To compare weekly healing touch to weekly sham therapy on fatigue in women receiving radiation therapy for breast cancer

Participants were randomized to receive either weekly healing touch or weekly sham therapy. Participants were blinded to group assignment. Each session was 45 minutes in length. Participants either wore a neck drape or blindfold so as not to see how the treatment was delivered.

• N = 41  
• MEAN AGE = 51.5 years (SD = 9.2)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Patients with breast cancer receiving radiation therapy
• OTHER KEY SAMPLE CHARACTERISTICS: 34 of 41 were Caucasian

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Not identified

• PHASE OF CARE: Active anti-tumor treatment

• Randomized, controlled pilot study

• Brief Fatigue Inventory (BFI)
• Hospital Anxiety and Depression Scale (HADS)
• Functional Assessment of Cancer Therapy–Breast (FACT-B)

Depression was positively correlated with fatigue measures. Anxiety was positively associated with fatigue interference. Healing touch participants reported higher levels of fatigue throughout study than control participants. The control group reported greater reduction in fatigue than did the healing touch group.

This pilot study demonstrated that the intervention was feasible. However the study did not demonstrate any benefit in reduction of fatigue in this small sample.

• Small sample (< 100)
• Baseline sample/group differences of import
• Selective outcomes reporting
• Findings not generalizable
• Intervention expensive, impractical, or training needs are required

Healing touch is not harmful to patients, but this small study does not support its use to reduce fatigue in women receiving radiation therapy for breast cancer.

To determine if Biafine was more effective than best supportive care (BSC) in preventing or reducing radiation (RT)-induced dermatitis.

Randomizaton to Biafine versus BSC depended on the institution and included aloe, Aquaphor, other interventions, and no treatment.

Patients were stratified by bra size:  small (32ab, 34ab, 36a), medium (32c, 34c, 36bc, 38abc), or large (all others).

• The sample was comprised of 172 women.
• Median age was 62 years for both groups.
• Patients had breast cancer and were not undergoing chemotherapy.
• Dose was 50 to 59 cGy versus 59 to 64 cGy.

• Dearborn, Michigan
• Philadelphia, Pennsylvania
• White Plains, New York
• Newark, Delaware
• San Francisco, California
• Baltimore, Maryland
• Ann Arbor, Michigan
• Joliet, Illinois
• Albuquerque, New Mexico

The study was a randomized, controlled trial.

• Radiation Therapy Oncology Group (RTOG) toxicity scale weekly and at two and six weeks after RT
• Maximum toxicity was determined to be the worst skin toxicity observed.
• Weekly completion of the Spitzer QOL questionnaire and patient satisfaction

• There was no overall difference in maximum toxicity between the treatment arms during RT.
• No statistical difference was found between arms in the time grade 2 toxicity.
• All had resolution by week 9.
• Large breasted women receiving Biafine were more likely to have no toxicity week 6 after RT (p = 0.002).
• There was an interaction with treatment healing and tobacco use. Smokers in the Biafine arm had 26% no toxicity in follow-up, and smokers in BSC had 57% no toxicity in follow-up (p = 0.06). Those who never smoked and received Biafine had no skin toxicities at 6-week follow-up (p = 0.026).

• Rater bias occurred.
• The authors did not state who rated the patients and what training occurred.
• The authors did not state if patients were checked the same day every week or at the beginning of each patient week.
• The authors did not record what the application technique was and if it was the same across the different institutions.

PURPOSE: To study the effects of yoga on limb volume in women with breast cancer-related lymphedema

SECONDARY OBJECTIVES: To determine the effects of eight weeks of yoga on quality of life, self-reported arm function, and grip strength

Participants attended eight weeks of Hatha yoga three times a week. Participants went to the studio two times per week (60 minutes) and watched a prerecorded DVD at home (45 minutes) once per week. They all wore compression sleeves. 

