To evaluate fluconazole versus voriconazole in terms of fungal-free survival (FFS) (i.e., alive and free from proven, probable, or presumptive invasive fungal infection [IFI]) at 180 days posttransplant.

Patients who met the eligibility criteria were randomly assigned to receive voriconazole 200 mg twice daily or fluconazole 400 mg once daily before transplantation.  To maintain the blind, placebo was administered to match the number of doses for the two arms.  Study drugs were continued from days 0 until 100 posttransplantation.  Premature withdrawal of study drug was mandated for the occurrence of documentation of IFI, grade 3 or 4 toxicity, or relapse of underlying disease.

• Six hundred patients were included (295 in the fluconazole arm [55% male, 45% female] and 305 in the voriconazole arm [56% male, 44% female]).
• Median age for both groups was 43 years.
• Two hundred thirty-four (78%) patients had acute myeloid leukemia (AML), 122 (41%) had acute lymphoblastic leukemia, 103 (34%) had chronic myelogenous leukemia, 98 (33%) had myelodysplastic syndrome, and 43 (14%) had non-Hodgkin lymphoma.
• Human leukocyte antigen matched 6/6 encompassed 96% of patients, and the remaining 4% being 5/6 matches.

• Mutli-site  
• Thirty-five centers participated in the Blood and Marrow Transplant Clinical Trials Network.

Patients were undergoing the active treatment phase of care.

This was a randomized, double-blind, multi-center study.

• Routine galactomannan testing on serum samples were collected twice weekly through day 60 and once weekly through day 100.    
• Computed tomography scans were obtained.
• Bronchoalveolar lavage/biopsies were performed.

By 180 days after hematopoietic cell transplant (HCT), 55 patients had developed IFIs (14 proven, 24 probable, and 17 presumptive), and by one year after HCT, 79 patients had developed IFIs (28 proven, 33 probable, and 18 presumptive). Aspergillus was the most frequent pathogen, accounting for 26 (47%) and 38 (48%) IFIs at days 180 and 365, respectively.  Cumulative incident rates of IFIs were 11.2% and 7.3% for fluconazole and voriconazole, respectively, at 180 days and 13.7% and 12.75%, respectively, at 356 days.  At 180 days, there was a trend toward fever and Aspergillus spp. infections in the voriconazole arm, but no difference existed in the rates of other IFIs, including those caused by Zygomycetes. Fungal-free survival rates were similar at 180 days:  75% and 78% for fluconazole versus voriconazole, respectively, and 65% and 64%, respectively, at 365 days. There was no difference in overall survival at 180 days or 365 days between the two groups. Toxicity was similar between the two arms. There were no significant differences in study outcomes between the groups.  Significant predictors of IFIs in both groups were a diagnosis of AML and age >18 and grade 2–4 graft-versus-host disease among those at high risk.

There were no differences in fungal infection-related outcomes between patients receiving fluconazole or voriconazole.

• Enrollment was limited to patients who were not at high risk for early death or relapse.
• Patients who had little or excessive risks for IFI or death were excluded.
• The patient population was selective.

Data indicated that there was no difference in FFS at 6 months between the voriconazole and fluconazole arms in intensive monitoring and early intervention in standard-risk HCT patients.  However, it is unclear if this would be true in patients who are not intensively monitored and/or at higher risk of IFI.  Further studies are needed to optimize outcomes in higher-risk groups.

The primary aim was patient evaluation of the usefulness of information provided. The secondary aim was to assess whether patients reported exercising during cancer treatment.

Patients starting a course of radiotherapy or chemotherapy (inpatient and outpatient) at Tayside Cancer Centre in the United Kingdom were given a “Fatigue Initiative” folder containing information on fatigue combined with advice on starting aerobic walking exercise during treatment. Patients were also encouraged to attend workshops on fatigue management as listed on flyers in the folder. Materials included home exercise information, walking information, and a guide for good sleep.

• In total, 146 patients (90 females, 115 males) were included. 
• Mean age was 63.4 years. 
• Patients had genitourinary (n = 119), gynecologic (n = 37), breast (n = 46), and other (n = 3) cancers.
• There were four treatment groups:  radical radiotherapy, postoperative radiotherapy, palliative radiotherapy, and chemotherapy.

