To evaluate whether standardized educational tools, with or without telemonitoring, can improve the pain levels, pain interference, anxiety, depression, distress, performance, and quality of life of outpatients with cancer who have advanced tumors

Patients were randomized to receive either standard pain education plus telemonitoring or standard education alone. A nurse practitioner (NP) performed telemonitoring of pain every day for one week. The NP telephoned the patients and asked for average visual analog scale (VAS) pain score and worst VAS pain score in the last 24 hours. This provided patients with the opportunity to assess the severity of pain themselves. Using the National Comprehensive Cancer Care Network (NCCN) guidelines for pain management, the NP advised patients whether to increase or decrease medication. The NP was trained in pain management but had no specific training for other psychosocial interventions. Standard education included a video and booklet with individual coaching, to correct misconceptions, and an outline of decision making for pain control. Outcomes were measured at one week, and average pain was measured at two months.

• The study reported on a sample of 108 patients.
• Mean patient age was 59.8 years.
• The sample was 67.6% male and 32.4% female.
• The sample included patients with stage IV solid tumors (breast, gastrointestinal, genitourinary, lung, head and neck, and other).
• Most patients had been prescribed opioid analgesics.

• Single site
• Outpatient
• Seoul, Republic of Korea

• Patients were undergoing the end-of-life phase of care.
• The study has clinical applicability for elder care and palliative care.

A randomized controlled trial design was used.

• Brief Pain Inventory (BPI)
• Hospital Anxiety and Depression Scale (HADS)
• Distress Thermometer
• European Organization for Research and Treatment of Cancer quality of life questionnaire
• Karnofsky Performance Status score

Pain intensity, for all patients, had significantly improved at one week, including worst pain (7.3–5.7, p < 0.01) and average pain (4.6–3.8, p < 0.01). Additionally, anxiety (HADS score ≥ 11, 75%–56%, p < 0.01), depression (HADS score ≥ 11, 73%–51%, p < 0.01), quality of life (fatigue and insomnia), and Karnofsky score (32–66, p < 0.01) were significantly improved at one week. However, the level of distress did not improve. The study revealed no significant differences between groups in these areas.

Standardized pain education delivered by a nursing specialist is an efficient means of improving not only pain but also anxiety, depression, performance, and quality of life. This study did not show that the addition of telemonitoring substantially improved pain management in the outpatient setting.

• The study had risk of bias due to the lack of an appropriate attentional control condition.
• A one-week study may be too short to show significant improvement in pain outcomes.
• To extend this study, researchers should conduct a baseline screening with multiple variable assessments in addition to the Karnofsky score.

Findings show that comprehensive pain education was associated with short-term reduction in pain, anxiety, and depression scores. The addition of telemonitoring follow-up for pain management did not result in a significant difference in these scores; however, the follow-up period  was only one week. Longer-term studies of the effects of monitoring via telephone and other technologies, for the purpose of improved symptom management, may be helpful in identifying effective methods of improving symptom control in outpatient settings.

To evaluate the effectiveness of prophylactic itraconazole in preventing fungal infections in pediatric autologous hematopoietic stem cell transplant (HSCT) recipients.

Patients with high-risk solid tumors undergoing autologous HSCT were divided into prophylaxis and empirical treatment groups to evaluate the effectiveness of itraconazole prophylaxis in pediatric autologous HSCT.  High-risk solid tumors included high-risk neuroblastoma, high-risk embryonal brain tumor, bilateral advanced retinoblastoma, and relapsed solid tumors. Patients were then randomized to prophylaxis or empirical treatment groups.  In the prophylactic group, itraconazole was given intravenously at 2.5 mg/kg/dose twice daily for the first two days followed by 2.5 mg/kg/dose once daily for the duration of treatment after the absolute neutrophil count (ANC) fell below 0.5x10⁹/L, even in the absence of fever.  In the empirical treatment group, a placebo was given once the ANC fell below 0.5x10⁹/L after the initiation of high-dose chemotherapy, and itraconazole was started only when a fever persisted for more than three days or if fever recurred despite the use of first-line antibiotics (in this case, cefepime) for more than three days. All antibiotics, including itraconazole, were discontinued after three consecutive days of no significant fever (<37.5°C), no evidence of documented or clinically suspected infection, and an ANC greater than 0.5x10⁹/L.  For microbiologically documented infections, the antibiotic regimen was altered as needed.

