To measure the efficacy of relaxation training for hospitalized patients with advanced cancer.

Patients were randomized to receive an immediate or delayed intervention, on day 3 or day 6 of a nine-day study period. The intervention was a one-hour training session delivered by a specially trained registered nurse (RN) in deep breathing and somatic tension release, as well as instruction on maintaining a state of somatic relaxation. Patients were given a CD of the audio training to repeat at night after the training.

• The sample was comprised of 18 patients (33% male, 66% female).
• Mean age was 61 years (standard deviation [SD] = 15 years) in the intervention group and 66 (SD = 12 years) in the delayed intervention group.
• Patients were hospitalized with advanced metastatic cancer, with a life expectancy of less than six months, a diagnosed sleep disorder, and fairly well-controlled pain and dyspnea.
• Multiple cancer diagnoses were included.
• Patients were hospitalized for at least five days.
• Patients had a Mini-Mental State Examination (MMSE) score of 20 or greater.
• Patients spoke French.

• Single site
• Inpatient
• Switzerland

• Patients were undergoing the end of life care phase of care.
• The study has clinical applicability for palliative care.

This was a pilot, randomized, controlled trial.

• Numerical Rating Scale of 1 to 10
• Sleep diary
• Hospital Anxiety and Depression Scale (HADS)

Only 11 patients were able to complete the treatment phase of the study. Both groups improved (not statistically) between the day of inclusion and day 2 of therapy. No improvement occurred between days 2 and 5, which was when the intervention occurred for half of the patients. No change occurred in the use of benzodiazepines during the nine-day study.

The study did not show that a simple relaxation therapy intervention improved satisfaction with sleep in patients with advanced cancer hospitalized on a palliative care unit.

Assessment and management of sleep disturbances should be integrated into patient care early in the disease process.  Further work is needed to identify and test interventions that can be used to improve sleep in patients with advanced cancer. Further work is also needed to determine whether relaxation therapies have an effect on sleep satisfaction.

• The study had a small sample size.  
• The study had risks of bias due to no blinding and no appropriate attentional control condition.
• Unintended interventions or applicable interventions not described would have influenced the results.
• Measurements/methods were not well described.
• Measurement validity/reliability was questionable.

It is critical to assess and manage sleep disturbances in patients with cancer early in the disease process. Ongoing evaluation and research is required into effective interventions to promote sleep in patients with cancer; specifically, further work is needed to look at relaxation therapies and determine if they are effective and a means of improving patient satisfaction with sleep.

To compare the effects of Comprehensive Health Enhancement Support System (CHESS) access intervention versus provision of internet with recommended websites for lung care cancer care on informal caregivers’ burden, disruptiveness, and mood

Patients and their caregivers were provided with laptops with internet that allowed access to CHESS. CHESS is a home-based e-health system that helps users to appraise the controllability of cancer-related stressors and improves their cognitive, behavioral, and supportive coping skills by providing them with a variety of information, communication, and coaching services appropriate for cancer caregivers based on their need and preference. CHESS allows sharing critical information with clinicians via Clinician Report, where caregivers are able to communicate their needs, ask questions, and rate patients’ symptoms on a scale of 0–10. A score of 7 or more triggers an email alert to the patient’s treating clinician so he or she is aware of the patient’s and caregiver’s situation on the next patient visit. Patients randomly were assigned to internet use only or CHESS plus internet use. Internet users were provided with internet access and a list of high-quality websites for information.

• N = 246 (122 in the control [internet] group and 124 in the intervention [CHESS] group)
• AGE RANGE = 18–84 years
• MEAN AGE = 55.56 years
• MALES: 31.7%, FEMALES: 68.3%
• KEY DISEASE CHARACTERISTICS: Patients with advanced non-small lung cancer IIIA, IIIB, and IV with a life expectancy no less than four months
• OTHER KEY SAMPLE CHARACTERISTICS: English-speaking adults who are primary caregivers; participants were primarily females (68.3 %), spouses/partners (72%), and highly-educated (53% had an associate's degree); most patients had advanced disease (IV) (66.4%) and other major diseases (57.7%)

• SITE: Multi-site    
• SETTING TYPE: Outpatient    
• LOCATION: Northeastern, Midwestern, and Southwestern United States

• PHASE OF CARE: Multiple phases of care
• APPLICATIONS: Pediatrics, elder care, palliative care 

• Randomized clinical trial with a randomization ratio of 1:1
  • Participants were stratified by study site, caregiver’s race, and relationship to patient.
  • Measurements were administered at pretest and post-tests every two months up to two years, or 13 months after a patient’s death, whichever came first.
  • Analysis involved data from the first eight months only.

