To conduct a preliminary exploration of mindfulness-based stress reduction (MBSR) participation of couples affected by cancer, particularly as participation affects symptoms of stress, mood disturbance, and mindfulness for patients with cancer and their partners

A convenience sample of 41 couples already enrolled in an MBSR program at a cancer outpatient center agreed to participate by completing the three study measures before the program started and two weeks following program completion. Weekly 90-minute classes held over an eight-week period, plus one weekend retreat lasting three to six hours, comprised the intervention. Of the 41 couples, only 21 completed post-test measures and at least six of eight MBSR classes.

• The sample was comprised of 21 couples (95% married).
• The sample was 52.4% female and 47.6% male.
• Mean patient age was 62.9 years (SD = 7.37); mean partner age was 62.8 years (SD = 9.34).
• The most common patient diagnoses were prostate cancer (28.6%), breast cancer (19%), and colorectal cancer (14.3%).
• Mean time since primary diagnosis for all patients was 2.03 years.
• Mean educational level for couples was 14.6 years.

• Single site
• Outpatient setting
• Cancer center in Calgary, Alberta, Canada

• Multiple phases of care
• Late effects and survivorship

A pretest/post-test design was used.

• Profile of Mood States (POMS): Measures identified mood and change in mood or affective states using a Likert scale with well-established reliability (Kuder-Richardson of six POMS subscales ranged from 0.84 to 0.95.)    
• Calgary Symptoms of Stress Inventory (C-SOSI): Uses a Likert scale to measure physical and psychologic responses to stress and consists of eight subscales (depression, anger, muscle tension, cardiopulmonary arousal, sympathetic arousal, neurologic/gastrointenstinal, cognitive disorganization, and upper respiratory symptoms). The tool has been validated in the oncology population with convergent and divergent validity (Cronbach's alpha = 0.95).
• Mindfulness Attention Awareness Scale (MAAS): Uses a Likert scale to  assess individual differences in mindfulness over time and measures the presence or absence of attention and awareness to the present moment. The scale has been validated with patients with cancer (Cronbach's alpha = 0.87).

Of the couples, 21 provided POMS data, 19 provided C-SOSI data, and 16 provided MAAS data for baseline and postintervention measures. Before MBSR intervention, patients reported significantly higher scores on the POMS fatigue subscale (p = 0.05), while partners reported significantly higher scores on the C-SOSI sympathetic arousal subscale (p < 0.05) than did patients according to t-test analysis. Patients with only baseline data reported significantly higher levels of total mood disturbance before MBSR classes than those who provided complete data (p < 0.05). After program completion, both patients and partners experienced significant reduction in mood disturbance (p < 0.05) and the C-SOSI subscales of muscle tension (p < 0.01), fatigue (p < 0.05), neurologic/GI (p < 0.05), and upper respiratory symptoms (p < 0.01). Both groups significantly increased their mindfulness (p < 0.05) as a result of the intervention. After the MBSR intervention, couples’ scores on the POMS and C-SOSI were more highly correlated with one another. Partners’ mood disturbance scores were positively correlated (p < 0.05) with patients’ symptoms of stress and negatively correlated with patients’ levels of mindfulness (p < 0.05).

As one of the first studies using a sample of patients with cancer and partners, the MBSR program benefited both patients and their partners by reducing mood disturbance and physical symptoms of stress, psychologically aligning patients and partners during the cancer journey, and increasing levels of mindfulness. Moderate effect sizes were found for both patients and partners on these variables.

• The sample was small and underpowered, with less than 30 participants.
• The study had no comparison group.
• The study had 51% attrition following collection of baseline data from 41 couples.

MBSR programs for patients with cancer and their partners may buffer physical and psychological challenges during their cancer journey. Nurses, as members of the healthcare team, may suggest these increasingly evidence-based programs as a complementary intervention for patients and partners who seek additional nonmedical ways to cope with the cancer illness. Validation of MBSR will enhance couples’ willingness to seek out MBSR that may respond to psychosocial gaps in care of patients with cancer and their partners who struggle with predominant high-technology approaches to oncology care. Further examination is also needed to identify cost-effective ways of meeting healthcare system goals for person-centered care in diverse populations of families facing cancer.

To compare the effectiveness of different 5-HT₃ receptor antagonists (RAs) in the control of acute- and delayed-onset emesis associated with highly emetogenic chemotherapy

Databases searched were Cochrane Register of Clinical Trials (CENTRAL), PubMed, Embase, and Latin American and Caribbean Health Sciences Literature (LILACS).

