To evaluate the effectiveness of preperitoneal continuous wound infusion (CWI) with ropivacaine, compared to continuous epidural infusion (CEI) with ropivacaine, on pain control after open colorectal surgery and on the quality of patient recovery

The intervention group had preperitoneal CWI analgesia. The control group had preperitoneal CEI analgesia. Participants were randomly assigned and received either CWI or CEI during first 48 hours postop. Infusion consisted of 0.2% ropivacaine at 10 ml/hour. All patients received morphine patient-controlled analgesia during the first 72 hours postop. All received standardized postoperative care not adhering to fast-track surgery programs. Investigators used the 100 mm visual analog scale (VAS) to measure pain.

A 4.5-point difference in VAS pain score showed that preperitoneal CWI was not inferior to CEI analgesia.

• The sample was composed of 106 patients. 
• The range of patient age was 57.9–73.5 years.
• Of all patients, 52% were male and 48% were female.
• All patients had colorectal cancer and underwent open nonemergency colorectal surgery for cancer.
• Types of surgery represented in the sample were hemicolectomy, rectal resection, segmentary colonic resection, and total colectomy. Authors noted differences regarding duration of surgery (in minutes), length of wound catheter in intervention group, and vertebral level of epidural catheter insertion in control group.

• Multisite 
• Inpatient
• Italy

• Phase of care: transition phase after active treatment
• Clinical application: eldercare

Multicenter randomized controlled trial (noninferiority design)

The primary outcome measure was a VAS whose scale ranged from 0 (no pain) to 100 (worst pain imaginable). 

Other outcome measures included

• Morphine titration and usage
• Morphine patient-controlled analgesia at varying intervals during the first 72 hours postop
• Time of first flatus
• Time of first bowel movement
• Duration of hospital stay, from surgery to discharge
• Quality of sleep (0–10 scale)
• Patient satisfaction with pain control (rated poor, good, or excellent) at 72 hours postop
• Side effects noted during the first 30 days postop (Side effects included hypotension requiring treatment, central nervous system toxicity, nausea and vomiting requiring medication, and presence of motor block [epidural complications in control group and abdominal complications in intervention group].)

• At 2, 6, 12, and 24 hours postop, the CEI and CWI groups demonstrated similar responses, indicating achievement of sufficient pain control. 
• At 48 and 72 hours postop, the CWI group—in contrast to the CEI group—demonstrated a statistically significant reduction in reported pain score.
• In terms of the secondary end-point measures, the results the CWI group achieved were similar to those the CEI group achieved in regard to duration of hospital stay, quality of night sleep, and requirement for rescue analgesia.
• In the CWI group, 45.3%  reported excellent pain control at 72 hours postop. In the CEI group, 7.6% reported excellent postop pain control.
• Compared to the CEI group, the CWI group demonstrated a significantly shorter time to first flatus (p = 0.002) and first bowel movement (p = 0.001). 
• Compared to the CEI group, the CWI group had a statistically significant lower incidence of postop nausea and vomiting at 24 hours (p = 0.02), 48 hours (p = 0.01), and 72 hours (p = 0.007).

CWI provides an acceptable alternative to CEI for the management of patients' pain after colorectal surgery for the treatment of cancer.

The study had a risk of bias due to no blinding.

This study shows that oncology nurses, as advocates for patients, can support CWI as an alternative to CEI as a means of postoperative pain management. Because CWI was associated with significant benefits regarding postoperative sleep disturbance, bowel function, and nausea and vomiting—as well as pain management—nurses can advocate for the use of CWI to address several symptoms of concern to oncology patients and direct-care nurses.

To evaluate the efficacy and safety of SAMITAL in reducing mucositis in patients undergoing treatment for hematologic malignancies

Patients used SAMITAL mouth rinse three to four times daily and held it in the mouth for one minute.

• N = 25  
• AGE: 18–84 years (Note: in the abstract, age was 18–74 years)
• MALES: 19 (76%), FEMALES: 6 (24%)
• KEY DISEASE CHARACTERISTICS: Adult patients with cancer undergoing treatment for hematologic malignancies

• SITE: Single site  
• SETTING TYPE: Inpatient   
• LOCATION: Hospital Clinico Regional de Valdivia, Valdivia, Chile

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

• Observational, uncontrolled study

• World Health Organization (WHO) mucositis grading scale (variables: stomatitis, dysphagia, gastritis, enteritis, pain, and feeding) performance status of less than 2

The grade of mucositis was reduced from grade 2 to 0–1 in seven patients (25%). It is stated that pain, mucosal erosions, bleeding, and dysphagia were reduced; however, it is unclear how these were measured.