• Fifty-five patients who underwent 90 autologous HSCTs were included.  
• Median age was 49 months (range 15–300) in the prophylactic group and 46 months (range 17–302) in the empirical group.
• The numbers and percentages of males and females were not reported.
• Key disease characteristics were neuroblastoma (38.1% in the prophylactic group, 41.9% in the empirical group), brain tumor (40.5% in the prophylactic group, 44.2% in the empirical group), retinoblastoma (9.5% in the prophylactic group, 9.3% in the empirical group), Wilms' tumor (4.8% in the prophylactic group, 4.7% in the empirical group), osteoscarcoma (4.8% in the prophylactic group, 0 patients in the empirical group), and primitive neuroectodermal tumor (1 patient in the prophylactic group, 0 patients in the empirical group).  Patients were newly diagnosed (83.3% in the prophylactic group, 83.7% in the empirical group) or had relapsed (16.7% in the prophylactic group, 16.3% in the empirical group).
• Patients were either receiving their first HSCT (47.6% in the prophylactic group, 53.5% in the empirical group) or their second HSCT (52.4% in the prophylactic group, 46.5% in the empirical group). Time to ANC greater than 0.5x10⁹/L was 10 days (range 8–15) in the prophylactic group and 9 days (range 7–16) in the empirical group; duration of ANC of less than 0.5x10⁹/L was 11 days (range 6–22) in the prophylactic group and 10 days (range 5–18) in the empirical group.
   

• Single site  
• Inpatient
• Pediatric Stem Cell Transplantation Unit of Samsung Medical Center

• Patients were undergoing the active treatment phase of care.
• The study has clinical applicability for pediatrics.

This was a prospective double-blind, randomized study.

• Total duration of fever    
• Duration of antibiotic treatment
   

No cases of proven, probable, or possible invasive fungal infection occurred in either group.  The duration of fever higher than 38ºC was significantly shorter in the prophylaxis group than in the empirical group.  The number of patients who had fever for more than seven days, which was the duration of antibiotic use, and the number of patients who needed additional second-line antibiotic treatment, were lower in the prophylactic group than in the empirical group.  There was no difference in the development of serious adverse events between the prophylaxis group and the empirical treatment group.  The expected benefit of prophylaxis in patients with severe mucositis did not seem to be relevant because there was a reduced duration of fever regardless of the severity of mucositis.

Although there were no infections in the prophylactic group, this was not different than the results in the empirical group.  There was no statistically significant finding to come from this study.  There were some promising findings, such as decreased need for second-line antibiotics and decreased duration of fever, but a larger study would be necessary to prove that these are relevant findings because the power was not high enough in this study.  This was a limited population, and the findings may not be generalizable to adult patients undergoing HSCT.

•  Small sample (<100)
•  Drug levels of itraconazole were not measured.
   

This article educated about fungal infections and the need for antibiotics, as well as neutropenia and the expected adverse effects of transplant.  There are no specific nursing implications for this study because there were no significant findings.

To determine the effect of intraoperative dexmedetomidine on incidence of catheter-related bladder discomfort

Patients were randomized to control and dexmedetomidine. After induction, the dexmedetomidien group had a loading dose of 1 mcg/kg over 10 minutes and then a continuous infusion of 0.5 mcg/kg per hour until the end of surgery. Control patients received an identical volume of normal saline.

• N = 109   
• AGE = Not provided
• MALES: 100%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: All were undergoing transurethral resection of the prostate (TURP)

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: South Korea

• PHASE OF CARE: Active antitumor treatment

• Double-blind randomized, controlled trial

• Patient response to verbal questions for pain severity or by patients reporting pain on their own

The incidence of catheter-related bladder pain was higher in the control group (p = 0.004) and, at one hour after surgery, pain severity was lower in the experimental group (p = 0.041). The incidence of moderate-to-severe pain was higher in the control group (p = 0.006).

Intraoperative dexmedetomidine may reduce postoperative catheter-related bladder pain.

• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable
• Method of pain measurement is very questionable, as more severe pain was identified only if the patient raised the issue. 
• Timing of measures was not explained.
• No information on use of analgesics was provided.
• No sample demographic information was provided.

