• FINAL NUMBER STUDIES INCLUDED; N (studies) = seven 
• TOTAL PATIENTS INCLUDED IN REVIEW:  706
• SAMPLE RANGE ACROSS STUDIES: 24-189 patients
• KEY SAMPLE CHARACTERISTICS: A majority of patients were in the outpatient setting. Studies were published from 1999 to 2013.

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

Four of seven interventions were educational. In some studies, education was combined with telemonitoring or progressive muscle relaxation. Counseling and coaching as self-care strategies for monitoring symptoms were evident in two studies. Two studies focused on expressive writing, and focused narrative interview. One study compared aromatherapy with massage. Interventions were performed by nurses and research nurses, with or without training.  Duration of interventions ranged from 1-3 contacts in one week to six months. Contacts were face-to-face or by telephone. None of the studies documented patient adherence to the interventions. The development of the interventions was limited to literature review. Two studies showed significant differences between the intervention and control group at six months (telemonitoring combined with education). One study did not show significance between the control and intervention groups at one week. A study of progressive muscle relaxation showed significance in anxiety at week 6 and week 12. No significant effect on anxiety was found between aromatherapy and massage. There was significantly decreased anxiety after each massage. This was also seen in a study that focused on narrative interview.

Although some of the studies described showed some significance, all had limitations. Studies are scarce; only seven met the inclusion criteria.

Some studies had a high attrition rate. The authors defined several areas of bias including selection, performance, attrition, and reporting. There was limited information regarding development of interventions. There was not enough information on any one intervention to be able to clearly to implement it as evidence.

Evidence regarding nonpharmacologic nursing interventions for anxiety is scarce. More nursing research is indicated, including well-developed interventions.

To determine the prophylactic platelet transfusion threshold (10,000/L versus 20,000/microL) in bone marrow transplant (BMT) patients, comparing transfusion requirements, incidence of bleeding, and adverse events

Patients undergoing BMTs that matched study requirements were randomized into two groups. One group would receive a prophylactic platelet transfusion if their morning platelet count was below 20,000/micro/L, and the other group would receive a transfusion at less than 10,000/L. For the 10,000/L group whose morning count was between 10–15,000/L, platelet count was checked a second time 12 hours later, and patients received a transfusion if this count fell below 10,000/L. A postplatelet count was taken 30–90 minutes post transfusion, and another bag was given if the threshold was not met with the first transfusion. If patients had scheduled procedures, acute bleeding events, or other safety concerns, platelets were transfused as needed. The threshold level was resumed following the acute event. Red blood cells were transfused as needed for hematocrit levels below 20%. Leukocyte-reduced, irradiated platelets were used for the study; they were single-donor, ABO matched when available. A transfusion algorithm was developed for both groups so that it was clear for the care team when to transfuse, redraw labs, and/or perform calculations.

• N = 159
• AGE RANGE = 3–70 years
• MALES: 52%, FEMALES: 48%
• KEY DISEASE CHARACTERISTICS: BMT patients with leukemia, lymphoma, myeloma, and solid tumor/other
• OTHER KEY SAMPLE CHARACTERISTICS: The median age in the 10,000/L group was 44. The median age in the 20,000/microL group was 47. The majority of patients received an autologous transplant followed by allogeneic and had a matched, unrelated donor. 98% of transfusions were from single donor products.  

• SITE: Single-site  
• SETTING TYPE: Inpatient  
• LOCATION: Florida, United States

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Pediatrics, elder care

Randomized, controlled trial, unblinded for patient safety

Bleeding events were scored by a single-study nurse using a modified Gruppo Italiano Malattie Ematologiche Maligne dell'Adulto (GIMEMA) Bleeding Severity Grading Scale.

There was no significant difference in bleeding events between the two groups with similar causes of bleeding in both (mucocutaneous and genitourinary). None of the patient deaths in the study were attributed to bleeding, although CNS bleeds occurred in both groups. The mean number of bleeding days were similar for the two groups. Bleeding was more frequent for the allogeneic or matched unrelated donor groups, but the results were not statistically significant. The time to first transfusion was 3.7 days in the 10,000/L group versus 4.2 days in the 20,000/microL group (p = 0.91). The total number of transfusions was similar in both groups. Amphotericin B, GVHD, transplant type, and VOD were statistically significant predictors of bleeding, while the threshold transfusion level was not.

