The residential, rehabilitative, psychoeducational intervention was conducted over a six-day period, followed by a four-day follow-up/booster intervention two months after the initial visit. Members of the intervention team included oncologists, social workers, art therapists, massage therapists, and a person trained in qigong and visualization; all had several years of experience and were trained according to the method reported by Grahn (1993). During the intervention period, participants received information about cancer, risk factors, treatment, psychological effects, and coping mechanisms. Physical exercise, relaxation training, qigong, and art therapy were mixed with educational lectures. Social activities, such as concerts and visits to museums and restaurants, were provided, along with opportunities for peer support. The residential rehabilitation environment was chosen for its beautiful and restful surroundings.

• Participants (n = 59) were primarily women; only two men participated.
• Median age was 53 years (range 29–81).
• Diagnoses included breast cancer (61%), gynecologic cancer (20%), and gastrointestinal malignancy (9%).
• Median time from end of treatment to the intervention was 1.2 years (range 6 months–3 years).

Residential rehabilitation setting selected specifically for the intervention

Patients were undergoing the long-term follow-up phase of care.

This was an uncontrolled study. Fatigue was evaluated immediately after the first six-day intervention, with follow-up at three, six, and 12 months postintervention.

The Norwegian fatigue questionnaire, an 11-item measure with two factors (physical and mental fatigue), was used. The total score was created by summing the 11 items.

At the conclusion of the intervention, there were statistically significant differences in fatigue reflected on most of the single-item scores on the Norwegian fatigue scale, as well as a statistically significant difference in the scores on the physical fatigue and mental fatigue factors. Only the improvement in physical fatigue remained statistically significant at three-month follow-up, and there were no significant improvements in fatigue at the six- and 12-month postintervention time points.

• No control group was included.
• The sample size was not justified by power analysis; it was unknown whether the study was powered to detect an effect.
• No information was provided relative to the psychometric properties of the fatigue measure.
• No explanation of the gender bias in study participation/recruitment was offered.
• Generalization of the results was limited by the primarily female sample and the overrepresentation of participants with breast and gynecologic malignancies.
• Costs of residential group treatment were unexplored.
• The program required the involvement of several skilled professionals.

To evaluate the effects of interferential therapy and long-wave diathermy at high power (ITH) compared to long-wave diathermy at low power (LDL) on peripheral neuropathy (PN) pain, sensory, and motor symptoms among adults with chronic chemotherapy-induced peripheral neuropathy (CIPN) symptoms in the lower extremities who completed chemotherapy treatment for various cancers

• N = 67   
• AGE = 64 years (SD = 10.57 years)
• MALES: 49.3%, FEMALES: 50.7%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: The medical record charted numbness, tingling, pain, or swelling sensation in the feet/lower legs, and physicians diagnosed chronic CIPN related to platinum-, taxane-, or vinca alkaloid–based chemotherapy completed a mean of 11.49 months (SD = 10.67 months) prior to the study; varied tumor types
• OTHER KEY SAMPLE CHARACTERISTICS: Participants were excluded if they had type 1 diabetes mellitus, PN related to other nonchemotherapy causes, or ongoing treatment with neurotoxic chemotherapy.

• SITE: Single site   
• SETTING TYPE: Not specified    
• LOCATION: Sweden

• PHASE OF CARE: Late effects and survivorship
• APPLICATIONS: Elder care, palliative care

Three-group, sham-controlled, randomized, controlled trial

There were no significant between-group differences at the 12-week and 37-week follow-ups in all outcomes: self-reported pain, discomfort, paresthesia/numbness, or balance, or in objectively measured balance. At the 12- and 37-week follow-ups, both groups reported significantly improved CIPN discomfort (p < 0.05), zones of paresthesia (p < 0.003), and subjective balance (p ≤ 0.025). Only the LDL group experienced improved pain at 12 weeks (p = 0.017), but neither group had significant improvements in pain at 37 weeks. Only the intervention group demonstrated significantly improved balance at 12 and 37 weeks, based on the objective measures (p ≤ 0.04).

