To investigate the mechanisms of action of elements of mindfulness-based stress reduction (MBSR) that lead to specific clinical improvements, specifically to postulate and examine how changes in fear of recurrence as a result of participation in MBSR program may mediate a range of positive changes in psychological and physical symptoms and quality of life

At orientation, subjects were consented and randomized, and they completed baseline assessments. The assessments were completed again at two and six weeks following the MBSR program or control period. The program was adapted from the 1990 Jon Kabat-Zinn program. Subjects who were randomized to the MBSR group (n = 40) attended six, weekly, two-hour MBSR sessions with a trained psychologist. Participants learned four meditative practices, sitting meditation, walking meditation, body scan, and yoga, while integrating mindful attention to self-regulate and manage stressful symptoms. Participant materials included a training manual and audio tapes for home practice. Subjects completed a diary daily. Home meditation was advised for 15–45 minutes daily. The usual care (UC) group was offered the MBSR program after the six-week study period.

• N = 82  
• MEAN AGE = 57.2 years (SD = 9.2 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All diagnosed with primary stage 0, I, II, or III breast cancer; completed treatment within the prior 18 months
• OTHER KEY SAMPLE CHARACTERISTICS: Able to read and speak English at an eighth grade level

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: H. Lee Moffitt Cancer Center, Tampa, FL

• PHASE OF CARE: Transition phase after active treatment
• APPLICATIONS: Elder care  

This was a randomized, controlled trial. Subjects were randomly assigned in a one-to-one ratio to either the MBSR or UC group. Randomization was stratified in an unblocked manner. Study personnel were blinded initially.

• To assess fear of recurrence as a potential mediator of the effects of MBSR, an analysis was conducted using six outcome measures in which MBSR demonstrated evidence of efficacy. These were perceived stress, depressive symptoms, state anxiety, trait anxiety, and aggregate mental and physical health.
• A 30-item Concerns about Recurrence Scale (CRS) was used.
• State and trait anxiety was measured by State-Trait Anxiety Inventory (STAI)
• Depression was measured by the Center for Epidemiological Studies Depression Scale (CES-D)
• Optimism was measure by the Life Orientation Test-Revised (LOT-R).
• Perceived stress was measure by the Perceived Stress Scale (PSS)
• Quality of life was measured by the Medical Outcomes Studies Short-Form General Health Survey (MOS SF-36) 
• Social Support was measured by the Medical Outcomes Study (MOS) Social Support Survey

From baseline to six-weeks, the MBSR group experience more favorable changes than the UC group for several potential mediators including fear of recurrence concerns (2.8 versus .2, p = .007); fear of recurrence problems (11.4 versus .2, p = .02); depression (7.2 versus 4, p = .04); physical functioning (3.8 versus .5, p = .01) and energy (8.8 versus 5, p = .07). After removing direct effects of MBSR on outcomes of interest, the strongest and most consistent evidence for mediating effects (how MBSR works) was for change in fear of recurrence problems and change in physical functioning. The results indicate that MBSR is associated with reduced fear of recurrence and improved physical functioning which in turn are associated with reduced perceived stress and state and trait anxiety. The women in the UC group who experienced reduced fear of recurrence and improved physical functioning by mechanisms other than MBSR also experienced significantly reduced perceived stress and anxiety. Both groups experienced reduced anxiety and depression over time. There were no significant differences in anxiety between groups. Postintervention, the MBSR group had significantly higher depression scores (p = .04).

The fear of recurrence is highly prevalent in breast cancer survivors and is associated with considerable psychological distress. The results of this study may indicate that one of the mechanisms for how MBSR (BC) works is through the cognitive process of self-regulation of fear of recurrence to improve stress, anxiety, and physical functioning. The fear of recurrence influence by MBSR (BC) appeared to be reliable and clinically relevant. The findings did not demonstrate a direct effect on anxiety or depression scores.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (sample characteristics)
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Trained psychologist and expensive intervention; included only early-stage breast cancer survivors; limited to short-term effects; symptoms at baseline were low for both groups, indicating a potential floor effect with little room for improvement

The findings of this study show a clustering of multiple symptoms among breast cancer survivors. Interventions to simultaneously address multiple symptoms should be studied. MBSR is supported as being beneficial in reducing fear of recurrence and improving physical functioning. Training programs and awareness for nurses and staff members should be supported in cancer centers and survivorship programs.