SAMITAL may have some benefit in the prevention and management of oral mucositis.

• Small sample (< 30)
• Risk of bias (no control group)
• Risk of bias (no blinding)  
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Selective outcomes reporting
• Findings not generalizable
• Other limitations/explanation: Due to the small sample, the researchers performed only descriptive statistics.

The authors suggested performing randomized, placebo-controlled clinical trials to confirm the suitability of SAMITAL for the treatment and prophylaxis of mucositis.

To assess feasibility and effects of an inpatient rehabilitation program on symptoms and physical function

Participants attended three weeks of inpatient rehabilitation and a follow-up five-day stay 8–12 weeks later. All attended group programs, which included physical training and education following cognitive behavioral approaches. Physical training was done twice a day for 60–120 minutes.

• N = 131
• AGE: 14% were 25–44 years old, 86% were greater than or equal to 45
• MALES: 23%, FEMALES: 77%
• KEY DISEASE CHARACTERISTICS: Participants had multiple tumor types, although breast and GI were most common.
• OTHER KEY SAMPLE CHARACTERISTICS: All had high school education, and 66% had some college education. Time since diagnosis was less than two years in 72%. Thirty percent were working full-time or part-time.

• SITE: Single site  
• SETTING TYPE: Inpatient  
• LOCATION: Norway

• PHASE OF CARE: Multiple phases of care

• Quasiexperimental

• EORTC Cancer Quality of Life Core 30 (EORTC–QLQ-C30) questionnaire
• Fatigue questionnaire
• Physical activity questionnaire
• Maximal oxygen consumption test (Vo₂ max test)
• Sit-to-Stand Test (SST)
• Maximum step length

Multiple symptoms showed decline. These were statistically significant; however, the degree of change seen from the end of the initial three weeks to the final measure was less than that which the authors identified as clinically relevant. Fatigue scores increased from baseline to postintervention measures (8.9–9.3 for physical fatigue and 4.9 for mental fatigue at both time points). All symptoms declined from baseline over time.

Findings suggest that a multicomponent rehabilitation program can improve multiple symptoms for patients with cancer.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Subject withdrawals of 10% or greater 
• Dropouts tended to be those with lower education levels, and significantly more males dropped out.
• The sample was self-selected.
• Lack of a control group does not enable determination if changes seen were due only to time, as it is known that many symptoms decline over time. 
• Authors noted that the three-week program was very resource intensive.  

Findings showed improvement of multiple symptoms after a three-week inpatient rehabilitation program. This was resource intensive and had many dropouts, causing one to question the practicality and cost-effectiveness of this approach. This study is limited by its design, with lack of a control group.

To compare the difference in occurrences of lymphedema and other postoperative complications following two different surgical approaches for stage 3 melanoma

Researchers divided patients into two groups, one that received vertical incisions, and another that received transverse incisions. Taking into account individual variables and any postoperative issues, patients were retrospectively studied for the presence of lymphedema.

• N = 53  
• AVERAGE AGE = 52.79 years
• MALES: 45% (rounded up), FEMALES: 55% (rounded up)
• KEY DISEASE CHARACTERISTICS: Histologic type of melanoma; Breslow's depth; Clark's level; ulceration and regression
• OTHER KEY SAMPLE CHARACTERISTICS: The presence of lymphedema, personal characteristics (i.e., height, weight, age, sex, body mass index, smoking status), skin necrosis, wound separation or infection, and seromas were taken into account.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Centre Hospitalier Universitaire, Rennes, France

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care 

Retrospective chart review

• Lymphedema was considered present or not present according to medical charts.
• There was no specific description of how lymphedema was measured or graded.

No statistically significant difference was noted between the two groups regarding any variable or characteristics, including the primary lymphedema status.

The difference in surgical approach didn't influence surgical outcomes, potential complications, or potential for chronic lymphedema.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no control group) 
• Risk of bias (no random assignment)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Measurement/methods not well described
• Measurement validity/reliability questionable

This study did not have a direct effect on nursing practice other than to help inform nurses about the low potential for surgical approaches to have a negative effect on outcomes.

