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Currin, J., & Meister, E. A. (2008). A hospital-based intervention using massage to reduce distress among oncology patients. Cancer Nursing, 31, 214–221.

Intervention Characteristics/Basic Study Process

Massage therapists who were specially trained in massage therapy for patients with cancer discussed the massage intervention process with patients and asked them which parts of their body they would like to have massaged. Massage sessions lasted 10 to 15 minutes, using Swedish massage. The most common areas for massage chosen by patients were the feet and leg or back, neck, and shoulder areas. Once patients were enrolled in the study, oncology social workers met with patients to perform a baseline assessment of pretreatment outcomes. After the massage intervention, the oncology social worker met with the patient to assess posttreatment outcomes.

Sample Characteristics

  • The study reported 251 patients with cancer (70% female, 30% male).
  • Mean patient age was 54.96 years.
  • Of the participants, 68.9% were Caucasian, 29.1% were Black, 1.2% were Asian, 0.4% were Hispanic, and 0.4% were Indian.
  • Multiple cancer types were included, but the most common type was gynecologic (25%).
  • Patients were recruited during a three-year period and were determined to be eligible for the study by their primary nurse.

Setting

Patients were hospitalized at a major university hospital in southeastern Georgia.

Phase of Care and Clinical Applications

Patients were undergoing the active treatment phase of care.

Study Design

The study used a nonrandomized, single-group, pre-/posttest, repeated-measures design.

Measurement Instruments/Methods

A modified version of MacDonald’s Patient Evaluation of Massage Experience Scale was used.

Results

The massage therapy intervention resulted in a statistically significant decline in fatigue mean scores (p <  0.001), which was observed between pre- and posttest treatment evaluations.

Limitations

  • The study was not a randomized controlled trial; therefore, no neutral comparison group existed to test for baseline similarities or postintervention differences between groups.
  • A substantial number of patients refused to participate, particularly men. This may be a result of preconceived notions regarding massage and human touch. Changing massage nomenclature to “back rub” may be more broadly acceptable in future investigations.
  • The study was not a longitudinal design; therefore, it could not be determined how long the observed benefits lasted.
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Cuomo, A., Russo, G., Esposito, G., Forte, C.A., Connola, M., & Marcassa, C. (2014). Efficacy and gastrointestinal tolerability of oral oxycodone/naloxone combination for chronic pain in outpatients with cancer: An observational study. American Journal of Hospice and Palliative Medicine, 31, 867–876. 

Study Purpose

To evaluate the efficacy and tolerability of prolonged-released (PR), fixed-dose oxycodone-naloxone

Intervention Characteristics/Basic Study Process

Patients were prescribed an oral PR oxycodone-naloxone combination for pain control at a dose according to level of pain, age, health status, and previous opioid use.

Sample Characteristics

  • N = 206  
  • MEAN AGE = 61.3 years (SD = 2.9 years), 89 (43.2%) g5 years or older
  • MALES: 47.1%, FEMALES: 52.9%
  • KEY DISEASE CHARACTERISTICS: Advanced cancer; moderate to  severe chronic pain
  • OTHER KEY SAMPLE CHARACTERISTICS: Constipation

Setting

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

Phase of Care and Clinical Applications

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

Study Design

  • Retrospective, 28-day, observational analysis

Measurement Instruments/Methods

  • Visual Analog Scale (VAS)
  • Bowel Function Index (BFI)

Results

The reported pain at baseline was severe (VAS = 70.9, SD = 7.8, range = 55–94). Less than a fourth of patients reported somatic or visceral pain only. The majority of patients (73.3%) complained of mixed neuropathic and nociceptive pain. At the first visit, 37.6% of patients reported one to four BTCP episodes (mean = 0.9 + 1.2) during background treatment. The mean baseline BFI score was 43.2 + 14.8, indicating that some degree of bowel dysfunction was already present before starting the new PR oxycodone-naloxone treatment. Almost all (97.6%) patients had abnormal baseline BFI values (i.e. > 28.8, 26), and 41% of patients were already taking laxatives.

Conclusions

This combination was a highly effective analgesic in ambulatory outpatients with cancer experiencing chronic pain. Combination PR oxycodone-naloxone was not associated with adverse effects on bowel function and was equally efficacious and well-tolerated in and opioid-naive and -experienced patients and in young and old patients alike.