United Kingdom

This was an observational cohort study.

• The Brief Fatigue Inventory (BFI) was used to assess level of fatigue before and after cancer treatment. The tool was administered four times:  at baseline, end of treatment, and the first and second follow-up visits. 
• Two study evaluation questionnaires were used:  one rated information usefulness and one provided information regarding exercise. No questions or scores were provided.

Overall, patients reported an increase in fatigue from baseline to the end of cancer treatment and from baseline to the first follow-up. Of the patients, 70% to 78% rated the information on fatigue helpful. Patients who said they used the information were more likely to exercise (odds ratio [OR] = 3.71; 95% confidence interval [CI] [1.19, 11.56]; p = 0.024). Patients who received radiotherapy were more likely to exercise than those receiving chemotherapy (OR = 14.9; 95% CI [2.43, 81.53]; p = 0.003). Higher levels of fatigue were reported by patients who used the information provided. Patients who exercised (p < 0.001), were older (p = 0.001), had other than breast cancer (p = 0.018), and who were not receiving chemotherapy (p < 0.05) reported lower fatigue scores on the BFI. Ten patients participated in a fatigue workshop.

Findings supported the positive effect of exercise on fatigue during cancer treatment and identified that age, breast cancer, and treatment with chemotherapy rather than radiotherapy were associated with the level of fatigue experienced. Findings suggested that the provision of written educational/informational materials can be helpful in encouraging patients to exercise.

• No appropriate control group was used.
• Time intervals varied between baseline and end of treatment for those receiving palliative radiotherapy (one to two weeks), radical or postoperative radiotherapy (four weeks), or chemotherapy (four months).
• Workshops were held in palliative care centers.

Fatigue did not decrease in any group. The study demonstrated the importance of providing information on fatigue encouraging a walking/home exercise program. Patients who were able to exercise during treatment had lower fatigue levels. The finding that those who used the information had higher levels of fatigue may suggest that patients who have the most fatigue are more likely to use information to help them cope with it.

For patients to evaluate the usefulness of the information provided.

Patients starting a course of radiotherapy or chemotherapy (inpatient and outpatient) at Tayside Cancer Centre in the United Kingdom were given a “Fatigue Initiative” folder containing information on fatigue together with advice on starting aerobic walking exercise during treatment. Patients were also encouraged to attend workshops on fatigue management as listed on flyers included in the folder. Materials included home exercise information, walking information, and a guide for good sleep.

• The sample was comprised of 146 patients (90 women and 115 men). 
• Mean age was 63.4 years.
• Patients had genitourinary (n = 119), gynecologic (n = 37), breast (n = 46), and other (n = 3) cancers.
• The study included four treatment groups:  radical radiotherapy, postoperative radiotherapy, palliative radiotherapy, and chemotherapy.

• Single site
• United Kingdom

This was an observational cohort study.

• Brief Fatigue Inventory (BFI) to assess level of fatigue before and after cancer treatment. The tool was administered four times:  baseline, end of treatment, and the first and second follow-up visits.
• Two study evaluation questionnaires were used:  one rated the information usefulness, and one provided information regarding exercise. No questions or scores were provided.

Overall, patients reported an increase in fatigue from baseline to the end of cancer treatment and from baseline to the first follow-up visit. Of the patients, 70% to 78% rated the information on fatigue helpful. Patients who said they used the information were more likely to exercise (odds ratio [OR] 3.71; 95% confidence interval [CI] [1.19, 11.56]; p = 0.024). Patients who received radiotherapy were more likely to exercise than those receiving chemotherapy (OR 14.9; 95% CI [2.43, 81.53]; p = 0.003). Higher levels of fatigue were reported by patients who used the information provided. Patients who exercised (p < 0.001), were older (p = 0.001), had cancers other than breast (p = 0.018), and were not receiving chemotherapy (p < 0.05) reported lower fatigue scores on the BFI. Ten patients participated in a fatigue workshop.

