RESOURCE TYPE: Expert opinion

PHASE OF CARE: Active antitumor treatment

N/A

Expert opinion level evidence only

Patients receiving immunotherapy need to be monitored for immune-related adverse events, and quickly managed appropriately to prevent more severe complications. In addition, nurses should be aware of potential side effects of systemic steroid therapy if initiated.

The study compared a complementary and alternative medicine (CAM) group intervention to a standard psychosocial support group.

The 12-week standard psychosocial support group meeting was offered weekly. A trained clinical psychologist taught cognitive behavioral therapy using group sharing and supportive therapies. Topics included coping with real-life issues, communication, body image, sexuality, grief, anger, anxiety management, and problem solving.

The 12-week CAM group meeting was offered twice a week. This group was taught meditation, affirmation, imagery, and ritual. Each session was two and one-half hours. The Tuesday session was a one-hour, RN-run, health-series discussion group, with topics including nutrition, exercise, menopause, lymphedema, pain management, sexuality, and others as requested by the group. The next 90 minutes were spent in six yoga classes and six dance therapy sessions. The Thursday session was one hour of experiential work using silent meditation, guided imagery, and writing and drawing exercises. The final 90 minutes was devoted to a discussion group led by a licensed clinical social worker exploring themes of experiential work as well as general support by the group. Topics included relationship with cancer, views of healing, sexuality, body image, death and dying, compassion, anger, forgiveness, and healing.

• The sample was comprised of 181 women with breast cancer within 18 months of initial diagnosis or who had been diagnosed with metastatic breast cancer.
• The CAM group had 93 participants; the standard support group had 88 participants.
• Twenty-seven were randomized to groups but never showed up for either group (6 in CAM group, 21 in standard support group).

A randomized controlled trial design was used.

• Functional Assessment of Chronic Illness Therapy (FACIT): Quality of life
• FACIT-Sp: Spiritual Well-being Scale
• Profile of Mood States (POMS)
• Principles of Living Survey: Spiritual well-being

• The CAM group showed significant decrease in distress as measured by POMS.
• Both groups showed significant decreases on the POMS anxiety subscales.
• Both groups were essentially equal in producing significant amount of change in anxiety over time.

• In this community, women choosing to participate in the study did so because they were willing or hoping to get into the CAM program: 7 dropped out from the CAM group compared to 17 dropouts from the standard support group.
• Specialized training was required to facilitate groups teaching cognitive behavioral education.
• Both groups had high effect size, without sufficient power to detect possible differences between groups on POMS measure.
• Which CAM intervention of the many offered helped with anxiety was unable to be ascertained.

To evaluate the effects of Kinesiology^® taping (KT) on upper extremity lymphedema and manual dexterity

Patients were randomized to one of three groups, (1) KT, pneumatic compression, and manual lymphatic drainage (MLD), (2) quasi-KT, pneumatic compression, and MLD, or (3) standard pneumatic compression, MLD, and multilayered bandaging. The groups received treatment once per day, three times per week, for four weeks. The same provider administered all sessions of MLD. KT was worn for four days.

• N = 82
• AVERAGE AGE = 61.9 years
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Unilateral lymphedema of upper limb for at least one year after radical mastectomy surgery and stage 2 or 3 edema
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusion criteria included patients who received chemotherapy or radiotherapy and hormone therapy within the past six months, hypertension, diabetes, atherosclerosis, scleroderma, psoriasis, collagenosis, rheumatoid arthritis, parasitosis, advanced heart failure, swelling from renal or hepatic disorders, dermatitis, steroid or diuretic use, active venous thrombosis, allergic reactions to compression garments, and primary lymphedema or other cancers.

