To assess the impact of education on analgesic medication for patients with cancer-related pain

Patients were randomly assigned to control or education groups. The education group received three information booklets and eight face-to-face education and counseling sessions over four weeks. Clinical pharmacists contacted patients daily to review outcomes and made recommendations to physicians based on patient response.   Pharmacists received standardized training. Pharmacists assisted patients to complete study questionnaires.

• N = 237  
• MEAN AGE = 51.3 years
• AGE RANGE = 23–70 years
• MALES: 79%, FEMALES: 21%
• KEY DISEASE CHARACTERISTICS: More than 80% had metastatic disease; tumor types not reported

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

• RCT

• Brief Pain Inventory

Pain and analgesic knowledge increased significantly from baseline in both groups, and pain intensity and interference decreased significantly in both groups from baseline (p < .05). Knowledge improved the most in patients who had not previously used analgesics. Pain intensity declined more in the intervention group.

Education and counseling were associated with improvement in pain scores.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Selective outcomes reporting
• Other limitations/explanation: Possibility of testing bias with repeated measure of the same tool. It is not clear if there was potential for contamination if the study was done in the same inpatient settings. It is stated that pharmacists made recommendations based on patient responses, but it is not stated if pain control regimens were changed during the study or what analgesics patients were receiving, so it is impossible to know if the education intervention was responsible for differences found.

The likely effectiveness of psychoeducation for improving pain control is known; this study supports that evidence in an inpatient setting.

To observe the curative effect of an acupoint application with a Dingqi analgesic patch on moderate-to-severe pain caused by liver cancer

Patients were randomized to a control or a treatment group. Patients with visual analog scale (VAS) scores of 4–6 were given 100 mg sustained-release tramadol daily. Those with VAS scores of 7–10 were given 4.2 mg fentanyl transdermal every three days. The treatment group was given the acupoint patch consisting of a mixture of traditional Chinese herbs on one to two pain points. The control group was given the same size patch without medication. The VAS scores were assessed at intervals throughout the 12 days of treatment.

• N = 40
• AGE = 18–80 years
• MALES, FEMALES: Not available
• KEY DISEASE CHARACTERISTICS: Liver cancer with pain

• SITE: Single site 
• SETTING TYPE: Not specified 
• LOCATION: China

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

• Single-blind, randomized, controlled study

• VAS
• Karnofsky Performance Scale

Findings suggest that the Dingqi patch might be helpful in pain management; however, this study provides very limited support for this approach.

• Small sample (less than 100)
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Key sample group differences that could influence results
• Other limitations/explanation: This study shows a decrease in pain over the 12-day period, almost equivocal in the treatment and control group. The patients scored their pain on the VAS scale and were given either controlled-release tramadol or Duragesic^® patches at the start of the study, in addition to the Dingqi patch, or the control patch. Additionally, during the 12 days, if a patient scored a 4–6 on the VAS, they were given a 50 mg tramadol injection; if they scored a 7–10 on the VAS, they were given a 5 mg morphine injection. The report was very limited with no information on patient demographics. Actual data are not reported.

This study does not provide evidence in support of the use of this analgesic patch for pain.

To determine the feasibility, safety, and effects of endoscopic ultrasound (EUS)-guided direct celiac ganglion irradiation with iodine-125 seeds in patients with pain secondary to unresectable pancreatic cancer

Patients were prehydrated and given intravenous ciproflosacin during the procedures and postoperatively for three days. After identification of celiac ganglion, two to four seeds were inserted via the biopsy channel of the endoscope. Computed tomography scans and abdominal radiography were done the day after surgery to ensure correct placement. Postoperative drug therapy was done following World Health Organization guidelines. None of the patients received radiotherapy. Patients were followed weekly until death.

• The study reported on a sample of 23 patients.
• Median patient age was 64 years, with a range of 38–77 years.
• The sample was 61% male and 39% female.
• All patients had unresectable pancreatic cancer.
• Half (50%) of the patients were within two months of diagnosis, and 50% had not had any previous antitumor treatment.

• Single site
• Multiple settings
• China

• Patients were receiving palliative care.
• The study has clinical applicability for late effects and survivorship.

An observational, prospective study design was used.