The findings of this study mirrored prior research of this kind that was done for other populations, finding that the lower, 10,000/L platelet count can be used safely as a threshold for transfusions for the BMT population as well. There were no significant differences among the two groups with respect to bleeding risks and/or safety to patients. Of note, amphotericin B use did lead to a significantly increased risk of bleeding to patients, and so those patients may need a higher platelet threshold although that level was not studied in this trial.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Measurement validity/reliability questionable

Nurses need to look at the policy and procedures for platelet transfusions at their own institutions and suggest changes in practice if patients are given platelets for values above 10,000/L unless otherwise contraindicated. This study implies that this threshold is as safe as a higher one, and it leads to fewer transfusions for patients, which can reduce risk of transfusion reactions and platelet refractoriness without increasing bleeding risk.

To evaluate the effectiveness of a cognitive rehabilitation program within two weeks of surgical resection for patients with primary brain tumors

Baseline neuropsychological assessments were performed within three days of admission to the inpatient rehabilitation unit and prior to treatment or control randomization. Treatment arm consisted of 16 one-hour individual sessions over a four week timeframe with content focused on time orientation, spatial orientation, visual attention, logical reasoning, memory recognition, and executive functions. Each session was therapist-guided with 45 minutes of computer-based exercises and 15 minutes of discussion about the exercises and how to apply the strategies to everyday life. In both arms of the study, patients received usual rehabilitation care with medication and physical therapies.

• N = 53    
• MEAN AGE: 58.7 years (treatment group), 52.7 years (control group)
• MALES: 56%, 47%, FEMALES: 44%, 53%
• KEY DISEASE CHARACTERISTICS: Two weeks post-neurosurgical primary brain tumor patients with no prior exposure to radiation or chemotherapy
• OTHER KEY SAMPLE CHARACTERISTICS: Inclusion criteria required cognitive deficits on a minimum of three neuropsych tests.

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Neurological Mediterranean Institute

PHASE OF CARE: Active antitumor treatment

Randomized double-blind control trial with pre- and post-test assessments at baseline and four weeks after randomization

• Mini-Mental State Exam for global cognition
• Digit Span and Corsi’s test for verbal and spatial immediate memory span
• Rey auditory verbal learning test (RAVLT), immediate recall (IR) and delayed recall (DR), for verbal memory  
• Logical memory, IR and DR, for verbal memory
• Raven’s Coloured Progressive Matrices 47 for non-verbal reasoning
• Frontal assessment battery for frontal functionality
• Trials Making Test Parts A & B (TMT-A and TMT-B) for processing speed and complex attention
• Attentive Matrices for visual selective attention
• Rey-Osterrieth Complex Figure Copy Test for visuo-constructional abilities and verbal fluency
• Esame Neuropsicologico per l’Afasia for expressive and receptive language abilities

Within-group analyses found significant improvements (p < 0.05) on all neuropsychological tests for the treatment arm, while the control arm showed a non-significant trend towards improvement. Significant differences between groups were observed for improvements in visual attention and verbal memory (RAVLT-DR, Logical memory-IR and DR, TMT-A, TMT-B, Attentive matrices). There was no difference between groups in the socio-demographic, clinical characteristics, or baseline neuropsychological test scores. There was no difference between groups for number of subjects withdrawing from study due to medical conditions.

This inpatient cognitive rehabilitation program was developed for patients with a post-surgical primary brain tumor. Those receiving the intervention showed significant cognitive improvement in all domains, yet only visual attention and verbal memory performances were significantly different when compared to usual rehabilitation care. These results are limited by sample size, lack of additional longitudinal assessments to demonstrate sustained improvement, and program cost.

• Small sample (< 100)
• Findings not generalizable
• Intervention expensive, impractical, and needs training
• Subject withdrawals ≥ 10%
• Other limitations/explanation: Only one post-test assessment immediately following completion of intervention occurred, thus lacking demonstration of sustained cognitive improvement. Findings not generalizable due to cost of inpatient rehabilitation program, which would need adapting for use in outpatient settings.

Post-surgical cognitive interventions may be helpful in developing cognitive strategies for everyday function. Further study is warranted and intervention adaptation is necessary for outpatient settings.

• FINAL NUMBER STUDIES INCLUDED = 12
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,014
• SAMPLE RANGE ACROSS STUDIES: 15–201 patients
• KEY SAMPLE CHARACTERISTICS: Four studies were of Asian women, eight studies were of Caucasian women, and all patients were receiving chemotherapy for breast cancer.

PHASE OF CARE: Active

The Revised Piper Fatigue Scale (RPFS) scores for patients with breast cancer were significantly lower in the intervention group than the control group. However, there was no significant difference in the Functional Assessment of Chronic Illness Treatment Fatigue (FACIT-F) scale scores between the intervention and control groups. A subgroup analysis by ethnicity indicated that there were significant differences in RPFS and FACIT-F scores between the intervention and control groups among Asian populations.