• SITE: Single site    
• SETTING TYPE: Outpatient    
• LOCATION: Rehabilitation Center ProVita in Zory

• PHASE OF CARE: Late effects and survivorship

Randomized, placebo-controlled, single-blinded study

• Perometer 400 T
• Goniometric device from Technomex
• Hercules dynamometer
• Nonparametric matched pair Wilcoxon test
• Spearman correlation analysis

A statistically significant decrease in limb volume occurred in comparison to initial size in all comparison groups (p < 0.001). However, a significant advantage was seen in group 3 treated with standard pneumatic compression, MLD, and multilayered bandaging. Shoulder range of motion was initially similar and statistically significance in all groups.

More research on when KT may be effective is needed. KT was not shown to be an effective intervention to reduce limb volume in patients with breast cancer.

• Small sample (< 100)
• Other limitations/explanation: Limited follow-up; quality of life evaluation would be helpful

KT is effective in increasing joint mobility, but it should not be used as a replacement for standard multilayered bandaging in the treatment of lymphedema. This study's participants had more extensive surgery than standard of care in the United States. Additional research to identify application with less swelling is needed.

PHASE OF CARE: Multiple phases of care

Intervention types that were included in the meta-analysis were educational, psychological support, cognitive behavioral therapy, relaxation training, music therapy, coping skills training, and communication skills training. The majority of studies incorporated two or more interventions together. Fifteen studies showed overall significant effects on anxiety (d = -8.71, p < .001). The combination of education and psychological support (d = -8.17, p = .04) or education combined with relaxation training (d = -12.95, p < .001) were effective in reducing anxiety. Large combined effects were seen on depression (d = -8.12, p < .001). No analysis of effects for specific intervention types was possible. In greater than 69% of studies, the interventions were performed by nurses.

The findings of this study support the effectiveness of psychoeducational interventions to reduce anxiety and depression in patients with cancer in China.

The studies included in this analysis had numerous flaws. The meta-analysis was primarily done across all types of interventions. Because most of the studies used combined interventions, the effectiveness of individual components could not be determined. The authors noted that the trials were carried out in Chinese regions where almost no negative studies are reported, so publication bias cannot be ruled out.

The findings of these studies support the effectiveness of psychoeducational interventions for anxiety and depression in patients with cancer. Although these findings were only in Chinese patients, they are in agreement with the bulk of overall evidence in this area. These results suggest that psychoeducational interventions are likely to have similar levels of effectiveness in various cultural groups.

To evaluate the efficacy and safety of olanzapine compared with 5-hydroxtryptamine3 (5-HT₃) receptor antagonists for the prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) in patients receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) and to evaluate the impact of olanzapine on quality of life (QOL) of those receiving chemotherapy

Patients were randomized into the test group or the control group. On day 1, the test group received 10 mg oral olanzapine, 10 mg IV azasetron, and 10 mg IV dexamethasone; the control group received 10 mg IV azasetron and 10 mg IV dexamethasone. On days 2–5, the test group received 10 mg oral olanzapine and the control group received 10 mg IV dexamethasone. Patients were permitted to take other antiemetic therapy for nausea or emesis based on clinical circumstances. Assessments occurred on days 1–5 post-treatment, and QOL was measure on day 6.

• The study consisted of 229 participants.
• Men in the test group had a mean age of 54 ± 9.23; women in the test group had a mean age of 48.25 ± 12.7. Men in the control group had a mean age of 54.5 ± 10.33; women in the control group had a mean age of 49.58 ± 12.12.
• The test group was 40.5% female and 59.5% male. The control group was 40% was female and 60% male.
• Cancer diagnoses were breast (24%), lung (23%), colorectal (13%), lymphoma (10%), stomach (9%), esophageal (5%), ovarian (5%), teratoma (2%), thymus (2%), cervical (1%), gingival (1%), glioblastoma (1%), laryngeal (1%), malignant melanoma (1%), and oropharyngeal (1%),
• Chemotherapy agents were cisplatin (44%), oxaliplatin (23%), epirubicin (18%), adriamycin (8%), carboplatin (6%), and dacarbazine (1%).

The setting was not identified.

All patients were in active treatment.

