To evaluate the effectiveness of a multidisciplinary rehabilitation program for individuals after treatment for primary brain tumors

Patients were assigned to treatment or wait-list control comparison groups according to an assessment of their needs by the clinical provider. The rehabilitation treatment team was blinded to study group assignment. The intervention included individualized 30-minute therapy sessions with social, psychological, occupational, and physical therapy in half-hour sessions two to three times a week for as many as eight weeks. The individualized intervention incorporated elements of education, health promotion, intensive mobilization, and task reacquisition programs as determined appropriate by the rehabilitation team. Study assessments were done at baseline and at three and six months. Functional independence measures were the primary outcomes of the study.

• N = 106 (85 completed the six-month assessment)
• MEAN AGE = 51.4 years (range = 21–77 years)
• MALES: 43%, FEMALES: 57%
• KEY DISEASE CHARACTERISTICS: Primary brain tumors with a median time since diagnosis of 2.1 years; all received initial treatment involving surgery, chemotherapy, and/or radiation therapy; 53% of subjects in both groups had World Health Organization grade III or IV tumors and similar rates of steroid use; intervention group reported more symptoms at baseline (i.e., ataxia, cognitive impairment, seizures, paresis, visual impairment, dysphasia, dysarthria, sensory-perceptual deficits, bowel or bladder dysfunction) than the wait-list control group; proportion of patients with ataxia, dysarthria, and visual impairment was significantly larger in the intervention group
• OTHER KEY SAMPLE CHARACTERISTICS: More than 80% of participants in both groups were living with a partner, and the majority had at least a secondary level education.

• SITE: Single site  
• SETTING TYPE: Outpatient  
• LOCATION: Australia

• PHASE OF CARE: Transition phase after active treatment

Prospective trial

• Visual Analog Scale (VAS) for pain
• Cancer Rehabilitation Evaluation System Short Form (CARES-SF)
• Depression Anxiety Stress Scale (DASS)
• Functional Independence Measures (FIM) for motor skills and cognition
• Perceived Impact of Problem Profile (PIPP)

At three months, FIM Motor (self-care, sphincter, location, and mobility subscales) and FIM Cognition (communication and psychosocial subscales) scores were significantly improved in the treatment group compared to the control group. At six months, the FIM Motor (sphincter subscale) and FIM Cognition (communication, psychosocial, and cognition subscales) scores were significantly improved in the treatment group compared to the control group. There were no significant differences between groups in DASS measures of anxiety or depression from baseline to three or six months. There also were no differences observed between groups in PIPP results from baseline to three or six months, which measured the impact of functional areas also on the FIM. The greatest improvements seen were at the three-month follow-up date.

The findings of this study demonstrated that multicomponent rehabilitation can improve measures of self-care and some specific areas of motor and cognitive function.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Selective outcomes reporting
• Key sample group differences that could influence results
• Measurement validity/reliability questionable 
• Findings not generalizable
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: Functional independence was higher at baseline in the wait-list control group by study design, because those with more obvious needs were given the intervention immediately. Therefore, the scoring of function by the control group may have been subject to a ceiling effect in the study measure. Results regarding motor and cognitive function were based on single subscales of the FIM assessment measure with no confirmatory data from a more objective measurement. It is not clear how many patients may have been receiving chemotherapy or radiation therapy during the timeframe of this study, which also could have affected outcome measurements. The fact that findings on perception of impact did not align with FIM results calls into question the overall reliability of findings. The findings are specific to patients with brain tumors and are not necessarily generalizable to other groups.

The findings of this study showed some functional benefits of multicomponent rehabilitation for patients with primary brain tumors. This study was limited by its design and the clinical nature of rehabilitation aimed to provide individualized interventions on the basis of needs assessed by care providers. This suggests that patients may benefit in the areas of self-care. The degree to which these benefits are maintained over time is not clear from this study.

To compare the efficacy and safety of sublingual metopimazine to ondansetron orally disintegrating tablet (ODT) in patients receiving highly emetogenic chemotherapy (HEC) for the prevention of delayed (not acute) chemotherapy-induced nausea and vomiting (CINV)

Participants were randomized to one of two treatment arms. In group 1, patients received 7.5 mg sublingual metopimazine every eight hours on days 2–6, and, in group 2, patients received ODT ondansetron on days 2–6.