This study provided additional support for aerobic exercise as an intervention for CRF in women receiving chemotherapy for breast cancer, especially Asian women. However, it did not help determine the frequency, intensity, or duration of aerobic exercise that is most beneficial for CRF.

• Relatively small sample sizes
• Retrospective study, which may result in recall or selection bias
• Lack of access to original data

Nurses can continue to recommend aerobic exercise for women receiving chemotherapy for breast cancer. However, additional research is needed regarding the frequency, intensity, and duration of exercise.

To determine whether sweet potatoes can alleviate constipation in patients with leukemia undergoing chemotherapy

Patients with leukemia, while receiving the first cycle of chemotherapy, were randomized to an intervention group (n = 57) or control group (n = 63). Both the groups were given routine care that included psychological intervention, abdominal massage, increased water intake (> 3000 ml per day), appropriate physical activities for condition of the patient during chemotherapy, and dietary modification (combination of course and refined grains plus fruit intake). If patients demonstrated symptoms of constipation, then laxatives or enemas were administered. The intervention group received routine care plus a diet containing sweet potato. The intervention started the day of admission and ended the day of discharge.

• N = 120 (57 intervention group, 63 control group)  
• AGE = 20–60 years
• MALES: 56% (intervention), 54% (control)  
• KEY DISEASE CHARACTERISTICS: ALL 31%; AML 40%; mixed phenotype acute leukemia 28%

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

• PHASE OF CARE: Active antitumor treatment

• Randomized trial

• Rome III Criteria for Functional Gastrointestinal Disorders (FGIDs) assessed constipation and defecation
• Other parameters collected were the number of participants in which defecation occurred within 24 hours of chemotherapy ignition; time required; satisfaction of bowel movement (BM) (score 1–3); administration of laxatives

On the second day after starting the chemotherapy, the rate of constipation was significantly lower in the intervention group compared with the control group (p < 0.001). All the items in the FGIDs criteria for evaluating constipation except for “almost no loose stools without purgative use” were significantly improved in the intervention group (p < 0.01), and the number of patients with first defecation within 24 hours after chemotherapy was significantly higher in the intervention group than in the control group (p < 0.001).  The duration of defecation was significantly shortened in the intervention group after chemotherapy (p < 0.001), but the satisfaction was similar in both groups. On the fifth day, the rate of constipation was significantly lower in the intervention group, and results were similar as day two.  All the items in the FGIDs criteria for constipation except for “sensation of anorectal obstruction” and “manual assistance” were significantly improved in the intervention group.

This study demonstrated that sweet potatoes have a positive impact on prevention of constipation and defecation satisfaction in patients receiving chemotherapy for leukemia.

• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• This was performed in Asia, where the food composition may be different than in other cultures.

Sweet potatoes are an inexpensive vegetable that can be easily and assessable to patients undergoing treatment for leukemia in prevention of chemotherapy-induced constipation.

STUDY PURPOSE: To evaluate the effectiveness of an exercise intervention and physical activity behavior on cancer-related cognitive impairment

TYPE OF STUDY: Systematic review

• FINAL NUMBER STUDIES INCLUDED = 19 (5 animal studies and 14 human studies) 
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,560 patients and 226 rodents
• SAMPLE RANGE ACROSS STUDIES: 4–447 patients
• KEY SAMPLE CHARACTERISTICS: Although educational status may influence neuropsychologic test results, this information was not provided. Likewise, menopausal status may affect cognition; because 14 studies primarily consisted of patients with breast cancer (four studies included other tumor types), this was not reported.

PHASE OF CARE: Late effects and survivorship

In patients, studies of exercise interventions had mixed results regarding their effectiveness in improving cognitive function. Interventions reviewed included an undefined physical activity (n = 3), cardiovascular fitness (n = 1), home-based walking and resistance band training (n = 1), yoga (n = 3), speed-feedback therapy on a bicycle ergometer (n = 1), medical qigong (n = 1), physical activity behavior change program (n = 1), Tai chi (n = 1), progressive aerobic endurance training on a treadmill (n = 1), and strength training (n = 1). Although the review reported cross-sectional studies that revealed correlations between physical activity with visual memory (n = 1), executive function (n = 1), attention (n = 1), and information processing (n = 1), the strength of these correlations was not reported. Randomized, controlled trial studies reported improved perceived cognitive functioning with walking, yoga, and medical qigong but not with the physical activity behavior change program. In addition, improvements were found for executive function with speed-feedback therapy, attention and verbal memory (but not working memory with strength training), and memory with yoga. However, in each of these results, the significance of these findings was not reported. These results are further complicated by the lack of consistency in regard to the cognitive functioning measures used.

