The study's primary aim was to assess the effectiveness of single-dose modafinil on cognitive function in patients with advanced cancer treated in palliative care settings. Its secondary aim was to assess the effectiveness of modafinil on other symptoms.

On day 1, patients were randomly assigned to receive either 200 mg of modafinil or an oral placebo. On day 4, each patient group was given the alternative treatment that was not dispensed on day 1.

• The number of participants was 28.
• The median participant age was 62, with a range of 40–79.
• 57% of the participants were male and 43% were female.
• All participants had advanced cancer, with a variety of hematologic and solid tumors.
• All participants had a tiredness score fo 50 mm on the Edmonton System Assessment Scale and a score range of 40–70 on the Karnofsky Performance Status Scale. 

The study took place in the palliative care department of Herning Hospital in Denmark.

The study was a double-blind, randomized, cross-over, single-dose trial.

• The Finger Tapping Test (FTT) is well-validated test of psychomotor speed that is used for detecting lateral cerebral lesions and unspecific psychomotor impairment.
• The Trail Making Test, Part B (TMT-B) is a test of visual information processing used to assess visual search skills, scanning, speed of processing, mental flexibility, attention, and psychomotor speed. 
• The Edmonton System Assessment Scale assesses nine symptoms common in patients with cancer: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath.
• The Karnofsky Performance Status Scale measures general well-being. Scores range from 0 (death) to 100 (perfect health with no complaints or signs of disease).

Patients on the modafinil treatment group saw statistically significant improvements in psychomotor speed with the dominant hand (as measured by the FTT) and speed of processing (as measured by the TMT-B), as compared with the placebo group (p = 0.006). The modafinil treatment group also showed statistically significant improvements in depression and drowsiness as compared with the placebo group (p = 0.042).

The frequency and intensity of side effects were similar on both treatments, and no statistically significant differences were reported. However, four patients experienced disrupted sleep and vivid dreams after modafinil treatment.

Modafinil improved attention and psychomotor speed and diminished depression and drowsiness.

• The number of participants was small, but was in congruence with priori power analyses.
• The study design had limited administration of the medication (only one single dose) and follow-up; therefore, no conclusions can be made about long-term usage of modafinil.
• The authors reported that patients were allowed to use supplemental doses of short-acting opioids for breakthrough pain throughout the study, except before testing on study days. The holding of as-needed opioids is an ethical concern for patient comfort. Although opioid use was controlled, patients may have been in pain, which would confound cognitive results.
• No information regarding pain prior to cognitive testing was noted.
• The authors did not address practice effects with repeated administration of the TMT-B.

To compare a single-dose infusion of tranexamic acid with a placebo given IV before the surgery of advanced ovarian cancer to compare blood loss and need for packed red blood cell (PRBC) transfusions

The patients were randomized via computer to receive either tranexamic acid or normal saline (0.9% NaCl) prepared by the local pharmacy. The amount of tranexamic acid of 15 mg/kg in 100 ml of normal saline or the same volume of placebo was administered. The infusion of the medication/placebo was administered via IV 15–20 minutes prior to surgery immediately after general anesthesia was established. A single dose of prophylactic antibiotic was given prior to surgery to all patients as well as 28 days of low-molecular heparin for 28 days postoperation. Hospital staff and patients were blinded to the treatment received. Perioperative bleeding was managed by established clinical protocol and blood transfusions were given during surgery or postoperatively if hemoglobin was below 90 g/L. A single dose of TA 1,000 mg or desmopressin (0.3 µg/kg body weight) was administered if deemed necessary by the surgeon. Drainage was allowed. Postoperative blood and plasma transfusions were given based on the patient’s clinical presentation and hemoglobin level. Hemoglobin levels were assessed five days after surgery or on the day of discharge if it was earlier. Patients were interviewed by a nurse five weeks after surgery.

• N = 93
• MEDIAN AGE = 63.75 years (range = 33–90 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Ovarian cancer, surgical patients

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

• PHASE OF CARE: Active antitumor treatment

Multi-center, randomized, double-blind, placebo-controlled trial

Outcomes measured were blood loss amount and total of red blood cell transfusions. Blood loss was assessed with drains, sponges, and drapes. Total blood loss was based on the hemoglobin balance method.

The overall results of the study showed that the total blood loss volume and the transfusion rate were lower in the tranexamic group using a single dose of tranexamic acid. Total blood loss p = 0.03 and transfusions given p = 0.02.

The evidence does suggest that using tranexamic acid immediately before surgery reduces blood loss and the need for transfusions as a prophylactic measure. However, one needs to take into consideration that the strength of this study may need to be further analyzed due to the lack of homogeneity in the participants and the validity of the measuring tools.

