To determine whether cranial electrical stimulation (CES) is feasible for symptom management in patients with breast cancer receiving chemotherapy and to examine the outcomes for reducing the symptoms of fatigue, depression, anxiety, pain, and sleep disturbances in these patients.

Symptom reports (on fatigue, depression, anxiety, pain, and sleep disturbances) were collected at baseline by a research associate and then weekly using an interactive voice response (IVR) phone system. Patients were trained on the use of the CES devices and were able to use them at a setting of 100 ​µA for up to sixty minutes per day. They began using the devices on the first day of their chemotherapy infusions. Patients receiving chemotherapy every two weeks used the CES device for a total of six weeks; those receiving chemotherapy every three weeks used them for a total of eight weeks. A follow-up interview was held after patients finished the protocol.

• The study included 34 women aged 18 years and older (mean = 48.3 years [standard deviation (SD) = 7.9 years]).
• All patients had breast cancer and were receiving chemotherapy.

Multisite

 Patients were undergoing the active treatment phase of care.

This was a prospective, double-blind, three-group, randomized, longitudinal pilot feasibility study.

• Hospital Anxiety and Depression Scale (HADS)
• Brief Pain Inventory (BPI)–short form
• Brief Fatigue Inventory (BFI)
• General Sleep Disturbance Scale (GSDS)
   

Positive correlations existed between all symptoms, except pain and anxiety. Pain and fatigue symptoms were highly correlated with C-reactive protein. 

CES appears to be a safe intervention during chemotherapy. This study showed that CES was a feasible and safe intervention during chemotherapy. It also showed positive correlations between several symptom management variables, but larger studies are needed to determine whether CES is effective for symptom management. 

• Some data were missing due to the ineffectiveness of the IVR system. 
• The study did not describe significant findings about this intervention on pain management in patients with cancer and would not be particularly valuable for the ONS Pain PEP project.
• The study had a small sample size, with less than 100 patients.
• No analysis of outcomes between groups was performed.

The study examined several symptoms seen in patients with breast cancer. Larger studies are needed to examine whether CES has a true effect on pain symptoms in patients with breast cancer.

To examine the effects of cranial stimulation on symptoms

Women were randomly assigned to receive actual or sham cranial stimulation. The device passed biphasic electrical stimulation via ear lobe electrodes. The active device was preset to deliver maximum stimulation at 0.5 Hz and 100 µA, the lowest setting below the level of perception. The sham device was identical but did not transmit a current. Patients were instructed to use the device daily for one hour during chemotherapy treatment and for two weeks after treatment cessation. Symptom data were collected weekly, and patients completed logs to record stimulator use.

• N = 163
• MEAN AGE = 51 years (SD = 0.78 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All participants had breast cancer, and 88.3% had stage 2 disease.
• OTHER KEY SAMPLE CHARACTERISTICS: In total, 61.7% were Caucasian, and 82% had more than a high school education.

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

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care

Double-blinded, randomized, sham-controlled trial

• Hospital Anxiety and Depression Scale (HADS)
• Brief Pain Inventory (BPI)
• Brief Fatigue Inventory (BFI) 
• General Sleep Disturbance Scale (GSDS)

There were no statistically significant differences in levels of depression, anxiety, pain, fatigue, or sleep at any time point during the study. Symptom levels were low. Anxiety was highest at baseline and decreased over time. Depression and fatigue increased over time.

This study did not demonstrate any benefit of microcurrent cranial stimulation in the management of pain, anxiety, depression, fatigue, or sleep disturbance among women receiving chemotherapy for breast cancer.

• The patients had low symptom severity, which may have caused the lack of significant changes.
• Adherence to the intervention was measured by patient self-reports.

Cranial stimulation did not benefit symptom management in this study.

