Balk, J., Day, R., Rosenzweig, M., & Beriwal, S. (2009). Pilot, randomized, modified, double-blind, placebo-controlled trial of acupuncture for cancer-related fatigue. Journal of the Society for Integrative Oncology, 7, 4–11.
To obtain feasibility and effect size data for the intervention of true acupuncture on cancer-related fatigue (CRF) in patients receiving radiation therapy.
Participants were randomized to receive acupuncture or sham acupuncture; there were three real intervention assignments for every two sham assignments. Needles were in place for 30 minutes per session, and participants had treatments once or twice per week during the four to six weeks of the trial. Needle placement for true and sham interventions were specifically described in the report.
The study was a double-blind, placebo-controlled, randomized trial.
FACIT-F scores in the true acupuncture group improved more over time than those in the sham group, but the differences were not significant. QOL and depression scores improved in both groups over time significantly but were not different between the groups. Observations regarding feasibility during the study included: there was difficulty getting patients enrolled; changes in staff, staffing, and procedures made protocol use difficult; and due to procedures to maintain blinding and use of sham procedures, therapists felt that there was less needle manipulation possible with the protocol used for true acupuncture and felt it was difficult to determine the actual depth of needle insertion. It was also felt that the sham procedure was actually more than sham, although less than true acupuncture, due to skin and pressure stimulation.
It was concluded that feasibility to conduct this type of trial in a large group of patients was low. Findings of this study did not support the use of acupuncture to reduce fatigue in patients receiving radiation therapy.
Baldwin, C., Spiro, A., Ahern, R., & Emery, P.W. (2012). Oral nutritional interventions in malnourished patients with cancer: A systematic review and meta-analysis. Journal of the National Cancer Institute, 104, 371–385.
STUDY PURPOSE: To examine the effect of oral nutritional interventions on outcomes among patients with cancer
Analysis indicates that oral nutritional interventions were associated with significant improvement in dyspnea and appetite symptom scales. It is unclear what the specific impacts of dietary counseling versus oral nutritional supplements were on these outcomes.
Nutritional interventions such as dietary counseling and oral nutritional supplementation may be helpful in managing symptoms of dyspnea and anorexia in patients cancer. Evidence does not provide strong support due to variability in timing of interventions, the exact nature of the interventions, actual nutritional status of patients included, and the timing of outcome data measurement. Nutritional interventions such as dietary counseling and oral nutritional supplement are low-risk interventions that may be helpful for some patients. Well-designed research and reporting in this area would be helpful to guide practice.
Balducci, L., Al-Halawani, H., Charu, V., Tam, J., Shahin, S., Dreiling, L., & Ershler, W.B. (2007). Elderly cancer patients receiving chemotherapy benefit from first-cycle pegfilgrastim. Oncologist, 12, 1416–1424.
The purpose of the study was to compare the proportion of elderly patients with febrile neutropenia while receiving pegfilgrastim from the first cycle of chemotherapy (proactive) with the proportion with febrile neutropenia using the current practice of receiving pegfilgrastim after observed severe neutropenia or neutropenia-related events.
Patients randomized to either proactive pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion staring with cycle one) or secondary prophylaxis with pegfilgrastim (subcutaneous injection 6 mg one time per cycle 24 hours after chemotherapy completion starting after cycle one) at physician’s discretion.
Multiple outpatient settings in community cancer center across the United States.
Phase IV, open-label, randomized, controlled trial.
For the reduction of febrile neutropenia, pegfilgrastim in all chemotherapy cycles was statistically significantly better than use of pegfilgrastim at the physician’s discretion for both solid tumors (p = 0.001) and non-Hodgkin lymphoma (p = 0.004). Pegfilgrastim throughout cycles showed better results than physician discretion for fewer events of grade 3 or 4 neutropenia, hospitalizations and antibiotic use for both solid tumor and non-Hodgkin groups, and for less dose delay and dose reduction in the solid tumor group.
The most common adverse events related to pegfilgrastim was arthralgia.
Pegfilgratim use in older adults undergoing chemotherapy appears safe and effective with use starting in the first cycle for the reduction of neutropenia, febrile neutropenia, grade 3 or 4 neutropenia, hospitalizations, and antibiotic use.
The study was not blinded. Fewer patients with non-Hodgkin lymphoma were able to be randomized to the discretion arm since physicians often wanted pegfilgrastim started early in these patients due to known neutropenic outcomes. It also was unclear as to the amount of pegfilgrastim delivered in the physician discretion arm.
The administration of pegfilgrastim starting with the first cycle of chemotherapy may reduce neutropenic events and related complications in older adults with cancer. Nurses can be at the forefront of advocating for this therapy, administering it, and monitoring patients for effective outcomes and/or adverse events.
