STUDY PURPOSE: To appraise the effectiveness of nonpharmacologic pain management approaches in children and young adults with cancer

• FINAL NUMBER STUDIES INCLUDED = 32
• TOTAL PATIENTS INCLUDED IN REVIEW = 1,117
• SAMPLE RANGE ACROSS STUDIES: 8–124 patients
• KEY SAMPLE CHARACTERISTICS: The studies included various tumor types, and the majority involved acute procedure-related pain.

PHASE OF CARE: Active antitumor treatment

Six studies examining distraction, including music and virtual reality, showed mixed results. Nine studies used hypnosis, seven of which showed a positive effect on procedure-related pain. Sample sizes in these studies ranged from 23–80 (357 total) patients. Four studies used touch therapy, including healing touch, massage, and acupressure, with mixed results. Nine studies provided multimodal cognitive behavioral interventions including relaxation, procedure preparation, deep breathing, and other approaches. These showed mixed results. Aromatherapy and art therapy were examined in one study each.

The findings of this study suggested that hypnosis had relatively consistent positive results for the management of acute pain in this patient population.

All studies were identified as low-quality with only fair or poor internal and external validity. The USPS grading system was only designed to grade the level of individual studies, and it was not appropriate for all the study designs included.

The findings of this study suggested that hypnosis may be an effective intervention to reduce procedure-related acute pain in children and young adults. Its findings for touch therapy also showed some promise. Additional well-designed research with larger samples is needed to provide stronger evidence in this area. These findings were limited by the low quality of evidence included.

To assess the effects of methylphenidate (MPH) in ameliorating fatigue in patients with advanced pancreatic cancer

Records of patients with stage 4 pancreatic cancer who were experiencing fatigue were retrospectively analyzed. The fatigue level was assessed at each visit prior to chemotherapy, and a trial of MPH was done for at least four weeks. MPH was begun at 5 mg by mouth daily and increased to 10 mg for those who did not benefit from the lower dose.

• N = 71   
• AGE RANGE = 38–76 years
• MALES: 57.7%, FEMALES: 42.3%
• CURRENT TREATMENT: Chemotherapy

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: United States

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

Retrospective

• Visual analog scale-fatigue (VAS-F)
• Numeric scale

Most patients continued MPH after four weeks, for up to 24 months. Fatigue improved at least from grade 3 to grade 2, or from grade 2 to grade 1 in 55%; and in 23%, fatigue resolved. Fourteen percent stopped MPH because of lack of benefit, and 13% stopped because of adverse effects. The most common adverse effects were weight loss, nausea, anorexia, and insomnia.

MPH appeared to provide some benefit in reducing fatigue for some patients but had important negative side effects in others.

• Small sample (< 100)
• Risk of bias (no control group)
• Risk of bias (no blinding)
• Risk of bias (no random assignment)
• Measurement/methods not well described
• Subject withdrawals ≥ 10% 
• States use of VAS, but data reported appear to be from a 10-point numeric scale.  
• No statistical analysis was conducted.

The findings regarding any potential benefit of psychostimulants, such as MPH, for the management of cancer-related fatigue have been mixed. MPH has also been associated with a number of adverse side effects. Nurses need to be aware of side effects and relevant monitoring if MPH is used.

STUDY PURPOSE: To evaluate the overall efficacy of pain education among patients with cancer by using a meta-analysis of randomized controlled trials (RCTs)

TYPE OF STUDY: Meta-analysis and systematic review

DATABASES USED: PubMed, EMBASE, Cochrane Library

KEYWORDS: cancer; pain; education; counseling

INCLUSION CRITERIA: RCTs that included patients with cancer with pain, used an education intervention for cancer pain management, and presented pain intensity at baseline and after intervention

EXCLUSION CRITERIA: Duplicated studies; same study in more than one publication

TOTAL REFERENCES RETRIEVED = 213 (36 thoroughly reviewed)

EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Two investigators independently reviewed and then compared discrepancies. Studies were rated on a 1–5 quality scale for RCT evaluation.