To test the feasibility, acceptability, and impact of family-centered advanced care planning for adolescents with cancer

Adolescent/family dyads were randomized to intervention and control study arms. All participants received a baseline assessment and were provided with an advanced care planning educational brochure. Those in the intervention group had five sessions of assessments and interviews and three weekly sessions with a trained or certified facilitator to explore values and beliefs, have conversations, share decision making processes about palliative care and goals, and express fears, values, beliefs, and goals about death and dying. Study measures were obtained at baseline and at three months.

• N = 30 patient/family dyads
• MEAN PATIENT AGE = 16 years (range = 14–20 years)
• MALES: 71%, FEMALES: 29%
• KEY DISEASE CHARACTERISTICS: Leukemia, lymphoma, brain tumors, and other solid tumors; most were receiving cure-directed treatments; those with significant depression were excluded
• OTHER KEY SAMPLE CHARACTERISTICS: 82% were in high school; 12% of families were at or below the federal poverty level; 41% were African American

• SITE: Single site  
• SETTING TYPE: Multiple settings  
• LOCATION: Washington, DC

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

Randomized, controlled trial

• Satisfaction questionnaire
• Beck Anxiety Inventory (BAI)
• Beck Depression Inventory (BDI)
• Pediatric Quality of Life Inventory (PQLI)
• Spiritual Well-Being Scale of the Functional Assessment of Cancer Therapy (FACT) scale

Anxiety declined in all adolescents over time. Among families, anxiety declined in those in the control group but increased in families in the intervention group. Baseline depression was significantly lower in the intervention group and increased over time. There were no significant differences between groups from the group and time analysis. There were no significant differences between groups in quality of life results. There were no other differences based on group assignment.

The family-centered advance care planning intervention tested here did not demonstrate any benefits for patients or families in regard to anxiety, depression, or quality of life.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no appropriate attentional control condition)
• Questionable protocol fidelity
• Other limitations/explanation: No method to evaluate intervention fidelity was mentioned. There were significant differences between the groups in baseline anxiety and depression scores.

Advance care planning is an important component of care for patients with cancer and their families. However, it might not reduce the emotional effects of the cancer trajectory. This study had numerous limitations and did not find benefit in terms of reducing anxiety or depression. Additional well-designed studies are needed to confirm the findings shown here.

TYPES OF PATIENTS ADDRESSED: Sample not described

PROCESS OF DEVELOPMENT: Study utilized previous Cochrane Systematic reviews along with current references to a United Kingdom national consensus on standards of practice for people at-risk for, or who have, lymphedema (LE)

Evidence weighed using the following classification:

• A = Clear research evidence
• B = Limited supporting research evidence
• C = Experienced common sense judgment.

Recommended for Practice

Complete decongestive therapy

• Patients with LE should receive a coordinated package of care appropriate to their needs (B).

Compression bandaging

• Multilayer inelastic lymphedema bandaging (B)
• Compression garments (C)

Management of infection: Cellulitis/erysipelas

• Criteria for hospitalization
  • Signs of septicemia (e.g., high fever, hypotension, tachycardia, confusion, vomiting).
  • Continuing or deteriorating systemic signs with or without deteriorating local signs after 48 hours of antibiotic therapy.
  • Unresolved or deteriorating local signs with or without systemic signs after first- and second-line oral antibiotics.
  • Close medical follow-up

Exclude other causes of systemic infection, DVT, or dermatologic conditions such as eczema and contact dermatitis.

• Before starting antibiotics
  • Swab any exudates, if present
  • Mark extent of rash and date edge
  • Note any painful or swollen regional lymph nodes
  • Obtain labs for ESR, CRP, WBC, and blood cultures.

Begin antibiotics as soon as possible (recommended for practice).

During bed rest, elevate limb, administer appropriate analgesia, and increase fluid intake.

Avoid simple lymphatic drainage (SLD) and manual lymphatic drainage (MLD). If tolerated, continue compression at a reduced level or switch from compression garments to MLLB.

Avoid long periods without compression.

Likely to be Effective

Manual lymphatic drainage (C)

Prevention of infection: skin care

• Good skin care regimens should be implemented by patients and caregivers in the management of LE (B).
• Use neutral pH soaps to avoid drying.
• Apply emollients. 
• Keep skin folds clean and dry.
• Inspect skin for cuts, scrapes, abrasions, and insect bites.
• Avoid scented products.