• Key sample group differences that could influence results
• Measurement validity/reliability questionable
• Other limitations/explanation: There is some concern that not all the women had advanced ovarian cancer and did not undergo an extensive debulking surgery. Also, the measurement tool of sponges and drapes used for blood loss volume can be very subjective in reporting amounts.

Given the fact that this medication is reasonably inexpensive and has no serious adverse side effects, nurses need to be aware that this intervention may decrease blood loss and subsequently the need for transfusions.

To design and evaluate an intervention to address caregiver information and needs when providing end of life care, and to evaluate the intervention for acceptability among caregivers and healthcare professionals, assessing the feasibility of healthcare workers adopting this as daily practice, and assessing its impact on caregiver burden, satisfaction, competence, and preparedness

The study was divided into two interventions. Phase 1 was comprised of interviewing caregivers about the need for practical information, support skills, and their preference on the form in which information should be delivered (identified as a booklet). Phase 2 evaluated the booklet used through validated questionnaires.

• N = 31 (phase 2)
• MEAN AGE = 62 years (range = 31–82 years) 
• MALES: 26%, FEMALES: 74%
• KEY DISEASE CHARACTERISTICS: Patients were in their last year of life.
• OTHER KEY SAMPLE CHARACTERISTICS: All participants were aged greater than 18 years, and caregivers lived in the home with patients.

• SITE: Community home-based palliative care
• SETTING TYPE: Hospice and palliative care
• LOCATION: United Kingdom

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

This was a mixed-method feasibility study with a convenience sample. Quantitative surveys were collected at recruitment and four to six weeks after initial recruitment. Qualitative data using semistructured interviews and structured personal diaries, logs, and interviews were collected.

• Family Appraisal of Caregiving Questionnaire (FACQ)
• Caregiver Competence Scale (CCS)
• Preparedness for the demands and tasks of caring (eight items)
• Hospital Anxiety and Depression Scale (HADS)
• Short Form 12 v2 (SF-12) Health Survey
• A single-item Likert scale of perceptions of patient symptom management (I feel I can manage my family member’s/friend’s symptoms)

This study demonstrated benefits from the booklet intervention on caregivers’ appraisal of caregiving. In addition, the study highlighted practical issues regarding the timing of the intervention delivery. A randomized control trial would be more effective in furthering the initial positive results identified by this study.  

• Small sample (< 30)
• Baseline sample/group differences of import
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement/methods not well described
• Questionable protocol fidelity
• Other limitations/explanation: As a feasibility study, it was not powered to detect statistic significance. A major limitation was the intervention focused on support for provision of care. There was low nursing participation .

Additional effort should be made to adopt an intervention like this into everyday practice to improve both patient and caregiver quality of life outcomes. Nurses can assist in identifying at-risk caregivers earlier in the disease trajectory so the intervention can be initiated earlier on in palliative care.

Databases searched included MEDLINE, PsycINFO, PSYNDEX, and CANCERLIT.

Randomized controlled trials (RCTs) conducted 1980–1995

Authors analyzed 15 studies.

Authors reported a small but significant effect on treatment-related symptoms, a significant medium effect on depression, and a small effect on anxiety.

Consistency of positive results showed reductions in treatment-related side effects and improved emotional adjustment.

Databases searched were MEDLINE, PsycINFO, PSYNDEX, and CANCERLIT (1980-Dec., 1995).

Search keywords were relaxation techniques, progressive muscle relaxation (PMR), autogenic training, hypnosis, imagination, and guided imagery in combination with neoplasms, cancer treatment, chemotherapy, radiotherapy, drug therapy, and bone marrow transplantation.

A total of 280 abstracts were found, 58 studies were relevant, and 15 met the inclusion criteria for meta-analysis. Moderator variables included intensity, schedule, and focus of intervention.

A total of 742 primarily female subjects with variable malignancies receiving highly emetogenic chemotherapy and trained in progressive muscle relaxation (PMR) were part of this review.

Consistent positive results in meta-analysis studies showed clinically significant reductions in nausea and other symptoms. Relaxation during the courses of treatment made the experience less stressful, reducing side effects. Studies supported the implementation of relaxation training into clinical routines as standard adjunctive treatment.

To evaluate the effects of a psychodynamic-oriented intervention in patients with cancer

Patients who consented were randomized to an immediate intervention group or a waitlist controlled group. Patients who did not want to participate were assigned to an observation group, and they agreed to complete study measurements. The intervention involved an immediate phase of four sessions during which the therapist aimed to link the patients’ biographical information with current responses to disease. The authors noted that this intervention was not considered psychotherapy, but it was designed as psychological support. After the initial sessions, subjects were able to participate in 12 additional sessions if they chose to. Study questionnaires were completed by patients in the home at baseline and at four, eight, and 12 months.

