Flank, J., & Dupuis, L.L. (2014). Comparative effectiveness research in antineoplastic-induced nausea and vomiting control in children. Journal of Comparative Effectiveness Research, 3, 185–196.
PHASE OF CARE: Active antitumor treatment
APPLICATIONS: Pediatrics
Two studies addressed the comparative pediatric evidence related to the selection of a 5HT3 receptor antagonist. One study found a complete control rate of nausea and vomiting of 30% with tropisetron (8 out of 27) and 32% with granisetron (7 out of 22). The other study found a complete control rate of 61% with granisetron (20 out of 33) and 45.5% (15 out of 33) with ondansetron. Three other studies showed improved control of AINV when a corticosteroid was used with a 5HT3 receptor antagonist versus an antiemetic alone in patients receiving highly emetogenic chemotherapy (HEC). Another comparison between the use of IV versus oral 5HT3 receptor antagonists found equivalent effectiveness when used for HEC or moderately emetogenic chemotherapy (MEC).
Because of inconsistencies in the the research studies' methodologies related to pediatric AINC, there were few comparative effectiveness research (CER) examples. The evidence available to support guidelines is of low quality, and many research gaps exist. Barriers related to CER in pediatric AINV include patient factors, discrepancies related to research design, and definitions of complete control, outcomes, and outcome measures.
Insufficient evidence to develop comprehensive guidelines or for CER for AINV control in pediatric patients
Research related to pediatric AINV control is very limited and lacks in quality for comparison. The conclusions ascertained from this article were that children who used a corticosteroid with a 5HT3 receptor antagonist experienced increased efficacy of AINV control, and both IV and oral routes of these drugs have similar efficacy when used with HEC and MEC.
Flank, J., Thackray, J., Nielson, D., August, A., Schechter, T., Alexander, S., . . . Dupuis, L.L. (2015). Olanzapine for treatment and prevention of acute chemotherapy-induced vomiting in children: A retrospective, multi-center review. Pediatric Blood and Cancer, 62, 496–501.
To explore the efficacy and safety of olanzapine in children aged 3–17 years for chemotherapy-induced vomiting (CIV) control
This was a retrospective review of 60 children (158 chemotherapy blocks) who received olanzapine for acute CIV control at institutions in Canada and the United States over a 30-month period. All CIV data were abstracted from the childrens' health records.
Retrospective chart audit
Sixty children were given olanzapine in 128 blocks of chemotherapy on the first day of chemotherapy (usually highly emetogenic chemotherapy). Children in 125 of the 128 blocks received ondansetron or granisetron, dexamethasone (55%), or aprepitant (18%). Acute-phase CIV control was obtained in 83 (65%) blocks. There was no association between complete response and the olanzapine dose. The most commonly reported side effects were sedation (7%) and increased plasma transaminase concentrations (5%).
Olanzapine may be a useful option for CIV control in pediatric patients. However, the findings from this study were inconclusive regarding clinical efficacy.
Nurses caring for children with acute CIV should know that olanzapine in a well-monitored situation may be a safe alternative. However, its efficacy was unclear in this study. A prospective study to determine the role of olanzapine alone and in combination with other antiemetics for varied levels of emetogenicity is warranted.
Flank, J., Robinson, P.D., Holdsworth, M., Phillips, R., Portwine, C., Gibson, P., . . . Dupuis, L.L. (2016). Guideline for the treatment of breakthrough and the prevention of refractory chemotherapy-induced nausea and vomiting in children with cancer. Pediatric Blood and Cancer, 63, 1144–1151.
RESOURCE TYPE: Evidence-based guideline
Five thousand nine hundred ninety-three citations were retrieved, and 59 studies were included—13 for breakthrough CINV and 46 for refractory CINV. Very limited evidence in children existed, of which much was weak, as well as evidence regarding the safety and optimal dosages of breakthrough medications, such as metoclopramide and methotrimeprazine, for children.
The review and guideline development process were conducted very well, but limitations include the lack of sufficient evidence for interventions in pediatric patients. Even those recommendations that were presented as strong recommendations were noted to be based on weak evidence.
This guideline provides specific recommendations for alterations in CINV prophylaxis to address breakthrough and refractory CINV in children. It has also exposed research gaps in the areas of efficacy of prophylaxis escalation, optimal dose, efficacy and safety of olanzapine, methotrimeprazine and metoclopramide, optimal palonosetron dose with multiple day chemotherapy, and the extent and clinical significance of interactions between aprepitant and chemotherapy. Safety of metoclopramide in children related to side effects of extrapyramidal symptoms is also questioned.
FitzHenry, F., Wells, N., Slater, V., Dietrich, M.S., Wisawatapnimit, P., & Chakravarthy, A.B. (2013). A randomized placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients undergoing radiation therapy. Integrative Cancer Therapies, 13, 105-113.
To compare weekly healing touch to weekly sham therapy on fatigue in women receiving radiation therapy for breast cancer
Participants were randomized to receive either weekly healing touch or weekly sham therapy. Participants were blinded to group assignment. Each session was 45 minutes in length. Participants either wore a neck drape or blindfold so as not to see how the treatment was delivered.