This randomized, controlled trial provides no evidence to support the efficacy of interferential therapy and ITH compared to LDL once per week for 12 weeks for pain, CIPN discomfort, patient-reported balance, and objectively measured balance among participants with physician-diagnosed chronic CIPN.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (sample characteristics)
• Unintended interventions or applicable interventions not described that would influence results
• Measurement validity/reliability questionable
• Findings not generalizable
• Questionable protocol fidelity
• Subject withdrawals ≥ 10%
• Convenience sampling used in this study increases the risk of sampling bias and decreases the generalizability of the results.
• The definition of chronic CIPN was not defined, and participants had completed neurotoxic chemotherapy aa mean of 11.49 months (SD = 10.67 months) prior to the study, meaning some participants may have had unstable CIPN that naturally improved over time (i.e., maturation effects were likely responsible for the outcome improvements).
• The primary outcome was pain, but about one-third of the patients had no pain at baseline. 
• No measurement or control for key potential influencing factors of CIPN and pain (e.g., concomitant analgesic or psychotropic medication changes during the study; smoking; comorbidities, such as type 2 diabetes, peripheral arterial disease, alcohol dependence, vitamin B deficiency)
• None of the measurements had sufficient validity and reliability. The NRS has not been validated as a measure of CIPN pain or discomfort, and the authors created the map of paresthesia zones but had not tested it psychometrically. No evidence was provided to support the validity and reliability of the balance measures for patients with CIPN.
• There was 25.4% attrition by the 37-week follow-up, and no report of how missing values were handled (despite stating that an intent-to-treat analysis was conducted) was provided.

No evidence supports the efficacy of interferential therapy and long-wave diathermy, and, currently, this intervention should not be recommended to patients with heterogeneous types of painful and nonpainful CIPN. However, evidence shows that CIPN symptoms and balance may recover for some patients by one year after completing treatment with neurotoxic chemotherapy. Additional studies of nursing interventions for CIPN are needed.

RESOURCE TYPE: Expert opinion

PHASE OF CARE: Active antitumor treatment

Expert opinion level only. The evidence is derived only from initial drug clinical trials.

Limited research evidence regarding interventions to prevent and manage side effects of immunotherapies exists, and most relies on corticosteroid treatment with increased dosing according to the severity of the side effects. Nurses need to be aware that diarrhea, in particular, with immunotherapy can lead to severe colitis, which can be life-threatening and require surgical removal of the colon. Patients need to be taught to report side effects promptly, and patients need to be monitored closely for these adverse events, with prompt intervention.

To determine whether zinc supplementation can accelerate the healing of mucositis and dermatitis after radiation therapy (RT).

There were two randomized groups:  the experimental (group A) received 25 mg of zinc three times per day and the control (group B) received the placebo (n = 48).

The principle researcher was blinded. Evaluation and grading of mucositis and dermatitis was performed weekly during treatment andtwo weeks after completion of RT, including the weekends.

• The sample was comprised of 97 patients (86% male, 14% female).
• Mean (standard deviation) age was 50 years (11 years) in group A and 51 years (11 years) in group B.
• Patients had head and neck cancer.
• The daily fraction was 180 t–200 cGy in five weekly fractions. Interruption was greater than three days.
• Of the patients, 59% were receiving concurrent chemotherapy.

Chi-Mei Foundation Medical Center Tainan, Taiwan, China

The study was a randomized, double-blind, placebo-controlled trial.

Radiation Therapy Oncology Group (RTOG) scores for dermatitis

• Group A had less interruption, and more patients completed treatment. Zinc supplementation use did not show much benefit in the patients who received concurrent chemotherapy.
• Survival curve analysis showed that grade 2 (p = 0.014) and grade 3 (p = 0.0092) dermatitis was less prevalent and occurred later in patients receiving zinc supplementation.
• No significant difference was found in the two weeks following treatment completion and resolution of dermatitis.

Oral zinc supplementation may delay the onset and reduce the severity of radiodermatitis.

The treatment design for the timing of the study was standard practice; it is not certain if one could correlate the study information to modern treatment delivery.

Zinc – 25 mg  versus placebo, 3x/day for 2 months

Patients started capsules on first day of RT and continued until completion of RT.

Block randomization

The study was comprised of 100 patients, 50 zinc, 50 placebo, with a mean age of 50–51 years.

RT dose 180–200 cGy daily in five weekly fractions

41-42% patients receiving RT + chemo
 

Jan 2003 – Aug 2004

Double-blind, randomized, placebo-controlled study

RTOG acute morbidity scoring

Serum zinc levels were higher in the zinc group: 20.5 versus –1.5 (p = 0.02).