Limitations

  • Findings not generalizable
  • Other limitations/explanation: Retrospective observational design; short time of observation; and the single-center nature of the study

Nursing Implications

This study may provide useful guidance for the daily management of outpatients with advanced cancer experiencing chronic pain. The long-term effectiveness of fixed-combination PR oxycodone-naloxone deserves additional investigation.

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Cunha, C. B., Eduardo, F. P., Zezell, D. M., Bezinelli, L. M., Shitara, P. P., & Correa, L. (2012). Effect of irradiation with red and infrared laser in the treatment of oral mucositis: A pilot study with patients undergoing chemotherapy with 5-FU. Lasers in Medical Science 27(6), 1233-40.

Study Purpose

To verify the efficacy of 660 nm laser associated with 780 nm laser in reducing the severity of oral mucositis (OM)

Intervention Characteristics/Basic Study Process

Investigators conducted two interviews before beginning treatment for OM and one interview after the therapies. In the first interview, patients were asked about demographics, medical and laboratory data, and types of food ingested. Oral health status was evaluated, and the oral cavity was examined. Oral hygiene was reviewed.

Following the first interview, participants were divided into one of three groups.

  • Group 1 was the control group (CG), which received no laser therapy. The CG used chlorhexidine mouthwashes twice per day for 5 days. 
  • Group 2 was irradiated with laser-emitting light in the red region, 660 nm for the treatment of OM. Group 2 received five daily sessions of low-level laser irradiation. 
  • Group 3 received five daily laser treatments of laser irradiation with two wavelengths. These patients were irradiated with laser-emitting light in the red region and immediately afterward with laser-emitting light in the infrared region, 660 nm laser with a sequential phase of 780 nm laser.

Sample Characteristics

  • The sample consisted of 18 patients ranging in age from 41–90 years.
  • The sample was 66.7% male and 33.3% female.
  • No significant differences existed between groups.
  • All participants were receiving 5-fluorouracil (5-FU) not in combination of other agents.
  • Cancer diagnoses were oropharyngeal (n = 8), gastric (n = 3), esophageal (n = 2), maxillary sinus (n = 1), colon (n = 1), colorectal (n = 1), rectal (n = 1), and breast (n = 1).
  • Periodontal disease, dental caries, and hematological data (total leukocytes and platelets) were not significantly different among groups.
  • In terms of smoking and alcohol use, 13 of 18 participants were smokers or ex-smokers and 15 of 18 participants did not drink alcohol.

Setting

This study was conducted in Brazil. The site and setting type were not specified.

Phase of Care and Clinical Applications

  • Patients were undergoing the active treatment phase of care.
  • This study has clinical applicability for palliative care.

Study Design

This was a pilot study, prospective trial.

Measurement Instruments/Methods

Symptoms of OM were classified according to a system validated by Monopoli et al. and applied by Vera-Llonch et al. The name of the tool was not given. Assessment was performed by a dental surgeon. This system was based on a grading system with the following grades.

  • 0 = absence of sites with erythema, ulceration, or pseudomembranes
  • 1 = presence of erythema and absence of ulceration
  • 2 = presence of erythema, ulceration, or pseudomembrane affecting only one site
  • 3 = presence of erythema, ulceration, or pseudomembrane affecting two sites
  • 4 = presence of erythema, ulceration, or pseudomembrane affecting three sites
  • 5 = presence of erythema, ulceration, or pseudomembrane affecting more than three sites.  

A faces visual scale was used to assess satisfaction with the results of treatment with a happy face meaning \"satisfied\" (i.e., I feel no pain, I am able to eat better, I can speak better, I am satisfied, I like the treatment) and a sad face meaning “dissatisfied\" (i.e., I feel pain, I cannot eat, I cannot speak, I am not satisfied, I don’t like the treatment).

Consistency of food eaten was measured; however, no tool was specified.

Results

The red laser group (Group 2) and the red laser plus infrared laser group (Group 3) had statistically significant differences in comparison to the CG group (Group 1) (p = 0.0190).

Statistically significant changes were found in the consistency of the foods ingested, favoring Group 3 (p < 0.001).