This was a randomized controlled trial.

• The Common Terminology Criteria for Adverse Events, version 3 (CTAE v.3) observation table was used to grade CINV.
• The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) was used to evaluate quality of life.

• No significant difference was noted between both groups for complete response (CR) for acute periods with HEC or MEC.
• Respective improvement in CR occurred in the test group for delayed nausea and vomiting with HEC (39%) and MEC (25%). The whole period of nausea improved 41% with HEC and 27% with MEC (p < 0.05).
• The olanzapine regimen protected more than two-thirds of patients from emesis after receiving HEC and MEC, thus avoiding the use of rescue therapy 2–4 days after chemotherapy.

Olanzapine can improve the CR of delayed nausea and vomiting and QOL in patients receiving HEC and MEC.

• The study was not blinded. The test group received oral medication, which the control group did not receive.
• Other antiemetic therapies were used as needed and not monitored or factored into the analysis.
• Validity and reliability of the measurement tools was not included.
• Drug safety and toxicity were not defined or monitored.
• Reporting of statistical results was unclear; the authors reported two values with each measurement (e.g., \"complete response for delayed nausea and vomiting in patients with HEC improved 39%, 22%\") without explanation of what these two measurements correspond to.
• Discrepeancies were reported with the QOL measurements.

Olanzapine may be effective in preventing delayed CINV in patients receiving HEC or MEC, but results should be used cautiously because of poor statistical evaluation and reporting.

To evaluate the efficacy and safety profile of pegylated liposomal doxorubicin (PLD) (Doxil^®) at different doses, as well as predictive factors of palmar-plantar erythrodysesthesia (PPE).

The regional cooling mechanism comprised application of ice packs to the wrists and ankles during PLD administration.

• The study reported on a sample of 330 women who received PLD as treatment for recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinomas.
• Median patient age was 60 years.

University of Texas MD Anderson Cancer Center in Houston

This was a retrospective chart review.

National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE); version not specified

• The proportion of patients with PPE was significantly higher among those who used a cooling mechanism compared to those who did not (39% versus 26%, p = 0.0067).
• Median overall survival and median progression-free survival did not differ between patients who received different doses of PLD.

Higher doses and additional cycles of PLD were associated with a higher incidence of adverse reactions, including PPE. Potential predictors of PPE were use of cooling mechanisms, higher numbers of PLD cycles given, occurrence of mucositis, neutropenia, and peripheral neuropathy.

This was a retrospective study only.

To evaluate trazodone for the treatment of insomnia in patients with cancer.

Patients were given trazodone 12.5 to 50 mg orally as needed for insomnia.

• The sample comprised 30 patients (40% male, 60% female).      
• Median age was 62 years (range 37–84).
• Patients had cancer and were experiencing insomnia that had not responded well to standard hypnotics.
• Diagnoses included gynecological, urological, breast, hepatobiliary-pancreatic, lung, colorectal, lymphoma, other cancers. 
• Patients were seeking palliative care consultations.

• Single site  
• University Hospital in Japan

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

The study was an observational, retrospective review.

Chart review looking for requests for additional request for hypnotics within seven days of initiation of the intervention

Of the patients with cancer treated with trazodone, 50% did not request additional hypnotics within seven days. Two of four patients reported improved nightmares.

Low-dose trazodone (12.5–50 mg) may be useful in treating insomnia with and without nightmares in patients with cancer.

• The study had a small sample size, with less than 30 patients.       
• Baseline sample/group differences were of import.
• The study had risks of bias due to no control group, no blinding, no random assignment, and no appropriate attentional control condition.
• Unintended interventions or applicable interventions not described would have influenced the results.
• Measurement/methods were not well described.
• Measurement validity/reliability was questionable.
• Findings were not generalizable.
• This was an observational study only.

Low-dose trazodone may be helpful in treating insomnia and improving nightmares in patients with cancer and insomnia. Further prospective studies are warranted.