• N = 191 (99 in observation group)
• MEAN AGE = 53.2 years (SD = 11.6 years)
• MALES: 34.7%, FEMALES: 65.3%
• KEY DISEASE CHARACTERISTICS: Various cancer types including breast, gastrointestinal, urogenital, respiratory, and hematologic among others
• OTHER KEY SAMPLE CHARACTERISTICS: 32% of patients were receiving psychotropic medications. Baseline anxiety and depression scores were low (below clinically relevant levels). Patients with schizophrenia, major depression, or severe psychiatric illnesses were excluded.

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

• PHASE OF CARE: Multiple phases of care

Randomized, controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ)
• Symptom checklist
• Toronto Alexithymia Scale (TAS)

Only four patients in the immediate intervention group demonstrated improvements in ​total HADS scores (defined as a 50% improvement in score). Only 31.5% of those initially entered in the study had data for follow-ups, and the number of drop-outs in the waitlist controlled group was higher. There were no significant differences in study outcome measures between groups, and at some time points, control group scores were better. Only 50% of participants were interested in additional sessions of the intervention.

This study did not show any effects for the tested intervention. Multiple study flaws could have contributed to these results.

• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%  
• Other limitations/explanation: There were significant differences in age, use of psychotropic medication, and study measurement scores between the groups at baseline with the intervention group being older with a larger proportion of participants taking medications. Baseline HADS scores were low, suggesting a potential floor effect with study measures. A few patients in the control group requested the intervention and were then added to the intervention group rather than eliminated from the study analysis. There were huge drop-out rates, a lot of missing data, and no ITT analysis. The authors noted that a large number of patients who were approached declined participation. This, along with the large number of drop-outs, suggests that this type of intervention may not be practical or acceptable to patients. It was noted that patients receiving cancer treatment living in rural areas had difficulty participating.

This study did not show any effects of the supportive psychodynamic intervention examined. These results need to be viewed with caution because of the multiple flaws and limitations of the study. This report points to the difficulty of getting sustained patient participation in this type of therapy or research. It is not clear if drop-outs were caused by competing issues such as transportation for sessions, problems encountered during cancer treatment, a lack of patient interest, or sense of benefit. Supportive interventions for patients with cancer need to be practical in their implementation for both providers and patients.

To evaluate effects of nurse navigation on depression among patients newly diagnosed with cancer

The nurse navigation intervention was designed to address care delays, care coordination, information needs, and help in patient decision-making and lack of emotional and social supports for patients. Patients randomized to receive the intervention had weekly nurse navigator contacts for 16 weeks. Nurses used a distress thermometer to identify problems and monitor progress. Those with high distress scores and suspected to have depression were referred for further assessment and treatment. Outcomes were evaluated in a four month follow-up telephone interview.

• N = 248  
• MEAN AGE: 61.3 years
• MALES: 11.3%, FEMALES: 88.7%
• KEY DISEASE CHARACTERISTICS: Breast, colorectal, and lung cancers, mostly stage I and II
• OTHER KEY SAMPLE CHARACTERISTICS: Most had at least some college education, they were predominantly Caucasian, and the majority were married.

• SITE: Multi-site  
• SETTING TYPE: Not specified    
• LOCATION: Seattle, WA

PHASE OF CARE: Active antitumor treatment

• Randomized cohort controlled study
• Secondary analysis

• Patient Health Questionnaire-9 (PHQ-9)
• Distress Thermometer (DT)
• Patient Assessment of Chronic Illness Care (PACIC)

Most patients did not have depression at baseline. For those with higher baseline PHQ-9 scores, nurse navigation patients had higher PACIC scores; however, differences were not statistically significant.

Findings did not show that nurse navigation was of greater benefit for patients with depressive symptoms or had an impact on depression scores.

• Risk of bias (no appropriate attentional control condition)

Findings of this study did not show that nurse navigation affected depressive symptoms or was of greater benefit to patients with depression among those newly diagnosed with cancer.

• FINAL NUMBER STUDIES INCLUDED = 17 (10 experimental and seven descriptive)
• SAMPLE RANGE ACROSS STUDIES: 6–64 patients (experimental), 5–100 patients (descriptive)
• KEY SAMPLE CHARACTERISTICS: Age range was 6–84 years; only one study reported on patients with cancer (n = 23)

PHASE OF CARE: Late effects and survivorship

Improvements were noted in fatigue in eight of 17 studies, and improvement was noted in cognition in 14 of the 17 studies reviewed. Neurofeedback interventions were well tolerated with only three studies reporting any side effects.

Insufficient evidence was presented to suggest that these complementary and alternative medicine therapies (neurofeedback) are useful in the management of cancer-related fatigue or cognition.