Search keywords were MeSH for granisetron; ondansetron, tropisetron, dolasetron, ramosetron, palonosetron, azasetron, in all possible comparison sets; chemotherapy, antineoplastic agents, and cisplatin. Internet databases of gray literature were searched, and hand searching was performed of potentially relevant journals and conference proceedings.

Studies were included in the review if they

• Were randomized controlled trials (RCT) comparing different 5-HT₃ RAs in adults with cancer.
• Had at least 20 participants per treatment group.
• Reported on patients older than 16 years.
• Reported on patients receiving cytotoxic drugs for which emesis is expected in more than 90% of administrations according to American Society of Clinical Oncology (ASCO) emetic risk classification (2006).

Studies were excluded if they 

• Had insufficient concealment of allocation in the study procedures.
• Included patients with nausea and vomiting associated with moderately emetogenic chemotherapy, radiotherapy, surgery, or bone marrow transplant.

Of the 25 studies found that met the eligibility criteria, 16 RCTs were included. These studied granisetron, ondansetron, tropisetron, ramosetron, palonosetron, and dolasetron. Four studies were excluded because of inadequate outcome assessment, two studies because of the unavailability of the protocol, one study because of very poor methodological quality, and one study because it included patients receiving only moderately emetogenic therapy.

The final sample of 16 studies reported on 7,808 patients across all studies.

Acute nausea

• Pooled data from seven studies (involving 4,160 participants) that evaluated granisetron versus ondansetron were included.
• Pooled results favored ondansetron (odds ratio [OR] = 0.97, confidence interval [CI] = 95%, 0.85–1.10).

Total control of acute nausea and vomiting

• Data from six studies of granisetron versus ondansetron, involving 2,809 patients in total, were included.
• No significant differences were found with respect to different 5‑HT₃ RAs or any other factors.

Delayed nausea

• Data were combined and analyzed from two studies with a total of 1,024 patients.
• Palonosetron appeared to be superior to granisetron in controlling delayed nausea.
• Both drugs were given in combination with dexamethasone (OR = 1.63, CI = 95%; 1.27–2.10).

Total control of delayed nausea and vomiting

• Data were pooled and analyzed from two studies involving 1,045 patients.
• Palonosetron was superior to granisetron.

Meta-analysis of granisetron and ondansetron

• Both had similar effects on either acute or delayed nausea and vomiting.
• Both had similar side effects.

• Ondansetron and granisetron were essentially equivalent for prevention of acute and delayed nausea and vomiting with highly emetogenic chemotherapy.
• No 5-HT₃ RA appeared to be superior to any other for acute nausea.
• Palonosetron plus dexamethasone may perform better than others for delayed nausea and vomiting; however, this was shown by a single study and more evidence should be obtained in this area before a firm recommendation can be made.
• Findings suggested that 5-HT₃ RAs are equally effective for management of nausea and vomiting with highly emetogenic chemotherapy.
• Some suggested differences were found in terms of side effect profiles and effectiveness for delayed nausea.

Further RCTs comparing palonosetron and dexamethasone for delayed nausea are warranted.

To assess the effects of same-day pegfilgrastim administration compared to standard delayed administration among women being treated for gynecologic cancer

Medical records were used for data collection. Women received 6 mg pegfilgrastim on the same day as chemotherapy or within 24–72 hours of chemotherapy administration. Results of absolute neutrophil count (ANC), chemotherapy delay, regimen change related to neutropenia, and incidence of febrile neutropenia (FN) were compared. A 25% difference in risk of these outcomes was established as the noninferiority margin of interest. Sixty-one patients crossed over to the alternate timing of pegfilgrastim during treatment.

• N = 421   
• MEAN AGE = 59.4 years (SD = 12.1)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Seventy-nine percent had ovarian cancer. The majority had stage III or IV disease.

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: United States

• PHASE OF CARE: Active antitumor treatment

• Retrospective cohort comparison, noninferiority

• FN was ANC < 1000/mcl and a single temperature of 101 or sustained temperature of at least 100.4 for over one hour

Grade 3 or 4 neutropenia was observed more often in the same-day administration group (2.6% versus 1.8%, risk ratio [RR] = 1.62, p = 0.05). No significant differences in treatment delays or dose modifications existed within the established margin.

Same-day pegfilgrastim administration was associated with slightly higher grade 3 or 4 neutropenia.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Key sample group differences that could influence results
• Much smaller number of patients who received same-day pegfilgrastim

This study did not provide sufficient evidence to establish safety and effectiveness of same-day pegfilgrastim administration. The findings suggest that altered timing may be safe in terms of looking at treatment delays related to neutropenia. Prospective studies are needed to determine whether same-day administration is appropriate. This approach can be very helpful for patients who need to travel long distances for treatment and may reduce the number of visits required for treatment.