STUDY PURPOSE: To determine the effect of prophylactic or preemptive treatment with lamivudine for patients with breast cancer who were hepatitis B surface antigen positive on the following: (a) the rate of hepatitis B virus (HBV) reactivation, which was defined as an increase in HBV DNA levels more than 10 times or an absolute increase of HBV DNA levels that exceeded 1×109 copies/ml; (b) incidence of hepatitis, which was defined as greater than a three times increase in alanine aminotransferase (ALT) that exceeded the upper limit of normal range (ULN) or an absolute increase of ALT of more than 100 u/l; (c) rate of chemotherapy disruption, which was defined as either a premature termination of chemotherapy or a delay of more than eighty days of chemotherapy between cycles; and (d) overall mortality. Secondary outcomes included incidence of HBV-related hepatitis, rate of HBV-related chemotherapy disruption, HBV-related mortality, occurrence of YMDD mutations, and withdrawal hepatitis.

TYPE OF STUDY: Meta-analysis and systematic review

• FINAL NUMBER STUDIES INCLUDED = 6
• TOTAL PATIENTS INCLUDED IN REVIEW = 430
• SAMPLE RANGE ACROSS STUDIES: 43–50 patients (median range)
• KEY SAMPLE CHARACTERISTICS: Patients with breast cancer undergoing systemic chemotherapy who were HBV carriers (HBsAg)

PHASE OF CARE: Active antitumor treatment
 
APPLICATIONS: Elder care

An early preemptive strategy is superior to a therapeutic strategy in decreasing the incidence of HBV reactivation, HBV-related hepatitis, and the rate of chemotherapy disruption in patients with breast cancer.

• Limited search
• High heterogeneity

In this study, 16% of patients who were HBsAg positive undergoing chemotherapy for breast cancer developed overt hepatitis. Using a preemptive strategy of prescribing lamivudine at the commencement of chemotherapy decreased the rate of hepatitis to 2.2%. The authors noted that, as level III evidence, the AASLD (American Association for the Study of Liver Diseases) recommends that HBV carriers receiving cancer chemotherapy or immunosuppressive therapy with a baseline HBV DNA of less than 2,000 iu/ml should start antiviral therapy at the commencement of treatment and continue it for six months after the completion of chemotherapy or immunosuppressive therapy.

To explore the effects of acupressure on fatigue and other symptoms in patients with lung cancer undergoing chemotherapy

Patients were hospitalized for four days. On day 1, a research assistant (RA) taught patients how to self-administer acupressure, and patients received a handbook including an acupoint map and acupressure methods. On days 2–4 and in subsequent hospitalizations for chemotherapy, an RA assisted patients in acupressure and confirmed their accuracy. Three acupoints were used, and the intervention was done once daily every morning for five months. Patients were instructed to do the acupressure at home each day. Patients were randomly assigned to one of three groups by a coin toss; group A received acupressure with essential oils, group B received only acupressure, and group C received sham acupressure using three sham acupoints. Study data were collected one day before starting chemotherapy, on day 1 of the third chemotherapy cycle, and on day 1 of the sixth chemotherapy cycle. Data were collected 30 minutes after the acupressure intervention.

• N = 45  
• MEAN AGE = 58.3 years
• MALES: 57.9%, FEMALES: 42.1%
• KEY DISEASE CHARACTERISTICS: All had lung cancer, the majority were stage IV
• OTHER KEY SAMPLE CHARACTERISTICS: Education level was varied with most patients having a sixth grade or less education. 70%–80% were married.