Satisfaction with oral condition was significantly different from the initial to the final evaluation with regard to Groups 1 and 2 (p < 0.001). No statistical difference was found in Group 3 from the initial to the final evaluation (p = 0.491).

Conclusions

A statistically significant difference was found between the CG and the red laser groups in OM scores but not necessarily in the severity of the OM lesions. The addition of laser light emission in the red region with infrared emission was found to be advantageous for the treatment of OM. The study provided support for the use of good oral hygiene alone in reducing the grade of OM.

Limitations

  • The sample size was small, with fewer than 30 patients.
  • Even though it was described as a blinded study, it clearly was not.
  • The study only included adults and patients receiving 5-FU.
  • Information regarding how data was collected, especially in regard to the tools, was lacking.
  • The article did not describe how patients were assigned to groups, which was apparently not random.
  • Frequency of oral assessment was not described, and values used in the analysis were unclear.

Nursing Implications

Using good oral hygiene alone is still the cornerstone of OM prevention and treatment. The addition of laser therapy may be helpful. Laser therapy may not be available in all settings. This study did not substantially add to evidence in this area. This study was too small to make definitive decisions regarding laser therapy, but it provides promising results.

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Cummings, G.G., Olivo, S.A., Biondo, P.D., Stiles, C.R., Yurtseven, O., Fainsinger, R.L., & Hagen, N.A. (2011). Effectiveness of knowledge translation interventions to improve cancer pain management. Journal of Pain and Symptom Management, 41, 915–939.

Purpose

To determine the effectiveness of interventions to facilitate uptake of new knowledge by healthcare practitioners, patients, and family caregivers to improve cancer pain management. Primary outcomes of interest were change in behavior or practice of healthcare professionals or patients and caregivers. Secondary outcomes included change in patient quality of life or satisfaction with treatment.

Search Strategy

Databases searched were CINAHL, MEDLINE, EMBASE, AMED, Web of Science, Cochrane Database of Clinical Trials and Cochrane Database of Systematic Reviews, National Cancer Institute of Canada, Canadian Cancer Society, American Cancer Society, American Society of Clinical Oncology, European Association for Palliative Care, and other websites.

An extensive listing of specific search terms and operators is provided. Main search terms included pain, analgesia, cancer, practice guidelines, evidence based medicine, and organizational innovation.

Studies were included in the review if they

  • Were randomized controlled trials, controlled clinical trials, time series, and pre-post studies that evaluated the effect of knowledge translation interventions on patient outcomes
  • Included patients with cancer.

Case reports, cross-sectional studies, or noncontrolled pre-post studies were excluded.

Literature Evaluated

  • The initial search yielded 15,625 articles.
  • A total of 308 articles were retrieved and reviewed according to inclusion criteria.
  • Risk of bias assessment was done using methods of the Cochrane Effective Practice and Organization of Care Group.

Sample Characteristics

A final sample of 26 studies was included: 16 examined interventions for patients only, 4 focused on family caregivers, and 5 investigated effects of interventions targeted to health professionals. One study compared a solo intervention for patients only, and a dyad intervention for patients and their significant others, within the same study.

Results

  • Of 26 studies, 25 were rated as having high risk of bias due to lack of blinding in the design, incomplete data, lack of allocation concealment, and other issues. Inter-rater reliability of this scoring showed only slight agreement between raters.

Interventions targeting health professionals (5 studies)

  • Findings related to patient outcomes were mixed, with two studies showing decrease in pain intensity and two studies showing no change in patients’ pain.
  • Two studies showed significant increases in healthcare professionals’ knowledge and attitudes.

Interventions targeting patients and caregivers (21 studies)

  • Most interventions were face-to-face coaching sessions and distribution of printed material. In more than half of the studies, in-person or telephone follow-up was used to reinforce education.
  • Eight studies showed significant decrease in patients’ pain intensity with the intervention, and five showed positive change in patient behavior regarding pain control strategies.
  • Five studies targeting patients and family caregivers showed mixed results, with two showing improvement in pain intensity and adherence to therapy, and three showing no effect.