• Only one of the 17 studies included a population of cancer survivors (BCS, n = 23)
• Heterogeneity of other samples; majority non-clinical samples
• Majority of studies were low-quality

Additional research needs to be done before this type of therapy can be recommended.

To study the efficacy of palifermin for prophylaxis of OM in pediatric patients undergoing hematopoetic cell transplant (HCT)

Patients were randomly assigned to receive either IV palifermin 60 mcg/kg per day starting three days prior to transplant conditioning chemotherapy or placebo. All patients received basic oral hygiene and invasive nutrition as needed. All other aspects of care were essentially the same between groups. OM was assessed daily from 7 days prior to transplantation to 28 days after transplantation. Assessment was conducted by the same clinician.

• N = 54
• MEDIAN AGE = 11 years
• AGE RANGE = 7–16 years
• MALES: 48%, FEMALES: 52%
• KEY DISEASE CHARACTERISTICS: All had lymphoblastic leukemia and were undergoing HCT.

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

• PHASE OF CARE: Active antitumor treatment

• Placebo-controlled randomized controlled trial

• Oral Mucositis Daily Questionnaire (OMDQ)
• World Health Organization (WHO) Oral Mucositis Toxicity Scale

Significantly fewer patients in the palifermin group developed grade 2 (p = 0.038) and grade 4 (p = 0.006) mucositis compared to the placebo group. Grade 4 was seen in 11% of patients in the palifermin group and 59% of patients in the control group. Fewer patients in the palifermin group had any grade mucositis, but not all differences in grades were statistically significant. The duration of grade 3 and 4 OM in patients in the palifermin group was three days compared to eight days in the control group (p < 0.001). The only adverse reactions reported were rashes and altered taste, lasting for 48–72 hours. The cumulative morphine daily dose per body weight was lower in the palifermin group (p = 0.04).

Palifermin was shown to effectively reduce the severity, prevalence, and duration of OM among pediatric patients undergoing HCT and was not associated with any significant adverse effects.

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

Palifermin was shown to be beneficial to pediatric patients undergoing HCT for primary prophylaxis for OM. OM is one of the most painful and debilitating effects of high-dose myeloablative chemotherapy. Nurses can advocate for the consideration of palifermin in these patients. Additional research in support of these findings is warranted, and research regarding the potential role of palifermin in other types of chemotherapy regimens associated with OM is needed.

The purpose of the study is to investigate the use of acupuncture during chemotherapy on white blood cell count, absolute neutrophil count, and endogenous G-CSF level.

Patients were randomly assigned to receive acupuncture or sham acupuncture sessions 2–3 times weekly beginning one week prior to chemotherapy cycle 2 and ending at the beginning of cycle 3 of chemotherapy.  A standard acupuncture protocol was administered by five different experienced providers. An electroacupuncture machine was connected to needles and a heat lamp was placed above the feet of the patient. Lab work was obtained at baseline, the nadir of cycle 1 and then every seven days during the study period.

• The sample consisted of 20 participants with a mean age of 50.4 years.
• All participants were female.
• All had newly diagnosed ovarian cancer and were receiving myelosuppressive therapy.

Multiple sites in New England

Active antitumor treatment

 Double-blind, randomized, placebo-controlled trial

• Complete blood counts
• NCI Common Terminology Criteria for Adverse Events (version 3)
   

Five patients withdrew from the trial due to disease progression, side effects of chemotherapy, or time commitment. After patients received six acupuncture sessions, there was a significant different in white blood cell counts between groups in favor of acupuncture (p = 0.04). These differences remained at nadir and the second recovery day. Average absolute neutrophil counts (ANCs) were higher in the acupuncture group at several time points, but this difference was not statistically significant. G-CSF levels in the acupuncture group were about four times higher; however, this difference between groups was not statistically significant.

Acupuncture may be helpful in  in patients receiving myelosuppressive chemotherapy in reducing neutropenia and associated problems. More definitive study in this area is needed to better evaluate the clinical efficacy of acupuncture in this area

• Small sample size (less than 30 participants)
• Intervention was expensive, impractical, or training was needed
• Recruitment was done over 24 months; however, few patients out of a large pool were successfully enrolled. The dropout rate in the study was high. These factors raise the question of practicality to provide this type of intervention. 
• The authors noted that patient travel to receive the acupuncture treatments was a barrier encountered.

Study findings suggest some promise for use of acupuncture among strategies for the prevention of infection; however, due to the very small sample size, no firm conclusions can be drawn. Issues seen in this study point to the problem of time and frequent travel for patients involved in cancer treatment to participate in this type of intervention. Further research in the use of acupuncture with larger trials is needed for further evaluation of efficacy.