In this prospective trial, patients were randomly assigned to one of two groups. Patients in the intervention group received five massage sessions (effleurage), lasting about 20 minutes. Patients in the control group received visits by a hospital staff member (attention control).

• The study consisted of 39 patients with breast cancer who were enrolled prior to the start of their third cycles of chemotherapy.
• The intervention group had 19 patients and the control group had 20 patients.

This was a prospective trial with random assignment.

• Patients completed a 100-mm visual analog scale (VAS) for nausea and anxiety before and immediately after the massage intervention or after the staff visit for the control group.
• The Hospital Anxiety and Depression (HAD) Scale was completed before the first and last massage sessions.

• No differences were found in anxiety as measured by the VAS between the groups.
• No differences were found between groups or within groups over time in anxiety or depression as measured by the HAD.
• The authors stated that nausea was significantly reduced in the massage group, as measured by the VAS; they did not report raw scores but, rather, “percentage improved.”

Interpretation of the findings as written was difficult. Although the authors concluded that massage reduced nausea, nausea was not assessed at expected problem points. For example, severe nausea was measured 30 minutes into the chemotherapy infusion after patients received antiemetic prophylaxis with 5-HT₃ and steroid.

• The hospital staff (nurses and nurses' aides) delivered the massage intervention after one day of training.
• No control was provided for consistency or adequacy of the intervention.
• Only nausea was assessed, not vomiting.
• Nausea was assessed by VAS immediately before and after the massage, but the massage was delivered during the chemotherapy infusion and nausea measured right after.
• The measurement period did not coincide with when nausea is expected to occur or be most severe. For example, nausea was measured prior to the start of massage, but nausea would not be expected to be present or severe at this time.

The study assessed the efficacy and the tolerability of gabapentin 900 mg/day compared to vitamin E for the control of vasomotor symptoms in women with breast cancer.

Vitamin E was chosen as a placebo-equivalent on the basis of previous experience  showing only minimal effect on hot flushes in breast cancer participants, and no toxicity or side-effects. Participants were randomly allocated to one of two treatment groups: vitamin E 800 IU/day or gabapentin 900 mg/day by oral route (Neurontin 300 mg capsules) for a period of 12 weeks.

The sample was comprised of 115 postmenopausal women with a median age of 50 years. 

• Inclusion criteria:
  • Breast cancer surgically treated at least one year prior; no evidence of systemic disease 
  • Eight or more hot flushes per day 
  • Postmenopausal status (amenorrhea for more than 12 months or amenorrhea for 6–12 months with a serum FSH level greater than 40 mIU/ml and estradiol less than 20 pg/ml or bilateral oophorectomy or ovarian suppression by GnRH analogs) 
  • Adjuvant therapy with tamoxifen, aromatase inhibitors or GnRH analogs, provided that it was started at least two months before
• Exclusion criteria:
  • Use of any antidepressant treatment, progestagens, or any other medication to treat hot flushes within the previous three months 
  • Concomitant chemotherap
  •  Uncontrolled hypertension 
  • Impaired renal or hepatic function
  • Diabetes

This was a randomized, non-placebo-controlled, nonblinded study.

Each participant completed a one-week self-report diary on hot flushes at study entry and daily during the 12 weeks of study. In order to assess the duration of treatment efficacy, participants filled out the hot flush diary for three months after treatment discontinuation.

Treatment efficacy was assessed by two measures: frequency (total number of hot flushes) and severity score, calculated by assigning scores of 1, 2, 3 and 4, respectively, to mild, moderate, severe, and very severe hot flushes. This hot flush diary had previously been validated. Each value was obtained by averaging data collected over 1 week. Differences and percentage changes from baseline to weeks 4, 8, and 12 were calculated. Among the women allocated to vitamin E, 16.36% never started therapy, and 34.78% dropped out because of inefficacy. Hot flush frequency and score decreased by 57.05% and 66.87%, respectively (p = 50.05) in the gabapentin group. The effect of vitamin E was fairly small: hot flush frequency and severity score were reduced by 10.02% and 7.28%, respectively (p > 0.05).

Gabapentin 900 mg/day is effective for relieving hot flushes in participants previously treated for breast cancer. Vitamin E has only marginal effect on vasomotor symptoms.

Study limitations were small sample size and high dropout rate.