Balagula, Y., Garbe, C., Myskowski, P.L., Hauschild, A., Rapoport, B.L., Boers-Doets, C.B., & Lacouture, M.E. (2011). Clinical presentation and management of dermatological toxicities of epidermal growth factor receptor inhibitors. International Journal of Dermatology, 50, 129–146.
To describe the underlying mechanisms, clinical presentation, National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) (version 4.0) severity grading, and strategies to prevent and manage epidermal growth factor receptor inhibitor (EGFRI)-associated skin side effects, emphasizing evidence based practice approaches.
The type of patients addressed was those receiving EGFRIs, including monoclonal antibodies (e.g., cetuximab, panitumumab) and low-molecular-weight tyrosine kinase inhibitor (e.g., gefitinib, erlotinib, lapatinib).
The search strategy in this expert opinion article was not defined.
The article provided a table with results from four randomized controlled trials. Algorithms for the treatment of papulopustular rash, xerosis, hyperpigmentation, and paronychia were provided. Each algorithm was based on the grading defined in the NCI CTCAE (version 4.0, May 2009).
General Skin Reactions
Preventative:
Rash
Preventative:
Treatment:
Xerosis
Prevention:
Treatment:
Hyperpigmentation
Prevention:
Treatment:
Paronychia
Prevention:
Treatment:
This expert opinion article cannot be considered a consensus guideline because it lacks clear comprehensive search and design strategies, clear evaluation of evidence, and a description of the method used to apply that evidence in the development of the recommendation.
A variety of interventions have been studied to prevent or manage various EGFRI-induced skin reactions, including papulopustular rash, xerosis, hyperpigmentation, and paronychia. Although 76 references were cited, this is an expert opinion article based on the lack of clear comprehensive search and design strategies, unclear evaluation of the evidence, and lack of description of the method to apply that evidence in development of the recommendation.
The authors commented on the lack of evidence-based practice recommendations for preventing and managing skin reactions caused by EGFRIs. The authors stated, “The overall lack of adequate data from prospective RCTs and lack of evidence-based standardized guidelines is reflected by differences in treatment methods utilized by clinicians.” The authors also stated, “The relative paucity of clinical data arising from prospective, large, and placebo-controlled randomized controlled trials has been the major limitation of the currently available treatments.”
Considering the frequent use of EGFRIs, healthcare providers should be familiar with these toxicities, as well as available prevention and management strategies.
Implications for nursing practice include using the tables and algorithms in this article as practical tools to prevent or manage several types of EGFRI-induced skin reactions.
Bala, I., Bharti, N., Chaubey, V.K., & Mandal, A.K. (2012). Efficacy of gabapentin for prevention of postoperative catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor. Urology, 79, 853–857.
To evaluate the effect of 600 mg and 1200 mg oral gabapentin pretreatment for the prevention of postoperative catheter-related bladder discomfort (CRBD) in patients undergoing catheterization after transurethral resection of bladder tumor (TURBT)
Patients were randomized to three groups. Group I received four placebo capsules. Group II received two capsules of 300 mg gabapentin and two identical placebo capsules. Group III received four capsules of 300 mg gabapentin. All patients received the study drug orally, with sips of water, one hour prior to administration of anesthesia. Lumbar subarachnoid block was administered with 2.5 ml 0.5% hyperbaric bupivacaine. An anesthesiologist unaware of group assignment observed patients in the Postanesthesia Care Unit (PACU) at 1, 2, 4, 6, 12, and 24 hours.
Active antitumor treatment
Randomized controlled double-blind trial
Pretreatment with gabapentin reduces bladder discomfort in patients with an indwelling postoperative catheter. Gabapentin 1200 mg is more effective than gabapentin 600 mg in decreasing the incidence and severity of CRBD.
To decrease the postoperative discomfort of patients undergoing catheterization after transurethral resection of bladder tumor, nurses may want to advocate for the preoperative use of 1200 mg gabapentin.
Bakhshi, S., Batra, A., Biswas, B., Dhawan, D., Paul, R., & Sreenivas, V. (2015). Aprepitant as an add-on therapy in children receiving highly emetogenic chemotherapy: A randomized, double-blind, placebo-controlled trial. Supportive Care in Cancer, 23, 3229–3237.
To evaluate the efficacy of aprepitant in treating chemotherapy-induced vomiting when given as an additional antiemetic to children receiving highly emetic chemotherapy
All patients received ondansetron at 0.15 mg/kg IV then dexamethasone at 0.15 mg/kg IV 30 minutes prior to chemotherapy. Oral ondansetron was given at 0.3 mg/kg every eight hours, and oral dexamethasone at 0.15 mg/kg was given every eight hours until 48 hours after the completion of chemotherapy. In the treatment group, patients weighing 15–40 kg received aprepitant capsules of 80 mg for one hour before chemotherapy on days 1–3, and patients weighing 41–65 kg received 125 mg on day 1 then 80 mg on days 2–3. The control group received placebo capsules.
