In both studies, the dose of Propax was given to patients three times daily in a packet that contained four tablets and one softgel capsule. Supplements were administered with food to limit potential gastrointestinal upset. In the open-label study, patients received the Propax nutritional supplementation five to seven days prior to chemotherapy treatments and continued throughout the next 12 weeks of the chemotherapy regimen. After six weeks of chemotherapy, patients crossed over to the other product (placebo to Propax or Propax to placebo). Outcomes were evaluated at baseline, week 6 (mid-point), and week 12 (end of the intervention).

• The sample was comprised of 16 patients who completed the unblinded study and 22 patients who completed crossover randomized, controlled trials.
• Cancer diagnoses varied, including advanced unresectable non-small cell, small cell lung, colon, rectal, pancreatic, sarcoma, breast, or ovarian cancers.
• Patients were excluded if they were younger than 21 years, women of childbearing age, mentally incompetent, renally impaired, had serum bilirubin of 2.0 mg/dL or higher, had weight loss greater than 15% within the last four months, spent more than 50% of waking time in bed, or were currently consuming vitamin or nutritional supplements.

Outpatient chemotherapy centers in California, Florida, Maine, Massachusetts, New Jersey, and New York

Patients were undergoing the active treatment phase of care.

This was a crossover, placebo-controlled, randomized, controlled, trial and a pilot open-label study.

The article did not discuss which measurement instruments were used.

In the open-label trial, patients reported significant improvements in fatigue (>0.5 change in score). Patients who began with Propax in the crossover randomized, controlled trial reported improvement in fatigue during the 12-week study period. Patients who began with the placebo experienced improved quality of life; however, fatigue was not specifically mentioned.

• The study had a small sample size.
• The duration of the crossover study was short; therefore, the rapid crossover design may not have permitted adequate separation from Propax effects and placebo effects.

To review existing research on the use of acupuncture and acupressure in the management of nausea and vomiting in order to provide nurses the information required to assist their patients receiving chemotherapy and experiencing chemotherapy-induced nausea and vomiting (CINV)

Databases searched were described as scientific and internet sources, Institutes of Health Consensus statement, and federal regulations.

Search keywords included acupuncture and acupressure in combination with chemotherapy-induced nausea and vomiting.

Numerous studies tested the effectiveness of acupressure, acupuncture, and the combination. Few focused on acupressure alone for managing CINV.

A total of five studies were found, representing a total of 409 patients.

Very few studies were found, but, overall, results indicated improvement in nausea and vomiting, supporting the use of acupressure and acupuncture of the treatment of CINV. Acupuncture and acupressure were found to be safe and effective for the relief of CINV in combination with current antiemetic drugs.

The sample sizes were small in the studies; therefore, determining applicability to various practice settings and populations is difficult.

To evaluate the effect of family caregiver–provided massage, as instructed through a multimedia home-based training program, on patient symptom ratings, caregiver attitudes (confidence, self-esteem), and perceived stress

The experimental group received a DVD and written manual instructing caregivers on how to prepare for and safely practice providing massage and acupressure to patients with cancer in the home setting. Dyads were requested to practice at least three times per week for four weeks. Control group caregivers were asked to read to patients for the same frequency and duration. Caregiver/patient dyads were randomized to the intervention or control (reading) group for a four-week period, after which controls could opt to receive the intervention. An additional 16-week observation period followed.

• The sample included 97 caregiver/patient dyads.
• Age range of participants was 18–82 years.
• The caregiver sample was 56% male and 44% female; the patient sample was 76% male and 24% female.
• Patients with any type or stage of cancer were eligible.
• Participants had to be at least 18 years old and able to read and write English, Spanish, or Chinese.

• Multisite  
• Home setting
• Three U.S. cities: Boston, MA, Portland, ME, and Portland, OR

• Mutliple phases of care
• Palliative care

A randomized controlled trial design was used.