Exercise may improve perceived cognitive function. However, further research is needed to validate if specific types of exercise affect cognitive functioning and to determine the dose or duration required for a durable response. Longitudinal studies with larger sample sizes that incorporate both objective and subjective measures of evaluating cognitive function are needed before recommendations for exercise can be made as a means to counteract chemotherapy-related cognitive impairment.

• High heterogeneity
• Low sample sizes
• A small number of studies with humans (n = 14) was included in the review for multiple types of exercise and physical activity interventions.  
• Studies of low quality were included.

The findings suggest that some forms of exercise or physical activity interventions may be helpful in improving patients’ perception of chemotherapy-induced cognitive impairment; however, these findings are based on a small number of studies per intervention. Recommendations cannot be made based on this review.

To illuminate the moderators of the effect of psychosocial interventions and better understand the variability of these effects in patients with cancer; to test the hypothesis that cancer type, intervention type, and interventionist can moderate intervention effect

• Databases searched were PsycINFO, PSYNDEX, MEDLINE (1980–October 2004). Search keywords were cancer, neoplasm, carcinoma, oncology, breast cancer, psychological therapy, psychotherapy, intervention, counseling, group support, peer support, relaxation, imagery, coping skills training, cognitive therapy and psychological support. Investigators also did some manual searching, using references from retrieved articles.
• In cases in which the literature reported incomplete outcomes, investigators communicated with the authors of the studies to get the data. Some authors provided the necessary data.
• Literature included in the meta-analysis reported, in English or German, on randomized controlled trials (RCTs) and provided complete documentation of outcome measures.
• Literature excluded from the meta-analysis did not report on an RCT or did not include complete data, including the sample sizes of the treatment and control groups; group means; standard deviations or values of t tests, F tests, and chi-square tests.

Initially, investigators retrieved 127 articles, of which 46 were eliminated because they did not report on RCTs. Four of the 127 articles were unavailable. Of the remaining 77 reports of RCTs, the data in 26 were incomplete. Communication with the authors of studies with incomplete data resulted in obtaining complete data for five studies.

• The final number of studies included in the meta-analysis was 56. Sample range was 19–638.
• Meta-analysis, across studies, included a total of 6,419 patients. Mean patient age was 52.4 years (SD = ±4.7 years), and the age range was 40–65 years. The majority of study participants  (89%) were female.
• Studies in the meta-analysis were conducted in the United States or in multiple European countries. Thirty-four studies involved a homogeneous group of patients with breast cancer, and 22 studies involved mixed diagnoses.

• Across all studies, effect size (ES) d = –0.47–2.66; overall average, ES d = 0.56.
• Types of interventions were as follows. Some studies involved more than one treatment group.
  • Psychoeducational (EDU): 8 studies (ES/d = 0.53).
  • Cognitive behavioral therapy (CBT): 24 studies (ES/d = 0.19).
  • Supportive therapy (SUP): 15 studies (ES/d = 0.13).
  • Relaxation (REL): 12 studies.
• Moderator effects were as follows.
  • The majority of studies were led by psychologists (n = 21) or nurses (n = 11). Psychologist-led interventions had a higher ES (d = 0.30) than did those led by nurses (d = 0.15) (p < 0.001).
  • Nature of the control group in studies was identified as active if active interventions of some type were delivered. The control group was identified as passive if controls received usual care or were wait-listed. Passive control groups had higher ES (d = 0.34) than did those with active controls (d = 0.11) (p < 0.001).
  • Formats of the intervention were individual, group, couple, self-help, and patient with family-member. Comparison between group and individual formats showed higher ES for individual interventions (d = 0.30) than for group interventions (d = 0.19) (p < 0.001).
  • Timing of the intervention was reported in 82% of studies. Timing options were directly after diagnosis or surgery, during or following chemotherapy or radiation therapy, and months or years after initial diagnosis. Interventions conducted directly after diagnosis or surgery (d = 0.33) had higher ES than did those during treatment (d = 0.18) or those conducted months or years after diagnosis (d = 0.16) (p < 0.001).
  • Patients with early-stage (I–III) disease had higher ES (d = 0.32) than those with advanced disease (d = 0.13) (p < 0.01).
  • For EDU, moderate ES (d = 0.73) resulted if the intervention had been conducted by nursing or medical staff rather than by psychologists. Psychologist-delivered ED resulted in small ES (d = 0.27).
  • CBT resulted in moderate ES (d = 0.40) if conducted by psychologists. CBT resulted in no effects if nurses or social workers delivered the intervention.
  • Authors found no difference in the results of interventions delivered by different SUP interventionists.