To compare the incidence of oral mucositis (OM) in patients conditioned with myloablative conditioning (MAC) versus reduced-intensity conditioning (RIC) and to determine the effect of a new oral care protocol

A radiographic full-mouth exam and an oral exam by an investigating dentist were performed one week prior to hematopoietic stem cell transplantation (HSCT). Prior to the start of conditioning, daily oral exams began three days prior to HSCT for 25 days or until discharge. A dentist or dental hygienist assessed oral cavities three times per week. From 2007 to 2010, 142 patients used a protocol (soft tooth brushing twice daily only; no interdental brushes, toothpicks, or flossing were allowed). From 2010 to 2011, 29 patients received the intensive protocol (intensive protocol brushing, interdental brushes or flossing, sucking on ice chips every two to three hours while awake, rinsing normal saline solution every two hours while awake from transplantation until neutrophil count was > 0.5). Dental infections foci were treated conservatively.

• N = 171
• MEDIAN AGE = 50 years
• MALES: 53.2%, FEMALES: 46.7%
• KEY DISEASE CHARACTERISTICS: Allogeneic HSCT; 94% malignant disease; 5% nonmalignant; 12% previous HSCT; 44% early-stage; 56% late-stage
• OTHER KEY SAMPLE CHARACTERISTICS: 57 human leukocyte antigen identical sibling or related donors; 101 unrelated donors; 13 antigen-mismatched, unrelated donors

• SITE: Single-site
• SETTING TYPE: Inpatient
• LOCATION: Karolinska University Hospital in Huddinge, Sweden

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care

Quasi-experimental

• World Health Organization (WHO)
• Visual Analog Scale (VAS) for pain
• National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE v3)
• Oral function (ability to swallow)
• Subjective opinion of function of saliva

Patients treated with the oral protocol in 2011 had significantly lower OM scores than those treated with the previous protocol (p = 0.013).

MAC conditioning was correlated with significantly higher OM scores (p < 0.001). Lower OM scores were associated with the intensive oral protocol intervention. Patients treated in later years (2011) demonstrated a decrease in OM scores, which were caused by an increased use of RIC and improved standards of oral care.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Other limitations/explanation: The actual sample size for the oral care intervention was only 29 participants. In addition, the authors began the article comparing different conditioning regimens then added in the oral care intervention.

Oral mucositis is a side effect of the conditioning regimens for HSCT. This study revealed that with consistent assessment, support, and a more intensive oral care protocol using ice and normal saline rinses, there is a potential to reduce the severity of this side effect. More nursing research is needed in this area.

To compare, in patients undergoing breast reconstruction, the efficacy of levobupivacaine in conjunction with oral paracetamol and IV morphine to the efficacy of placebo in conjunction with oral paracetamol and IV morphine

Levobupivacaine 2.5 mg/ml or normal saline (NS) was administered through an indwelling catheter every 3 hours for 45 hours with

• Four doses of paracetamol, 1 gm each, starting one hour before surgery
• IV PCA morphine, 2 mg/dose every 6 minutes

• The sample was composed of 34 patients.
• The age range of patients was 34–71 years.
• All patients were female.
• All patients were undergoing delayed breast reconstruction after previous mastectomy for breast cancer. All mastectomies were unilateral, with or without reduction on the other side or augmentation mammaplasty.