• The study consisted of 210 participants.
• The sublingual metopimazine group had 103 patients, and the ODT ondansetron group had 97 patients.

• Patients recorded symptoms in daily diaries.
• The Functional Living Index–Emesis (FLIE) was used.

No significant differences were found between the two groups in control of delayed CINV, quality of life (QOL), or safety; however, control of delayed CINV was inferior compared to other studies.

• This study evaluated an “old” regimen that has since been considered suboptimal care per current consensus guidelines because of availability of newer, superior agents.
• Corticosteroids were not allowed in the study.
• The overall dose of metopimazine was low (ineffective).

To compare granisetron plus dexamethasone to granisetron alone in the prevention of acute emesis

Patients were randomly assigned to receive either granisetron alone or in combination with dexamethasone. One group received a single IV dose of 3 mg granisetron and the other group received 3 mg IV granisetron and 8 mg IV dexamethasone 30 minutes prior to chemotherapy. Patients were evaluated for 24 hours. Efficacy was determined according to a scale established by investigators.

• The study consisted of 125 participants, 63 in the granisetron only group (group 1) and 62 in the granisetron plus dexamethasone group (group 2).
• Median age was 64 years old in group 1, with a range of 40–72 years, and 63 years old in group 2, with a range of 20–70 years.
• The granisetron group was 33% female and the granisetron plus dexamethasone group was 40% female.
• Cancer diagnoses were GI, breast, and hematologic.
• The majority of patients (79% in group 1 and 77% in group 2) were receiving more than 60 mg/m² of cisplatin.

The study was conducted at a single setting in Iran.

All patients were in active treatment.

This was a randomized, single-blind, prospective study.

The number of emetic episodes was recorded. Complete response was defined as no emetic episodes.

The investigators developed a scale to record efficacy of the intervention with \"moderately effective\" defined as \"did not interfere with daily life,\" \"slightly effective\" as \"interfered with normal daily life,\" and \"not effective\" as \"bedridden due to nausea.\"

A higher percentage of patients (66.7%) in the group receiving both granisetron and dexamethasone had 0 emesis episodes, compared to fewer than half (42.8%) of patients who received granisetron alone (p < 0.0001).

The combination of granisetron plus dexamethasone was superior to granisetron alone for prevention of acute emesis.

• Minimal information was provided on the chemotherapeutic regimens used.
• The authors did not indicate if patients were chemotherapy naïve.
• Some data, such as age ranges and average reported, were different in the abstract than the body of the article, leading to questionable overall report.
• No valid, common measure of nausea and vomiting was used, and how this was recorded was not clear.

Findings indicate that dexamethasone should be included in antiemetic regimens, which is consistent with current care standards.

To test the feasibility and effectiveness of a computerized home-based cognitive intervention program

Subjects were randomly assigned to the intervention group or a wait-list control group. The intervention was a 12-week computerized training program (Lumos Labs) using the subjects' home computers. It included 48 sessions that were 20-30 minutes long, involving combinations of 13 exercises to improve executive function. Subjects were assigned five exercises to complete four times per week. Exercises were designed for practice and training in cognitive flexibility, working memory, processing speed, and verbal fluency.  Completion, duration and performance of exercises were recorded in the computer system, providing an adherence measure. Outcome measures were collected at baseline and within three days of intervention completion; wait-list controls had pre-post measures taken 12 weeks apart.

• N = 41    
• MEAN AGE = 55.5 years (SD = 0.5 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All subjects had stage I-IIIA  breast cancer, received surgical intervention and adjuvant chemotherapy, and completed treatment at least 18 months prior to study participation.
• OTHER KEY SAMPLE CHARACTERISTICS: Subjects had at least a high school education; 60%-70% also received radiation therapy and hormonal therapies.

• SITE: Single site    
• SETTING TYPE: Home  

PHASE OF CARE: Late effects and survivorship

Randomized controlled trial

• Wisconsin Card Sorting Test (WCST)
• Delis-Kaplan Executive Functions System, Letter Fluency Test
• Hopkins Verbal Learning Test Revised
• Wechsler Adult Intelligence Scale (digit span and symbol search subscales)
• Behavioral Rating Inventory of Executive Function (Global Executive Composite score)
• Clinical Assessment of Depression

There was 95% compliance with the training program. The intervention group had significant improvement as shown by Cohen’s d, the WCST (EF = 0.58, P = .008), the Letter Fluency Test (EF = 0.82, P = .003), and symbol search (EF = 0.87, P = .009). While there were no significant effects of age, education, radiation, or hormonal treatment, presence of depressive symptoms had a significant effect on self-reported global executive function.