• Evaluation of low-dose venlafaxine hydrochloride for the therapy of hot flashes in breast cancer survivors
• Evaluate the efficacy and tolerability of a longer treatment (eight weeks) at a lower dose of venlafaxine (37.5 mg/day)

• N = 40
• Patients attending the outpatient clinic for menopausal symptoms 
• All witha history of breast cancer without evidence of recurrence and no requirement of fulfilling menopausal status
• Anti-estrogen therapy was allowed provided that it had been started at least four months before study entry and continued the next three months

Outpatient

Open label study

Measures included:

• Hot flash diary and computation of daily hot flash scores
• Weekly documentation in diariesof side effects experienced  
• Beck Depression Inventory (BDI) as completed at baseline and at week 8 
• At weeks 4 and 8,a clinical visit to monitor blood pressure, assess side effects, and hot flash frequency
  • Patient was excluded from study if blood pressure found diastolic above 95 or systolic above 160, or if important side effect occurred

Thirty patients completed the first 4 weeks of treatment with reduction of hot flash frequency of 39% compared to baseline. After eight weeks of treatment, a further significant reduction in hot flashes by 53% and a hot flash score by 59% was observed. Very few side effects were reported, mainly nausea during first the two weeks and mouth dryness. Only 23 women completed the BDI at week 8 with a reduction of 23% reported. No patient was withdrawn for blood pressure increase or major toxicity.

Low-dose venlafaxine hydrochloride can be effective in reducing frequency and severity of hot flashes in patients with breast cancer.

• Not blinded or placebo-controlled  

The sudy evaluated the efficacy and safety of mirtazapine to reduce hot flashes in women with a previous breast cancer and assessed the influence of the same treatment on sleep quality and other menopausal symptoms.

Treatment was mirtazapine 15 mg/day at bedtime for one week, then 30 mg/day for the next 11 weeks. Primary end point was to compare hot flash score and frequency after 4, 8, and 12 weeks of treatment to the basal values.

The study enrolled 40 consecutive postmenopausal women with a previous history of breast cancer.

It was conducted in an outpatient treatment clinic for menopausal symptoms.

This was a pilot, open-label study.

Sample size was calculated under the assumptions of the detection of a 50% reduction in hot flash frequency, with 80% power at a two-sided alpha level of 0.05. These assumptions, using a dependant samples t-test, required at least 20 evaluable patients. Tools included: Hot flash diary, hot flash score, MRS, PSQI, and the SF 36 Health Survey.

Twenty patients completed the study. After four weeks of treatment, a significant decrease of vasomotor symptoms compared to baseline values was reported. The mean decrease in hot flash frequency was 46.9% and mean reduction in hot flash score was 49%. The benefit increased at week 8 when the mean decreases in frequency and score were 56.5% and 62.16% respectively. The effects remained stable during the last month.

The study was limited by its small sample size. Out of 40 women enrolled in the study 13 (32.5%) withdrew after signing consent and recording basal data and never began therapy;  reasons given for withdrawal included were reluctance to take antidepressant drugs or the fear that thedrug may adversely affect cognitive function or cause side effects.

The study should be duplicated in a larger blinded, placebo-controlled trial. There was a possible negative interaction between the antiproliferative effect of tamoxifen on the breast and mirtazapine.

• Assess efficacy and tolerability of gabapentin 900 mg/day compared to vitamin E for the control of vasomotor symptoms.
• Secondary objective to evaluate effect of the treatments on quality of sleep and other aspects of quality of life (QOL).

Patients were randomized to gabapentin 900 mg/day or vitamin E 800 IU/day for 12 weeks.

The study population included 115 adult postmenopausal women with history of breast cancer experiencing eight or more hot flushes per day. Sixty women completed the study. 

• Median age: 50 years
• Inclusion: Previous breast cancer surgically treated one year prior; no evidence of systemic disease; eight or more hot flushes per day; postmenopausal status; adjuvant tamoxifen, aromatase inhibitors or gonadotropin releasing hormone (GnRH) analogs allowed if started at least two months prior.
• Exclusion: Use of any antidepressant treatment, progestagens, or other medication to treat hot flashes within three months; concomitant chemotherapy; uncontrolled hypertension; impaired renal or hepatic function or diabetes.

Oncology Department University of Turin, Italy

Non–placebo-controlled, non-blinded trial

• Hot flush diary completed daily
• Pittsburgh Sleep Quality Index (PSQI)
• Menopause Rating Scale (MRS) 
• SF-36 Health Survey

Hot flush frequency and score decreased by 57.05% and 66.87%, respectively (p < 0.05) in the gabapentin group. Hot flush frequency and score were reduced by 10.02% and 7.28% respectively (p > 0.05) in the vitamin E group. Gabapentin improved the quality of sleep (PSQI score reduction: 21.33%, p < 0.05).