• Caregivers’ demographics
• CHESS use (number of logins, number of pages viewed, and time spent on the CHESS system)
• Disruptiveness was measured by the Caregiver Quality of Life-Cancer Scale (CQOLC) Disruptiveness Subscale.
• Burden was measured by the CQOLC Burden Subscale.
• Negative mood was measured by a 16-item subset of the Short Version Profile of Mood States (SV-POMS) focusing on measurement of Tension-Anxiety, Anger-Hostility, and Depression-Dejection.
• Patient symptom distress was measured by the caregiver’s perception of the patient’s symptom distress using the Edmonton Symptom Assessment Scale (ESAS).

Average use of CHESS among the intervention group was 14.6 logins, averaging browsing 293 pages and spending 177 minutes on the system (almost 50 minutes monthly). Statistically significant improvement was seen in the intervention group over the control group at six months follow-up in burden (p = .02) and negative mood (p = .006), but not in disruptiveness. These effects persisted even when patient symptom distress (on the ESAS) and other covariates were controlled. Analyses also show that these significant differences existed only at six-month follow-up, not at any other times. 

Targeted electronic systems that are designed comprehensively to help caregivers can improve their experience of caregiving by minimizing their perceived burden and improving their mood.

• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Intervention expensive, impractical, or training needs
• Subject withdrawals/attrition 10% or greater
• Physician consent was needed first before a candidate could be admitted into the study because the intervention required a clinician’s responsiveness to patients’ and caregivers’ needs. 
• Although training was given to participants who needed training on accessing CHESS and the internet, the study does limit participation of those who may not be computer savvy or would prefer receiving support in means other than electronic.

Targeted e-health systems are more likely to be beneficial to caregivers of patients with cancer when they are self-directed and have a comprehensive approach to caregivers’ needs (e.g., information, communication, coaching, interaction with healthcare providers). The benefits of e-health vary among cancer caregivers and depend on how they use the tools offered by such systems. Which feature or combination of features would be most helpful to this group of caregivers remains to be determined.

• FINAL NUMBER STUDIES INCLUDED = 10 
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,534
• SAMPLE RANGE ACROSS STUDIES: 30–282 patients
• KEY SAMPLE CHARACTERISTICS: Multiple types of cancer were represented across studies.

Interventions included exercise in eight studies, sleep hygiene in seven, relaxation training in six, and nutritional guidance in six. Six studies included the use of a booklet as supplement material. Four studies included telephone follow-up, and one was provided via an Internet-based program. The program duration ranged from 1 week to 12 weeks. Attrition rates ranged from 7%–46.7%. Two studies demonstrated significant reduction of fatigue with ES ranging from –0.76 to –1.41 (p < 0.001). Six studies concluded achieving a limited positive effect, with a small effect size and no statistical significance. One study showed no effect, and one showed worse outcomes in the intervention group. High heterogeneity existed across trials, so no meta-analysis was deemed appropriate.

Inconsistent evidence of effects of patient education programs on cancer-related fatigue existed across all 10 studies.

• Variability of cancer types, stages, treatments, and phases of care across studies
• Various types of control conditions could contribute to bias.
• Variability existed in program duration, methods of delivery, and follow-ups.
• High attrition existed in some studies.
• Many studies included exercise, which alone has been shown to be of benefit for fatigue.

Some mixed evidence exists regarding the effects of patient education programs on cancer-related fatigue, which are related to the variability in interventions that have been studied. More rigorous research is needed to sort out those program characteristics and populations of patients who can benefit most from educational interventions.

The purpose of this study was to determine if guideline-based antiemetic therapy would improve chemotherapy-induced nausea and vomiting (CINV) in patients with multiple risk factors for CINV

• N = 152 
• AGE RANGE = 26–76 years
• MEDIAN AGE = 54 years
• MALES (%): Not provided, FEMALES (%): Not provided
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Early-stage breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Anthracycline-based chemotherapy

• SITE: Multi-site   
• SETTING TYPE: Multiple settings    
• LOCATION: Canada

• PHASE OF CARE: Active antitumor treatment

• Randomized controlled trial (RCT)

• The Functional Living Index-Emesis (FLIE) was used to measure the impact of CINV on the patients' quality of life. This assessment was given to patients on day 5.
• Patients used a diary daily to record the frequency, intensity, and duration of CINV. This diary was used for the first five days post administration of chemotherapy. The research nurse called the patient on days 1 and 5.