• N = 6  
• AVERAGE AGE = 57 years (49–69 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer and lymphedema
• OTHER KEY SAMPLE CHARACTERISTICS: Female breast cancer survivors diagnosed with ipsilateral upper extremity lymphedema and independent mobility not requiring assistance
• EXCLUSION CRITERIA: Congestive heart failure, chronic obstructive pulmonary disease, pacemakers, pregnancy, previous heart surgery, current radiation or chemotherapy, or current yoga practice  

• SITE: Single site    
• SETTING TYPE: Home    
• LOCATION: Dayton, Ohio

• PHASE OF CARE: Late effects and survivorship

Pilot study with a pre- and postintervention design

• Date of breast cancer and lymphedema diagnosis, breast cancer therapies, and height and weight data were collected one week prior to start of classes.  
• Functional Assessment of Cancer Therapy, Breast (FACT-B)
• Disabilities of the Arm and Shoulder, and Hand (DASH)
• Jamar^® dynamometer (strength and grip)
• Volumeter (arm volume, best of three measurements was used)
• Descriptions of the poses were included in the study.
• Measurements were recorded at baseline, after the completion of four classes, and after the completion of all classes (eight weeks).  

• Significant reduction in arm volume (p = 0.02)
• No effect on quality of life, self-reported arm function, or hand grip strength

It was too early to conclude that yoga benefits breast cancer-related lymphedema. Many variables may affect arm reduction such as body mass index and duration of disease. Participants had lymphedema for greater than seven years, and their lymphedema may have been less influenced by activity and therapy. It is likely that the length of the intervention is was long enough to affect quality of life.

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (no appropriate attentional control condition)
• Risk of bias (sample characteristics)
• Other limitations/explanation: A control group and a third group doing a different activity would have enhanced this study.    

Many evidenced-based guidelines encouraging exercise, including yoga, exist for the breast cancer patient population. However, there is a lack of data available regarding the effects of yoga on lymphedema. Nurses can confidently refer patients to an instructor-based program or a physical therapist for safe upper body exercise. More studies with rigorous designs are needed to examine the impact of yoga on patients with cancer-related lymphedema.

To evaluate the effectiveness of antifungal prophylaxis in children with acute myeloid leukemia (AML)

Medical data for children newly diagnosed with AML were obtained from a database of hospitals associated with the Children's Hospital Association nationwide. Only patients with AML receiving induction therapy involving cytarabine, aunorubicin, and etoposide regimens were included. Patients were followed until inpatient death, loss to follow-up, or completion of induction. Data for antibiotic use, blood cultures, and chest CTs were obtained. Exposure to antifungal prophylaxis with any agent was obtained, and decision rules were used to ensure antifungals were used for prophylaxis rather than empiric therapy. Those who did not receive any antifungal agent during the first 21 days of induction chemotherapy were considered “no prophylaxis” patients. Outcomes were analyzed and compared for those who did and did not receive prophylaxis

• N = 871
• MEAN AGE = Not provided
• AGE RANGE = younger than 1 year to younger than 19 years
• MALES: 53.4%, FEMALES: 46.6%
• KEY DISEASE CHARACTERISTICS: All had AML and were receiving induction chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: 69% were Caucasian

• SITE: Multi-site  
• SETTING TYPE: Inpatient  
• LOCATION: United States of America

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics

• Retrospective cohort comparison

Of those who did not get antifungal prophylaxis, 5.32% died during induction compared to 2.42% of those receiving prophylaxis (RR = 0.42, 95% CI [0.19, 0.9]). Those receiving prophylaxis had less use of antibiotics and fewer blood cultures and CT scans. There was no significant difference in mortality between those receiving anti-mold prophylaxis and others.

Findings show that primary antifungal prophylaxis was associated with lower mortality and utilization of resources during induction for AML among pediatric patients.

• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• There was no demonstration of mortality related to invasive fungal infection.
• Cause of mortality is not discussed.

Findings suggest that primary antifungal prophylaxis among pediatric patients may reduce mortality and resource utilization. These findings support the use of antifungal prophylaxis among at-risk pediatric patients.