• Single setting
• Inpatient
• University hospital, Stockholm, Sweden

Prospective placebo-controlled, double-blind study

• 100 mm visual analog scale (VAS)
• Use of morphine (opioid consumption)
• Measure of nausea
• Measure of infection
• Length of hospital stay
• Time to request for rescue analgesic

When patients were at rest, levobupivacaine significantly reduced pain (p < 0.05) 15 hours postoperatively. With movement, levobupivacaine significantly reduced pain for 6 hours (p = 0.01) and significantly reduced pain for 18–24 hours (p = 0.045). Total dose of morphine used did not differ between groups. Two patients in the levobupivacaine group became infected. Authors noted no significant intergroup differences related to nausea or length of hospital stay.

Compared with patients who received placebo, those who were intermittently injected with levobupivacaine had better pain relief at rest for the first 15 hours after surgery. Those who received intermittently injected levobupivacaine also had better pain relief during mobilization, for the first 6 hours and for 18–24 hours.

• The study had a small sample size, with fewer than 100 participants.
• Variations in pain site and surgical technique could have contributed to the intensity of postoperative pain.

Boluses of local anesthetic, delivered via patient-controlled anesthesia, tend to have good results because patients prefer to control their own treatment.

STUDY PURPOSE: To access the effectiveness of acupuncture as a treatment option for hot flashes in patients with breast cancer through a systematic review

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 6
• TOTAL PATIENTS INCLUDED IN REVIEW = 281
• SAMPLE RANGE ACROSS STUDIES: Sample size ranged from 20–72.
• KEY SAMPLE CHARACTERISTICS: Women with breast cancer experiencing hot flashes

PHASE OF CARE: Transition phase after active treatment

Of the six studies that were reviewed, three compared the effects of manual acupuncture with sham acupuncture, one compared the effects of electroacupuncture (EA) with hormone replacement therapy, one compared acupuncture with venlafaxine, and one compared manual acupuncture with relaxation therapy. Of the studies examined, all were randomized, controlled trials. Of the three comparing manual acupuncture with sham, one showed favorable results of acupuncture reducing the frequency of hot flashes, whereas the other two studies failed to do so. The study comparing EA with hormone therapy demonstrated that hormone replacement therapy was more effective in controlling hot flashes than EA. The study comparing acupuncture and venlafaxine showed no difference. When relaxation therapy was compared with acupuncture, no intergroup difference occurred.

This systematic review of six articles using acupuncture to treat hot flashes in women with breast cancer failed to demonstrate that acupuncture was a clearly effective treatment tool. When comparing acupuncture with sham acupuncture, the three studies were not consistent in their findings, with one demonstrating that acupuncture was effective and two that did not. In the additional three studies, acupuncture was not found to be superior to hormone replacement therapy, venlafaxine, or relaxation therapy.

• Limited number of studies included
• High heterogeneity
• The researchers acknowledged that some of the studies had suboptimal data in the primary study reviewed.

This review of randomized studies did not demonstrate that acupuncture was a superior therapy to hormone replacement, venlafaxine, or relaxation therapy in controlling hot flashes in women with breast cancer.

STUDY PURPOSE: To evaluate the effect of acupuncture on hot flashes in men with prostate cancer

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 6 
• TOTAL PATIENTS INCLUDED IN REVIEW = 132
• SAMPLE RANGE ACROSS STUDIES: 7–60 patients diagnosed with and treated for prostate cancer
• KEY SAMPLE CHARACTERISTICS: Multiple treatments for prostate cancer

PHASE OF CARE: Not specified or not applicable
 
APPLICATIONS: Elder care

Five of the six studies included were uncontrolled observational studies. All six studies showed a reduction in the severity and frequency of hot flashes in men with prostate cancer. Some studies reported no follow-up; one study followed patients for 12 months. Mild adverse effects reported included distress, fatigue, hematoma at the insertion site, and a very short (few seconds) increase of vasomotor symptoms.

The researchers concluded that the evidence from these six studies is not convincing to recommend acupuncture as an effective treatment for hot flashes in men treated for prostate cancer. The researchers recommended more research with larger randomized, controlled trials. Mild adverse effects were noted with acupuncture.

• Limited number of studies included
• Mostly low quality/high risk of bias studies
• High heterogeneity
• Low sample sizes
• No exclusion criteria stated
• Five studies were uncontrolled observational studies.  
• Some studies did not report any follow-up.