• FINAL NUMBER STUDIES INCLUDED = 12
• TOTAL PATIENTS INCLUDED IN REVIEW = 2,169 total patients; 1,069 patients enrolled in an intervention and 1,100 in a control arm
• KEY SAMPLE CHARACTERISTICS: Mean age was 57.2 years; 59% women

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

• Overall pain education for patients with cancer showed a small but insignificant effect (standardized mean difference -0.11).
• Pain education was more effective in inpatients than outpatients.
• Pain education was more effective within two weeks of a first follow-up.
• A difference existed in the efficacy of the pain education based on pain intensity.
• Pain education was effective when tailored to an individualized patient. No beneficial effect was observed in high-quality studies, but lower pain was found in low-quality studies.
• Overall, insufficient evidence exists to support the use of pain education in patients with cancer.

This study showed that overall pain education in patients with cancer showed a small efficacy on pain relief in the meta-analysis of these RCTs.

• Authors note that many studies were not included because of lack of data.
• Predictors of pain response were not evaluated (e.g., age, socioeconomic status, education).
• Attention control inconsistent within the studies
• Quality of life or distress of pain on the patient not examined

Further studies are needed regarding the use of pain education on patients with cancer and the relation to pain relief. Because some patients benefited from the interventions, nurses may focus on situations in which patients received the most benefits (e.g., inpatients, patients with the most severe pain, education within the first two weeks of follow-up).

To determine the impact of bethanechol administration concomitant to radiotherapy on oral mucositis, candidiasis, and taste loss

Patients were randomly assigned to one of two treatment groups. Group 1 received 25 mg oral bethanechol, 3 times a day; group 2 received artificial saliva (OralBalance). Patients who experienced severe mucositis were subject to daily laser applications until remission of the lesions.

• The mean age of participants in the bethanechol group was 59 years and in the artificial saliva group was 55 years.
• The sample was 25% female and 75% male in both groups.
• Patients had been diagnosed with malignant neoplasms of the head and neck region and were receiving external beam radiotherapy (RT) encompassing one or more major salivary glands for a minimum of 45 Gy.

This was an outpatient radiation study conducted in Brazil.

Secondary analysis, stratified, open-label, random allocation to one of two groups.

• Mucositis was scored weekly using the World Health Organization (WHO) grading scale.
• Patients were examined weekly for Candida.
• Taste loss was defined as the patient’s subjective report of absence of taste.
• Fisher exact tests were used for categorical variables.
• t-tests were used for continuous variables.
• The Kaplan-Meier method was used.
• Log-rank tests were performed.

No significant differences in frequency and severity of mucositis, candidiasis, or taste loss were found.

Bethanechol did not appear to reduce the incidence of mucositis, candidiasis, or taste loss when administered during RT.

• The sample size was small
• Differences in the anticancer treatment regimen existed between the two groups.
• A wide variety of treatment protocols were used (bethanechol, sucralfate, and laser therapy).
• No delineation was provided as to the type of chemotherapy that patients received. Possible implications exist (e.g., perhaps taste was a factor of chemotherapy).

Larger, randomized, double-blind, placebo-controlled studies are needed possibly to further test the hypothesis that bethanechol could minimize RT-induced mucositis incidence or severity.

The intervention was directed at patients and caregivers (primarily at patients). The standardized nursing intervention protocol included three home visits and six telephone calls over four weeks from an oncology clinical nurse specialist. Intervention activities included

• Problem assessment and monitoring
• Symptom management and teaching of self-care behaviors
• Coordination of resources.

• The sample was comprised of 161 family caregivers of patients older than 60 years.
• Patients
  • Were newly diagnosed (in the past two months) with solid-tumor cancers
  • Were currently hospitalized for surgical cancer treatment
  • Had a prognosis of six months or greater
  • Lived within 50 miles of the study center
  • Had a complex problem at the time of discharge.

Home setting

A controlled trial design was used, with a major limitation.