To explore the impact of mindfulness-based cancer stress management (MBCSM) programs on depression, anxiety, and stress in individuals affected by cancer with a secondary aim to evaluate the impact of MBCSM on quality of life and spiritual well-being

Four MBCSM programs were run for clients experiencing psychological distress related to cancer diagnoses. Each group consisted of 9–13 participants. The program consisted of eight, two-hour, weekly sessions in which mindfulness exercises were provided by an experienced counselor trained in mindfulness-based cognitive therapy. Participants also were asked to complete 40 minutes of meditation per day with the aid of notes, practice CDs, and home worksheets. A three-hour follow-up session was offered six weeks after the completion of the program. The program was modified to incorporate elements of the mindfulness-based stress reduction program developed by Jon Kabat-Zinn in 1990. Session 4 specifically included education about the psychoneuroimmunology of stress and an exploration of the cancer survivorship experience within the context of anxiety, depression, and stress.

• N = 26  
• AGE RANGE = 38–79 years
• MALES: 13%, FEMALES: 77%
• KEY DISEASE CHARACTERISTICS: Twenty-one patients were directly affected by cancer, five were caregivers, and the most common type of cancer was breast (42%).
• OTHER KEY SAMPLE CHARACTERISTICS: Time since diagnosis ranged from 2–84 months.

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: South Australia

• PHASE OF CARE: Diagnostic
• APPLICATIONS: Elder care  

Single-group, quasiexperimental study of participants directly and indirectly affected by cancer

• Global psychological distress was measured using a Visual Analog Distress Thermometer (VADT) scale.
• Levels of anxiety and depression were measured with a self-administered Hospital Anxiety and Depression Scale (HADS).  
• Quality of life and spiritual well-being were measured with the Functional Assessment of Cancer Therapy—General Version 4 (FACT-G).
• Mindfulness was measured with the short-form Freiburg Mindfulness Inventory (FMI).

Exploratory analysis indicated that there were no significant differences between baseline scores across sociodemographic groups. A series of Friedman tests indicated that there were significant differences in the levels of global psychological distress over time. Scores were significantly higher at baseline than postintervention for levels of global distress, anxiety, and depression. Global quality of life and spiritual well-being improved significantly over time. Emotional well-being and functional well-being were significantly higher postintervention than at the baseline assessment, which was maintained from baseline to follow-up (p = .001 and p = .001, respectively). Physical well-being improved from baseline to postintervention, which was determined to be significant at follow-up (p = .012). Mindfulness scores changed significantly over time. The level of mindfulness was significantly lower at baseline than postintervention, which was maintained through follow-up (p = .001).

Overall, the results of this study were positive with significant improvements in participants' levels of global distress, anxiety, and depression from baseline to postintervention. Improvements in psychological distress were sustained up to three months postintervention. This supports preliminary research on the effectiveness of mindfulness-based therapy in the treatment of cancer-related psychological distress.

• Small sample (< 30)
• Risk of bias (no control group)
• 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
• Intervention expensive, impractical, or training needs
• Subject withdrawals ≥ 10%

Mindfulness training should be considered for patients with cancer to improve their levels of distress, anxiety, and depression. Mindfulness programs require trained personnel, and the program should involve an intervention over time with opportunity for follow-up over time.

To examine the effects of six individual cognitive-behavioral therapy (CBT) sessions on sleep.

Individual CBT treatment consisted of six, one-hour weekly sessions comprised of education, behavioral components (sleep restriction, stimulus control, adhering to the sleep hygiene rules, and training in progressive muscle relaxation techniques), and cognitive interventions to counteract maladaptive thought. It also included homework assignments (sleep diaries and practicing behavioral and cognitive strategies) followed by six weeks of no-treatment follow-up. Data were collected at baseline and at the end of the first and second six-week components, and daily diary data were recorded during the treatment phase.

• The study enrolled 21 patients, and 14 finished treatment (six in the experimental group and eight in the wait-list control group).
• Mean age was 61 years (standard deviation = 11.6 years; range 45–85 years).
• All patients were female, and 12 were Caucasian.
• All patients were survivors of breast cancer who had completed treatment between 5 months and 24 years prior (mean years since completion = 6; median = 5).
• All patients met the criteria for insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV).