The study was designed to compare injected medroxyprogesterone vs. oral megestrol to control hot flashes in women with breast cancer.

Participants were randomized to two groups. Group 1 received I.M. depot MPA (500 mg on days 1, 14, and 28) and Group 2 received oral megesterol acetate (40 mg po daily days 1-42).

Eligible patients were postmenopausal females with a history of breast cancer, without evidence of relapse, whom had been suffering from hot flashes for at least 1 month prior to study entry. Group 1 enrolled 3 , and Group 2 enrolled 34.  Major Inclusion/Exclusion Criteria:

• Concurrent adjuvant tamoxifen 20 mg/day was allowed if started at least 1 month before study entry and if the planned residual duration of treatment was at least 6 months.
• No concurrent treatment with estrogens, androgens, progestins, corticosteroids, clonidine, veralipride, or ciclophenile was allowed.
• Patients who had received adjuvant chemotherapy had to have concluded treatment for more than 2 months.

Not described

The primary endpoint was the proportion of responding patients after 6 weeks of treatment (7 weeks after randomization). A patient was classified as a responder if she achieved a greater than 50% reduction in frequency of hot flashes and hot flash score. Frequency and severity of hot flashes were monitored through self compiled diaries. The three main efficacy parameters were:

1. Changes in average number of hot flashes per day
2. Average daily ‘hot flash score’ compared to baseline
3. Proportion of participants who obtained greater than 50% reduction in frequency and reduction in HF score as compared to baseline score

The mean number of hot flashes and hot flash scores did not differ significantly at baseline between the two groups. Differences between the two groups at week six were not statistically significant. Good control by both treatments was apparent. No significant difference in the proportion of responders between the two arms was observed (p=0.567) Overal,l 50 of 71 patients (70.4%, 95% CI 58-81%) achieved a response as previously defined.Maintenance of response in the group of 50 initial responders was assessed at 2-monthly follow up visits for 6 months after randomization. By patient report, a difference in the duration of response was observed: out of 28 responding patients in the MPA group, 25 (89.3%) were still responding at 6 months. In the megestrol group, only 10 of the initial 22 responders (45.4%) were still in response after 6 months.

For an 80% power and two sided 5% significance, 90 subjects were planned. Only 71 were accrued. After randomization, five patients in each group refused to start the assignment and withdrew from the study. Two more patients, both in group one, were found ineligible (one for medical contraindication and one not postmenopausal) and withdrawn. Six patients did not provide complete diary recordings during treatment (five patients who dropped out before completion for side effects and one who was lost to follow-up). Treatment allocation was not double-blinded because this would have required administration of I.M. placebo in group 2 which was judged impractical.

To review results of published randomized controlled trials (RCTs) and meta-analyses to determine the benefits that bisphosphonates provide to men with hormone-refractory prostate cancer

• Databases searched were MEDLINE, EMBASE, CANCERLIT, and the Cochrane Library. Investigators also retrieved selected conference proceedings. The date range searched, for all materials, was 1980–2004.
• Search keywords were text words and medical subject headings that were disease specific, treatment specific, and study-design specific.
• Studies were included in the review if they
  • Were RCTs or meta-analyses.
  • Involved a sample of men with hormone-refractory prostate cancer and compared bisphosphonate treatment with placebo, no treatment, or treatment with another bisphosphonate.
  • Reported outcomes regarding new bone metastases, skeleton-related events, symptom response, survival, or quality of life.

• Authors did not report total number of search results.
• Authors identified 17 reports as eligible.
• Authors stated quality characteristics of evaluated studies, but did not report quantitative grading.

The final sample of 17 reports included three systematic reviews and 12 RCTs. The sample included 1,446 patients. The range of sample size was 13–643. Eight trials supplied pain outcomes, and these eight trials involved 756 patients.

Variability of pain measurement across studies prevented statistical pooling. Overall, trials did not detect significant differences in pain outcomes between patients taking the study drug and patients taking placebo. However, over a relatively long period and among individuals with at least moderate pain severity at baseline, authors noted trends toward better pain relief with bisphosphonates than with placebo. Most trials were identified as underpowered, a fact that may have prevented investigators from detecting significant differences. In general, patients tolerated bisphosphonates well. Nausea was the most frequently reported adverse event; across trials 9%–33% of patients experienced nausea.