Patients from all risk levels had similar rates of acute and delayed vomiting; however, acute and delayed nausea remained higher in the high-risk patients.

• Findings not generalizable
• No report of comparison of outcomes across study groups

By assessing patient risk factors for CINV and prescribing antiemetic therapy based on patient risk stratification, acute and delayed vomiting may be managed; however, acute and delayed nausea remained significantly higher in the highest risk patients.

To evaluate the effectiveness of oral dexamethasone in attenuating or eliminating ​palmar-plantar erythrodysesthesias (PPE) induced by pegylated liposomal doxorubicin (PLD) (Doxil^®) in patients with recurrent gynecologic malignancies.

Patients were initially treated with PLD without dexamethasone (median number of cycles = 5). Patients who experienced grade 2 to 4 PPE had treatment delayed until symptom resolution, and then were retreated without dose reduction.

Patients in group 1 received a tapering oral dexamethasone regimen (8 mg BID) starting one day before infusion for five days, 4 mg BID on day 6, and 4 mg on day 7.

In group 2, patients who were not receiving dexamethasone and experienced grade 2 to 4 PPE had a weekly dose delay for up to two weeks until symptom resolution. If resolution occurred within three weeks of the delay, a 25% dose reduction was made. Patients who had persistent grade 3 or 4 PPE had PLD withdrawn.

• The study reported on a sample of 23 patients with recurrent gynecologic malignancies who received PLD 50 mg/m² on a 28-day cycle from January 1998 to December 2000.
• Sixteen patients had ovarian cancer, and seven had uterine cancer.

University of Texas Southwestern Medical Center in Dallas

This was a prospective, observational trial.

National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) was used to assess PPE (grades 1–4).

• Nine patients (39%) who received more than five cycles of PLD (50 mg/m²) developed grade 2 to 4 PPE. Median time to PPE was three cycles, and drug treatment was withheld until PPE symptoms resolved.
• On restarting treatment, six of nine patients who developed PPE received a scheduled tapering dose of oral dexamethasone. All six had complete or near complete resolution of PPE, and all continued treatment without subsequent dose modification or delay for an average of seven cycles.
• In group 2, three of the nine patients with PPE who did not receive dexamethasone required treatment delays, and doses were reduced.

Oral dexamethasone appears to be effective in attenuating or eliminating PLD-induced PPE in patients with recurrent gynecologic malignancies.

The sample size was small.

PHASE OF CARE: Active antitumor treatment

883 patients across studies did not receive G-CSFs, of which 21.97% developed FN (adjusted rate 23.2%). Compared to patients who did not receive G-CSFs, patients who received G-CSFs had an OR of 0.077 (95% CI [0.013, 0.460]), a 92.3% lower incidence rate. Patients younger than age 65 also had a lower rate of FN (4.2%–66.7%) compared to patients 65 and older (7.7%–88.2%).

Use of G-CSFpp significantly reduces the risk of FN in patients with early-stage breast cancer receiving TC therapy. Patients younger than age 65 also have a reduced risk of FN compared to patients 65 years and older.

The reporting of findings differed between use of G-CSF (OR) and no use (%). They did report a 93% lower risk with use of G-CSF. The reporting of age differences did not differentiate between use or no use of G-CSF.

Aside from the limitations noted above, use of G-CSF as primary prophylaxis reduces the risk of FN in this patient population. Oncology nurses should be aware of the risks of FN in patients being treated with TC for early-stage breast cancer and promote use of G-CSFpp.

To evaluate the effectiveness of foot massage on pain in patients with cancer 

This research was a nonrandomized, two-group, quasi-experimental time series design conducted among 60 patients with cancer. The experimental group received a 30-minute foot massage over a three-day period. Pain was assessed using the Numeric Rating Scale for pain, which used a 0–10 range. Pain was assessed prior to the intervention and after the intervention for three days.

• N = 60  
• AGE RANGE = 39–58 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Diagnosis of cancer within last one to three years with chronic-type pain in the second stage of cancer
• OTHER KEY SAMPLE CHARACTERISTICS: All were Hindu

• SITE: Single site    
• SETTING TYPE: Inpatient    
• LOCATION: Devaki Cancer Hospital and Research Institute in Madurai, India

• PHASE OF CARE: Transition phase after active treatment

Nonrandomized, two-group, quasi-experimental, time series trail

• Numeric Rating Scale (NRS) for pain

On day 1, all patients in both groups reported severe pain. On day 2, most of the patients reported moderate pain with no measurable differences between the two groups. On day 3, the experimental group reported mild to no pain, and there was no change in the control group from day 2. The intervention group experienced a significant reduction in pain (p < 0.001).