• Single site
• San Diego, California

Patients were undergoing the long-term follow-up phase of care.

This was a randomized, controlled, crossover pilot study.

• Actigraphy (Actillume®)
• Insomnia Severity Index (ISI)
• Pittsburgh Sleep Quality Index (PSQI)
• Sleep diary
• Sleep medications list
   

After six weeks, objective data (actigraphy) showed statistically significant differences in change scores between the treatment condition group and the delayed treatment control condition group on total sleep time, wake after sleep onset, number of awakenings per night, and percent of time asleep. There was a significant decrease in insomnia in the treatment group compared to the control group. Follow-up at six weeks showed continued improvement with a clinically significant decrease in PSQI scores. Cohen’s d effect size estimate for PSQI was large (d = 0.8).

These preliminary results suggest that individual CBT is appropriate for improving sleep in survivors of breast cancer.

• The study had a small sample size.
• There was little racial/ethnic diversity among the patients.

If found to be effective, the intervention is potentially useful in several different settings.

To appraise the evidence of the effectiveness of complementary and alternative medicine (CAM) interventions in reducing cancer-related fatigue (CRF).

Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, British Nursing Index, and Evidence-Based Medicine Reviews (EBMR).

The specific MEDLINE search strategy was provided.

Studies were included in the review if

• They were published in the English language
• They used a randomized, controlled trial or quasiexperimental design
• Patients were older than 18 years
• They tested at least one CAM as defined by the National Center for Complementary and Alternative Medicine (NCCAM)
• They measured fatigue and had CRF as primary or secondary outcome.

Studies were excluded from the review if they were psychosocial interventions.

In total, 2,398 references were retrieved. The Jadad scale was used to appraise study quality.

• The final number of studies included was 20. 
• The total sample included 1,560 patients (sample range 13–200).
• The majority of studies were performed in patients during treatment. 
• Most studies were performed in women with breast cancer.

Patients were undergoing multiple phases of care.

During treatment, the intervention that seemed to be the most effective was hypnosis (one study), whereas ginseng provided promising results (one study). Massage, multivitamins, herbs, yoga, relaxation therapy, and combined education and acupuncture were less effective. Sound and reliable conclusions could not be drawn due to the poor quality of the studies and varying interventions, timings, and dosages. Most studies did not describe processes to ensure intervention integrity, and the “dose” was often not well reported.

Evidence from the trials reviewed was not sufficient to support the use of the interventions examined.

• Studies were of low quality. 
• The appraisal method did not include consideration of factors such as sample size and power or difference between single and multisite studies.

Current evidence suggests a very limited role of CAM to contribute to improvement in fatigue among patients with cancer.

STUDY PURPOSE: To evaluate evidence from systematic reviews for the treatment of lymphedema

• FINAL NUMBER STUDIES INCLUDED = 21
• TOTAL PATIENTS INCLUDED IN REVIEW = Sample sizes not reported
• KEY SAMPLE CHARACTERISTICS: Not reported

• There was agreement that complete decongestive therapy (CDT) was effective in reducing limb volume. However, the most effective components and factors that affected efficacy were not defined. It appeared that ongoing therapy was needed to maintain the initial improvements of intensive CDT.
• There were inconsistent findings regarding the efficacy of manual lymphatic drainage, and the evidence did not support its efficacy as a stand-alone treatment.
• Volume reduction was demonstrated with low-level laser therapy, but the optimal dose and type was not clear.
• Pneumatic compression achieved volume reduction, but greater effects were seen when pneumatic compression was combined with other therapies.
• Compression bandaging or garments resulted in significant volume reductions.
• There was insufficient evidence to determine the contribution of exercise to volume reduction.
• Surgical treatments resulted in volume reduction, but these also had potential complications, and the continued use of conservative treatments was needed to maintain improvements.

Compression therapy alone and combined with manual lymphatic drainage was supported by strong evidence. Preliminary evidence suggested that a range of other treatments also are beneficial.