Overall, trials reviewed did not show significant differences in pain outcomes between those who received bisphosphonates and those who received placebo. However, at specific time points subgroups of bisphosphonate-using patients who had at least moderate pain showed trends toward improvement.

Findings suggest that bisphosphonates may be helpful in providing pain relief to men with hormone-refractory prostate cancer who have at least moderate pain levels. Clinicians should watch for nausea in bisphosphonate-using patients and be ready to provide relief. Further research, to define the most effective timing of bisphosphonate administration and the best way to use a bisphosphonate alone or in combination with other therapies, is warranted.

To compare tolerance for and the efficacy of granisetron at 10 µg/kg versus 40 µg/kg for the prevention of acute and delayed nausea and vomiting in patients receiving moderately emetogenic chemotherapy

Each patient was randomly assigned to receive either 10 µg/kg or 40 µg/kg of granisetron during alternating cycles of chemotherapy. Medication was given intravenously 30 minutes prior to the start of chemotherapy, and patients received no other prophylactic antiemetic medication. The dose was blinded from treating doctors, nurses, and patients. Data were collected the first five days following chemotherapy.

• N = 18
• MEAN AGE = 7.7 years (range = 1–23 years)
• MALES: 13 (72%), FEMALES: 5 (28%)
• KEY DISEASE CHARACTERISTICS: All had optic pathway tumors
• OTHER KEY SAMPLE CHARACTERISTICS: Scheduled to receive either carboplatin alone or carboplatin with vincristine

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Marmara University Medical Center in Istanbul, Turkey

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

Randomized, double-blinded crossover trial

• Nausea and emesis were recorded by patients and parents on self-reported diary cards that were scored as a 1 (complete response [absence of nausea or vomiting]), 2 (major response [one emesis episode or moderate nausea]), 3 (minor response [two to four emesis episodes independent of nausea]), or 4 for (treatment failure [more than four emesis episodes per day]).
• A safety assessment included any report of an adverse event by patients or parents and vital signs recorded by the physician.

Antiemetic efficacy scores were not different between the two doses (1.045 for the 40 µg/kg dose and 1.040 for the 10 µg/kg dose [p = 0.330]). Neither gender nor age affected antiemetic efficacy scores. No granisetron-related side effects were reported. No patients withdrew from the study.

Granisetron was an effective antiemetic medication for moderately emetogenic chemotherapy with the majority of patients experiencing a complete antiemetic response over five days postchemotherapy. Higher doses of granisetron were associated with no significant improvements in efficacy. Granisetron was safe with no adverse events associated with administration.

• Small sample (< 30)
• Measurement/methods not well described

Granisetron was a safe and effective medication that prevented acute and delayed nausea and vomiting associated with moderately emetogenic chemotherapy.

To compare the effects of physical treatment with and without manual lymphatic drainage (MLD) on lymphedema in breast cancer survivors after lymphadenectomy

Patients were randomized into three groups. Group 1 received MLD, skin care, bandaging, and remedial exercises. Group 2 received soft touch (a sliding touch on chest and upper limbs), skin care, bandaging, and remedial exercises. Group 3 received skin care, bandaging, and remedial exercises. Groups 2 and 3 were combined after an initial analysis revealed no differences, and additional patients were randomized into the two groups. A physiotherapist trained in lymphedema therapy administered treatments three times per week to all patients in two phases. In phase 1, all patients received skin care, compressive bandaging, and remedial exercises, and group 1 received 30 minutes of MLD using the Vodder technique while group 2 did not receive any MLD. When arm volume plateaued for one week, patients from both groups moved to phase 2, which consisted of skin care, exercises, and fitted garments. Volume was assessed at randomization, after each treatment session, and at each follow-up visit. For both groups, phase 1 lasted approximately 24 days.

• N = 57  
• AVERAGE AGE = 62 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Most participants were overweight (body mass index mean = 29.75).

• SITE: Single-site    
• SETTING TYPE: Outpatient    
• LOCATION: Brazil

• PHASE OF CARE: Late effects and survivorship

Randomized, controlled trial

• Volume was measured using the truncated cone formula with circumferences at 7, 14, and 21 cm under and 7 and 14 cm above the cubital fold
• Volume excess
• Absolute volume excess

Patients in group 1 completed phase 1 in an average of 21.54 days, and patients in group 2 completed it in an average of 27.34 days. A significant reduction in limb volume was seen during phase I for both groups (p < .001), but no difference was seen between the groups. Patients in groups 1 and 2 had an average volume excess reduction of 15.02%. In both groups, 73.7% of participants reported subjective feelings of improvement in swelling.