Grade 2 mucositis appeared earlier in the placebo group (p = 0.017 and larger proportion of patients).

Grade 3 mucositis also earlier and larger proportion of patients, p = 0.0003.

Results not as significant for patients receiving concurrent chemo.
 

Oral analgesics prescribed for pain.
 

Recommend continuing treatment out past end of RT as patients in both groups had similar recoveries.

Need to determine optimal dose.

To identify patients in high-anxiety states and to test the effects of a music intervention

Cancer and its treatment provoke a series of changes in the emotional sphere of patient anxiety. In addition, there is a subgroup of patients who are in a high-anxiety state. These patients, when identified, obtain the most benefits from music or verbal relaxation. This study consisted of 98 patients in three groups: the music therapy group, which received 60-minute, single-music sessions; the verbal relaxation group, which received 30 minutes of guided relaxation; and the control group, which received usual care. Because patients were asked to rate their anxiety preintervention, the study also was able to test the intervention's effects on those in high-anxiety states.

• N = 98
• AVERAGE AGE = 53 years
• MALES: 34%, FEMALES: 66%
• KEY DISEASE CHARACTERISTICS: Primarily patients' first chemotherapy session
• OTHER KEY SAMPLE CHARACTERISTICS: Participants who were married were more prevalent. Breast cancer was more prevalent than lung or other cancers. Cancers were in stages 2 and 3. Elementary-level education was the most prevalent educational status.  

• SITE: Single-site  
• SETTING TYPE: Outpatient  
• LOCATION: Outpatient clinic, University Medical Center, Taiwan

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

Randomized, controlled trial

• Spielberger State-Trait Anxiety Instrument (STAI)
• Emotional Visual Analog Scale (VAS)  
• Three biobehavioral indicators, skin temperature, heart rate, and consciousness level, were measured before and after chemotherapy.

All groups experienced a significant decline in anxiety. The music intervention group experienced a greater decrease in poststate anxiety (p = .005). Physiologic indicators also changed in patients with high-anxiety states in the music therapy group. This study highlighted the need to target patients in high-anxiety states and to offer additional support, relaxation, and interventions such as music therapy to this population.

Music intervention and relaxation therapy reduces chemotherapy-induced anxiety.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)  
• Risk of bias (sample characteristics)
• Selective outcomes reporting
• Key sample group differences that could influence results
• Other limitations: This study is difficult to reproduce as it requires one-on-one staff time. Relaxation and music during chemotherapy often is interrupted. Baseline anxiety was lower in the music intervention group.

This study highlighted the need to identify patients in high-anxiety states pretreatment. This population can then be offered additional interventions. Music and relaxation can reduce anxiety during chemotherapy. Most infusion centers offer personal music devices or allow patients to bring their own. Music can be offered via headphones if a patient desires. This intervention can be recommended safely.

To study the effect of step-therapy policy requiring an older 5-HT₃ receptor antagonist (RA) prior to palonosetron on the risk of chemotherapy-induced nausea and vomiting (CINV) associated with hospital or emergency department (ED) admissions

Patients with a diagnosis of breast or lung cancer and receiving moderately emetogenic chemotherapy (MEC) (cyclophosphamide, carboplatin) or highly emetogenic chemotherapy (HEC) (cisplatin) were selected from the PharmMetrics claims dataset (providing drug name, quantity dispensed, and length of supply) between January 2005 and June 2008. CINV events were followed for six months from initial chemotherapy administration through ICD-9-CM codes. Study duration was six months from the index chemotherapy date, and antiemetics investigated included dolasetron, granisetron, ondansetron, and palonosetron. Patients were divided into two groups: those initiated with palonosetron and maintained on the drug for the duration of the study and those who began therapy with one of the older 5-HT₃ RAs and maintained on the initial drug or alternated between any 5-HT₃ RAs. The use of dexamethasone was assessed for both groups. CINV events were calculated using paid and filed claims with ICD-9 codes for nausea, vomiting, or dehydration, and those with hospital admissions were selected.

• This study reported on 9,257 patients.
• Ages ranged from 53.7–65.03 years.
• The sample was 33.6% male and 66.4% female.
• Patients had been diagnosed with breast or lung cancer.
• Patients were chosen based on having at least six months of records available prior to the study index date; no prior history of vomiting, nausea, or dehydration during the six months preceding the index chemotherapy; and a follow-up period of at least six months after the first date of the first chemotherapy treatment cycle.