The six studies did not provide convincing evidence that acupuncture is an effective treatment for reducing hot flash frequency and severity in men diagnosed with prostate cancer. More large randomized, clinical trials are need to evaluate the effectiveness of acupuncture. Such studies should include longer periods of follow-up to determine the long-term effectiveness.

To summarize a systematic review of existing evidence regarding the effect of acupuncture on cancer-related pain

Databases searched were MEDLINE, EMBASE, CINAHL, Allied and Complementary Medicine Database (AMED), PsycINFO, British Nursing Index, the Cochrane Library, and databases relative to Journal of Korean Society for Acupuncture and Moxibustion and Journal of Korean Oriental Medicine. Investigators performed manual searches of department files and the reference lists of all located articles.

Search keywords were acupuncture, electroacupuncture, cancer, neoplasm, and tumor.

Studies were included if they were

• Published in any language
• Prospective clinical studies that used manual acupuncture, ear acupuncture, or electroacupuncture for the treatment of cancer-related pain in humans.

Studies were excluded if they related to laser acupuncture, acupressure, or moxibustion or used transcutaneous electrical nerve stimulation or other cointerventions that were complementary or alternative medicine modalities; were case series, case reports, or  abstracts with no details about the intervention; and involved acupuncture for postoperative pain in patients with cancer.

Investigators reviewed 29 studies initially and chose 7 for analysis. Two authors, working independently, read all articles in full and extracted data about trial methods, study design, participants, interventions, type of pain, pain outcomes, and adverse effects. Authors used a modified Jadad scale to rate the studies. (The study summary cites rating criteria.) Authors met to reach consensus, and discrepancies were settled by discussion with the third author. The Jadad scale was modified because of the near impossibility of blinding the acupuncturist to the treatment.

• The total sample size was not reported.
• The sample range across studies was 12–92.
• Characteristics of the sample were all cancer types (heterogeneous), neuropathic nociceptive (> 30/100), abdominal, back, and not specified.

• The studies of acupuncture for cancer-related pain were not evidence-based. Visual analog scale and patient’s verbal assessment were the primary pain-related measures. One study used the plasma leucine-enkephalin level as a measure.
• The quality of the included studies was lacking—only three of the seven studies were randomized controlled trials.

Data from this study do not support the use of acupuncture as an effective analgesic adjunctive method for the treatment of cancer pain. Note that 2003 is the most recent date of an article in this systematic review; articles excluded were published 1974–2003.

Appropriately powered randomized controlled trials that investigate the efficacy of acupuncture are needed.

To evaluate if armodafinil versus placebo reduced fatigue and improved quality of life when measured via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale at baseline and 42 days.

Prior to starting treatment, participants completed several questionnaires rating fatigue and quality of life. The participants were randomly assigned 1:1 to the armodafinil group or placebo group, and questionnaires were completed again at day 22, day 43, and day 56, with the primary end point being day 43, as this was the end of radiation therapy for most patients enrolled. Participants in the armodafinil group received 150 mg daily for eight weeks.

• N = 62   
• AGE RANGE =19–79 years; armodafinil group (median = 56 years), placebo group (median = 54 years)
• MALES: 55.6%, FEMALES: 44.4%
• CURRENT TREATMENT: Chemotherapy, radiation
• KEY DISEASE CHARACTERISTICS: Grade 2–4 glioma, grade 4 most common, receiving 50–60 Gy radiation therapy total
• OTHER KEY SAMPLE CHARACTERISTICS: Karnofsky score greater than 60, ability to read and write in English, no history of major mental illness. The majority of patients were receiving concomitant temozolomide.

• SITE: Multi-site   
• SETTING TYPE: Not specified    
• LOCATION: Dana–Farber Cancer Institute, Boston, MA

PHASE OF CARE: Active antitumor treatment

Randomized, placebo-controlled, pilot trial

• Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F)
• FACT-General (FACT-G)
• Brief Fatigue Inventory (BFI)
• Cancer Fatigue Scale (CFS)
• Beck Depression Inventory (BDI)

No statistically significant findings using any questionnaire were reported between the treatment arm and the placebo arm at any point measured (day 21, 42, or 26).