Benefits Balanced With Harm

Exercise

• Exercise/movement/elevation (C)
• Breathing exercises (C) 

Prophylactic antibiotics: prevention of infection 

• Patients are advised to travel with a two-week supply of antibiotics if they have a history of lymphedema. 

Effectiveness not Established

Intermittent pneumatic compression (C)

Simple lymphatic drainage (SLD)

Surgery (limited evidence, carefully selected patients may benefit, more research needed)

• Surgical reduction
• Bypass of lymphatic obstruction
• Liposuction/lipectomy

Expert Opinion

Patient education 

• People at risk of lymphedema should be identified early during routine assessment, monitored, and taught self-care (C).
• Patients and caregivers should be offered information about LE and its management.
  • Take good care of skin and nails.
  • Maintain optimal body weight (B).
  • Eat a balanced diet.
  • Avoid tight clothing, watches, and jewelry.
  • Avoid extremes in temperature.
  • Use sunscreen and insect repellent.
  • Wear compression garments if prescribed.
  • Undertake exercise and diaphragmatic breathing exercises.
  • Wear comfortable, supportive shoes.
• Risk factors for upper extremity lymphedema 
  • Surgery of breast with axillary node dissection
  • Scar formation, radiodermatitis from postoperative radiotherapy
  • Radiotherapy to breast
  • Drainage or wound complications
  • Cording or seroma formation
  • Obesity
  • Congenital predisposition
  • Trauma to affected extremity (venipuncture, injection, BP)
  • Taxane chemotherapy
  • Insertion of a pacemaker
  • AV fistula for dialysis
  • Living in or visiting a lymphatic filariasis endemic area
• Risk factors for lower extremity lymphedema
  • Inguinal node dissection
  • Postoperative pelvic radiotherapy
  • Recurrent soft-tissue infection
  • Obesity
  • Vein stripping or vein harvesting
  • Genetic predisposition
  • Intrapelvic or intra-abdominal tumor
  • Thrombophlebitis
  • Poor nutritional status
  • Chronic skin disorders or inflammation
  • Any unresolved asymmetric edema
  • Concurrent illness
  • Immobilization or prolonged limb dependency
  • Living in or visiting a lymphatic filariasis endemic area

Measurement

• Accurate assessment including staging (C)
  • Measurement  of LE
  • Assessment of skin
  • Assessment of vascular integrity
• Patients with LE should receive psychological screening to identify those who require help to cope with the condition and those who require specialist intervention (C).

The purpose of the study was to evaluate colony-stimulating factors (CSFs) administered prophylactically, before the onset of neutropenia or fever, compared with concurrent placebo or untreated controls not allowing any dose escalation.

MEDLINE, EMBASE, and Cochrane Library databases were searched, and hand searches of references from published reports were conducted.

Eight randomized, controlled trials (RCTs), including 1,144 patients receiving chemotherapy for solid tumors (n = 753) or malignant lymphomas (n = 391); studies of patients who were receiving high-dose therapy that required stem cell or bone marrow transplantation (BMT) support or who were being treated for acute or chronic leukemia were excluded.

The overall mean risk of febrile neutropenia was 51% among patients not receiving CSFs, and the overall mean risk of febrile neutropenia was 32% among patients receiving CSFs.

CSFs significantly reduced:

• Febrile neutropenia by 37%
• Documented infections by 6%
• Chemotherapy dose reduction or treatment delay by 20%.

CSFs increased the risk of:

• Bone pain by 15%.

CSFs did not improve infection-related mortality.

The authors concluded that CSFs are effective in reducing the risk of febrile neutropenia, documented infections, and chemotherapy dose reductions or delays, but they increase the risk of bone pain. CSFs had no impact on infection-related mortality.