The study was conducted in multiple settings in the United States. Specific sites were not reported.

All patients were in active antitumor treatment.

This was a longitudinal, retrospective cohort study.

• Severity of patient conditions identified through comorbidities were summarized using an aggregate measure, the Charlson Comorbidity Index (CCI).
• CINV events associated with hospital/ED admissions were selected.
• Investigators calculated treatment days with CINV events.

Patients with breast or lung cancer receiving MEC who were initiated and maintained on palonosetron were at significantly lower risk for potentially costly CINV versus those on older 5-HT₃ RAs. More studies indicating the impact of step-therapy policy are necessary.

• A risk of bias exists because of the sample characteristics.
• The authors used selective outcomes reporting.
• Findings may not be generalizable to other populations.
• CINV events were based on pharmacy claims and not actual CINV experiences.
• The majority of these patients had health insurance and, thus, could take palonosetron, which is more expensive. People of low economic status may be unable to obtain coverage for this expensive drug.
• Additional important variables that could affect patients’ CINV experiences are not found in claims data. These include race, alcohol consumption, cancer staging, and history of motion sickness. The claims dataset used in this study was mainly employer-based. Because the sample had one cohort of breast cancer, more than two-thirds of patients were female, and female patients experience more CINV than males.

Patients with breast or lung cancer undergoing MEC or HEC who are initiated and maintained on palonosetron experience fewer CINV events compared to patients receiving older 5-HT₃ RAs. Nurses should be aware that palonosetron is more expensive than older 5-HT₃ RAs, and, thus, patients with low economic status or who are self-insured may not be able to pay for this drug. The reduced antiemetic claims noted here suggest that cost may be equivalent because palonosetron requires fewer doses.

To assess the effectiveness of inhaled ginger essential oil in reducing the incidence of chemotherapy-induced nausea and vomiting (CINV) in patients with breast cancer as a complementary intervention to standard antiemetic care, and to assess the patients’ quality of life (QOL) related to their health following aromatherapy

An aromatherapy necklace was worn by the participants for five days, 24 hours/day, after receiving highly emetogenic chemotherapy. It was used for patients to inhale at least three times a day. Patients were assigned to two groups: For course 1, Group 1 had a ginger fragrance oil (placebo) in the necklace while Group 2 had ginger essential oil. For course 2, Group 1 had the ginger essential oil while Group 2 used the fragrance oil. Standard antiemetics were also given prior to chemotherapy—IV granisetron and IV dexamethasone in addition to scheduled take-home medications of oral granisetron, oral dexamethasone, and oral metoclopramide. Data were collected at baseline, on days 1–5, and on day 8.

• N = 600   
• AGE RANGE = 20–79 years
• MEAN AGE = 47 years
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy
• KEY DISEASE CHARACTERISTICS: Breast cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Received an anthracycline and cyclophosphamide

• SITE: Multi-site   
• SETTING TYPE: Outpatient    
• LOCATION: Malaysia

• PHASE OF CARE: Active antitumor treatment

• Single-blind, randomized, controlled, cross-over study

• 100 mm visual analog scale (VAS) in a diary card
• European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

The use of ginger essential oil inhalation significantly lowered the VAS nausea score during the acute phase (p = 0.04) compared to the placebo, but its effect was not sustained over time. No appreciable effect on vomiting was revealed. Inhaled ginger essential oil positively affected the global health status from baseline.

Inhaled ginger essential oil did not demonstrate significant reductions in CINV and may not be effective as complementary therapy for CINV overall. It may be a useful adjunct for nausea symptoms.

• Baseline sample/group differences of import

No evidence suggested that the use of inhaled ginger essential oil is effective in improving CINV control, but it may be helpful in improving QOL during treatment. Further research is warranted as nausea control continues to be a challenge.