Depression was positively correlated with fatigue measures. Anxiety was positively associated with fatigue interference. Healing touch participants reported higher levels of fatigue throughout study than control participants. The control group reported greater reduction in fatigue than did the healing touch group.
This pilot study demonstrated that the intervention was feasible. However the study did not demonstrate any benefit in reduction of fatigue in this small sample.
Healing touch is not harmful to patients, but this small study does not support its use to reduce fatigue in women receiving radiation therapy for breast cancer.
Fisher, J., Scott, C., Stevens, R., Marconi, B., Champion, L., Freedman, G. M., … Wong, G. (2000). Randomized phase III study comparing best supportive care to Biafine as a prophylactic agent for radiation-induced skin toxicity for women undergoing breast irradiation: Radiation Therapy Oncology Group (RTOG) 97–13. International Journal of Radiation Oncology, Biology, Physics, 48, 1307–1310.
To determine if Biafine was more effective than best supportive care (BSC) in preventing or reducing radiation (RT)-induced dermatitis.
Randomizaton to Biafine versus BSC depended on the institution and included aloe, Aquaphor, other interventions, and no treatment.
Patients were stratified by bra size: small (32ab, 34ab, 36a), medium (32c, 34c, 36bc, 38abc), or large (all others).
The study was a randomized, controlled trial.
Fisher, M.I., Donahoe-Fillmore, B., Leach, L., O'Malley, C., Paeplow, C., Prescott, T., & Merriman, H. (2014). Effects of yoga on arm volume among women with breast cancer related lymphedema: A pilot study. Journal of Bodywork and Movement Therapies, 18, 559-565.
PURPOSE: To study the effects of yoga on limb volume in women with breast cancer-related lymphedema
SECONDARY OBJECTIVES: To determine the effects of eight weeks of yoga on quality of life, self-reported arm function, and grip strength
Participants attended eight weeks of Hatha yoga three times a week. Participants went to the studio two times per week (60 minutes) and watched a prerecorded DVD at home (45 minutes) once per week. They all wore compression sleeves.
Pilot study with a pre- and postintervention design
It was too early to conclude that yoga benefits breast cancer-related lymphedema. Many variables may affect arm reduction such as body mass index and duration of disease. Participants had lymphedema for greater than seven years, and their lymphedema may have been less influenced by activity and therapy. It is likely that the length of the intervention is was long enough to affect quality of life.
Many evidenced-based guidelines encouraging exercise, including yoga, exist for the breast cancer patient population. However, there is a lack of data available regarding the effects of yoga on lymphedema. Nurses can confidently refer patients to an instructor-based program or a physical therapist for safe upper body exercise. More studies with rigorous designs are needed to examine the impact of yoga on patients with cancer-related lymphedema.
Fisher, B.T., Kavcic, M., Li, Y., Seif, A.E., Bagatell, R., Huang, Y.S., . . . Aplenc, R. (2014). Antifungal prophylaxis associated with decreased induction mortality rates and resources utilized in children with new-onset acute myeloid leukemia. Clinical Infectious Diseases, 58, 502–508.
To evaluate the effectiveness of antifungal prophylaxis in children with acute myeloid leukemia (AML)
Medical data for children newly diagnosed with AML were obtained from a database of hospitals associated with the Children's Hospital Association nationwide. Only patients with AML receiving induction therapy involving cytarabine, aunorubicin, and etoposide regimens were included. Patients were followed until inpatient death, loss to follow-up, or completion of induction. Data for antibiotic use, blood cultures, and chest CTs were obtained. Exposure to antifungal prophylaxis with any agent was obtained, and decision rules were used to ensure antifungals were used for prophylaxis rather than empiric therapy. Those who did not receive any antifungal agent during the first 21 days of induction chemotherapy were considered “no prophylaxis” patients. Outcomes were analyzed and compared for those who did and did not receive prophylaxis
Of those who did not get antifungal prophylaxis, 5.32% died during induction compared to 2.42% of those receiving prophylaxis (RR = 0.42, 95% CI [0.19, 0.9]). Those receiving prophylaxis had less use of antibiotics and fewer blood cultures and CT scans. There was no significant difference in mortality between those receiving anti-mold prophylaxis and others.
Findings show that primary antifungal prophylaxis was associated with lower mortality and utilization of resources during induction for AML among pediatric patients.
Findings suggest that primary antifungal prophylaxis among pediatric patients may reduce mortality and resource utilization. These findings support the use of antifungal prophylaxis among at-risk pediatric patients.
Fish, J.A., Ettridge, K., Sharplin, G.R., Hancock, B., & Knott, V.E. (2014). Mindfulness-based cancer stress management: Impact of a mindfulness-based programme on psychological distress and quality of life. European Journal of Cancer Care, 23, 413–421.