Pain visual analog scale (VAS)

Average duration of follow-up was 79 weeks (range 43–156 weeks). Patients received morphine sulfate for pain. Baseline VAS mean score was 5.78 (range 4–8), and average morphine sulfate conception was 68.26 (range 40–90). Initial pain score and opioid consumption increased over the first two weeks. By week 3, pain and opioid consumption declined, and by week 7 VAS mean score was 2.91 (range 1–6) and morphine sulfate consumption was 40.45 (range 20–80). These values continued to decline weekly.  By five months, only two patients remained: pain score was 1.5 and opioid consumption with morphine sulfate was 20. None of the patients achieved complete relief of pain. No procedure complications were reported.

The EUS-guided celiac ganglion irradiation with iodine-125 seeds as done here was effective in reducing pain in these patients with pain due to unresectable pancreatic cancer.

• The study has a small sample size, with less than 30 patients.
• The study has risk of bias due to no control group, no blinding, and no random assignment.
• Validity and reliability of measurement is questionable.
• Findings are not generalizable.
• The exact timing and method of VAS scoring is not described.
• Findings are only applicable to patients with unresectable pancreatic cancer.

Control of pain secondary to pancreatic cancer is a challenge, and many of these patients had severe intractable pain. The procedure tested here showed a positive effect for pain control. As such, this procedure may provide another option for pain management in these patients as an adjunct to other pain control approaches. Further well-designed research in this area is warranted, and studies comparing various pain-control methods in this group of patients would be helpful to identify the most beneficial approaches.

To evaluate the effect of abdominal massage on reducing ascites, pain, and other ascites-related symptoms

Gentle abdominal massage consisting of straight rubbing, point rubbing, and kneading was provided by a trained nurse practitioner (NP) for 15 minutes, twice a day (7–8 am and 4–5 pm) for three consecutive days. Control participants received social attention by the same NP who delivered the massage. The NP followed a script during the interaction exploring the patient’s feelings and thoughts and providing information about treatment. Symptoms and body weight were measured in the morning for four successive days (pre- to post-test).

• N = 80
• MEAN AGE = 59.11 years (SD = 11.05 years)
• MALES: 66%, FEMALES: 34%
• KEY DISEASE CHARACTERISTICS: Stage IV cancer; had not received chemotherapy in the preceding month; most common type of cancer was liver followed by colorectal, gastric, and pancreatic
• OTHER KEY SAMPLE CHARACTERISTICS: 54% of the patients had mild ascites, 28% were moderate, and 18% were severe as defined by the Moore and Aithal grading system

• SITE: Single site
• SETTING TYPE: Inpatient
• LOCATION: Northern Taiwan

• PHASE OF CARE: End of life care
• APPLICATIONS: Palliative care 

Randomized, controlled trial using repeated measures

• Symptoms were measured using the Edmonton Symptom Assessment System–Ascites Modification (ESAS-AM).
• Body weight was measured with a scale.
• A blinded assessor collected the data.

There was no significant change in pain, tiredness, nausea, drowsiness, poor appetite, shortness of breath, mobility limitation, or body weight among patients who received massage. The intervention group did experience a significant improvement in depression (p = 0.003), anxiety (p = 0.002), poor well-being (p = 0.001), and perceived abdominal bloating (p < 0.001). These symptoms improved gradually over time for the intervention group, but slightly increased over time for the control group. No massage-related adverse events occurred.

Abdominal massage did not improve pain in this study; however, this may be related to the low level of pain among patients at baseline. Massage improved depression, anxiety, well-being, and perceived abdominal bloating. Additional study is needed with larger groups of patients with malignant abdominal ascites.

• Small sample (< 100)
• Baseline sample/group differences of import
• Findings not generalizable
• Intervention expensive, impractical, or training needs
• Other limitations/explanation: Patients were from one medical center. All the patients were randomized except patients in the same patient room who were assigned to the same group. The intervention group had more multiple-organ metastases, and this was controlled for in the analysis. In addition, the intervention group at baseline had significantly more nausea, poorer appetite, and more shortness of breath, but less drowsiness than the control group.

This non-invasive, inexpensive intervention was not effective in reducing pain for patients with abdominal ascites, but it may provide relief for other symptoms such as abdominal bloating, depression, anxiety, and poor well-being. After additional study, if this intervention is proved to be appropriate for pain management, nurses will need training on proper massage techniques.