• Using a 1–10 scale, patients rated their level of pain, stress/anxiety, depression, fatigue, nausea, and patient-specified “other” symptoms prior to and 15 minutes after one of the weekly massage or reading sessions.
• Caregivers completed weekly reports on the number, content, and duration of the sessions.
• At baseline and four weeks, caregivers completed a seven-question investigator-designed survey on attitudes toward caregiving and the seven-item caregiver esteem subscale of the Caregiver Reaction Assessment; dyads completed the Perceived Stress Scale; and patients completed the Functional Assessment of Cancer Therapy–General.

Both control and intervention caregivers had good compliance with the protocol, and both experienced significant improvements in caregiver attitudes (ability to help patient feel better and worry about causing distress through touch). Intervention group caregivers reported increased self-efficacy in providing massage.

Patients in both groups reported significantly improved symptoms after each session. Over the four-week period, patients in the intervention group had significant mean decreases in symptom ratings for pain (p = 0.04), nausea (p = 0.02), and patient-specified symptoms (p = 0.02; these symptoms were not listed by the authors). There were some significant pre-/postsession symptom ratings improvements in the massage group when scores by week were compared, but no linear association of time and symptom trajectory was noted.

Both massage and reading interactions within patient/caregiver dyads appear to have a positive effect on caregiver attitudes and patient symptom ratings. Dyads utilizing massage based on the home instruction materials may receive more benefit regarding caregiver self-efficacy specific to that skill and greater symptom relief over time.

• The study had risk of bias (no control group).
• Given the improvements noted in both groups, it is possible that control group dyads intentionally (as a result of learning about the potential benefits of massage during the consent process) or unintentionally engaged in forms of touch that provided some benefits over the four-week observation period.

This study measured the benefits of massage on caregiver and patient outcomes as compared to a control (reading) and found both activities were potentially beneficial. The method by which the intervention group was instructed was innovative, multilingual, and widely reproducible, as it is offered through a DVD recording and written manual, and was tested in a sample that was very inclusive (open to all cancers and stages of adult patients who spoke three common languages, from three geographic sites in the United States). However, despite the study title, which leads the reader to believe that an aim of the study was to examine the effectiveness of the instruction method itself, this is not the case. A prior feasibility study was noted to pilot the included content, and a patient convenience sample (n = 18)  was noted to have tested the multimedia program for usability, but no report of testing the effectiveness of teaching the content in this manner versus any other method was reported. There were no implementation challenges or adverse events reported in the study (these were assessed by biweekly phone calls), and an oncology massage therapist made one home visit to the dyads to ensure the intervention was delivered safely. It is implied that the multimedia tool was an effective instruction method, but this was not explicitly studied. Study findings suggest that providing carers with any specific concrete way to intervene to help patients may be what is actually beneficial.

A home-based exercise program was used that included aerobic and resistance training. The exercise group received an individualized exercise prescription, with strength levels and aerobic capacity at first testing. The control group received usual care. Outcomes were exercise, fatigue, mood, and sleep.

• The sample was comprised of 24 Caucasian patients (10 women, 14 men).
• Mean age was 55 years.
• Patients were on high-dose chemotherapy and were receiving peripheral blood stem cell transplant for multiple myeloma (with bone involvement).

• Outpatient
• Cancer research center
• Midwestern United States

Patients were undergoing the active treatment phase of care.

The study was a pilot feasibility, randomized, controlled trial.

• A wrist actigraph was used to measure latency, minutes of sleep at night, percent of time asleep at night, number of nighttime awakenings, frequency of daytime naps, minutes of sleep during the daytime, and total minutes of sleep during each 24-hour period.
• The Epworth Sleepiness Scale (ESS) also was used.

The feasibility of an individualized exercise program for patients receiving aggressive treatment for multiple myeloma was determined.

• The study had a small sample size.
• The study had a 42% attrition rate; equal attrition was noted in both groups.
• Valid and reliable sleep latency is difficult to determine from actigraphy.
• The test is time consuming and a burden to patients.
• An exercise testing facility is needed.