This study shows the need to understand the purpose of foot massage techniques on pain levels in patients with cancer. The researcher assumed that with a decrease in pain, there would be an increase in patients' quality of life including stability in physiologic, psychological, sexual, vocational, and lifestyle aspects. These areas were not measured, and additional research is needed.

• Small sample (< 100)
• Baseline sample/group differences of import: Did not identify types of cancer
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Risk of bias(sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results: Did not identify any medications given for pain
• Key sample group differences that could influence results: Cancer diagnoses not identified
• Measurement/methods not well described: Unclear when intervention was done in response to pain assessment  
• Findings not generalizable
• Other limitations/explanation: The use of the NRS for pain is very subjective. It is unclear when or where the assessment was done in relation to the intervention. Although all the patients were female, the types of cancer studied were not reported. Different types of cancer can cause many different types of pain in different locations. The second stage of cancer was not defined. The types of pain medications used were not defined. The positions of those providing the intervention and their training were not identified. It is unclear if the foot massages were done consistently between patients using similar techniques.

Foot massage is an easy and cost-effective nursing intervention that could be used to help ease patient pain. This research article identified the need to continue research in this area. The patient parameters need to be more specific in future research designs.

To evaluate the overall effectiveness and safety of neurokinin 1 (NK1) receptor antagonists (RAs) in the prevention of chemotherapy-induced nausea and vomiting (CINV) when compared to standard antiemetic regimens including a 5-HT₃ RA plus dexamethasone

Databases searched were MEDLINE, Embase, Cochrane Central Register of Controlled Trials (Central), and Latin American and Carribean Health Sciences Literature (LILACS).

Search keywords were neurokinin, aprepitant, casopitant, ezlopitant, netupitant, vestipitant, chemotherapy-induced nausea and vomiting, nausea in cancer patients, vomiting in cancer patients, and randomized trials.

Studies were included in the review if they

• Were randomized controlled trials (RCTs) that addressed the addition of an NK1 RAs to standard antiemetic therapy (dexamethasone plus 5-HT₃ RA) for the prevention of CINV.
• Provided an adequate description of outcomes that could be pooled in the meta-analysis.
• Used adequate antiemetic therapy in the control arm.

No specific exclusion criteria were identified.

A total of 4,034 references were retrieved.

Two reviewers assessed the quality of each study. Items from Delphi list and Jadad score were utilized for data extraction; however, the authors did not describe if any specific scoring system was used for quality assessment.

• The final number of studies included was 17.
• The sample range across all studies was 36–1,933.
• The total number of patients included in the review was 8,740. Data from 8,173 patients in 13 studies were used for analysis about complete response (CR), which is defined as no vomiting, no retching, and no use of rescue medication. Data from 8,376 patients from 15 studies were used for acute and delayed phase analysis.
• All patients were diagnosed with cancer and receiving either highly or moderately emetogenic chemotherapy.

All patients were in active antitumor treatment.

• The use of an NK1 RA increased the CR rate in the overall phase from 54% to 72% (overall response [OR] = 0.51, 95% confidence interval (CI) = 0.46–0.57, p < 0.001), in the acute phase (OR = 0.56, 95% CI = 0.48–0.65, p < 0.001), and in the delayed phase (OR = 0.48, 95% CI = 0.42–0.56, p < 0.001).
• The addition of an NK1 RA to standard antiemetic therapy improved CR rates in the overall phase for patients who received highly emetegenic chemotherapy (OR = 0.46, 95% CI = 0.40–0.53, p < 0.001) or moderately emetogenic chemotherapy (OR = 0.59, 95% CI = 0.51–0.67, p < 0.001).
• The addition of an NK1 RA increased CR rates in the overall phase independently depending on if ondansetron was used in the control arm beyond day 1 or not (ondansetron: OR = 0.64, 95% CI = 0.54–0.76, p < 0.001; no ondansetron: OR = 0.47, 95% CI = 0.41–0.53, p < 0.001). CR in the acute phase and delayed phase demonstrated a strong correlation (r = 0.91, p < 0.001).
• Three trials (n = 1,480) suggested a statistically significant increase (from 2% to 6%) in the risk of severe infection among patients receiving NK1 RAs (OR = 3.10. 95% CI = 1.69–5.67, p < 0.001).