• FINAL NUMBER STUDIES INCLUDED = 8 (with one study used twice) 
• TOTAL PATIENTS INCLUDED IN REVIEW = 458
• SAMPLE RANGE ACROSS STUDIES: 23–122 patients
• KEY SAMPLE CHARACTERISTICS: Patients with hematologic malignancies     

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care

Oral cryotherapy for patients with hematologic malignancies receiving HSCTs with high-dose melphalan decreased the incidence of severe OM. Cryotherapy also may be helpful for patients receiving other preparative regimens. Cryotherapy may decrease the duration of TPN usage and shorten hospital stay. Oral cryotherapy did not appear to affect on the length of analgesic use.

Limitations of this study included the small number of RTCs and the small sample sizes of those RCTs. The methodologic quality of the studies might have resulted in bias.

Oral cryotherapy is a low-cost, easy modality that demonstrated efficacy in decreasing the severity of OM in patients with hematologic malignancies receiving HSCTs. Additional studies on the efficacy of cryotherapy with other conditioning regimens are needed.

• FINAL NUMBER STUDIES INCLUDED = 27 (evaluated 30 trials in total)
• TOTAL PATIENTS INCLUDED IN REVIEW = 6,037
  • Primary lipegfilgrastim compared to primary pegfilgrastim (two studies n = 306) 
  • Primary lipegfilgrastim compared to no primary G-CSF/placebo (one study n = 375) 
  • Primary lenograstim compared to no primary G-CSF/placebo (five studies n = 467)
  • Primary filgrastim compared to no primary G-CSF/placebo (11 studies n = 2,181) 
  • Primary pegfilgrastim compared to no primary G-CSF/placebo (five studies n = 2,060) 
  • Primary pegfilgrastim compared to primary filgrastim (six studies n = 647)
• KEY SAMPLE CHARACTERISTICS: Adult patients who received myelosuppressive chemotherapy for solid tumors or non-Hodgkin lymphoma

PHASE OF CARE: Active antitumor treatment

• Primary prophylaxis using filgrastim, pegfilgrastim, lenograstim, and lipegfilgrastim were statistically significantly better than not using G-CSF or placebo for the reduction of FN risk. Across all chemotherapy cycles, pegfilgrastim was slightly better than lipegfilgrastim for reducing NF risk, but this finding was not significant.

• Using direct comparison, FN risk was significantly reduced following PP with pegfilgrastim, filgrastim, or lenograstim compared to no G-CSF PP or a placebo. 
• Using indirect comparison, PP with pegfilgrastim or filgrastim significantly reduced FN risk compared to no G-CSF PP or a placebo.  
• Using mixed-treatment comparison, PP with pegfilgrastim, filgrastim or lenograstim, significantly reduced FN risk compared to no G-CSF PP or a placebo. PP with pegfilgrastim significantly reduced FN risk compared to filgrastim PP. PP with lipegfilgrastim significantly reduced FN risk compared to no G-CSF or a placebo.
• Using mixed-treatment comparison, PP with pegfilgrastim, filgrastim, and lipegfilgrastim significantly reduced FN risk in the first cycle and across all cycles of chemotherapy compared to no G-CSF or a placebo. PP with pegfilgrastim significantly reduced FN compared to filgrastim PP. No significant difference was found in FN risk during first cycle of chemotherapy using PP with either pegfilgrastim or lipegfilgrastim.
• A meta-analysis of all cycles with adjustment of RDI could not be evaluated.

Prophylaxis with G-CSF reduces the risk for NF during myelosuppressive chemotherapy.

• More information could be obtained if the RDI adjustment could have been conducted.
• There was some heterogeneity between studies, limiting the ability to evaluate relative dose intensities, number of chemotherapy cycles, and dose delays.
• Detailed study characteristics were lacking.
• The Bayesian method was appropriate to use as a prediction model but may not accurately capture true events.
• Publication bias: No specific data comparing G-CSF effect and type of myelosuppressive regimen

Patients with cancer undergoing myelosuppressive chemotherapy are at risk for FN. Prophylaxis with G-CSF can reduce this risk for improved patient outcomes.