This approach for training and home-based exercises is feasible, and compliance was high. The program was effective for improving some components of executive function. Further study with longitudinal measures is warranted to demonstrate maintained improvements in cognitive function after program completion or if continued program use is needed to maintain any improvements.

• Small sample (< 100)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Findings not generalizable
• Intervention expensive, impractical, or needs training
• The computerized training cost was covered by the research study; however, it is commercially available for individual cost, which may be an issue for some patients. The sample was a homogenous group of patients, potentially limiting generalizability to other patient groups.

The commercially available computerized “brain training” program studied here improved components of executive function after 12 weeks. This approach was associated with high patient compliance. Nurses can suggest that patients complaining of cognitive impairment consider trying this program.

The objective of this study was to compare the safety and efficacy of gabapentin with opioid versus opioid monotherapy for the management of neuropathic pain.

Patients were randomized to one of two groups: Group GO included gabapentin added to ongoing opioids, gabapentin titrated to pain, and opioids kept constant; group OO saw the continuation of opioid monotherapy using the World Health Organization ladder approach.

Regarding dosing, gabapentin was initially given at 100 mg three times daily for patients aged 60 and older and 300 mg three times daily for those younger than age 60. Doses were titrated over the three days—up to 3,600 mg per day according to response. Patients in the GO group also could take gabapentin as a rescue drug.

• Seventy-five patients who were receiving opioids with minimal opioid side effects and had unrelieved neuropathic pain were enrolled in the study.
• A total of 63 patients completed the trial.
• Patients had a Karnofsky score higher than 60 and pain intensity rated as 4 or greater.
• Potential participants were excluded if they were taking adjuvant drugs and nonopioid analgesics.
• Patients were removed from the study if new pain from disease progression occurred or if intolerable side effects developed.

The study was conducted in Turkey.

The study was a randomized, single-site, open trial.

• Pain intensity, specifically burning and shooting, was recorded with a numeric rating scale.
• The mean absolute change in pain intensity was recorded at day 13.
• Allodynia and analgesic drug consumption, including rescue, were evaluated at days 4 and 13. Side effects also were recorded.
• Allodynia was assessed by a light cotton material being stroked on painful and non-painful areas. Allodynia was said to be present if a normal response was noted in non-painful areas but pain or an unpleasant sensation was noted in the painful area.

Both groups (GO and OO) saw a significant reduction in pain intensity on days 4 and 13 compared to baseline. The mean pain intensity for burning or shooting pain was significantly higher in group OO compared to group GO at both assessment times (p = 0.0001); however, a clinically meaningful reduction was noted in group OO. In addition, a significant decrease in allogynia was seen in the GO group at day 4 (p = 0.002) and the rate of side effects was significantly lower in GO (p = 0.015). Of note, one patient in the GO group withdrew from the study due to respiratory depression. The patient was taking gabapentin and SR morphine and was age 66. Depression occurred three days after gabapentin was added.

The most frequent causes of pain included malignant sacral plexopathy (32%) in group GO and brachial plexopathy (28%) in group OO. Patients in the GO group remained at the same step of the ladder at day 4; group OO patients who took weak opioid at the second step all progressed to the third step. This may explain less SE in the GO group.

The findings suggest that gabapentin added to opioids provides better relief than opioid monotherapy alone and may represent a potential first-line treatment for these patients. Gabapentin added to opioids may create a synergistic effect. Gabapentin also may extend opioid efficacy.

• The measurement of allodynia was seen as a limitation, as were the primary neuropathic syndromes being different in each group.
• The World Health Organization ladder has been abandoned by many practitioners in favor of National Comprehensive Cancer Network or American Pain Society guidelines.

Nurses should be aware of possible respiratory depression when patients are treated with gabapentin and morphine, particularly older adult patients.