The results of this study do not support the addition of MLD to treatment protocols for lymphedema after breast cancer. Patients in both groups of this study showed a statistically significant reduction in total arm volume after phase 1, and there were no differences in arm volume reduction between groups. Patients in group 1 did complete phase 1 in fewer days than patients in group 2.

• Small sample (< 100)
• Risk of bias (no blinding)

This study does not support the use of MLD to treat lymphedema in breast cancer survivors after lymphadenectomy. Nurses should regularly assess patients who have completed breast cancer treatment for lymphedema and should provide appropriate referrals for treatment, give education about completing exercises at home, advise patients about wearing compression garments, and explain how to properly conduct skin care for a limb affected by lymphedema.

Each of the three intervention programs included seven sessions. Group size varied from 3 to 10 participants. The physical training session lasted 60 minutes and consisted of light physical activity with movement and fitness training, relaxation, sitting, and breathing exercises. A booster session was held two months after the conclusion of training exercises. In the 60-minute information session, emphasis was placed on providing participants with information about prostate cancer, its treatment and side effects, and effective means to cope with side effects. Participants were encouraged to discuss their experiences and reactions regarding diagnosis and to communicate with group leaders and other participants. In the 135-minute information and physical training session, participants were given physical training and information in the same session. In the control, participants receiving standard care could telephone a nurse if they had questions. Questionnaire materials were obtained two weeks after inclusion into the study and at the six- and 12-month follow-ups.

• The study included 211 men diagnosed with prostate cancer within six months. 
• Mean age was 69 years (range 43–86).
• Twenty percent of participants had metastasis.
• The most common curative treatment was radical prostatectomy.
• Proportions of marriage (80%) and retirement (70%) were comparable among the groups.
• Participants were excluded if they had another cancer diagnosis, participated in other studies, were participants in other care programs, had hearing/vision impairment, were non-Swedish speaking, or were physically or mentally disabled.

University hospital in Uppsala, Sweden, Regional Oncological Centre

Participants were undergoing the active treatment phase of care.

Participants were stratified and randomized to one of four groups:  physical training (n = 53), information (n = 55), information and physical training (n = 52), and the control group (n = 51).

European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30)

Participants with metastases scored less than participants without metastases on the fatigue subscale of the EORTC QLQ-C30 at baseline and at 12 months. No significant differences were observed between the psychosocial rehabilitation groups when compared to the no intervention group.

The lack of effect on outcome measures may be due to the low power and complicated design. Heterogeneity of the sample, despite stratification, may have led to an unbalanced distribution of participant clinical and demographic characteristics in each treatment group.

To evaluate the effect of psychosocial rehabilitation on patients newly diagnosed with prostate cancer

Patients enrolled in the “Between Men” program were randomized to one of four groups. Each intervention group met for seven sessions. The group that received physical training participated in 60-minute sessions of light physical training that included movement, fitness training, relaxation, and breathing exercises. The group that received informationattended a 60-minute session about prostate cancer, treatment, side effects, etc. The \"combination\" group participated in exercise and received information, for a total of 135 minutes. The control group received standard care. Investigators asked four research questions, including whether physical training reduces depression among men with prostate cancer.

The sample included 158 patients who had been newly diagnosed with prostate cancer.

• Single site
• Uppsala, Sweden

Randomized controlled trial (RCT)

• Hospital and Anxiety Depression Scale (HADS)
• EORTC Cancer Core Quality of Life (EORTC QLQ-C30) questionnaire
• A cancer-specific multidimensional tool with subscales of functioning and symptoms

This RCT did not find any differences in depression or anxiety symptoms among participants at the preintervention, 6-month, or 12-month assessment. The group that received physical training appeared to have experienced the most improvement in symptoms of depression. This improvement occurred between baseline and 12 months, but the confidence intervals overlapped too much for the improvement to be conclusive.

• Possibly ineffective intervention diminished control over activity and information in the control group.
• Of all participants, 20% dropped out after 12 months.
• The sample lacked heterogeneity among participants, and the size of each group was small; therefore, the study has limited generalizability.