To compare the efficacy of dioctahedral smectite and iodine glycerin (DSIG) cream to a topical mouth rinse in the treatment of chemotherapy-induced oral mucositis

After oral mucositis (OM) developed, patients were randomized to receive DSIG or a topical rinse solution administered by two nurses. Nurses were not blinded to the intervention. The DSIG cream consisted of 3 g of dioctahedral smectite and 10 ml of iodine glycerin. The cream was applied to oral mucosa four times per day for one hour during each application while the patient was fasting. The topical mouth solution consisted of saline 400 ml, gentamicin 640,000 u, and vitamin B12 500 mg. Patients rinsed with the solution four times per day and gargled the solution for one minute with each application. Both treatments were administered for five consecutive days. Data were collected daily once OM was identified and continued for five days.

• N = 130  
• AVERAGE AGE = < 53 years (46.9%), ≥ 53 years (53.1%)
• MALES: 72.3%, FEMALES: 27.7%
• KEY DISEASE CHARACTERISTICS: Multiple types of cancer

• SITE: Single-site    
• SETTING TYPE: Not specified    
• LOCATION: China

• PHASE OF CARE: Active antitumor treatment

Randomized, controlled trial

• Oral Assessment Guide (OAG)

Both groups of patients had OM of similar severity on day 1 of the study. Over the five days of the study, when compared to a topical rinse solution, DSIG improved the severity of OM. Patients who received DSIG healed faster than those who received the topical rinse. DSIG is a promising treatment for chemotherapy-induced OM, and additional studies to compare DSIG to other available OM treatments and to study the efficacy of DSIG over a longer period of time are needed. Studies also are needed to determine whether DSIG has a role in the prevention of chemotherapy-induced OM.

• Risk of bias (no blinding)

DSIG may be a useful intervention for patients who already developed chemotherapy-induced OM. Patients who received the DSIG treatment had less severe OM than those who received a topical rinse solution, and they had a faster rate of healing and more thorough healing. Nurses can conduct physical assessments of patients to determine the extent to which OM is present and educate patients about the various options for OM treatment.

To examine the differences between caregiver quality of life when caring for a patient in a home hospice program and an ambulatory patient receiving formal palliative care program services

Governmentally supported home hospice services provided to patients with advanced cancer by a multidisciplinary team

• N = 258   
• MEDIAN AGE = 41–50 years
• MALES: 33%, FEMALES: 67%
• CURRENT TREATMENT: Other
• KEY DISEASE CHARACTERISTICS: Patients with advanced (stage III/IV) mixed cancer diagnoses and expected to live at least three months 
• OTHER KEY SAMPLE CHARACTERISTICS: Caregivers had to be aged at least 21 years and able to communicate in either Mandarin or English 

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

• PHASE OF CARE: End-of-life care
• APPLICATIONS: Palliative care 

Cross-sectional study with combined data from two studies

• Caregiver Quality of Life Index-Cancer (CQOLC)
• Domain-specific and validated in both ambulatory and hospice care settings

Significant Pearson intercorrelations (rs = 0.18-0.84, ps < 0.05) for CQOLC total scores and subscales excluding positive adaptation and disruptiveness subscales were found. Males had significantly lower total CQOLC scores (p = 0.012) and disruptiveness scores (p = 0.003). Significantly lower CQOLC scores also resulted in caregivers caring for parents (and tertiary education [all values = p < 0.05]). Chinese ethnic caregivers had better QOL related to burden (p = 0.031) and financial concerns (p = 0.024), but less successful positive adaptation resulted in lower QOL (p = 0.024). Although data analysis controlled for significant differences in age and spousal caregiving, ambulatory patient caregivers were older and more likely to be spousal caregivers. Analysis of covariance (ANCOVA) supported home hospice caregivers experiencing better QOL than ambulatory patient caregivers but only in total CQOLC scores (p = 0.008) and subscales of financial worries and burden (p = 0.004).

Home hospice care programs for patients with palliative cancer care needs appear to benefit caregiver QOL, particularly in minimizing perceptions of burden and financial concerns. Those programs, composed of multidisciplinary teams focused on responding to patient end-of-life needs, seem to improve caregiver confidence in care and satisfy caregivers’ desire for personalized support by healthcare providers.

• Risk of bias (no random assignment)
• Unintended interventions or applicable interventions not described that would influence results
• Lack of control on potential study confounding variables; study focus on Chinese caregivers only, so data findings cannot be generalizable.

Models of home hospice services to mutually benefit caregivers and those they care for need further testing in a variety of cultures with variant healthcare systems to more clearly validate the efficiency of and benefits of those models in meeting caregiver improved QOL.