To compare a gabapentin-opioid combination to opioid monotherapy, in terms of safety and efficacy, in the management of neuropathic pain

Patients were randomized to one of two groups. One group received treatment with gabapentin added to ongoing opioids. Gabapentin was gabapentin titrated to pain; in this group (group GO), opioids were kept constant. In the other group (group OO), opioid monotherapy was continued according to the World Health Organization (WHO) ladder approach. The initial gabapentin dose was 100 mg three times daily for patients older than age 60 and 300 mg TID for those younger than age 60. Treatment was titrated to these doses in three days and to 3,600 mg per day according to response. GO patients could take gabapentin as a rescue drug.

• The sample was comprised of 75 patients who were receiving opioids with minimal opioid side effects and had unrelieved neuropathic pain; 63 patients completed the trial.
• All patients had a Karnofsky Performance Status score greater than 60 and a pain intensity score of 4 or higher.
• Patients were excluded from the study if they were taking adjuvant drugs and nonopioid analgesics.
• Patients were removed from the study if new pain from disease progression occurred or if intolerable side effects developed.

• Single site
• Turkey

The study was a randomized, single-site, open trial.

• Numeric rating scale (NRS) to measure pain intensity, specifically burning and shooting
• Mean absolute change in pain intensity at day 13
• Allodynia (Allodynia was assessed by stroking painful and nonpainful areas with a light cotton material. If normal response was noted in nonpainful area but pain or unpleasant sensation was noted in painful area, allodynia was said to be present.)
• Analgesic drug consumption, including rescue, evaluated on day 4 and day 13
• Side effects

• Both treatments resulted in significant reduction in pain intensity on day 4 and day 13, compared to baseline.
• Mean pain intensity for burning or shooting pain was significantly higher in group OO than in group GO at both assessment times (p = 0.0001). However, there was a clinically meaningful reduction in group OO.
• Data showed a significant decrease in allodynia (p = 0.002) in group GO at day 4.
• The rate of side effects was significantly lower (p = 0.015) in group GO.
• One patient in the group GO withdrew from the study because of respiratory depression. The patient was taking gabapentin and sustained-release morphine and was age 66. Depression occurred three days after the addition of gabapentin. Respiratory depression should be considered when using gabapentin and morphine, particularly in older adults.
• In terms of the most frequent causes of pain, 32.3% of GO patients had malignant sacral plexopathy, and 28.15% of OO patients had brachial plexopathy.
• GO patients remained at the same step of the ladder at day 4. Group OO patients, who took a weak opioid at the second step, all progressed to the third step. This may explain why fewer patients in group GO experienced side effects.

This study suggests that gabapentin added to opioids provides better relief than opioid monotherapy. Gabapentin-opioid treatment may be a first-line treatment for the specified patients.

• The means of measuring allodynia are questionable.
• The primary neuropathic syndromes were different in each group.
• The WHO ladder has been abandoned by many practitioners, who now follow National Comprehensive Cancer Network or American Pain Society guidelines.

To systematically review the literature for benefits of exercise in patients with prostate cancer.

Databases searched were PubMed, CINAHL, and Google Scholar.

Search keywords were exercise, physical activity, prostate cancer, and training and all word derivatives.

Studies were included if they 

• Were full, published articles
• Included patients with prostate cancer
• Involved an exercise intervention of at least four weeks duration
• Reported changes in body composition, fitness, quality of life (QOL), and/or fatigue.

The total volume of studies retrieved and excluded was not provided. An adaptation of methods reported by Sackett was used to evaluate methodological rigor, involving six criteria. How the criteria were applied by investigators was not described.

• A sample of 12 studies was included, involving a total of 360 patients.
• Study sample sizes ranged from 10 to 82 patients.
• All patients had prostate cancer.
• Demographics were not reported in all studies used; however, most patients were said to be Caucasian, married, and between ages 66 and 72 years.

Seven studies reported group-based exercise. The authors reported that most of these patients showed significant improvement in some QOL measures and fatigue.  Five studies reported home-based exercise. These showed no significant increase in QOL, and two of these reported significant reduction in fatigue.  Resistance, aerobic, and combined types of exercise appeared to be similarly effective. The timing of exercise interventions related to cancer treatment were not described. Comparative findings regarding changes in muscle strength and endurance were provided.