• Caregiver reaction assessment
• Center for Epidemiologic Studies–depression

No significant differences existed on any outcome measure. No effect on caregiver esteem was found. Among caregivers with physical problems, those in the treatment group had an increase in lack of family support between interviews 1 and 2 followed by a decrease between interviews 2 and 3. Control group subjects displayed the opposite pattern. Caregivers with physical problems had greater decreases in difficulty with finances than those with no physical problems. Caregivers in the control group had a decrease, whereas those in treatment group did not. No significant effect on depression was found. Caregivers in the control group had a decrease in the effect of providing care on physical health between interviews 1 and 2 and then remained constant between interviews 2 and 3. Caregivers in the treatment group displayed the opposite pattern. The analyses are based on some caregivers who had received nonprotocol home care and were dropped from analyses.

Little information is presented on the details of the intervention. The control group had some contamination (32.4% of the control group and 32.2% of the intervention group received referrals for home care that were not connected with the study). Findings were difficult to interpret.

To measure the effect of a music intervention on anxiety related to bronchoscopy

Patients undergoing bronchoscopy were randomly assigned to listen to music via earbuds during the procedures or use earplugs with no sound. On admission to the hospital, patients completed a study questionnaire, and blood cortisol samples were obtained. On admission to the operating area, baseline vital signs were taken, and actigraph sensors were applied to the patients' wrists, ankles, head, and hips. After 10 minutes, study measures were obtained again. About 60 minutes after bronchoscopy, the study measures were repeated.

• N = 135   
• MEAN AGE = 63.7 years (SD = 11.6 years)
• MALES: 51.7%, FEMALES: 48.3%
• CURRENT TREATMENT: Other

• SITE: Single site   
• SETTING TYPE: Inpatient    
• LOCATION: Denmark

PHASE OF CARE: Diagnostic

Single-blind, randomized, controlled trial

• State-Trait Anxiety Inventory (STAI) 
• Vital signs

Prior to bronchoscopy, the music group had lower STAI scores. After the bronchoscopy, anxiety was lower in both groups, with no difference between groups. No differences in duration of the procedure, sedatives, or amount of patient movement during the procedure were reported.

Music was not shown to reduce anxiety associated with bronchoscopy.

• Risk of bias (no blinding)
• Measurement validity/reliability questionable
• Subject withdrawals ≥ 10%

Music during bronchoscopy was not shown to affect patients' level of anxiety. Measurement of anxiety immediately prior to or during a procedure to perform this type of research is difficult and questionable.

To evaluate the effects of a pulmonary rehabilitation education program for caregivers on pain and pulmonary function in patients after lung resection

Patients were assigned to experiment and control groups. The control group received usual care including education on pain management, general postoperative care, incentive spirometer use, trunk and limb mobilization, and nebulizer instructions. In addition, caregivers in the experimental group received 30 minutes per week of instruction in splint coughing, airway clearance techniques, diaphragmatic breathing, and various exercises. Assessments were done at baseline (two weeks after surgery) and at four weeks after surgery.

• N = 41
• AGE = Not provided
• MALES: Not provided        
• FEMALES: Not provided
• KEY DISEASE CHARACTERISTICS: All had lung cancer
• OTHER KEY SAMPLE CHARACTERISTICS: Not provided

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: Republic of Korea

• PHASE OF CARE: Active antitumor treatment

Prospective trial

• Visual Analog Scale (VAS)
• Pulmonary Function Testing (PFT)

Forced expiratory volume in one second was higher in the experimental group at baseline and at four weeks (p < 0.01). There was no difference between the groups in pain scores after the intervention.

Pulmonary rehabilitation education may improve pulmonary function in patients after lung resection.

• Small sample (< 100)
• Baseline sample/group differences of import
• Risk of bias (no blinding)
• Risk of bias (no random assignment) 
• Risk of bias (no appropriate attentional control condition)  
• Key sample group differences that could influence results
• Measurement/methods not well described 
• Other limitations/explanation: It was not clear whether patients were randomized. There were significant differences between groups in outcome measures at baseline. It was not clear how the VAS for pain was administered.