To determine whether prophylactic treatment with the antidepressant citalopram hydrobromide can prevent major depression in patients undergoing treatment for head and neck cancer

The intervention consisted of 40 mg citalopram hydrobromide (a selective serotonin reuptake inhibitor). Medication began with 20 mg/day for week 1 and increased to 40 mg/day until week 12; after week 12, the dosage decreased to 20 mg/day for one week and then the drug therapy was stopped. Data were collected at baseline and at weeks 4, 8, 12, and 16 as well as at any time during the study.

• A total of 23 patients participated in the study (13 in the intervention group and 10 in the control group).
• Mean patient age was 61 years. The age range was 43–81 years.
• Eleven patients were female, and 12 were male.
• Patients were diagnosed with head and neck cancer only, mostly stage III or IV.
• No group differences existed in patients' age or sex, in tumor grade or type, in location of cancer, or in the number of treatment modalities.
• Patients began cancer treatment (surgery and/or radiation with or without chemotherapy) at baseline.

• Single site
• Outpatient
• Nebraska

Active treatment

Prospective, randomized, placebo-controlled trial with double blinding

• Hamilton Rating Scale for Depression (HRSD)
• Psychiatric interview using Mini-International Neuropsychiatric Interview I (MINI) for depression
• University of Washington disease-specific Quality-of-Life Questionnaire (UW-QOL)
• Clinician Global Impression-Severity (CGI-S) scale for global assessment of depression severity

During the 12 weeks of the study, 5 out of 10 taking the placebo and 2 out of 12 taking citalopram met the cutoff criteria for depression (measured by HRSD). However, the difference was statistically insignificant (Fisher exact test, p = 0.17). At the end of the study, of those receiving citalopram 15% were at least mildly ill in terms of global mood state as measured by the CGI-S scale; 60% of those in the control group were at least mildly ill as measured by the same means. Quality of life, measured by the UW-QOL, deteriorated in both groups from baseline to week 16, but less deterioration occurred in the citalopram group (p = 0.14).

Prophylactic treatment with citalopram hydrobromide may decrease the incidence and severity of depression during head and neck cancer therapy.

• The sample size was small, with fewer than 30 participants.
• Because of the small sample size and the inclusion of subjects from only one setting, the external validity and detection of intervention effect may be skewed.
• A priori sample estimation was set at N = 80, and the sample size of this study was much smaller. (Personnel factors led to early conclusion of the study.) As a result, researchers were unable to draw meaningful conclusions.

The risk of major depressive disorder can be very high in patients with head and neck cancer who are undergoing active treatment. Prevention of depression may be an attainable goal, although more research in this area is needed.

To determine whether prophylactic use of the antidepressant escitalopram oxalate would decrease the incidence of depression in patients receiving primary therapy for head and neck cancer

Patients were randomized and stratified by sex, site, stage (early vs. advanced), and the primary means of treatment (radiation or surgery). During the study, patients received either escitalopram or placebo. This was dosed at one tablet (10 mg if escitalopram) and increased by one tablet during the second week. This was the study dose until week 16. At this point, all patients were “weaned” by 10 mg per week, then “medication” was discontinued. Patients were reassessed at 20, 24, and 28 weeks.

• N = 125 
• MEAN AGE: 63.5 years
• MALES: 118 (79.7%), FEMALES: 30 (20.3%)
• KEY DISEASE CHARACTERISTICS: Newly diagnosed head and neck cancer (newly diagnosed or recurrent stage II–IV epidermoid cancer of head and neck)
• OTHER KEY SAMPLE CHARACTERISTICS: Patient must be willing to participate and must be non-depressed (excluded if cognitively impaired, had advanced cancer or limited life expectancy of less than six months, met diagnostic criteria for mental illness, or undergoing treatment for depression or anxiety).