The findings supported the positive effect of exercise on fatigue during cancer treatment and identified that age, breast cancer, and treatment with chemotherapy rather than radiotherapy are associated with the level of fatigue experienced. The findings suggest that the provision of written educational/informational materials can be helpful in encouraging patients to exercise.

• The study lacked an appropriate control group.
• Time intervals varied between baseline and end of treatment for those receiving palliative radiotherapy (one to two weeks), radical or postoperative radiotherapy (four weeks), and chemotherapy (four months). Workshops were held in palliative care centers.

Fatigue did not decrease in any group. The study demonstrated the importance of providing information on fatigue and encouraging a walking/home exercise program. Patients who were able to exercise during treatment had lower fatigue levels. The finding that those who used the information had higher levels of fatigue may suggest that patients who have the most fatigue are more likely to use information to help them cope with it.

To systemically evaluate the evidence regarding the effectiveness of mindfulness-based stress reduction (MBSR) for sleep disturbance.

Databases searched were MEDLINE, AMED, CINAHL, PsycINFO, The Cochrane Central Register of Controlled Trials, and Digital Dissertations.

Search keywords were mindfulness-based stress reduction, meditation, mindfulness, sleep, and insomnia. The terms mind-body relations and mind-body relaxation techniques were searched in combination with sleep and insomnia. The Cochrane Central Register was searched using the keywords meditation and sleep.

Studies were included if they

• Were clinical trials, systematic reviews, or meta-analyses
• Were published in the English language
• Used MBSR (including several forms of meditation techniques) with multiple treatment sessions and pre- and postintervention assessment of sleep quality and duration.

Studies were excluded if they investigated only one of several modalities of MBSR provided to a treatment group or reported only qualitative outcomes.
 

• In total, 38 references were retrieved.
• The first and second author identified and reviewed potentially relevant articles. When necessary, the authors of excluded articles were contacted to confirm nonuse of MBSR interventions.
• No specific method for evaluating study quality was described.

• The final number of studies included was seven.
• The total sample included 423 participants.
• The sample range across studies was 16 to 115 participants.
• In all studies included, at least 50% of the participants were women.
• Seventy-six percent of all participants had at least one medical and one mental health diagnosis.
• Mean age ranged from 46 to 57 years. 
• Studies were conducted in patients with cancer (n = 3), patients on sleep medicine (n = 1), patients with fibromyalgia (n = 1), solid organ transplant recipients (n = 1), and patients seen at a community health center (n = 1).
• All MBSR interventions lasted 8 to 10 weeks and included formal home practice.

Outcome measures included the Pittsburgh Sleep Quality Index (PSQI), sleep diaries, visual analog assessment of sleep quality, and self-reports. Four studies found significant differences in sleep quality from pre- to postintervention. Both studies with control or comparison groups showed no significant differences in sleep quality from pre- to postintervention.  One study that included English- and Spanish-speaking participants demonstrated that English speakers showed more improved sleep quality than Spanish speakers. Two studies found significant differences in sleep quality related to home MBSR practice; however, one study found no significant differences related to practice time.

Given the very mixed results of the included studies, more research is needed to determine the impact of MBSR on sleep quality. Controlled studies that closely adhere to standardized MBSR interventions are necessary to fully describe the effects of MBSR on sleep quality. Comparisons between studies were limited due to the variability of sleep measures used. Studies using well-established and standardized measures of sleep quality are also needed.

• Only one study included a control group.
• Only one study on patients with cancer was included.

Given the mixed results seen and because only one study on patients with cancer was included, this review did not provide strong evidence of the efficacy of MBSR.

The purpose of the study was to assess the use of antimicrobial-coated sutures compared with conventional polyglactin and poliglecaprone for skin closure after breast cancer surgery for the reduction of surgical site infections.