Findings suggest that intraoperative dexmedetomidine may reduce bladder pain associated with an indwelling catheter; however, more well-designed research is needed. This study had multiple limitations.

To investigate the effects of complex decongestive physiotherapy with and without active resistive exercise on volume reduction of the upper limb and improvement of quality of life (QOL) in patients with breast cancer-related lymphedema

Patients were randomly assigned to the active resistive exercise (ARE) group or the the nonactive resistive exercise group. Both groups received complete decongestive physiotherapy (CDPT) led by a physical therapist once a day, five days a week, for two weeks. The nonactive resistive exercise group then continued self-administered CDPT for another six weeks. The ARE group performed shoulder stretching exercises followed by using dumbbells for 15 minutes while wearing a compression stocking or multilayer bandage.

• The study sample was comprised of 40 patients.
• Mean age of the ARE group was 50.5 years and for the nonactive resistive group 50.9 years.
• Patients were included in the study if they had a greater than 2 cm circumference difference between the affected and normal arm or had lymphedema diagnosed via lymphoscintigraphy.
• Patients were excluded from the study if they were aged 70 years or older; had cancer recurrence within six months from time of entering study; had lymphedema in both arms; had vascular disease; had any neurologic signs, such as decreased motor power, sensory changes, or decreased deep tender reflexes; or could not communicate

The study took place in an outpatient setting at Kosin University Gospel Hospital in Korea.

The study has clinical applicability for late effects and survivorship.

The study used a randomized controlled trial design.

• Circumference was measured every 3 cm before and after eight weeks of treatment to determine limb volume.
• QOL was measured using the 36-Item Short Form Health Survey Version 2 (SF-36v2) before treatment and after eight weeks of treatment.
   

Both groups showed significantly reduced volumes after treatment, but the difference between the reduced volume in the distal arm and that of the total arm was not significant. The ARE group showed a significantly reduced volume in the proximal arm. Although CDPT  is described as manual lymphatic drainage, compression therapy, and remedial exercise, description of the remedial exercises does not identify whether or not a compression garment or multilayer bandages were worn. Patients in the ARE group wore a compression stocking or a multilayer bandage to avoid aggravation of the lymphedema in the shoulder and arm while doing exercises.

Both groups had reduced QOL demonstrated by baseline values on the SF-36v2. After treatment, patients in the ARE group showed significant improvements in the SF-36v2 categories of physical functioning, role-physical, body pain-general and mental health. The nonactive resistive exercise group experienced improvements in physical functioning, role-physical, body pain, and mental health. By comparison, the ARE group showed significant improvements in role-physical and general health as compared with the nonactive resistive exercise group.
 

ARE demonstrated volume reduction in the proximal arm, with no statistically significant reduction in the distal or overall measurement. More robust research focusing on the relationship between resistive exercise and lymphedema is needed.

• The study had a small sample size (N < 100).
• No binding was done for the study.
• Findings not are not generalizable.
• The study does not indicate if patients are male or female.
• The age range of participants exceeds the exclusion criteron of older than 70 years, indicating that the sample size was potentially even smaller.

Exercise, including ARE, appear to be beneficial for patients with BCRL.  It is important to note that all participants in this small study received CDPT, with self-administration techniques included. Nurses should encourage patients to speak with a therapist experienced in CDPT prior to initiating an exercise program.

To study the effects of a self-administered home-based exercise video program designed to help women regain shoulder mobility immediately following surgery for modified radical mastectomy and axillary node dissection

Patients were randomly assigned to usual care control or home-based exercise groups. Usual care consisted of standard written information on diet and skin care and a nine-page brochure entitled “Exercise Guide After Breast Surgery”. Participants were not encouraged to follow exercises, nor were they instructed not to do the exercises. The study was conducted during the immediate two-week recovery period following surgery. Over the next 11 days, women assigned to the home-based exercise intervention received the usual care education and followed the home-based exercise video program. Exercises involved upper-extremity movement designed to increase general range of motion, various neck movements, and stretches.