There is relatively strong to strong evidence that exercise performed a minimum of two to three days per week can significantly improve physical fitness, functional performance, and QOL and reduce fatigue in patients with prostate cancer.

The context in which the exercise was performed and type of exercise (aerobic, resistance, or combined) may mediate the magnitude of benefit derived.  Group-based exercise appeared to offer greater benefit than home-based programs in the studies included.

Findings suggested that exercise recommendations should be a part of care for survivors of prostate cancer for fitness, QOL, and fatigue benefits. Group-based activity may have greater benefit than individual home-based exercise recommendations.

To determine whether antioxidant vitamins, by counteracting oxygen-free radical injury, would relieve symptoms of chronic radiation proctitis

Patients received 400 IU vitamin E and 500 mg vitamin C three times per day for eight weeks.

• This study reported on 20 consecutive patients (10 prostate cancer survivors and 10 gynecologic cancer survivors) from a single gastroenterology clinic. 
• Patients were experiencing persistent, postradiation proctitis with disabling diarrhea, urgency, or fecal incontinence.

This study used a nonrandomized, before-and-after design in which patients served as their own controls.

Patients completed questionnaires that assessed severity, frequency, and lifestyle impact of four factors (rectal bleeding, rectal pain, diarrhea, and fecal urgency) with each factor rated on a five point, Likert-type scale ranging from 0–4.

The majority of patients (14 out of 16) reported less diarrhea, and eight said diarrhea stopped completely. Among patients with rectal bleeding or urgency, symptoms completely resolved in 36% and 19%, respectively. Lifestyle improved in 13 patients, and seven reported a return to normal.

The study is limited because it is nonrandomized and noncontrolled, involves a single clinic, and has a small sample size.

The use of vitamins E and C to manage radiation-induced diarrhea symptoms represents a low risk of harm.

Researchers sought to show that  some SSRI antidepressants reduce tamoxifen’s effectiveness by inhibiting its bioactivation by cytochrome P450 2D6 (CYP2D6).

The study enrolled postmenopausal women with breast cancer using tamoxifen therapy and a single SSRI antidepressant (paroxetine fluoxetine, sertraline, citalopram, fluvoxamine, or venlafaxine.)

The study included women living in Ontariowho were 66 years or olderand treated with tamoxifen for breast cancer between 1993 and 2005 and with a single SSRI. (24,430 women were identified; 2,430 entered into study; mean age was 74 years).

Inclusion criteria: Postmenopausal women with breast cancer newly treated with tamoxifen (defined as no tamoxifen prescription in the preceding year) and a single SSRI antidepressant (paroxetine fluoxetine, sertraline, citalopram, fluvoxamine, or venlafaxine)

Exclusion criteria: Antidepressant use of duloxetine or escitalopram

Ontario Cancer Registry provided the data.

This was a retrospective cohort study.

The study examines the total duration of tamoxifen therapy (index date: date tamoxifen was last dispensed plus an additional 60 days) and the extent to which co-prescription of potentially interacting medications occurred during the course of treatment. The primary outcome was death from breast cancer

Of 2,430 women treated with tamoxifen and single SSRI, 374 (15%) died of breast cancer during follow up. Absolute increases of 25%, 50%, and 75% in the proportion of time on tamoxifen overlappingthe  use of paroxetine were associated with 24%, 54%, & 91% increases in the risk of death from breast cancer. (p < 0.05) No such risk was seen with other antidepressants

Reported study limitations included lack of information on breast cancer stage and lack of information on indication for antidepressant use.

This intervention was therapeutic touch (TT). The experimental group received 10 minutes of TT and 20 minutes of dialogue, and the control group received 10 minutes of quiet time and 20 minutes of dialogue. Data were collected as part of a larger experimental study of the effects of TT on pre- and postoperative anxiety and mood and pain in women with breast cancer. Telephone interviews were conducted at the completion of an experimental or control nursing intervention administered in the women’s homes before and after breast cancer surgery. The interview consisted of six open-ended questions.

The study reported on a sample of 18 women with early-stage breast cancer.

Mixed methods of qualitative and quantitative study were used.

Telephone interviews consisting of six open-ended questions

Regardless of experimental or control intervention, women expressed feelings of calmness, relaxation, security, and comfort. No objective measures were reported.

• Validity and reliability of measures are unknown.
• The study had a very small sample size.