• SITE: Single-site    
• SETTING TYPE: Multiple settings    
• LOCATION: Taiwan

• PHASE OF CARE: Active antitumor treatment

Three-group, sham controlled, randomized trial

• Tang Fatigue Rating Scale 
• Eastern Cooperative Oncology Group (ECOG) Performance Status rating
• Hospital Anxiety and Depression (HADS) scale 
• Pittsburgh Sleep Quality Index

Adherence rates to acupressure varied significantly across groups – for group A, 93%, group B, 91.9%, and group C, 77.3%. Only subscale scores for fatigue in daily activity were lower for the two acupressure groups on day 1 of the third chemotherapy cycle. There were no other significant differences between groups for fatigue. There were no significant differences between groups in anxiety or depression scores. Sleep scores were lower for group A at one time point and group B at another time point compared to the sham control group (p < .05). However, these differences were not consistent across all study time points, and there were no other differences between groups in sleep results.

Potential benefits of acupressure for fatigue and sleep disturbance among patients receiving chemotherapy for lung cancer are not clear in this study. Differences in patient outcomes were not consistent across study time points according to the study group. No effect was demonstrated on anxiety or depression scores.

• Small sample (< 100)
• Risk of bias (no blinding)
• Key sample group differences that could influence results
• Subject withdrawals ≥ 10%
• Other limitations/explanation: The sham control group was significantly older than the other study groups. 21% were lost to follow-up for various reasons; no ITT analysis was described. Data were collected only 30 minutes immediately after acupressure when the patient was in the hospital, so response duration is not known. Repeated use of the same tools may have resulted in testing effect. Adherence was much lower in the control group, so actual group differences due to acupressure cannot be determined.

This study does not provide strong evidence in support of the effectiveness of acupressure for management of fatigue, sleep disturbance, anxiety, or depression. The study did show that self-administration of acupressure was feasible and had no associated adverse effects in patients with advanced lung cancer. This is a low-risk, low-cost intervention that some patients may be interested in using.

To determine the effect of a home-based walking exercise program on the sleep quality and quality of life (QOL) of cancer patients and to determine if enhanced sleep quality was associated with improvement in QOL over time.

Patients were recruited from oncology outpatient clinics in two university-based medical centers and were allocated to either usual care (n = 35) or a home-based walking exercise intervention for eight weeks (n = 36). The exercise intervention involved brisk walking for 30 minutes three times per week in the evening before supper, with a five-minute warm-up and five-minute cool-down. Questionnaires were delivered in interview format.

• The sample was comprised of 71 patients (24% male, 76% female).
• Mean age was 51.80 years (standard deviation = 12.13 years).
• Cancer sites included breast (n = 39), gastrointestinal (n = 11), nasopharyngeal (n = 7), lung (n = 4), and other (n = 10).
• Of the patients, 74% were married, 32% were working, and 30% were receiving cancer treatment.
• Mean time since diagnosis was 3.84 years.

• Multisite
• Outpatient
• Hospital in Taipei, Taiwan

Patients were undergoing the active treatment phase of care.

The study was a randomized, controlled trial.

• Pittsburgh Sleep Quality Index (PSQI), Taiwanese version
• Medical Outcomes Study Short Form-36 (MOS-SF), Taiwanese version
• Borg rating of perceived exertion (RPE) scale     
• Walking exercise log

Patients in the exercise group reported significant improvements in sleep quality (p < 0.01) at one and two months, and the mental health dimension of QOL; no change was reported in the control group. Physical components of QOL were also improved in the exercise group (p < 0.0001). Among patients who exercised, enhanced sleep quality also corresponded with reduced bodily pain and improvements over time in the mental health dimension of QOL.

A home-based walking exercise program can be easily incorporated into care for cancer patients who are suffering from sleep disturbances and may benefit sleep quality and aspects of QOL.

• The study had a small sample size, with less than 100 patients.
• Confounders of sleep (environment, light exposure, and social factors) were not controlled.
• Only subjective sleep data were collected.
• The objective measure of physical activity was not collected, and additional physical activity, apart from the walking intervention, was not measured.
• The short follow-up did not provide information about whether patients continued adherence to the walking program, and the benefits.  

A home-based exercise program appears promising for improving sleep quality and QOL for cancer patients that can easily be incorporated into care, but further study is warranted with more objective measures and measurement of potential confounding variables.