To compare usual care with a home-based individualized exercise program (HBIEP) in patients receiving intensive treatment for multiple myeloma (MM) and epoetin alfa therapy.

This was a randomized trial with repeated measures of two groups (one experimental and one control) and an approximate 15-week experimental period for the HBIEP. The control group received a recommendation to walk 20 minutes three times per week. In the HBIEP, patients were given color-coded stretch bands and materials to illustrate exercises to be used, and they were to perform aerobic walking to reach 65% to 80% of the maximal heart rate. Patients mailed in weekly activity summaries. Assessments were performed at baseline, 10 to 12 weeks later prior to the second chemotherapy cycle, and three to four weeks later when finishing stem cell collection.

• The study was comprised of 187 patients (92 in usual care and 95 in the intervention).
• Age ranged from 35 to 76 years in the usual care group and 25 to 76 years in the intervention group.
• In the usual care group, 60% of patients were male and 40% were female.  In the intervention group, 57% of patients were male and 43% were female.
• Patients were newly diagnosed with MM and were eligible for treatment with an aggressive protocol that included stem cell transplant. 
• The majority of patients were well educated and had great motivation to exercise. The intent of the intervention was to determine whether specific exercises were more effective in improving sleep and decreasing fatigue.

• Single site
• Multiple settings
• Southern United States international referral center

• Patients were undergoing the active antitumor treatment phase of care.
• The study has clinical applicability for elder care. 

This was a randomized, controlled trial with repeated measures of two groups and a 15-week experimental period.

• Profile of Mood States (POMS) Fatigue Scale
• Functional Assessment of Cancer Therapy-Fatigue (FACT-F)
• Actigraph recordings
• Six-minute walk test
• Hemoglobin levels at baseline and before and after stem cell collection
• Descriptive statistics used to compare demographics
• Treatment effects and repeated measures ANOVA used to determine effects of HBIEP

No statistically significant differences existed among the experimental and control groups for fatigue, sleep, or performance (aerobic capacity). Statistically significant differences (p < 0.05) were found in each of the study outcomes for all patients as treatment progressed, and patients experienced more fatigue and poorer nighttime sleep and performance.

The effect of exercise seemed to be minimal on decreasing fatigue, improving sleep, and improving performance. Exercise is safe and has physiologic benefits for patients undergoing MM treatment and, when combined with epoetin alfa, helped to alleviate anemia.

• The study had a risk of bias (sample characteristics) because it consisted of mostly well-educated patients.
• A key sample group difference that could influence the results included the inclusion of mostly well-educated patients.
• Patients self-reported compliance with HBIEP. This was a home-based program, so no observation was performed. 
• Patients in the control group were not discouraged from exercising.
• No patient could perform the strength tests.
• Anemia was present at baseline in the majority of patients, and all participants would become anemic with treatment; therefore, all patients received treatment for anemia, which potentially limited the results.

Although the results might indicate no derived benefit, patients became more fatigued, slept less, and experienced a decline in performance with more treatment. The HBIEP group required fewer red blood cell transfusions to maintain a similar hemoglobin level, less platelet transfusions, and fewer days to collect stem cells. When combined with epoetin alfa therapy, exercise had an effect in decreasing cancer-related anemia and improving cell count recovery after high-dose chemotherapy. These are benefits to patients and the healthcare economy. Cancer rehabilitation exercises may result in improved performance. Having fatigue prior to treatment might predict having fatigue after treatment. Energy conservation measures should be considered with endurance and resistance exercises. Rehabiltation therapy might be needed for deconditioned patients. Exercise should be tailored individually based on the patient's disease stage, presence of bone lesions, and values. The HBIEP may have helped to alleviate anemia, but there is no evidence that HBIEP combining muscle strengthening and aerobic walking exercises decreases fatigue.