Meta-analysis results

     Interventions targeting patients and caregivers

  • There was no significant effect of interventions on pain interference with activities.
  • In six studies, the effect on usual/average pain showed a tendency favoring the intervention (SMD = 0.43, 95% CI 0.13 – 0.74, effect = 2.76, p = 0.006). These findings are limited by the high heterogeneity among studies.
  • There was no significant overall effect of interventions on worst pain, current pain, or overall pain measures in meta-analysis.
  • There was a significant effect of the intervention on least pain intensity (SMD = 0.93, 95% CI 0.44 – 0.142, p = 0.0002), but this was from only two studies.

Intervention dose and intensity

  • It is noted that the “dose” and intensity of knowledge translation interventions varied greatly. Authors define high- and low-dose parameters and show that those studies with higher dosage of the intervention tended to report significant results on patient outcomes.

Conclusions

Knowledge translation interventions aimed at healthcare professionals have demonstrated change in practitioner behavior and attitude, but have not demonstrated an effect on patient pain outcomes measured. There is some evidence to suggest that higher intensity and “dose” of these interventions, indicating amount of time spent in education, inclusion of follow-up, patient/family contact, and longer duration of follow- up, tend to be more effective.

Limitations

Knowledge translation interventions aimed at patients and caregivers have been associated with improvement in patients’ least and average pain scores, but not other pain measures. These findings need to be viewed with caution, since studies included showed high heterogeneity, and the timing, dosage, and intensity of the interventions varied.

Nursing Implications

Educational and knowledge translation interventions regarding pain management that are aimed at the patient and caregiver have been shown to be effective in improving some measures of pain intensity, and have often, but not always, resulted in improved knowledge, attitudes, and skills related to pain management. Elements of success included more intensive education such as involvement of a multidisciplinary team in face-to-face education, locally constructed education materials, standardized approaches, and patient follow-up to reinforce the education. Pain management educational programs should be constructed to include key elements that are likely to improve outcomes.

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Culos-Reed, S. N., Robinson, J. W., Lau, H., Stephenson, L., Keats, M., Norris, S., . . . Faris, P. (2010). Physical activity for men receiving androgen deprivation therapy for prostate cancer: benefits from a 16-week intervention. Supportive Care in Cancer, 18, 591–599.

Study Purpose

To investigate the effects of a physical activity intervention for men receiving androgen deprivation therapy (ADT) on physical activity behavior, quality of life (QOL), and fitness.

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to either the intervention or a wait-list control group. Assessments were performed in both groups at baseline, after completion of the 16-week activity intervention, and two and six months postintervention. The exercise program included a home-based portion and weekly group sessions of an individualized program provided by a certified fitness professional. Exercises were tailored to ability but consisted mostly of walking, stretching, and resistance exercises with a Thera-Band. A physioball and Thera-Band were provided to each patient for use in the home-based activity. Home exercise was suggested three to five times per week. Group sessions were conducted weekly for 16 weeks and monthly thereafter until completion of all follow-up measures. These included a group-based workout with individualized feedback, education, and group discussion. Discussion focused on common concerns, goal setting, monitoring behavior, overcoming barriers, role of a positive attitude, social support, relapse prevention, and nutrition.

Sample Characteristics

  • One hundred patients were randomized, and 66 completed the study.
  • Mean age was 67.6 years (standard deviation = 8.6 years). 
  • Patients had any stage of prostate cancer and were expected to receive ADT for at least six months.
  • Patients with a high risk of osteoporosis were excluded (long-term steroid use or a T-score less than –2.5 on bone mineral densitometry).
  • Of the patients, 88% were married and 61% were retired.
  • Patients were recruited between 2004 and 2006 and had physician clearance to participate in the exercise program.

Setting

  • Single site
  • Calgary, Canada

Study Design

The study used a randomized, controlled, repeated measures design.

Measurement Instruments/Methods

  • European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
  • Expanded Prostate Cancer Index Composite (EPIC):  This instrument assesses function and bother in three organ systems:  sexual, urinary, and bowel, and has recently expanded to include possible effects of ADT. The test retest reliability and internal consistency is reported to be high for the urinary, bowel, sexual, and hormonal domain summary scores (r ≥ 0.80; α ≥ 0.82).
  • Fatigue Severity Scale (FSS)
  • Center for Epidemiologic Studies Depression scale (CESD)
  • Godins’ leasure score index (LSI) of Godin’s leisure time exercise questionnaire:  a three-item measure assessment of frequency of exercise
  • Fitness assessment, including resting heart rate, blood pressure, six-minute walk, grip dynamometer, and flexibility by testing modified sit and reach
  • Body mass index (BMI)
  • Baseline bone densitometry
  • Variety of bloodwork