• SITE: Multi-site  
• SETTING TYPE: Outpatient   
• LOCATION: Nebraska Methodist Cancer Center, University of Nebraska Medical Center

PHASE OF CARE:  Active antitumor treatment

APPLICATIONS: Elder care, palliative care

Randomized, double-blind, placebo-controlled

• Quick Inventory of Depressive Symptomology-Self Rated (QIDS-SR)
• Mini-International Neuropsychiatric Interview (MINI)
• Quick Inventory of Depressive Symptomology-Clinician (QIDS-C)

Prophylactic escitalopram reduced the rate of depression in patients with head and neck cancer undergoing treatment. Rate of depression was 10% with escitalopram and 24.6% among those on placebo (p = .04). The rate of depression was significantly higher in patients receiving radiation as their primary therapy as compared to  surgery. Those patients who received drug reported better overall and health-related quality of life throughout the trial and during three consecutive months following drug cessation. Due to unacceptable side effects of medication, 12.8% withdrew from the study.

Escitalopram used in the setting of head and neck cancer immediately following diagnosis can have a positive effect on depression, possibly preventing depression from occurring. It also positively affects quality of life and ability to cope with cancer treatments, possibly enabling patients to continue with treatments.

Subject withdrawals ≥ 10%

Nurses do not have influence as to what the practitioner prescribes for patients (i.e., escitalopram). However, they can suggest it to practitioners. Some oncology practitioners are reluctant to prescribe anti-depressants, as they feel that this is outside their scope of practice. However, consideration is also generally recommended in professional guidelines. Depression may be underdiagnosed in patients with cancer; nurses can advocate for patients by raising attention to the problem in clinical practice. Initial and ongoing assessments for this patient population is imperative based on the high risk for depression. Results should be reported to the provider so patients who are exhibiting signs of depression can be addressed.

The literature search yielded 4,287 articles. Of these, the review of evidence included of the sample 25 randomized clinical trials, 20 prospective single-arm studies, and four meta-analyses/systematic reviews. No method of evaluation of study quality was described.

• Various fractionation schedules can provide significant palliation of symptoms and/or prevent the morbidity of bone metastases.
• Stereotactic body radiation holds theoretical promise in the treatment of new or recurrent spine lesions, and the task force recommended it be limited to highly selected patients, preferably within a prospective trial.
• Surgical decompression and postoperative radiotherapy is recommended for spinal cord compression or spinal instability in highly selected patients with sufficient life expectancy and performance status.
• The use of biophosphonates, radionuclides, vertebroplasty, and kyphoplasty for the treatment or prevention of cancer-related symptoms does not obviate the need for external beam radiotherapy in appropriate patients.  

• Limited search database
• No stated method of evaluating or grading study quality

This systematic review provides information for nurses about evidence regarding use of radiation therapy for the palliation of pain from bone metastases. It points out that use of bone-modifying agents does not preclude use of radiation therapy. It also points out that for patients with multiple sites of disease-related pain, the use of radiopharmaceuticals may be more useful.

To examine the effects of healing touch on natural killer (NK) cell activity, mood, and specific clinical and quality-of-life outcomes among women receiving chemoradiation for locally advanced cervical cancer

After consent, patients randomized to one of three treatment arms: healing touch, relaxation, and control (usual care). The healing touch and relaxation interventions were administered individually four days per week throughout chemoradiation, on nonchemotherapy days, immediately following radiation. Healing touch participants received on average 15.25 (±6.97) sessions versus 11.75 (±5.20) sessions for relaxation (p = 0.08). Psychosocial surveys were completed for a total of four assessments (including baseline) over six weeks of chemoradiation. Each healing touch or relaxation session lasted 20–30 minutes and was delivered by experienced practitioners.

• The sample was composed of 51 participants.
• The mean age of the healing touch group was 48.1 years (SD = 16.0 years); the range of ages was 25–82 years. The mean age of the relaxation group was 43.1 years (SD = 9.6 years); the range of ages was 24–60 years. The mean age of the usual-care group was 48.0 years (SD = 13.8 years); the range of ages was 26–77 years.
• Female: 100%, with stages IB1–IVA cervical squamous or adenocarcinoma. All patients were receiving a standard six-week course of chemoradiation.