To examine the effectiveness of an exercise program on quality of life (QOL), fatigue, sleep disturbances, exercise self-efficacy, exercise behavior, and exercise capacity in women with breast cancer.

Patients were randomly assigned to an exercise or usual care group. The exercise intervention was a six-week walking program based on modified exercise guidelines of the American Cancer Society and American College of Sports Medicine. This program included use of a heart rate ring monitor, pedometer, weekly telephone call, weekly meetings, and an exercise diary. Exercise was of low to moderate intensity (40%–60% maximum heart rate). In this program, patients did weekly goal setting and were given advice and information, and several specific strategies were described that were intended to boost self-efficacy. Patients were oriented to the exercise program prior to surgery, and exercise was begun within a few days after surgery. Data were collected 24 hours prior to surgery and at 24 hours prior to the first cycle of chemotherapy, 7 to 10 days after chemotherapy, and at the end of six weeks.

• The sample was comprised of 62 women. 
• Mean age was 50.42 years (standard deviation = 9.64 years).
• All patients had undergone mastectomy.
• Of the patients, 36% had at least a college education, 80.6% were married, and 51.4% were working full-time.
• All patients had stage I or II disease and were newly diagnosed.

• Single site
• Outpatient
• Taiwan

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

• Functional Assessment of Cancer Treatment–General and Fatigue scales (FACT-G, FACT-F)
• Pittsburgh Sleep Quality Index (PSQI)
• Exercise Self-Efficacy Scale (EXSE)
• Godin Leisure-Time Exercise Questionnaire
• 6-minute walk test (6MWT)

The pattern of change in QOL over time showed significant consistent improvement among those in the exercise group compared to usual care controls (p < 0.001). Patterns of change in sleep and sleep disturbance also showed significant improvement over time compared to controls (p < 0.006). The pattern of fatigue showed higher fatigue levels in the exercise group at all study time points. Average fatigue scores changed from 40.5 to 45.8 at week 6 in the exercise group and from 40.1 to 40 with usual care. Patients in the exercise group had significantly better exercise self-efficacy (p ≤ 0.001) and higher levels of exercise behavior (p < 0.001) than those receiving usual care. Patients in the exercise group walked farther on the 6MWT than controls after the intervention (p ≤ 0.001).

Findings showed that a self-managed home exercise program, along with intervention strategies aimed at boosting self-efficacy, had a positive effect on QOL and exercise behavior among women newly diagnosed with breast cancer.

• The study had a small sample size, with less than 100 patients.
• It is not clear what type of relevant patient information and education was provided in the usual care group.
• The duration of the study was relatively short at six weeks.
• The sample was very slightly underpowered.
• Lack of any blinding suggests a potential for bias.
• It is not clear if both groups received weekly telephone calls so that attentional control was provided.
• There was a 30% contamination rate, with 30% of control group patients also exercising at least three times per week.

The findings did not show a positive impact of a home-based exercise self-efficacy intervention on fatigue in the first six weeks after surgery in newly diagnosed patients. However, over a longer period of time, patients in the exercise group did better. Nurses may need to educate patients that adherence to an exercise program may not show results in the short term and that effects may take some time to be felt. Nurses can educate and encourage patients to exercise at home, and support activities to boost patient sense of efficacy may improve patient adherence to an exercise prescription.

• FINAL NUMBER STUDIES INCLUDED = 6 
• TOTAL PATIENTS INCLUDED IN REVIEW = 726
• KEY SAMPLE CHARACTERISTICS: All studies defined complete response as no vomiting or use of rescue medications. Five studies compared standard antiemetic regimens without olanzapine to standard antiemetic regimens with olanzapine.

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care, palliative care

Five out of six studies demonstrated an increase in complete response in patients receiving standard antiemetic regimens plus olanzapine on day 1 of chemotherapy (odds ratio [OR] = 1.95, 95%; confidence interval [CI] = 1.17–3.23; p = 0.01). Five out of six studies showed a cumulative delay in vomiting (OR = 2.65, 95%; CI = 1.36–5.15; p = 0.004). Overall complete response relative risk was improved (4.07, 95%; CI = 1.59–10.43). Also note the following: delayed-phase antinausea effects in olanzapine-containing antiemetic regimens (OR = 2.79, 95%; CI = 1.76–4.43; p = 0.0001); antinausea effects in the overall phase (OR = 3.40, 95% CI = 2.32–5.00; p = 0.00001); and no superiority in the acute phase (RR = 1.34, 95%; CI = 0.77–2.34; p = 0.30).