Results

  • Of the patients, 34% dropped out.
  • LSI scores pre- to postintervention showed a significant interaction effect (p = 0.004) with the intervention group reporting increased physical activity and the controls reporting decreased levels.
  • No significant changes were seen in QOL measurements.
  • Of the patients who dropped out, 67% were in the wait-list control group. In the intervention group, 10 patients withdrew; five of these withdrew for medical reasons.
  • Attendance for group sessions was 77.8%, with attendance on average at 12 of 16 sessions.
  • At baseline, both groups had similar BMI measures and were considered in the overweight category. After the program, the intervention group had a very slight decrease in average BMI (change of –0.23), whereas the controls showed an average increase to 29.04 (change of 0.75), just below the level that differentiates overweight from obesity.
  • In the intervention group, there were nonsignificant improvements seen in depression over time; however, the intervention group had a higher level of depression at baseline than the control group.
  • There were no significant changes in fatigue scores over time or between groups.

Conclusions

The physical activity intervention was associated with an overall increase in reported physical activity. There were no significant effects seen in QOL or fatigue.

Limitations

  • The high drop-out rate reduced the statistical power of the study, which may have resulted in an inability to detect significant differences between groups.
  • No mechanism was used to evaluate patient adherence to the home-based part of the program.
  • The study lacked an attentional control.
  • There may have been sample selection bias because individuals interested in or already having a more active lifestyle may be more likely to participate in this type of program, so any results seen cannot be attributed to solely to the program.
  • The duration of the intervention may not have been sufficient to see significant changes in the outcome measures.
  • The study demonstrated that maintaining involvement and adherence to exercise in this patient population is challenging.
  • The findings showed that additional studies of the use of exercise in various patient types should continue because effects and issues seen in this study differ somewhat from those in other patient groups.
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Cullum, J. L., Wojciechowski, A. E., Pelletier, G., & Simpson, J. S. (2004). Bupropion sustained release treatment reduces fatigue in cancer patients. Canadian Journal of Psychiatry, 49, 139–144.

Intervention Characteristics/Basic Study Process

Bupropion sustained release was initiated at 100 or 150 mg daily, and the dose was adjusted according to the patient’s response. The final bupropion dose ranged from 100 to 300 mg daily. The modal bupropion dose was 150 mg, and patients were treated and observed for as long as two years.

Sample Characteristics

  • The study included 15 patients consecutively referred for assessment due to the presence of fatigue or depression with marked fatigue.
  • Age ranged from 37 to 87 years.
  • Diagnoses included breast cancer, primary brain tumor, prostate cancer, and lymphoma.
  • Patients were excluded if they were receiving erythropoietin treatment, were anemic, had a history of diabetes mellitus, or had an active rheumatologic condition.

Setting

  • Single site
  • Comprehensive cancer center

Study Design

The study was a single-arm, open-label, case series.

Measurement Instruments/Methods

Fatigue was evaluated on the Clinical Global Improvement (CGI) Scale by a clinician not directly involved in the trial.

Results

  • The degree of fatigue was rated as very much improved (n = 6), much improved (n = 2), and minimally improved (n = 5).
  • One patient showed no change, and another was much worse with respect to fatigue symptoms following bupropion treatment.
  • Most patients (n = 13) reported some of the most common bupropion side effects, such as increased anxiety, dry mouth, nausea, insomnia, tremor, and tinnitus. These were rated as mostly mild to moderate.
  • Thirteen patients were reported as improved, and eight were rated as much improved or better.
  • In all patients, improvement occurred in two to four weeks.

Limitations

  • The study had a single arm, and no random assignment or comparison group was included.
  • The trial used an open-label design.
  • Clinician-evaluated measures of fatigue may be less sensitive to a change in rating of a subjective symptom, such as fatigue.
  • Bupropion should be used with caution in patients at risk for seizure and those receiving concurrent therapies that lower the seizure threshold.

Nursing Implications

Cost is incurred to acquire the drug.