• Psychosocial interventions of various types can have a positive effect on patients with cancer.
• Psychoeducational interventions appear to have the greatest effect, and this effect is higher when the education is delivered by professionals with medical expertise than when delivered by others.
• Interventions appear to be most effective in cases of early-stage disease and when delivered early in the phase of care.
• Individualized interventions appear to have an effect that is greater than interventions delivered in groups.

• The quality of individual studies included was highly variable.
• Some studies provided actual data on significant findings only, although the studies had measured several outcomes. As a result, the ES reported in this meta-analysis may be somewhat overestimated.
• Long-term effects of intervention types are still unclear because most studies did not include long-term follow-up.

Nurses are particularly suited to providing psychoeducational and educational interventions for patients, and these types of nurse-led interventions can have a positive effect on patient outcomes. Psychologist-delivered CBT interventions seem to be more effective than nurse-delivered CBT interventions. This finding suggests that, if nurses are to provide CBT, the nurses must develop significant expertise.This finding may also suggest the importance of interdisciplinary approaches to providing psychosocial interventions. This meta-analysis demonstrated that moderators have a significant effect on intervention effectiveness; therefore, future studies should provide information about potential moderators.

To obtain data to support conducting a phase III trial of venlafaxine to prevent oxaliplatin-induced neurotoxicity

Patients were stratified according to planned calcium and magnesium administration, cancer stage, and treatment cycle, then randomized to receive venlafaxine extended release 37.5 mg versus placebo twice daily. The study treatment was begun on the evening of the first or second chemotherapy treatment and continued for one week following completion of the FOLFOX treatment. Assessments were taken at baseline, prior to each FOLFOX treatment, and at 1, 3, 6, and 12 months postcompletion.

• N = 43
• MEAN AGE = 61.3 years
• MALES: 52%, FEMALES: 48%

• SITE: Multi-site  
• SETTING TYPE: Not specified  
• LOCATION: USA

PHASE OF CARE: Active antitumor treatment

Randomized, double-blind, placebo-controlled trial

• European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ)-CIPN20 symptom questionnaire
• Common Terminology Criteria for Adverse Events (CTCAE), version 4.0
• Oxaliplatin Acute Symptom Questionnaire

No significant differences in any measures of neuropathy outcomes existed between groups.

Venlafaxine did not reduce neuropathic toxicities associated with oxaliplatin.

Small sample (< 100)

Data from this trial do not support the use of venlafaxine for the prevention of neuropathic symptoms associated with oxaliplatin. Ongoing research is needed to identify effective interventions for this treatment complication.

To evaluate effectiveness of manual lymphatic drainage (MLD) for prevention of secondary lymphedema after breast cancer surgery

From the second post-operative day, women received a standard program of exercises. Thirty-three women were randomly chosen to also receive MLD five times a week for the first two weeks, then twice a week until six months after surgery. The other control group women applied self-drainage. Data were collected prior to surgery and at six months postoperatively. Arm volume measurements were done on days 2, 7, 14, and 3 and 6 months.

• The study sample (N = 67) was comprised of female patients with breast cancer.
• Mean age was 59.4 years.
• In the sample, 80% had breast conserving surgery and 40% had modified radical mastectomy; 52% had axillary lymph node dissection.
• In the control group, 74% had radiotherapy, compared to 67% in the MLD group. 
• More women in the control group also received other adjuvant therapy, compared to the MLD group.

The study took place at a single outpatient site in Poland.

The patients were undergoing multiple phases of care.

The study used a prospective trial design.

Water displacement was used to measure arm volume.

Women in the MLD group showed a reduction of 14 ml volume (SD = 470 ml) on the operated-side arm over six months. Women in the control group showed an overall increase in arm volume of 16 ml (SD = 470, p = 0.0033). Analysis of variance showed significant effect of having MLD (p = 0001) and radiotherapy (p = 0.0499) on arm volume.

Findings showed that use of MLD may have some benefit for prevention of lymphedema secondary to breast cancer surgery. Several study limitations suggest that findings should be used with caution.

• The sample size was small, with less than 100 participants.
• The baseline sample and group differences could influence results.
• The study had a risk of bias because of no binding and no random assignment.
• The ample included various surgical types. 
• It is not clear that patients were randomly assigned to groups. 
• Adherence to MLD and self-management are not discussed, and no other interventions that may affect lymphedema are discussed. 
• The control group had a higher percent of women receiving radiotherapy, which was shown to predict arm volume increase.
• There was high variability in arm volume results in both groups compared to mean changes observed.

Findings of the study do not provide strong support for effectiveness of MLD to prevention lymphedema after breast surgery because of the multiple study design and results limitations.