Based on this study, one can conclude that armodafinil is not effective in reducing fatigue or improving quality of life in this patient population. It would be helpful to know if the FACIT-F questionnaire has been used in this patient population previously with no concurrent interventions.

• Small sample (< 100)
• Risk of bias (no blinding)
• Findings not generalizable

The findings of this study indicate that more education regarding the multiple factors that can cause fatigue in this patient population is needed, as well as tools to measure this fatigue more effectively to better gauge interventions. The study stated that fatigue is reported during radiation therapy in this patient population, but the questionnaires used did not capture that.

To compare the effectiveness of standard fluoroquinolone prophylaxis with fluoroquinolone plus ceftriaxone in the prevention of infection post prostate biopsy

Patients received one of three prophylaxis regimens: (a) 500 mg fluoroquinolone by mouth twice a day for three days, (b) 500 mg fluoroquinolone by mouth twice a day for three days plus 2 g IV ceftriaxone once before biopsy, or (c) 500 mg fluoroquinolone by mouth twice a day for more than seven days plus 2 grams IV ceftriaxone once before biopsy.

• N = 5,577   
• MEAN AGE = 64 years
• AGE RANGE = 18–92 years
• MALES: 100%
• CURRENT TREATMENT: Immunotherapy
• KEY DISEASE CHARACTERISTICS: None described
• OTHER KEY SAMPLE CHARACTERISTICS: N/A

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

• PHASE OF CARE: Diagnostic

• Retrospective case review

Infection post prostate biopsy was defined as any of the following: a temperature greater than 38 degrees Celsius, a white blood cell count greater than 12,000/mm³, a urinary tract infection, or acute prostatitis.

A significant decrease of infections was observed post prostate biopsy for patients that received prophylaxis with fluoroquinolone plus ceftriaxone (p < 0.001). One percent of patients who received fluoroquinolone prophylaxis had infectious complications compared to 0.3% of patients who received fluoroquinolone plus ceftriaxone. Patients who received fluoroquinolone prophylaxis for more than seven days had no added reduction of infection compared to patients who received fluoroquinolone prophylaxis for three days.

Infection prophylaxis with fluoroquinolone alone after prostate biopsy may be insufficient because of increasing resistance among pathogens, including Escherichia coli. The addition of 2 grams IV ceftriaxone before prostate biopsy was correlated with a significant reduction in infectious complications at one hospital in South Korea.

• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Findings not generalizable
• The time frame of the retrospective comparison groups differed by several years (group 1: 2005–2009 versus groups 2 and 3: 2010–2012); thus, other clinical practice variations may have affected the results.
• Patient adherence to oral fluoroquinolone was not assessed.
• For infectious cases to be identified, patients with complications needed to return to the participating hospital. Patients with complications may have gone to other hospitals, affecting results.
• Groups were not assessed for risk factors, so comparison between groups is limited.
• The study was conducted at one hospital, limiting generalizability to other hospitals.
• Observation/reporting time frame for infectious complications after prostate biopsy not defined

Adequate patient education on potential infectious complications is necessary post prostate biopsies. To tailor infection prophylaxis, nurses should consider assessing for individual risk factors for infection (e.g., diabetes, history of organ transplant, etc.) and collect rectal swabs to identify quinolone-resistance organisms.

To examine the effects of nurse-led cognitive-behavior therapy (CBT) on fatigue and quality of life (QOL) experienced by patients with breast cancer who were currently undergoing radiotherapy.

An oncology nurse-led six-week intervention program that included cognitive restructuring, education about breast cancer and medical treatment, relaxation therapy, and rehabilitation exercise was offered to women receiving radiation therapy at a university hospital in Korea. Nurses who led the course attended the beginner’s course of CBT for 36 hours.