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Cullen, M.H., Billingham, L.J., Gaunt, C.H., & Steven, N.M. (2007). Rational selection of patients for antibacterial prophylaxis after chemotherapy. Journal of Clinical Oncology, 25, 4821–4828.

Intervention Characteristics/Basic Study Process

Adult patients with cancer receiving cyclic chemotherapy for solid tumors or lymphoma who were at risk for temporary, severe neutropenia (absolute neutrophil count [ANC] < 500/mm³) were treated with oral levofloxacin 500 mg or matching placebo daily for seven days during the expected neutropenic period. Treatment began on day 5 for regimens associated with early onset of neutropenia (e.g., docetaxel), day 8 for 14-day and 21-day cycles, and day 15 for 28-day cycles.

Patients were on study for a mean of 4.4 cycles of chemotherapy, with 45% of patients completing six cycles.

784 patients were randomly assigned to the placebo arm and received 3,459 cycles of chemotherapy (mean = 4.4 cycles per patient).

Random assignment of patients in the SIGNIFICANT trial was stratified by age (younger than age 40, 40–59, and 60 years of age and older) and cancer type (breast, testicular, small cell lung, Hodgkin disease, non-Hodgkin lymphoma [NHL], and others).

Sample Characteristics

1,565 adults starting chemotherapy for solid tumors or lymphomas; eligible regimens were known to be associated with a risk of neutropenia (ANC <  500/mm³), but were not routinely given with granulocyte–colony-stimulating factor (G-CSF) support. Many different types of cancer were included.

Setting

60 oncology centers in the United Kingdom.

Study Design

The study was a prospective, multicenter, randomized, double-blind, placebo-controlled trial with secondary univariate and multivariate analysis.

Measurement Instruments/Methods

  • The primary outcome measure was the incidence of clinically-documented febrile episodes (FEs), defined as a core temperature exceeding 38°C and attributed to infection.
  • The original results demonstrated a reduction in FEs in patients receiving levofloxacin. However, the use of prophylactic antibiotics may increase the rate of antibiotic resistance, so the data from a 2005 study by the authors were analyzed to determine which patients benefit most from prophylactic antibiotics. The analysis measured rates of FEs across all cycles, calculated as the proportion of randomly assigned patients experiencing the event at least once during the chemotherapy program (per patient FE rate). The analysis separates events in cycle 1 because chemotherapy dose reductions and possibly antibiotic resistance may affect later cycles. Per cycle FE rates are calculated as the proportion of observed cycles in which an event occurs.
  • Rates of hospitalization for the treatment of suspected infection (HTSI) also were analyzed. HTSI occurred in a subset of patients with FEs and also in some patients not meeting the trial criteria for an FE.
     

Results

119 of 784 (15.2%) control group participants had at least one FE during chemotherapy.

Treatment benefit of quinolone prophylaxis was present across all cycles.

As reported in a 2005 article by the authors, the per-patient FE rate was 10.8% (84 of 781) for patients receiving levofloxacin compared with 15.2% for patients receiving placebo (119 of 784), giving a statistically significant reduction in the risk of FE (odds ratio = 0.67; 95% confidence interval [0.5, 0.91]; p =0.009).

For the first cycle only, the per-patient FE rate was 3.5% in patients receiving levofloxacin compared with 7.9%  in controls (odds ratio = 0.42; 95% confidence interval [0.26, 0.66]; p =0.0001),  whereas for non–first cycles, the per-patient FE rate was 7.8% (61 of 781) and 9.8%  (77 of 784), respectively (odds ratio = 0.78; 95% confidence interval [0.55, 1.11]; p = 0.16).

Conclusions

Per-cycle FE rates in cycle 2 and cycles 2–6 indicate that prophylactic benefit is gained in the small number of patients who experience an FE in cycle 1, but not in the much larger group of patients who do not experience an FE in cycle 1.

The data suggest that the benefit of antibiotics is greatest in those who experience an FE in cycle 1 because they are at higher risk of developing an FE in subsequent cycles compared with patients who do not develop an FE in cycle 1.
 