• The study sample was comprised of female patients.
• Mean age for the control group was 49.1 years and for the home-based exercise group was 50.6 years.
• All patients had a modified radical mastectomy with axillary node dissection.
• Patients were excluded from the study if they had a history or presence of shoulder dysfunction, were older than 65 years, or had sentinel node biopsy dissection only.

The study took place at an outpatient setting in Montreal, Canada.

The study used a randomized controlled trial design.

• The Oxford Manual Muscle Testing Scale
• Hand-grip dynamometry
• Circumferential tape measurements of both extremities
• Participant self-report using the CR-10 Pain Scale and Borg's Category Scale for Rate of Perceived exertion

The experimental group demonstrated a significantly greater increase in flexion (p = 0.003) and abduction (p = 0.036) of shoulder. There was no significant difference in forearm circumference measurements, external rotation, grip strength, or pain. None of the patients in the home-based exercise group demonstrated any significant change in forearm circumference that would indicate lymphedema. Fifty percent of the patients in the home-based exercise group did not complete exercises because of pain at the shoulder joint and axillary swelling, 25% because of lack of support from family and others, 12.5% for no specific reason.

Self-directed home exercise was associated with greater improvement in some range of motion over time and did not appear to aggravate lymphedema development. There was generally low adherence to the self-directed program.

• The study had a small sample size (N < 30).
• The study was short, with insufficient evidence about how the program might affect women at longer intervals.
• Because the control group was aware of the exercise arm of the study, they may have completed more exercise than they otherwise would have, and no control was put in place to not exercise.
• In the home-based exercise group, 50% did not adhere to the exercise program for a variety of reasons.
• It is not clear if the exercise program contributed to join pain and axillary swelling experienced by 25% of patients.

Poor adherence to the home based self-directed program point to the challenges associated with the approach described in the study.

The MBSR intervention emphasized the following.

• Learning to meditate
• Systematic monitoring of the body
• Exploring one’s limits and trying to shift these limits
• Recognizing and investigating thoughts and cognitions
• Recognizing daily stress inducing conditions and their emotional impact
• Learning more ways to handle daily stress

The intervention was offered in eight weekly sessions that were each 2.5 hours in length. Participants were encouraged to practice at home for 45 minutes using an exercise CD and other homework assignments. Each training group was guided by two therapists experienced in working with patients with cancer. Outcomes were assessed at baseline, at week 8, and a year after intervention.

The intervention was modeled after the MBSR program at the Stress Reduction and Relaxation Clinic, Massachusetts Medical Center as described by Kabat-Zinn (1990).

• N = 47
• MEAN AGE = 48.4 years
• AGE RANGE = 31–65 years
• MALES: 72%
• KEY DISEASE CHARACTERISTICS: Patients with cancer with multiple diagnoses, the most common being breast cancer (40%)
• OTHER KEY SAMPLE CHARACTERISTICS: Undergoing treatment (e.g., chemotherapy, hormonal therapy, radiation treatment, surveillance, alternative/complementary) throughout the intervention period.

Not described

• PHASE OF CARE: Active treatment

• Pre-post intervention study

• Profile of Mood States (POMS)

The MBSR intervention did not significantly improve fatigue outcomes for patients at the eight-week intervention end-point or at one-year follow-up.

• Lack of a neutral comparison group
• Observed changes in quality of life may be a consequence of the passage of time.
• Participants were self-referred to program.
• High dropout rate observed throughout the study (no significant differences in demographic characteristics, disease variables, and well-being scores observed between completers and non-completers)

STUDY PURPOSE: To assess the effects of tranexamic acid for reducing blood loss in women undergoing surgery for advanced ovarian cancer

PHASE OF CARE: Active antitumor treatment

Preoperative tranexamic acid was associated with reduced loss of blood compared to placebo; however, the difference from placebo was not statistically significant, and the difference seen did not demonstrate a clearly clinically important benefit (mean difference = -248.59, 95% CI [-550.9, 53.79]). Average number of RBC units were not different between groups, although the rate of RBC transfusion was lower in those given tranexamic acid.

Evidence regarding the effectiveness of tranexamic acid from this review is inconclusive because only one study was found and reviewed.

• Single study in the review
• Risk of bias related to most of the evaluated outcomes was deemed high, and the overall quality of evidence was low.

This review provided no new information to evaluate efficacy of tranexamic acid for prevention of bleeding.