• Small sample size
• High dropout rate

To determine if ionic silver surgical dressings could reduce the incidence of surgical site infection in adult patients undergoing elective laparotomy for colorectal cancer

Subjects randomly were assigned to have their surgical wound covered with either an ionic silver dressing (AQUACEL^® Ag Hydrofiber^®) or a common dressing. To achieve blinding for patients, nurses, and medical staff, both groups had an additional layer of a common dressing applied by scrub nurses over the main dressing. Patients were monitored for surgical site infection for 30 days postoperatively.

• N = 112          
• AGE = 18–75 years (mean = 64 years)
• MALES: 58, FEMALES: 42
• KEY DISEASE CHARACTERISTICS: Elective laparotomy surgery for colorectal cancer

• SITE: Multi-site    
• SETTING TYPE: Inpatient    
• LOCATION: Italy

• PHASE OF CARE: Active antitumor treatment

• Randomized, prospective trial (double-blinded)

• Surgical site and vital signs evaluated daily during hospitalization, upon discharge, and at 30-day follow-up (surgical wounds remained covered for seven days)

The authors evaluated the primary outcome of surgical wound infection. Patient characteristics were similar across the two study arms. Surgical wound infection rates were lower in the arm receiving the antimicrobial dressing. This was true with respect to grade 1 versus grade 2 and 3, and grade 1 and 2 versus grade 3. However, the difference in infection rates was not great enough to be of statistical significance (p = 0.623).

Infection rates were slightly lower in the experimental group, but not enough to be statistically significant.

• The cover dressing purportedly provided blinding, but blinding would have been removed when the surgical dressing was removed. The article does not state whether surgeons or nurses were present when dressings were removed.
• Using the second layer of a common dressing over the antimicrobial dressing may have affected its performance, or may have affected the performance of the first layer of the common dressing in those patients randomized to the arm that received a double layer of the common dressing.
• The presence and severity of necrosis, erythema, edema, rigors, and hematoma are subjective analyses.

Patients having rectal surgery for cancer are at higher risk for surgical wound infection compared to colon surgery. Novel antimicrobial dressings may help reduce infection rates, but further study is needed.

To compare the effects of chlorhexidine-containing dressings and nonchlorhexidine dressing on catheter-related infections (CRIs) in neutropenic patients

Patients were randomized to receive either a transparent central venous catheter (CVC) dressing with a chlorhexidine gel pad or the transparent dressing without the gel pad. All catheters were nontunneled and placed in the subclavian or internal jugular vein with strict aseptic technique. Dressings were changed every 3–4 days. In the case of neutropenic fever, blood cultures were drawn, and if central line–associated bloodstream infections (CLABSI) were suspected, the catheter was removed and the tip was sent for culture. Patients were followed for 14 days.

• N = 613   
• MEAN AGE = 58 years
• AGE RANGE = 18–85 years
• MALES: 57.3%, FEMALES: 52.7%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All were expected to have neutropenia for at least five days and expected CVC use of at least 10 days. All had hematologic malignancies. About half were undergoing autologous hematopoietic cell transplanation (HCT).
• OTHER KEY SAMPLE CHARACTERISTICS: Over 90% were receiving antimicrobials.

• SITE: Multi-site   
• SETTING TYPE: Inpatient    
• LOCATION: Germany

PHASE OF CARE: Active antitumor treatment

• Randomized, open-label

• Definite or probable catheter colonization—definite CLABSI was the primary endpoint
• Catheter-related sepsis

The study was discontinued early because the interim analysis did not show a significant difference in the primary endpoint of the study (definitive CLABSI) and further enrollment was not expected to make a difference. The incidence of probable bloodstream infection was less frequent in the study group (p = 0.014). No differences existed in sepsis, infection-related mortality. More unscheduled dressing changes occurred in the control group. Patients with coated CVCs had higher rates of catheter-related colonization and bloodstream infection (p = 0.007).

The use of a chlorhexidine gel pad CVC dressing was associated with a lower incidence of probable CLABSI but did not demonstrate a significant effect on definite catheter-related bloodstream infection within 14 days of CVC placement.

• Risk of bias (no blinding)
• Key sample group differences that could influence results 
• Measurement/methods not well described
• The study was underpowered.
• No complete subgroup analysis based on use of coated catheters
• The definition of probable and definitive infection was not well described.

Although this study did not show an effect of chlorhexidine gel pad CVC dressings on definitive CLABSI within 14 days, the gel pad dressing was associated with a lower incidence of probable catheter-related infection. This study had a large sample but was underpowered because of an overall low incidence of definitive CLABSI. The findings suggest that the use of a dressing with a chlorhexidine pad may be beneficial in reducing catheter-related infections.