Limitations

  • Secondary analysis
  • The primary outcome is the incidence of FEs rather than documented infections, and a reduction in documented infections may be a more meaningful endpoint.
  • The sample is at low risk for febrile neutropenia. An important consideration for low-risk patients with short durations of neutropenia is whether quinolone prophylaxis is of greater benefit than the option of outpatient quinolone treatment for fever and neutropenia, should it occur. Both the National Comprehensive Cancer Network and the Infectious Diseases Society of America recommend oral quinolone-based regimens as outpatient empirical therapy for neutropenic fever in adults meeting criteria for low risk for complications.
  • Use of quinolone prophylaxis may preclude later use of the regimens as empirical therapy for neutropenic fever in the same patient. Guidelines on outpatient management of adults with neutropenic fever assume that quinolones were not used as prophylaxis and the use of quinolones for prophylaxis precludes their use for treatment.
     
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Cui, Z., Xin, M., Yin, H., Zhang, J., & Han, F. (2015). Topical use of olive oil preparation to prevent radiodermatitis: Results of a prospective study in nasopharyngeal carcinoma patients. International Journal of Clinical and Experimental Medicine, 8, 11000–11006. Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4565279/

Study Purpose

To evaluate the effect of olive oil on radiodermatitis

Intervention Characteristics/Basic Study Process

Patients were randomly assigned to the olive oil group or the control group. Patients treated with olive oil used it three times daily beginning on the first day of radiation therapy (RT) and continued for two weeks after completion of RT. The control group used water in place of the olive oil. Both groups were instructed to gently wash with water alone or mild soap and water. Side effects were recorded by a dermatologist and radiologist who were blinded to the study group assignment.

Sample Characteristics

  • N = 94
  • MEAN AGE = 55.9 years
  • MALES: 93.6%, FEMALES: 6.4%
  • KEY DISEASE CHARACTERISTICS: All had nasopharyngeal cancer, and most were stage III.
  • OTHER KEY SAMPLE CHARACTERISTICS: All were receiving high-dose RT (total dose = 70 Gy) with weekly cisplatin and docetaxel. Intensity-modulated radiation therapy (IMRT) was used in two Gy daily fractions for seven weeks.

Setting

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

Phase of Care and Clinical Applications

PHASE OF CARE: Active antitumor treatment

Study Design

Single-blind, randomized, controlled trial

Measurement Instruments/Methods

  • Radiation Therapy Oncology Group (RTOG) skin scoring
  • Visual analog scales (VASs) for itching, pain, and burning (0–10)

Results

Grade I and II skin reactions occurred in 93.6% of those using olive oil and 72.3% of those using water. Grade III reactions were seen in 6.4% of those in the experimental group and 27.7% of those in the control group (p < 0.01). Symptoms from VAS scores were also lower in the experimental group (p < 0.01). No patients developed grade IV skin toxicity.

Conclusions

Olive oil appeared to provide some protection against the development of severe radiodermatitis compared to cleansing and water alone.

Limitations

  • Small sample (< 100)
  • Measurement/methods not well described
  • Whether all symptoms were on a single VAS score and the frequency of that scoring were unclear. 
  • Whether patients were instructed not to use any other skin treatments was not stated.

Nursing Implications

Prophylactic use of topical olive oil may provide protection from the development of more severe radiodermatitis. Results of this study provide promising results. Further research to confirm these findings would be beneficial.

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Cuesta-Vargas, A.I., Buchan, J., & Arroyo-Morales, M. (2014). A multimodal physiotherapy programme plus deep water running for improving cancer-related fatigue and quality of life in breast cancer survivors. European Journal of Cancer Care, 23, 15–21.  

Study Purpose

To assess feasibility and effectiveness of aquatic-based exercise in the form of deep water running as part of a multimodal physiotherapy program for breast cancer survivors in an effort to decrease cancer-related fatigue

Intervention Characteristics/Basic Study Process

Eight week program of one hour sessions, three times per week, of multimodal physiotherapy program combined with deep water running delivered by physiotherapists in groups of 8–10 participants. Each session included 30 minutes of land-based exercise, followed by 20 minutes of deep water running.

Sample Characteristics

  • N = 42  
  • MEAN AGE = 47.27 years for the intervention group and 48.67 years for the control group
  • FEMALES:100%
  • KEY DISEASE CHARACTERISTICS: Patients were within one year of breast cancer diagnosis, were aged 25–65 years, and post-cancer treatment within past six months.
  • OTHER KEY SAMPLE CHARACTERISTICS: Patients were excluded if they had a fear of aquatic exercise.