• Single site
• Outpatient
• Iowa, United States

Active treatment

Prospective, randomized clinical trial with repeated measures

• Center for Epidemiological Studies Depression Scale (CESD). Scores of 16 or higher indicate ‘‘probable cases of depression.”
• Two subscales from the Profile of Mood States-Short Form (POMS-SF), to differentiate effects on anxiety versus depressed mood.
• Functional Assessment of Cancer Therapy (FACT) quality-of-life measure.
• Fatigue Symptom Inventory (FSI).
• Five-item scale, modified from the Treatment Credibility Scale (TCS), administered at study entry to assess patient expectations before receiving group assignment.
• Mean of three blood pressure measurements taken at two-minute intervals before and three measurements after the second relaxation or healing touch session, in weeks 1, 3, and 5, to assess extent of relaxation
• Clinical and demographic information.
• Immune measures as quantified by NK cell activity.

• Healing touch group showed preservation of NK cell activity over time, as compared to NK activity in the other two groups, which had significant declines in NK cell activity over time (weeks 1–6). The usual-care group showed a 68% drop in NK cell activity. The relaxation group showed a 43.7% drop in NK cell activity. The healing touch group showed a 26.6% decrease in NK cell activity.
• Authors reported a significant decline in depression in the healing touch group over time (p = 0.03), but the other two groups did not show such a decline. By week 6, mean CESD scores of healing touch patients were below 16 (the cutoff for clinical depression), whereas mean scores of the relaxation and usual-care groups were still in the depressed range (p = 0.07).
• Anxiety significantly decreased in all groups over time.
• Authors reported no significant effects on quality of life or fatigue in any group.

Results indicate that, in patients with cervical cancer who are undergoing chemoradiation, healing touch may be effective in preventing some aspects of decreased immunity and reducing depressed mood.

• The study had a small sample size, with fewer than 100 participants.
• The study was possibly underpowered and had a risk of bias due to no blinding to the treatment condition. Relaxation was offered as a way to control for expectation of active treatment.
• Brachytherapy protocol changes over the course of the study may be a confounding factor.

Complementary interventions may be an important adjunct for patients during active treatment, in both improving depressed mood as well as maintaining immunocompetence. However, the intervention must be feasible and acceptable to patients. This very well-reported study took five years to accrue a final sample of 51 patients (fewer than one patient per month), which illustrates the complexity of performing such research.

To evaluate the efficacy and safety of Kangfuxin solution, a pure Chinese herbal medicine, on mucositis induced by chemo/radiotherapy in patients with nasopharyngeal carcinoma

The treatment patients gargled three times a day after each meal. Patients were monitored from the first day of chemotherapy or radiotherapy until the emergence of grade 3 oral mucositis or when the patients finished the entire course of radiotherapy using the Common Terminology Criteria for Adverse Events (CTCAE), version 3.0. Oral mucositis and pain were measured according to guidelines.

• N = 215   
• AGE = 46.3 years (SD = 11)  
• MALES: 62 (28.8%), FEMALES: 153 (71.2%) 
• CURRENT TREATMENT: Combination radiation and chemotherapy
• KEY DISEASE CHARACTERISTICS: Nasopharyngeal carcinoma

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

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Elder care

Randomized, parallel-group clinical trial

• CTCAE, version 3.0 
• Verbal rating scale (VRS) 
• Karnofsky Performance Scale

Kangfuxin solution reduced the incidence of all levels of mucositis, especially high-grade mucositis, to improve patients' tolerance to radiation, ensuring the continuity of radiotherapy. So, it demonstrated its superiority to compound borax gargle on mucositis induced by chemo/radiotherapy.

• Small sample (< 100)
• Risk of bias (no blinding)
• Control intervention not standard

Kangfuxin solution effectively prevented chemo/radiotherapy-induced oral mucositis, reduced the incidence of upper gastrointestinal inflammation, and decreased the severity of oral pain compared with compound borax gargle. It improves the quality of life in patients. Additional research to confirm the effects is warranted.