Pulmonary rehabilitation education provided to caregivers was not shown to reduce postoperative pain scores, but it may have been beneficial in terms of pulmonary function testing results.

To determine if acupuncture administered to Korean women receiving tamoxifen or anastrozole for breast cancer can be safe and feasible in controlling their hot flashes during eight weeks of intervention

Each intervention session lasted 40 minutes and consisted of 20 ± 5 minutes of acupuncture. Patients received three sessions per week for four weeks for a total of 12 sessions. The following acupuncture points were selected for the intervention: GV 20, M-HN-3, HT 8, KI 10, and LV 2. Acupuncture was administered by a physician with three years of experience.  After appropriate skin preparation, eight needles were inserted 10-20 mm deep into the skin and were manipulated to obtain De Qi.  Needles were rotated after 10 minutes.  Data were recorded at baseline, weekly during the intervention (visits 5, 8, 11, and 13), and four weeks post study.

• N = 10 
• MEAN AGE = 46.60 years ± 4.93 (range = 38–53 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: Breast cancer diagnosis; pre-menopause = 80% and post-menopause = 20%
• OTHER KEY SAMPLE CHARACTERISTICS: Previous treatments were surgery, radiotherapy, and chemotherapy in different proportions; any participant took dietary supplements concomitant to the study.

• SITE: Single site  
• SETTING TYPE: Not specified  
• LOCATION: East-West Medical Center at Daegu Catholic University Center in Daegu, Korea

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

Interventional study in a nonrandomized series of cases enrolled prospectively

Data was self-reported using a hot-flash diary to record number and severity of hot flashes. A visual analogue scale was used to record severity of hot flashes. A total score was calculated by multiplying the severity and frequency of hot flashes.

Findings are limited in explaining completely the efficacy of acupuncture to decrease hot flashes in women receiving tamoxifen or anastrozole to treat breast cancer. Although safety and statistical significance result from the study, the sample size, the lack of a random design, and the lack of a control group limit the generalization of data.

• Small sample of < 30
• Baseline sample/group differences of import
• Risk of bias from no control group
• Risk of bias from no blinding
• Risk of bias from no random assignment
• Risk of bias from no appropriate attentional control condition
• Risk of bias related to sample characteristics
• Selective outcomes reporting
• Key sample group differences that could influence results 
• Findings not generalizable
• Other limitations/explanation: Previous cancer treatments in the sample group, such as chemotherapy or radiotherapy, can also affect the final outcome. Pre- and post-menopausal women should not be in the same group in the sample. No control group is the main limitation. Follow-up described to eight weeks is limited. Subjective measures self-reported by participants may differ from other objective ways of measuring the symptom. Comparison with other references in the literature shows that Korean technic and Chinese technic are performed differently.

Implications for cancer nurses are limited since applying this intervention requires professional training. However, oncology nurses are vital in providing information to patients about complementary treatments that are safe and feasible in controlling hot flashes related to hormone cancer treatments. No related adverse events were described.

To evaluate whether Bojungikki-tang has beneficial effects on fatigue and overall quality of life in patients with cancer.

Patients were randomized to the experimental group or the wait-list control group. The experimental group received Bojungikki-tang for two weeks. Bojungikki-tang was administered as granules containing a mixture of 10 medicinal plants given three times daily. Patients were randomized through computer generation. Patients were recruited through newspaper and hospital advertisements.

• The final sample included 36 patients (37.5% male).
• Mean age was 52.6 years. 
• Diagnoses included breast cancer (27.5%), stomach cancer (12.5%), lung cancer (12.5%), colon cancer (12.5%), and other (35%).

Unknown

The study was a randomized, controlled trial.

• Evaluation forms included the Visual Analogue Scale of Global Fatigue, which was used as the primary outcome variable.
• The secondary outcome was measured using the Functional Assessment of Cancer Therapy–General (FACT-G), the FACT-Fatigue (FACT-F), and the Trial Outcome Index–Fatigue (TOI-F).