Complete response is more likely in patients who received antiemetic regimens containing olanzapine compared to patients who did not receive olanzapine. Olanzapine is more effective in delayed CINV than acute.

• Small sample
• Differences in what drugs were included in standard antiemetic regimens in each study
• One study used aprepitant in the standard antiemetic regimen.

Olanzapine may add CINV control when added to a standard antiemetic regimen during the delayed phase.

To compare the effects of ondansetron and olanzapine to ondansetron alone for management of chemotherapy-induced nausea and vomiting (CINV)

All patients received 8 mg IV ondansetron 30 minutes before chemotherapy. Patients in the experimental group also received 10 mg olanzapine for eight days. CINV was evaluated after one chemotherapy cycle.

• N = 84   
• MEDIAN AGE = 60 years
• AGE RANGE = 39–76 years
• MALES: 72.6%, FEMALES: 37.4%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: All had non-small cell lung cancer and were receiving a cisplatin-gemcitabine regimen.
• OTHER KEY SAMPLE CHARACTERISTICS: All were chemotherapy-naive.

• SETTING TYPE: Outpatient    
• LOCATION: China

PHASE OF CARE: Active antitumor treatment

Randomized, two-group trial

World Health Organization toxicity grading criteria

The incidence of vomiting in the acute phase was 33.33% in the olanzapine group and 54.76% in the control group (p < 0.05). The incidence of delayed CINV was 16.67% with olanzapine and 47.62% in the control group (p < 0.01).

The use of olanzapine as part of an antiemetic regimen was associated with a lower incidence of vomiting in the acute and delayed phases.

• Small sample (< 100)
• Risk of bias (no blinding)
• Measurement validity/reliability questionable
• Typical antiemetic regimens were not employed. CINV was measured only in terms of vomiting, rather than control of nausea as well.

This study adds to the body of evidence demonstrating the potential role of olanzapine for control of CINV. Olanzapine may have particular benefit for control in the delayed phase. Nurses need to evaluate the patterns of CINV in patients receiving chemotherapy and can identify patients who may benefit from the use of olanzapine along with other antiemetic agents.

STUDY PURPOSE: To evaluate the effects of probiotics for the prevention of diarrhea in patients receiving chemoradiotherapy for cancer

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 9 placebo controlled studies for assessing efficacy, 11 studies for assessing safety
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,265 patients for efficacy analysis, 1,612 for safety analysis
• SAMPLE RANGE ACROSS STUDIES: 24–490 patients for efficacy

PHASE OF CARE: Active antitumor treatment

• Six RCTs looked at frequency of diarrhea at grade 2 or lower. No significant differences in this level of diarrhea existed with probiotics. For diarrhea greater than grade 2 (four studies), the odds ratio (OR) was 0.36 (p < 0.001) in favor of probiotics compared to placebo.
• For chemotherapy-induced (seven studies), the overall OR was 0.48 (95% confidence interval [CI] [0.27, 0.85], p = 0.01) with high heterogeneity.
• For radiation-induced (two studies), the overall OR was 0.47 (95% CI [0.28, 0.76], p = 0.002) with high heterogeneity.
• Variation existed across studies in the use of antidiarrheal medications.
• No adverse events caused by probiotics were reported in seven studies, and four studies reported varying degree adverse events. Reporting of adverse events was insufficient to allow for pooled analysis. 
• Studies used differing combinations of probiotics

Probiotics may have a role in the prevention or management of chemotherapy- and radiotherapy-induced diarrhea. The risk of probiotic-associated infections is unclear.

• High heterogeneity
• Low sample sizes
• Many studies had very small samples.  
• Varying risk of bias among studies included
• Varied combinations of probiotics were studied.

Probiotics may have a role in the prevention and management of chemotherapy- and radiotherapy-induced diarrhea; however, studies have used different probiotic combinations, and the best combination is unclear. Infection-related risks are unclear, but some associated infections have been reported. Caution should be used in patients who are severely immunocompromised.