To compare the safety and efficacy of bisacodyl and sodium picosulphate.

Patients received 5 to 10 mg of bisacodyl sugar-coated tablets or sodium picosulphate drops daily over four weeks. The study schedule included four visits: an initial screening visit followed by a seven-day baseline period, a randomization visit (1:1 basis) and two follow-up visits on days 15 and 29.

• The study reported on a total sample of 144 patients with chronic constipation, defined as fewer than three stools per week for at least six months, or pain or straining with bowel movements for six months.
• Patients were aged older than 18 years (range 23–64).
• The study comprised 70 patients in the bisacodyl group ( 21 men and 49 women) and 74 patients in the sodium picosulphate group (19 men and 55 women).
• Patients were included in the study if they were aged 18 years or older and had a confirmed diagnosis of chronic constipation. 
• Patients were excluded if they had a history of organic disease of the colon, ileus, any acute surgical abdominal conditions, organic diseases of the rectum and anus, presence of active gastrointestinal disease, obstruction or dehydration, ingestion of any drug affecting gastrointestinal motility, hypersensitivity to triarylmethane compounds, and recent use (within the past seven days) of bisacodyl or sodium picosulphate.

15 centers (outpatient clinics and specialist gastroenterology units) in Germany

This was a phase IV, open-label, randomized, parallel group study.

• Primary efficacy was assessed as number of bowel movements per day and daily stool consistency using a five-point scale (from liquid to hard).
• Secondary efficacy was assessed as degree of straining using a scale from 0 (absent) to 5 (severe) and physician global efficacy assessment.
• Safety assessments included adverse-event monitoring, tolerability, and changes in laboratory parameters.
• Physical examination and blood samples were completed on days 1, 15, and 29.

• Demographic distribution and baseline characteristics of the two treatment groups were similar.
• Stool frequency and consistency and occurrence of straining after 14 and 28 days was significantly improved for both groups compared to baseline (p < 0.0001).
• Physician global rating improved in 74.6% of patients in the bisacodyl group and 79.2% of patients in the sodium picosulphate group.

Bisacodyl and sodium picosulphate are equally tolerated and effective in the treatment of chronic constipation.

• The study lacked a placebo group.
• Secondary efficacy parameters were subjective, but generally accepted.
• The study evaluated safety over 28 days and did not address potential long-term changes in gastrointestinal mucosa.
• No patients with cancer or opioid-induced constipation were included in the study.

To determine the effect and safety of oral bisacodyl on stool frequency and consistency.

Patients received bisacodyl 10 mg (two 5-mg tablets) or placebo (two tablets) orally once daily on three successive days following a three-day run-in period. The study had a three-day baseline period and three treatment days. Patients were asked not to drink milk or take antacids at the same time as study medications because they could dissolve the enteric coating. Randomization was 1:1. Unused medication was collected at the end of the treatment period. Primary endpoints during the three-day treatment period were mean number of stools per day and mean stool consistency.

• The study reported on a sample of 54 Caucasian patients with idiopathic constipation, aged 19 to 89 years.
• The bisacodyl group (n = 27) comprised 19 women and 8 men, whereas the placebo group (n = 27) comprised 20 women and 7 men.
• Patients were included in the study if they were aged 18 years or older, had a documented history of constipation well known to the investigator, and were otherwise in good health.
• Patients were excluded if they had constipation associated with drug treatment, organic disease (e.g., tumors), strictures, inflammatory disease, obstructive conditions, other gastrointestinal (GI) disorders, history of GI surgery, or pregnancy.

Eight primary care practices in Germany

This was a phase IV, multicenter, double-blind, randomized, placebo-controlled, parallel group design study.

• Constipation was defined as fewer than three bowel movements per week on average during the past three months, or excessive need for straining, hard stool, low-stool weight, or sensation of incomplete evacuation in more than 25% of evacuations.
• Patients recorded stool frequency and consistency and adverse events in a bowel diary.
• Blood specimens (complete blood counts and chemistries) were obtained.
• Global assessment of efficacy was made by the investigator based on severity of constipation compared with baseline on a four-point Likert-type scale.