Women diagnosed with breast cancer who were scheduled for primary elective surgery at a single center were approached for participation in the study. Following consent, they were block randomized in groups of 50 using random computer numbers. Sequential sealed envelopes were used and the type of suture to be used was revealed in the surgical suite just prior to surgery. The surgeon, patient, and assessor at follow-up were blinded. Following surgery, surgical sites were assessed at two weeks and six weeks using the Centers for Disease Control and Prevention (CDC) and ASEPSIS definitions for surgical site infections. In addition, patients completed a diary up to six weeks post-op, which included added details by the general practitioner and/or practice nurses. Other wound infection information also was gathered and included delays in radiotherapy or chemotherapy.

• The sample was comprised of 150 participants, all female, and all older than age 18.
• 75 participants were in each study arm
• Patients were included if they had breast cancer that was not inflammatory or did not have skin ulcerations.
• In addition to inflammatory breast cancer or skin ulcerations, patients were excluded if they received neo-adjuvant chemotherapy or radiotherapy, were having surgery for benign or reconstructive reasons, had known immune deficiency or allergy to triclosan, or were unable to give consent or appeared as if they were unlikely to comply with follow-up.

A single site (both inpatient and outpatient) in Wales

Active treatment

Randomized, controlled trial; double-blinded

•  CDC criteria for surgical site infections 
•  ASEPSIS criteria for surgical site infections
•  Southampton wound scores
•  Demographics (age, weight, type of operation)
•  Patient diary
•  Document

The overall rate of surgical site infections was 18.9% at six weeks, with six patients needing an intervention or readmission for the infection. No statistically significant differences were found between types of sutures; however, use of the anti-microbial sutures did show less surgical site infections (15.2% in the anti-microbial group versus 22.9% in the control group).

Anti-microbial sutures may be beneficial in the reduction of surgical site infections in adult women with breast cancer. A larger study is needed to have enough power to show statistically significant differences.

Surgical site infections following breast cancer surgery is prevalent. Careful and frequent evaluation of the surgical site is highly important. Use of anti-microbial sutures may reduce infections.

A 20-minute audiotape was used that included education about the self-care behaviors of exercise and relaxation to manage anxiety, fatigue, and sleep problems. A self-care diary mirrored the audiotape. The control group received education about side effects. Outcomes were fatigue, anxiety, and sleep.

• The sample was comprised of 71 patients.
• Mean age was 50.4 years (range 30–74).
• Of the patients, 85% had stage I or II breast cancer and were receiving chemotherapy regimens with cyclophosphamide.

• Tertiary medical center and a satellite cancer treatment clinic
• Southeastern United States

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

A modified self-care diary measured the number of side effects, severity of each side effect, number of self-care behaviors performed for each side effect, and the effectiveness of each self-care behavior.

More women in the control group reported difficulty sleeping at baseline; both groups experienced increased severity of sleep disturbance between the first and second self-care diary.

• Control was lacking regarding how much and what kind of information was given to women at the time of treatment. The use of the self-care audiotapes may have been insufficient.
• The trial had a small sample size.

To determine if aloe vera gel can prevent the development of radiodermatitis in patients undergoing breast radiation therapy (RT).

In both studies, gels were applied twice a day starting within three days of RT initiation. Each patient received instruction on skin care. Patients were stratified by age groups:  younger than 45 years, 45 to 60 years, and older than 60 years.

• Study 1 included 194 patients.  
• Study 2 included 108 patients. 
• Patients were younger than 45 years (21.5%), 45 to 60 years (35%), or older than 60 years (43.5%). 
• All patients were women. 
• Patients had breast cancer.
• Patients were not receiving concomitant chemotherapy, and there were no scars or ulcers in the treatment field.

Two studies were reported:  a randomized, double-blind, controlled trial of aloe versus placebo gel and a randomized trial of aloe versus no treatment.

• Patients were rated by an MD/RN on scale of 0 (normal) to 3 (moist desquamation and/or ulceration).
• Patients self-rated on the same scale and completed questionnaires at the start and weekly until one month post RT. 
• Kaplan-Meier curves and log rank test were used to compare treatment arms.
• Severity scores were compared using Wilcoxon test.
• Spearman rank correlation coefficients were calculated to compare maximum severity.

