p < 0.001). There were no significant differences in baseline pain scores or change in pain scores between study groups. There were no significant differences between groups in analgesic use. Among patients receiving taxane, 90% benefited from loratadine, compared to 27.3%  in the placebo arm (p = 0.0008). Both study groups receiving taxanes showed increased worst pains scores from baseline.

In the total sample, antihistamine prophylaxis did not demonstrate a benefit for prevention of CSF-induced bone pain. Findings suggest that there may be some effects for patients receiving taxanes; however, the sample size is too small to draw firm conclusions.

• Small sample (< 100)
• Measurements used were designed to measure chronic pain rather than the acute episodic pain associated with CSFs. Pain was measured only at two time points. Some data regarding analgesic use were missing.

This study did not show any benefit of antihistamine for prevention of CSF-related bone pain. Findings suggest that further research in this area is needed, and specific examination of any benefits in patients receiving taxanes should be further investigated.