The experimental group had statistically significant improvements in VAS-F scores, as well as FACT-G, FACT-F, and TOI-F (p < 0.05) at week 2.

The study had a possible effect from the study drug, although p-values were on the edge of significance. The benefit shown suggests additional study is required in a larger, placebo-controlled trial.

• The study had no placebo in place, and the treatment time was short.
• The plant mixture was not controlled for variability.
• One patient experienced an increase in BUN and creatinine above the reference ranges, and other adverse effects were reported (flatulence and dyspepsia); therefore, the potential for harm needs to be considered and the risks weighed versus potential benefits if additional study is to be performed with a larger population.
• Exclusion criteria for patients needs to be more rigorous and include consideration of antihypertensive medication and other drug interactions and baseline renal function.

Patients pursuing this treatment should be educated on the current need for additional research.

To evaluate the efficacy and complications of continuous epidural analgesia to improve its efficacy for control of cancer-related pain

Most patients received morphine, bupivacaine, and ketamine via continuous epidural infusion. Dosing was determined by converting the daily total opioid dose to an IV morphine equivalent. The epidural morphine was delivered at 25%–17% of the IV morphine dose. Bupivacaine 12.5–25 mg per day and ketamine 10–20 mg per day were administered at 2 mL/h and varied according to pain location, severity, and type, as well as progression of disease. Additional adjuvant therapies were used and included antiepileptic drugs, antidepressants, anti-inflammatory drugs, and steroids. Pain levels were evaluated at baseline and at two weeks postepidural.

• The study reported on 96 patients.
• Nine patients were 40 years old or younger, 35 patients were 41–59 years old, and 52 patients were 60 years or older.
• Patients had been diagnosed with terminal lung, upper genitourinary, hepatobiliary, pancreatic, rectosigmoidal, urogenital, or other (10.4%) cancers.
• The majority of patients (91.6%) had pain in the chest, abdomen, back, sacral, or lower extremity, and 8.3% had pain in the head, neck, and upper extremity.

The study was conducted at a single site in Korea. The setting type was not specified.

• Patients were at the end-of-life phase of care.
• This study has clinical applicability for elder care and palliative care.

The study design was a retrospective chart analysis.

• Paired sample t-tests were used to evaluate the morphine-equivalent drug dose (MEDD).
• Statistical analysis was performed using SPSS software version 13.0.

The MEDD decreased from 213.4 mg (SD = 221.7 mg) per day to 94.1 mg (SD = 145.0 mg) per day at two weeks follow up. Prior to receiving the epidural, 78.1% of patients reported severe pain; at the two-week follow up, only 19.6% reported severe pain (p < 0.05). Mild catheter complications occurred in 15.6% of patients. Moderate complications occurred in 14.6% of patients, including infection that had to be controlled with antibiotics or removal of the catheter.

Continuous epidural anesthesia is an effective pain control method for patients with cancer at the end of life. However, risk of infection and complications exist because of catheter placement.

• The sample size was small, with fewer than 100 patients.
• A risk of bias exists because of the lack of a control group, blinding, and appropriate attentional control condition.
• The subject withdrawal rate was 10% or greater. The study had an extremely high attrition rate because of patient death (over a two-week span, the sample was reduced from 96 to 56 patients).
• Variations in documentation practices within the medical record were a weakness of this study.
• This was a retrospective study.

For patients seeking more pain control, continuous epidural infusions may be an option for pain relief. The charts reviewed cited inappropriate pain control (78.1%) and intolerable side effects (21.9%) as the reasons for placing the epidural, which are key factors in working to improve comfort in patients with terminal cancer.  Risks of complications include infection, occlusion, catheter removal, risk of respiratory depression, motor block, hypotension, sensory deficits, and gastrointestinal and genitourinary function that must be evaluated while the catheter is in place. In patients with terminal cancer, patient and caregiver education is important.