Setting

  • SITE: Multi-site  
  • SETTING TYPE: Outpatient  
  • LOCATION: Two primary care centers in Andalusia, Spain

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment

Study Design

  • Non-randomized study with a wait-list control group 
  • Outcomes were measured/evaluated by one assessor who was blinded to participant group allocation.

Measurement Instruments/Methods

  • Piper Fatigue Scale–Revised
  • SF-12 Health Survey
  • European Quality of Life (five dimensions)
  • European Visual Analog Scale

Results

Statistically significant differences in fatigue were found between groups after eight weeks, with the intervention group reporting greater improvement in behavioral severity, affective/meaning, and sensory fatigue.

Conclusions

Demonstrated positive effects of exercise on cancer-related fatigue. Supports prior studies that demonstrated greater improvement combining educational and exercise programs

Limitations

  • Small sample (< 100)
  • Risk of bias (no random assignment)
  • Intervention expensive, impractical, or training needs existed
  • No long-term follow-up

Nursing Implications

This is a difficult program to replicate, but it appears that it is likely to be effective in reducing cancer-related fatigue.

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Cubero, D.I., & del Giglio, A. (2010). Early switching from morphine to methadone is not improved by acetaminophen in the analgesia of oncologic patients: A prospective, randomized, double-blind, placebo-controlled study. Supportive Care in Cancer, 18, 235–242.

Study Purpose

To evaluate the efficacy of methadone as a substitute for morphine, and to investigate whether the addition of acetaminophen improves pain control in switching to methadone

Intervention Characteristics/Basic Study Process

Patients using morphine for oncologic pain who were on a stable dose for at least one week were recruited. Patients were rapidly switched to oral methadone without a transition period and randomized to receive acetaminophen or placebo with methadone for seven days. The daily morphine dose was converted to methadone in ratios according to the total daily morphine dose. In case of additional pain, patients were instructed to use extra methadone no more than every two hours using a dose equal to 25% of the total daily dose. Use of coanalgesics such as anti-inflammatory drugs, antidepressants, and neuroleptics was allowed. Pain intensity was evaluated daily and recorded by patients in a diary along with all analgesic medications used. Patients were followed for seven days.

Sample Characteristics

  • The study reported on 49 patients.
  • Median patient age was 58.5 years (range = 19–81 years).
  • The sample was 53% male and 47% female.
  • Various tumor types were cited, with the most frequent being colorectal, breast, and lung.
  • Eighty-eight percent of patients had non-neuropathic pain.
  • Median pain intensity at baseline was 5 in the acetaminophen group and 3.5 in the placebo group. Median morphine daily dose at baseline was 60 mg, with a range of 40–540 mg.

Setting

  • Single site
  • Outpatient setting
  • Brazil

Study Design

The study design was double-blind, randomized, placebo-controlled for use of acetaminophen, and open label for switch to methadone.

Measurement Instruments/Methods

  • Numeric rating scale (0–10)
  • Faces pain rating scale
  • Four-point rating scale for side effects
  • European Organization for Research and Treatment Cancer Core Quality of Life questionnaire (EORTC QLQ-C30)

Results

Of the original study sample, 16% ended participation early due to treatment failure with intense pain, somnolence, or vomiting. Most patients who completed the study had a significant improvement in pain by the faces (p = 0.05) and numeric (p = 0.03) rating scales. There were no differences between patients who did and did not receive acetaminophen.

Conclusions

Study findings show that most patients can be switched from morphine to methadone with no transition period, with some improvement in side effects of constipation and xerostomia and adequate pain control. The addition of acetaminophen in this process was of no benefit.

Limitations

  • The study had a small sample, with less than 100 participants.
  • No data were provided on total opioid consumption or use of rescue doses during the study.
  • The study period was very short, and even within this time frame, 16% experienced treatment failure with methadone.
  • No information was provided on actual use of adjuvant medications for pain control.

Nursing Implications

This study shows that patients can be rapidly switched from morphine to methadone; however, this approach failed in 16% of patients. Methadone may be associated with less constipation and dry mouth, and may be a good pain control option for patients with these problems. Acetaminophen did not improve pain control with this switching process.

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