The addition of an NK1 RA increased CINV control in the acute, delayed, and overall phases.

The use of an NK1 RA may be associated with a statistically significant increase in the risk of severe infection. A more comprehensive evaluation of the safety profile of NK1 RAs and additional appraisal of specific data from RCTs is needed.

• Subgroup analysis requires careful scrutinization. In this review, most patients in the moderately emetogenic chemotherapy group received an AC regimen, which is now considered highly emetogenic chemotherapy.
• Favorable ondansetron use for the delayed phase was suggested after comparing its effect with placebo control. However, current guidelines suggest the use of dexamethasone rather than ondansetron as a combination regimen for delayed CINV control. Comparison should have been between an NK1 RA plus dexamethasone versus NK1 plus ondansetron.
• Toxicity analysis was based on reports  of 3 studies (out of 17 studies included) which reported on the most prevalent adverse events. NK1 RA use did not increase the risk of febrile neutropenia or any other hematologic toxicity. OR findings are not clearly interpretable.

• This systematic review summarized the results from RCTs which investigated the effect of an NK1 RA for CINV control. Overall, the use of an NK1 RA improved the CR in acute, delayed, and overall phases.
• Further studies are warranted to determine whether adding an NK1 RA to standard antiemetics could improve CINV control in non-AC, moderately emetogenic chemotherapy as most NK1 RA RCTs were based on cases receiving highly emetogenic chemotherapy (including an AC regimen).
• Although further study is warranted, occurrence of infection with NK1 use requires special attention.

To determine if the use of guarana extract affects fatigue or quality of life in patients with head and neck cancer undergoing chemoradiotherapy

Patients were randomized to receive either guarana or placebo, with both given twice daily before meals for six weeks while they were undergoing chemoradiotherapy. The patients receiving guarana took 50 mg twice daily. The patients were assessed three times throughout treatment at day 1, day 21, and day 42, and once three weeks after the completion of treatment on day 63. The three assessments during treatment corresponded with cisplatin administration. Each assessment included fatigue and quality of life questionnaires, evaluation for guarana toxicity according to the World Health Organization scale, as well as weight and renal function.

• N = 52   
• AGE = Not specified
• MALES (%): Not specified, FEMALES (%): Not specified
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Stage I–IV head and neck cancer, mainly squamous cell carcinoma. Patients underwent 30 sessions of radiotherapy and three cycles of cisplatin.

• SITE: Not stated/unknown   
• SETTING TYPE: Not specified    
• LOCATION: Brazil

PHASE OF CARE: Active antitumor treatment

Phase II, placebo-controlled, double-blind, randomized study

• General questionnaire
• Guarana Toxicity Assessment 
• Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
• Functional Assessment of Cancer Therapy-Head and Neck (FACIT-HN), version 4.0
• European Organization of Research and Treatment of Cancer Core Quality of Life (EORTC QLQ-30) questionnaire
• EORTC QLQ-H&N-35 questionnaire

No statistically significant reduction in fatigue or improvement in quality of life was identified in either group using any questionnaire. Some initial or transient improvements were noted but were not statistically significant or did not last the length of treatment. The authors do not recommend the use of guarana in this patient population.

This intervention was not successful for this patient population. Although the authors reported some positive benefits, based upon the description of the results, it is unclear if this is related to the guarana or other factors that could influence quality of life in the patient population.

• Small sample (< 100)
• Measurement/methods not well described
• Subject withdrawals ≥ 10%

In terms of nursing practice, this study highlights the significance of malnutrition, weight loss, and mucositis in this patient population, and addressing these complications of chemotherapy and radiation in this patient population seems like a promising area for nursing attention and research.

Proteolytic enzymes comprised of papain (100 mg), trypsin (40 mg), and chymotrypsin (40 mg) were administered orally 3 x 4 tablets per day.

The study reported on 69 patients with tumors of the oropharynx or oral cavity undergoing a radiation dose higher than 40 Gy.

The study was conducted at a multicenter site from June 1996 to May 2000.

This was a prospective, randomized, triple-blind, placebo-controlled, parallel group study.

• Maximum grade of mucositis was recorded.
• The Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer (RTOG/EORTC) toxicity criteria were used.

No statistically significant difference was found in analysis. Treatment with Wobe-Mugos E resulted in an earlier onset of mucositis and increased average scores for treatment duration.

The sample was not sufficient according to power analysis.