Evaluate the efficacy of sodium hyaluronate to decrease pain and severity of oral mucositis

Patients affected by oral mucositis were consecutively recruited. Patients were instructed to apply the hylauronic based spray on oral lesions 3-4 times per day for 14 days after meals. All patients did mouth care, including oral rinses with 0.12% chlorhexidine gluconate based mouthwash 3 times daily. Patients were evaluated with oral examination and photo recording at baseline, at 24 hours, 72 hours, 7 days, and 14 days.

The study was comprised of 27 patients with a mean age of 61 (SD = 18.6 years) and a range of 18-96 years. There were 12 femailes and 15 males.

Diagnosis Information: Recent treatment for head and neck cancer, daily radiotherapy, or chemo for neoplasm

Other Key Characteristics: signs of at least grade 1 oral mucositis

Mutli-site: University of Naples and University Hospital of Palermo

Open label prospective clinical trial

• WHO mucositis scale
• Visual Analog Scale (VAS) for pain
• Clinical resolution index

Pain scores with VAS reduced over time and was significantly reduced after two hours from spray provision (p  < 0.0001). Similar differences were shown at every other measurement time point as well (p < 0.0001). Patients treated showed improvement of lesion at 72 h (p = 0.0005) and progressive improvement in ability to swallow food and liquids.

Findings suggest that hylauronic acid/sodium hyaluronate may be helpful for management of oral mucositis.

Small sample <30. No appropriate control group; variety in treatment regimens (chemo versus non-chemo) may skew results. Patients already had mucositis at study entry and were using chlorhexidine, which is contrary to guideline recommendations. It is unclear if this may have affected findings.

May be effective but what are side effects? Does it lead to numbing? What does it taste like? Etc.

To examine the effectiveness of two different types of patient-controlled analgesia (PCA)—peripheral (IV) versus epidural in an effort to develop best practice in pain management for this population

• Phase 1: Control group of 50 patients received peripheral/IV PCA with morphine sulfate
• Phase 2: Experimental group of 50 men received PCEA with bupivacaine and fentanyl

• N = 100
• OTHER KEY SAMPLE CHARACTERISTICS: Patients received four HDR radiation treatments during their hospital stay. Ninety-two patients were implanted with a mean of 20 interstitial HDR catheters. Thirteen percent of patients had diabetes mellitus, 36% had osteoarthritis, and 11% were obese.

• LOCATION: Radiation oncology department in an acute care university medical center in the United States

• Nonrandomized
  • Convenience sample of 100 men receiving HDR brachytherapy

• Pain assessment, number of HDR catheters, comorbid conditions
• Pain assessed at five points—baseline, pre-CT 2 hours after HDR implant, 5 hours after implant, 13 hours after implant, 24 hours after implant, and 30 hours after implant
• Brief Pain Inventory Scale (BPIS) was used (0–10). Sites of pain evaluated were foley catheter, interstitial catheters (perineum), and back (lumbosacral).
• Pain score was given to the nurse verbally, who then recorded it.

The phase 1 control group with PCA had the following mean ratings for pain: back, 2.7; foley catheter, 3.4; perineal interstitial catheter, 3.0.

The phase 2 experimental group with PCEA had the following mean ratings for pain: back, 0.5; foley catheter, 0.6; perineal interstitial catheter, 0.7.

PCA was associated with increased pain intensity. Foley pain was worse with arthritis and obesity.  Back pain increased, interstitial pain decreased, and pain increased with the number of catheters. The PCEA group experienced significantly less pain at five-points-of-pain assessment from the control group.

Patients with PCA had greater pain and less pain relief.

• PCA had demand dosing but no basal dose. PCEA had demand and basal doses. Maybe the pain improved because of having basal and demand dosing.  
• The drug was different for each group, so it is difficult to ascertain if the changed route or the changed drug improved pain relief.  
• Nonrandomized, convenience sample
• Not noted if patients’ comorbidities were stratified.
• Participants’ age, stage of disease, history of opioid use, use of non-opioid or coanalgesics, and dose of brachytherapy were not noted.
• Each group was treated sequentially—the first group from July 2003–November 2003 and the second group from December 2003–February 2004. Were there any practice changes?