• Study 1:  Mean severity score in aloe versus placebo gel was 1.9 and 1.9 by patient judgment. Mean severity score in aloe versus placebo gel was 1.5 versus 1.6 as judged by a healthcare provider. No significance was found.
• Study 2: Mean severity score in aloe versus no treatment was 1.9 versus 2 by patient judgment. Mean severity score in aloe versus no treatment was 1.7 versus 1.5 as judged by a healthcare provider. No significance was found.

The study does not support the hypothesis that aloe vera gel can decrease RT-induced dermatitis.

• The study lacked interrater reliability.
• The study did not use a valid or reliable scale.
• Patients were able to use other treatments, such as hydrocortisone or domeboro if they had skin problems, so it is not clear if confounding treatments were given.
• No skin care regimen log was used to determine adherence.

To compare the effectiveness of a pain management protocol with usual care

Patients who were referred for pain control were screened for worst pain severity on a 10-point numerical scale, and those who scored four or more were randomized to usual care or the experimental protocol group. The protocol treatment was individualized to the patient based on assessments. Protocols included the formulation of a pain treatment plan, weekly reassessments, the provision of an educational brochure, a discussion with a pain control doctor, and a referral to palliative care or other services as needed. Patients were followed for three months. Usual care patients could be referred to the pain control group but were not proactively scheduled for ongoing weekly assessments. Study assessments were done at baseline and at one and two months.

• N = 129
• MEAN AGE = 59 years (range = 19–80 years)
• MALES: 58%, FEMALES: 42%
• KEY DISEASE CHARACTERISTICS: All patients had head and neck cancers, and the majority were cancers of the larynx and pharynx.
• OTHER KEY SAMPLE CHARACTERISTICS: Overall, 87% of participants were receiving weak opioids at baseline, and the average morphine equivalent dose at baseline was 29 mg per day (range = 5–510 mg).

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: United Kingdom

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Palliative care 

Single-blinded, randomized, controlled trial

• Brief Pain Inventory (BPI), the average of four scales as a pain severity index
• Pain Management Index (PMI)
• EuroQol Five Dimensions Questionnaire (EQ-5D)
• Patient satisfaction
• Cost effectiveness analysis

There were no significant differences between the groups in pain measures throughout the study. Patient satisfaction was higher in the study group. The mean cost of pain treatment was significantly higher in the study group. The analysis showed a low probability of the intervention being cost-effective. Pain scores declined significantly over time in both groups.

The protocol did not demonstrate any significant benefit over usual care.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Unintended interventions or applicable interventions not described that would influence results 
• Key sample group differences that could influence results 
• Measurement/methods not well described 
• Other limitations/explanation: The sample was underpowered. At baseline, the range of morphine equivalents was much higher in the usual care group. The timing and method of BPI measures was not described. Changes in medications and the use of additional referrals between groups over time was not discussed, so it was unclear if there were substantial differences in the care between groups. The phase of care was not clearly stated. Both groups were managed in the same pain practice, so it was possible that protocol aspects also were applied to usual care patients.

The findings of this study did not show a benefit of the specific protocol approach with weekly reassessments in the clinic as used here. This study did show that pain screening could be implemented and combined with good usual care to reduce pain severity.

Patients were given a 20-minute audiotape that provided information about exercise and relaxation to manage anxiety, fatigue, and sleep problems. A printed self-care diary (SCD) of self-care behaviors that mirrored the audiotape was also provided. Participants were instructed to listen to the audiotape 12 to 24 hours before the start of chemotherapy cycles and as often as desired during the course of treatment. Patients in the control group received the standard education and care given to all patients during chemotherapy, whereas the experimental group received standard education and care, the audiotape, and the printed SCD.

• The study included 71 women (control group, n = 33; experimental group, n = 38) who were newly diagnosed with breast cancer; 85% had stage I or II breast cancer.
• Mean age was 50.41 years (range 30–74); 50% were younger than 50 years. 
• Of the women, 50% were Black, 56% were Caucasian, and a few were Hispanic.
• Mean education level was 13.23 years (range 6–24).
• Of the women, 60% had an income of less than $29,000 (US).
• About half of the women were married.
• Most women received cytoxan/adriamycin; less than 13% received cytoxan/adriamycin/5FU.
• Patients were excluded if they were undergoing any therapy other than chemotherapy, were younger than 18 years, had a Karnofsky Performance Status (KPS) rating of less than 70%, or were non-English speaking.