• Twenty-seven patients were evaluable in each group for efficacy.
• Two patients were excluded secondary to taking restricted concomitant medications.
• One subject was lost to follow-up before taking study medication.
• Patient demographics were comparable.
• Mean number of stools per day was significantly greater in the bisacodyl group (1.8, SD = 1.5) compared to placebo (0.95, SD = 0.6) over the treatment phase (p = 0.0061).
• Mean stool consistency score improved from hard at baseline for both groups to soft and well formed (2.8, SD = 1.1) during bisacodyl treatment, remaining from moderately hard to hard for placebo (4.2; p < 0.0001).
• In terms of global efficacy assessment, 19 of 27 patients in the bisacodyl group compared to 14 of 27 patients in the placebo group were assessed as significantly or somewhat improved; the finding was not statistically significant (p = 0.423).

Bisacodyl is effective and safe in improving stool frequency and consistency.

• The power analysis needed 28 patients per group, but only 27 patients per group completed the study.
• All patients were Caucasian.
• The sample was predominantly female, which is reflective of a higher proportion of women experiencing constipation in the general population.
• Although adverse events were reported, no evidence suggested patients were specifically asked about abdominal cramping and flatulence, which were listed as objective rather than subjective symptom data by the authors.
• Patients in the study were in good health; therefore, patients with cancer were excluded.

To assess the effects of yoga on inflammation, mood, and fatigue and to test the hypothesis that yoga would decrease inflammation, depressive symptoms, and fatigue in breast cancer survivors

Women were randomly assigned to the intervention group or a wait-list control group. The intervention consisted of two 90-minute Hatha yoga sessions per week for 12 weeks delivered in a group setting. Sessions were audiotaped, and 50% were randomly assessed for differences from predetermined poses to assess fidelity of the intervention. Yoga teachers called anyone who missed a class. Home practice was encouraged, and all practice times were recorded by participants in weekly logs. Data were collected at baseline, immediately after the intervention, and after three months post-treatment.

• N = 186 (completed initial data), 181 (finally included)
• MEAN AGE = 51.6 years (SD = 9.2 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer survivors who had completed cancer treatment within the past three years and were at least two months post-treatment intervention (other than tamoxifen or aromatase inhibitors)
• OTHER KEY SAMPLE CHARACTERISTICS: Those who already completed five hours or more of vigorous physical activity per week were excluded. Those with any prior yoga practice for more than three months were excluded. The majority of participants were college graduates, were employed full or part time, and were married. The average time since treatment was 10.9 months (SD = 7.9 months).

• SITE: Single-site
• SETTING TYPE: Outpatient
• LOCATION: Ohio, United States

• PHASE OF CARE: Late effects and survivorship

Single-blinded, randomized, controlled trial

• Multidimensional Fatigue Symptom Inventory Short Form (MFSI-SF)
• Short Form (SF-36)
• Center for Epidemiological Studies Depression Scale (CES-D)
• Pittsburgh Sleep Quality Index (PSQI)
• Fasting blood samples for proinflammatory cytokines

Patients attended a median of 79% of yoga classes and reported an average of 24.69 minutes of practice per day at home and in class over 12 weeks. Immediately after the intervention, there were no differences between the groups in fatigue; however, in the yoga group, fatigue was significantly lower at three months (Cohen’s d = -0.36, p = 0.002). Vitality in the yoga group was significantly higher immediately post-treatment and at three months (p = 0.01). There were no differences between the groups in depressive symptoms. Immediately postintervention, there were no differences between groups in cytokine levels; however, at three months, the yoga group had significantly lower cytokine levels compared to the control group (p < 0.05). Yoga participants reported improved sleep compared to patients in the control group (p = 0.03).

Yoga was associated with reduced fatigue, increased vitality, improved sleep, and reduced cytokine levels. Yoga did not appear to have an effect on depressive symptoms in this study.

• Baseline sample/group differences of import
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Other limitations/explanation: The sample included only women who were highly educated and had higher income levels.

The findings of this study demonstrated that yoga practice was effective in reducing fatigue and improving vitality and sleep in this patient population. Nurses can suggest that patients become involved in yoga practice as a way to manage fatigue and sleep disturbance. These findings also suggest that yoga can have an impact on subclinical inflammation, which may be a mechanism that fuels fatigue and the decline of physical function.