• In total, 71 patients (71% female) were included.           
• Age ranged from 25 to 60 years.
• Patients had breast cancer.
• Of the patients, more than half had a partial mastectomy, 93% had no family history of breast cancer, and nearly half had received chemotherapy.

Single site

Patients were undergoing the active antitumor treatment phase of care. 

The study used a quasiexperimental pre-/posttest design with a nonequivalent control group.

• Korean version of the Revised Piper Fatigue Scale (PFS)
• QOL Scale for Korean Patients With Cancer

Levels of fatigue increased in both groups at the posttests. Increases in the levels of fatigue were greater in the control group than in the experimental group. Levels of QOL increased in the experimental group and decreased in the control group.

Nurse-led CBT did not show a significant effect in reducing the levels of cancer-related fatigue, although the increments of fatigue were significantly lower than the control group. Nurse-led CBT was effective in increasing QOL.

• The study had a small sample size, with less than 100 patients.
• The study had a risk of bias due to no blinding.
• Findings were not generalizable
• Intervention expensive, impractical, or training needs.
• Authors mentioned seasonal influence – fatigue is exacerbated in the winter and alleviated in the summer.

There is a role for oncology nurses to lead a structured cognitive-based intervention program to help alleviate cancer-related fatigue in women with breast cancer receiving radiotherapy.

To systematically review randomized, controlled trials that investigated the efficacy of acupressure for the management of symptoms.

Databases searched were CINAHL, MEDLINE, and PubMed.

Search keywords were acupressure, clinical trial, human, and/or randomized.

Studies were included in the review if

• They were randomized, controlled trials published from January 1, 2000 to January 31, 2010
• They were published in English
• They used acupressure as the sole intervention for one group
• There were four or more studies of the efficacy of acupressure for that particular symptom.

Studies were excluded from the review if they

• Had sample sizes of less than 30 patients
• Used auricular or hand pressure, reflexology, shiatsu, and electronic or magnetic devices
• Were unpublished studies and abstracts.

In total, 108 references were screened.

Each experimental study was evaluated for quality using the Cochrane risk of bias (RoB) tool. Articles were evaluated for the presence of each of the six domains, and one point was assigned for each domain present. Scores ranged from zero to six, with higher values indicating higher quality and less risk for bias. All trials were evaluated by two authors, and agreement between them was 100%. A significant likelihood of bias was found in the evaluation.  

Only six randomized, controlled trials included were performed to determine the efficacy of acupressure on the reduction of fatigue and improvement of sleep in adults in various populations. Fatigue and insomnia were grouped together because those investigations were typically studied simultaneously.  
 

• The final number of studies included was 43.
• The total sample size was 5,021 patients across all studies of all symptoms. For studies that specifically focused on fatigue and insomnia, the sample size was 211 patients.
• The sample range across all studies was 36 to 739 for all studies of all symptoms.
• Multiple diagnoses and symptoms were included:  nausea, pregnancy, chemotherapy, radiation, surgery, motion sickness, pain, dysmenorrhea, labor, back pain, fracture, trauma, dyspnea, asthma, chronic obstructive pulmonary disease (COPD), bronchiectasis, endstage renal disease (ESRD), and insomnia.

Patients were undergoing the active treatment phase of care.

Only three studies conducted included a measure of fatigue. Six studies concluded that acupressure was effective in improving fatigue and reducing insomnia. Multiple symptoms were discussed in topic areas; findings from other symptom reviews were not included in the summary.

The review did not provide rigorous support for the use of acupressure for the efficacy of symptom management.

• Significant bias existed according to the Cochrane RoB tool. 
• Lack of fidelity to the intervention confounded the results and may have added bias to the studies.

Well-designed randomized, controlled trials are needed to determine the utility and efficacy of acupressure to manage various symptoms in several patient populations. Issues exist when looking at fatigue and insomnia concurrently, such as determining whether fatigue is an intervening variable for insomnia or an outcome variable of insomnia or whether insomnia is an intervening variable for fatigue. A conceptual framework is needed to guide how concurrent or symptom clusters are studied.