• Multisite
• Tertiary medical center in the Southeastern United States and a satellite cancer treatment clinic 

Patients were undergoing the active treatment phase of care.

This was a randomized study; patients were randomly assigned to either the control or experimental group.

SCD

A higher percentage of women in the control group reported fatigue compared to the experimental group. Although the experimental group increased the number of self-care behaviors to address fatigue compared to the control group, this difference was not statistically significant.

• There was no control over information from outside sources that was provided to the women at the time of treatment; therefore, this varied between patients.
• The lack of significant findings may be due to insufficient use of self-care tapes, and measures to promote compliance will be needed in the future.
• The study had a small sample size.

To perform a systematic review of studies regarding the efficacy of psychotherapeutic and antidepressant interventions for cancer patients with depression or symptoms of depression

• Authors searched these databases: PubMed, CINAHL, Database of Abstracts and Reviews of Effects (DARE), Cochrane Database of Systematic Reviews (CDSR), Cochrane Controlled Trials Register (CCTR), PsycARTICLES, and manual searches of items from reference lists. Searched keywords consisted of multiple terms relevant to depression and cancer; the terms were from articles relevant to the review and U.S. National Library of Medicine medical subject headings (MeSH). Intervention terms included antidepressant agents, SSRI, fluoxetine, and cognitive therapy.
• Studies included related to randomized controlled trials (RCTs), reported in English, that involved pharmacologic and psychotherapeutic interventions for depression in adult patients with cancer.
• Excluded studies were those that used combined pharmacologic and psychotherapeutic interventions, complementary or alternative treatment for cancer, or informational or educational strategies.
   

The total number of references retrieved was 164. Authors conducted analysis according to the methodological-quality instrument developed Bo, Cho, and Bero.
 

The final number of included studies was 24. The sample range across studies of pharmacologic intervention was 892 (range = 40–549); of psychotherapeutic intervention, 2,518 (range = 36–450). Studies related to multiple disease sites.
 

• Authors analyzed reports of six pharmacologic trials, 18 psychotherapeutic interventions, and two studies of computer-based assessment and care planning. Most studies did not control for cointerventions. Most aimed at treatment of depression.
• The majority of psychotherapeutic trials involved use of cognitive behavioral therapy. Other interventions were social support, counseling, support and education, and psychotherapy.
• None of the trials using antidepressants reported avoidance or monitoring of cointerventions.
• One trial found paroxetine to be effective in cases of major depression. One found paroxetine to be effective in reducing symptoms of depression. 
• One trial reported that fluoxetine was ineffective in patients who presented with major depressive disorder. Response was not significantly higher than that of patients using placebo.
• Two trials were reported to show effectiveness in reducing symptoms of depression.
• Symptoms were measured at various time points with various instruments. 
• Of all studies analyzed, 42% demonstrated significant improvement in depression as measured.
   

Some evidence indicates that antidepressants are effective in reducing symptoms of depression in patients with cancer. Overall tolerability of antidepressants appeared to be good. Cognitive behavioral therapy was effective in reducing symptoms of depression. Another intervention that might be effective is the use of social support groups.

• Almost no trials monitored, avoided, or reported co-interventions that could affect symptoms of depression. 
• Most psychotherapeutic trials were single-center trials, a fact that limits generalizability.
• In many studies, recruited patients did not have significant psychological morbidity.
• Few pharmacologic studies reported tolerability data.
• The analysis included few studies of the use of antidepressants by the included patients.
• No studies described patients receiving palliative care.

Findings suggest that antidepressants, cognitive behavioral interventions, and support-group interventions can have a positive impact on symptoms of depression in patients with cancer. Variability in findings suggests that these interventions are likely to be of most benefit to patients who actually have clinically meaningful symptoms of depression. Further research regarding the efficacy of antidepressants in the included patients is needed. Studies should include data about co-interventions for depression.