To evaluate the relationship between patient expectations of postchemotherapy nausea and subsequent reports of nausea

Databases searched were MEDLINE, PsycINFO, and CINAHL.

Search keywords were expectancy, expectations, placebo effects or placebo responses with chemotherapy and nausea or emesis.

Studies were included if they

• Measured patient expectation for post-chemotherapy nausea.
• Reported occurrence, severity, or frequency of post-chemotherapy nausea.

Studies were excluded if they focused only on anticipatory nausea.

The authors independently coded the sample characteristics, the independent and dependent variables, and whether the study met the inclusion criteria for each study. Differences were discussed, and a final assessment negotiated for each study. A global effect size was calculated for each study. No formal scoring was used to assign a quality score to each study. Publication bias was addressed using the Egger test and calculations of failsafe.

• The review consisted of 17 studies.
• The average study sample size was 141 participants, ranging from 29–67, and totaling 1,497 patients.
• Patients with breast cancer were most frequently studied.
• Ten studies involved highly emetogenic chemotherapy (HEC), and four involved therapy with low emetogenic potential.

• Patients who expected to experience nausea were almost twice as likely to experience postchemotherapy nausea (pooled effect size, Cohen’s d = 0.35, OR = 2.07, p < 0.0001).
• No significant relationship was found among nausea frequency, severity, duration, or peak nausea level.
• Findings differed based on the timing of measurement in the study. Larger effect sizes were seen in studies in which post-treatment nausea was assessed after multiple infusions compared to those in which nausea was assessed after the first infusion.
• A slightly higher effect size was seen in studies that controlled for nausea history.

This meta-analysis confirmed that nausea expectations and experience of post-chemotherapy nausea are positively correlated. The discussion also identified research methods, such as incorporating expectancy-based manipulations that consider the source of the patient’s expectations, actively investigating the possible moderators of the association between expectancy and post-chemotherapy nausea (e.g., age, anxiety), and measuring the expectancies before the first chemotherapy administration.

• Methods and timing of nausea measurement varied among studies, which influenced effect sizes seen here.
• No subgroup analysis was provided based on the level of emetogenic potential of the chemotherapy, which would be expected to influence actual symptom occurrence.
• Forms for abstraction of data (no documented protocol) were not used and, therefore, not available for replication or expansion of the meta-analysis.

Prechemotherapy assessment needs to include patient expectations regarding the experience of postchemotherapy nausea. If a patient expects that he or she will experience nausea, additional evidence-based interventions to minimize nausea should be used prior to and during chemotherapy administration.

The Tibetan yoga (TY) intervention involved seven weekly sessions with a yoga instructor who used imagery and exercise and included four aspects:  controlled breathing and visualization, mindfulness, two types of posture, and daily practice. Outcomes were psychological adjustment, sleep, and fatigue.

• The sample comprised 39 (final N = 38) patients with lymphoma.
• Mean age was 51 years in both groups.

• Community outpatient setting affiliated with a comprehensive cancer center
• Southern United States

Patients were undergoing the active treatment and long-term follow-up phases of care.

The study used a prospective, quasiexperimental design with two groups, including a wait-list control.

Pittsburgh Sleep Quality Index (PSQI)

The TY group reported significantly lower sleep disturbances scores (total PSQI) at follow-up (5.8 for TY versus 8.1 for the wait-list control). At follow-up, the TY group reported better subjective sleep quality, shorter latency, longer duration, and use of fewer sleep medications.

• The study had a small sample size.
• The study did not control for time since diagnosis.
• Methods of yoga taught may vary with instructor.
• Training in yoga is required.
• Costs are incurred for a space for the class and an instructor.