To explore the impact of mindfulness-based cancer stress management (MBCSM) programs on depression, anxiety, and stress in individuals affected by cancer with a secondary aim to evaluate the impact of MBCSM on quality of life and spiritual well-being
Four MBCSM programs were run for clients experiencing psychological distress related to cancer diagnoses. Each group consisted of 9–13 participants. The program consisted of eight, two-hour, weekly sessions in which mindfulness exercises were provided by an experienced counselor trained in mindfulness-based cognitive therapy. Participants also were asked to complete 40 minutes of meditation per day with the aid of notes, practice CDs, and home worksheets. A three-hour follow-up session was offered six weeks after the completion of the program. The program was modified to incorporate elements of the mindfulness-based stress reduction program developed by Jon Kabat-Zinn in 1990. Session 4 specifically included education about the psychoneuroimmunology of stress and an exploration of the cancer survivorship experience within the context of anxiety, depression, and stress.
Single-group, quasiexperimental study of participants directly and indirectly affected by cancer
Exploratory analysis indicated that there were no significant differences between baseline scores across sociodemographic groups. A series of Friedman tests indicated that there were significant differences in the levels of global psychological distress over time. Scores were significantly higher at baseline than postintervention for levels of global distress, anxiety, and depression. Global quality of life and spiritual well-being improved significantly over time. Emotional well-being and functional well-being were significantly higher postintervention than at the baseline assessment, which was maintained from baseline to follow-up (p = .001 and p = .001, respectively). Physical well-being improved from baseline to postintervention, which was determined to be significant at follow-up (p = .012). Mindfulness scores changed significantly over time. The level of mindfulness was significantly lower at baseline than postintervention, which was maintained through follow-up (p = .001).
Overall, the results of this study were positive with significant improvements in participants' levels of global distress, anxiety, and depression from baseline to postintervention. Improvements in psychological distress were sustained up to three months postintervention. This supports preliminary research on the effectiveness of mindfulness-based therapy in the treatment of cancer-related psychological distress.
Mindfulness training should be considered for patients with cancer to improve their levels of distress, anxiety, and depression. Mindfulness programs require trained personnel, and the program should involve an intervention over time with opportunity for follow-up over time.
Fiorentino, L., McQuaid, J. R., Liu, L., Natarajan, L., He, F., Cornejo, M., . . . Ancoli-Israel, S. (2009). Individual cognitive behavioral therapy for insomnia in breast cancer survivors: a randomized controlled crossover pilot study. Nature and Science of Sleep, 2010, 1–8.
To examine the effects of six individual cognitive-behavioral therapy (CBT) sessions on sleep.
Individual CBT treatment consisted of six, one-hour weekly sessions comprised of education, behavioral components (sleep restriction, stimulus control, adhering to the sleep hygiene rules, and training in progressive muscle relaxation techniques), and cognitive interventions to counteract maladaptive thought. It also included homework assignments (sleep diaries and practicing behavioral and cognitive strategies) followed by six weeks of no-treatment follow-up. Data were collected at baseline and at the end of the first and second six-week components, and daily diary data were recorded during the treatment phase.
Patients were undergoing the long-term follow-up phase of care.
This was a randomized, controlled, crossover pilot study.
After six weeks, objective data (actigraphy) showed statistically significant differences in change scores between the treatment condition group and the delayed treatment control condition group on total sleep time, wake after sleep onset, number of awakenings per night, and percent of time asleep. There was a significant decrease in insomnia in the treatment group compared to the control group. Follow-up at six weeks showed continued improvement with a clinically significant decrease in PSQI scores. Cohen’s d effect size estimate for PSQI was large (d = 0.8).
These preliminary results suggest that individual CBT is appropriate for improving sleep in survivors of breast cancer.
If found to be effective, the intervention is potentially useful in several different settings.
Finnegan-John, J., Molassiotis, A., Richardson, A., & Ream, E. (2013). A systematic review of complementary and alternative medicine interventions for the management of cancer-related fatigue. Integrative Cancer Therapies, 12, 276–290.
To appraise the evidence of the effectiveness of complementary and alternative medicine (CAM) interventions in reducing cancer-related fatigue (CRF).
Databases searched were Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, PsycINFO, British Nursing Index, and Evidence-Based Medicine Reviews (EBMR).
The specific MEDLINE search strategy was provided.
Studies were included in the review if
Studies were excluded from the review if they were psychosocial interventions.
In total, 2,398 references were retrieved. The Jadad scale was used to appraise study quality.
Patients were undergoing multiple phases of care.
During treatment, the intervention that seemed to be the most effective was hypnosis (one study), whereas ginseng provided promising results (one study). Massage, multivitamins, herbs, yoga, relaxation therapy, and combined education and acupuncture were less effective. Sound and reliable conclusions could not be drawn due to the poor quality of the studies and varying interventions, timings, and dosages. Most studies did not describe processes to ensure intervention integrity, and the “dose” was often not well reported.
Evidence from the trials reviewed was not sufficient to support the use of the interventions examined.
Current evidence suggests a very limited role of CAM to contribute to improvement in fatigue among patients with cancer.