• The methodologic quality of the studies included was variable, and the quality of most was deemed to be poor.
• Little attention was given to the subjective aspects of treatment outcomes.

CDT and compression bandaging alone or with manual lymphatic drainage were effective in managing lymphedema. Ongoing maintenance is needed to keep these gains, and nurses need to educate patients regarding this ongoing need.

To assess the safety of the herpes simplex virus (HSV)–based gene transfer platform (dose escalation)

To evaluate the delivery of vector-mediated delivery of PENK on pain and on concurrent use of opioid medication

NP2, an HSV vector, was injected intradermally into the dermatome(s) corresponding to the radicular pattern of pain: Pain relief was a secondary measure evaluated by a numeric rating scale (NRS) and the Short Form McGill Pain Questionnaire (SF-MPQ) on day 0 prior to doing and on postdosing days 1, 3, 7, 10, 14, 21, and 28. An SF-12 Short-Form Health Survey and complete Eastern Cooperative Oncology Group (ECOG) performance status were also completed on days 0 and 28. Concurrent opiate analgesic use was recorded on postdosing days 1, 3, 7, 10, 14, 21, and 28. Phase I dose escalation was administered as 10 intradermal injections of approximately 100 microliters (total 1.0 ml) distributed within the dermatome corresponding to the radicular distribution of the pain in a single session on study day 0. The first cohort (four patients) was given a dose of 1 x 10^7 plaque-forming units (pfu) and monitored for four weeks. A second cohort (three patients) was given 1 x 10^8 pfu, and a third cohort (three patients) was given 1 x 10^9 pfu. Patients were observed for at least 12 hours after dosing before being discharged and were scheduled for reexamination at 1, 3, 7, 10, 14, 21, and 28 days postdosing and monthly thereafter. The primary outcome was safety, so patients received a full evaluation for adverse events, physical examination, vital signs, mucositis evaluation, and labs.

• The study reported on 10 patients.
• Mean patient age was 63.3 years in cohort 1, 51.3 years in cohort 2, and 73 years in cohort 3.
• The sample was 70% female and 30% male.
• Patients had primary or metastatic cancer and were experiencing moderate-to-severe intractable pain despite doses of more than 200 mg of morphine or equivalents.

• Multisite
• Outpatient setting
• University of Michigan

• Patients were receiving end-of-life care.
• The study has clinical applicability for end-of-life and palliative care.

The study was a phase I trial.

• NRS (0–10) pain scale at one-week intervals for 28 days    
• SF-MPQ at one-week intervals for 28 days
• Concurrent opioid usage
• SF-12 Health Survey
• ECOG performance

Treatment was well-tolerated with no significant adverse effects attributable to the agent. The adverse events that were deemed as possibly related to treatment were all mild in severity and resolved. These included transient injection site erythema and pruritus, and one patient who had a transient elevation in body temperature. Those enrolled in the lowest dose of NP2 reported no changes in pain. Those enrolled in higher doses (cohorts 2 and 3) reported pain relief of approximately 50% on day 1 after dosing.

NP2 vector appears to be safe, and the method has potential to improve intractable pain. Pain relief was difficult to interpret due to the small number of patients and no control group.

• The study had a small sample size, with less than 30 patients.
• No placebo group was used for comparison.

Further investigation of this novel treatment is needed.

Describe the effects of acupuncture and self-accupuncture on hot flash frequency and intensity

The study enrolled 182 females ages 35 to 83 and 12 men ages 49 to 79 years of age.

Researchers performed a retrospective audit of electronic charts.

The primary outcome measurement was hot flash frequency and intensity. Participants used both traditional acupuncture and self-accupuncture.

The average pre-treatment hot flash count was 16 per day. When acupuncture was added, the chart audit showed that 114 (79%) subjects achieved a 50% or greater reduction in hot flashes.

• Data was not collected prospectively; the study relied on data available in the charts.
• Data was missing in 27 charts.
• The study reviewed only 24 weeks of charts.