Randomized, double-blinded, placebo-controlled study
In the acute phase, significantly less moderate and severe vomiting occurred in treatment group compared to the control group (38% versus 72%, p = 0.001). There was a significantly higher rate of complete response in the treatment group compared to the control group (48% versus 12%, p < 0.001). There was significantly less food and fluid intake in the control group than the treatment group (p = 0.04 and p = 0.03, respectively). In the delayed phase, there was no significant difference between the treatment and control groups in regard to moderate or severe vomiting or complete response. There was significantly less fluid intake in the control group versus the treatment group (p = 0.002), but there was no difference in food intake. In the overall phase, there were no grade 3 or 4 adverse events, and there was no difference in the number of rescue medications used in the groups. The incidence of febrile neutropenia was the same between the treatment and control group.
Oral aprepitant appeared to be safe, and no major adverse events were reported. It significantly reduced vomiting in the acute phase of highly emetic chemotherapy treatment when given in combination with ondansetron and decadron in a pediatric population. However, it did not help in the delayed phase.
Oral aprepitant may decrease vomiting in pediatric patients during the acute phase of highly emetic chemotherapy, but more studies are needed.
Baker, D.E. (2007). Lubiprostone: A new drug for the treatment of chronic idiopathic constipation. Reviews in Gastroenterological Disorders, 7, 214–222.
In phase III, placebo-controlled studies, lubiprostone 24 mcg twice daily was compared to placebo. Studies 1, 2, and 3 comprised a two-week drug-free period followed by treatment with lubiprostone 24 mcg twice daily for four weeks, followed by randomization to continue lubiprostone or placebo.
Open-label studies used lubiprostone 24 mcg twice daily. Three studies of long-term clinical safety assessed lubiprostone administered for 12 months in patients with chronic idiopathic constipation.
Phase III Studies
Open-Label Studies
Study 1 and 2
Study 3
Open-Label Studies
Placebo-controlled RCTs demonstrated lubiprostone was well tolerated and not associated with severe adverse effects. However, incidence of nausea was higher. Comparative studies with other therapies are needed.
Bahrami, M., & Farzi, S. (2014). The effect of a supportive educational program based on COPE model on caring burden and quality of life in family caregivers of women with breast cancer. Iranian Journal of Nursing and Midwifery Research, 19, 119–126.
To determine the effects of a supportive educational program based on the COPE model on caring burden and quality of life in family caregivers of women with breast cancer
Caregivers randomly were assigned to the experimental or control group. The experimental group had two educational sessions within the first nine days of caregiving and had a follow-up phone call between these two sessions. The education included problem solving, goal setting, learning how to get help for problem solving, and review and discussion of problems faced and actions taken. Study assessments were completed at baseline and at 30 days after study entry. Instruments were completed by questioning.
Quality-of-life scores after the intervention were higher in the experimental group in physical (p = .001), psychological (p = .017), and environmental (p -.047) domains, and overall (p < .001). Burden was significantly lower after the intervention in the experimental group (p < .001). In the experimental group, burden declined and scores in all quality-of-life measures improved, while burden scores increased and quality-of-life scores declined in the control group.
Findings showed that the program implemented was associated with improved quality of life and reduced caregiver burden.
Findings suggest that a supportive, psychoeducational intervention was beneficial to caregivers with improvement in quality of life and reduction in caregiver burden. Nurses can assist caregivers in working with them around problem solving, goal setting, and provision of supportive interactions. The intervention consisted of two educational sessions and one phone call in a one-month period.
Bae, H., & Kim, H.J. (2013). Clinical outcomes of extracorporeal shock wave therapy in patients with secondary lymphedema: A pilot study. Annals of Rehabilitation Medicine, 37, 229–234.
To research the effect of extracorporeal shock wave therapy (ESWT) in patients who had secondary lymphedema after treatment for breast cancer
In this study, ESWT was performed four times over two weeks. Four patients received manual lymphatic massage and pneumatic compression along with ESWT, and three patients received only ESWT. The three participants did not receive massage or compression because they reported that it was not successful in the past. It does not seem that there was a follow-up after the post-treatment measurements on patients.
To determine lymphedema presence, a limb-to-limb difference of 2 cm or more had to exist at a single measurement site in addition to lymphatic obstruction as determined lymphoscintigraphy. The following subjective measurements were used: hardness of the skin, edema of the involved upper extremity, and sensory impairment. Each was measured using visual analog scale (VAS), with 10 points being most severe. Objective measurements used were volume of the upper extremity, thickness of the skin, and circumference of the upper extremity. Volume measurement was a direct technique was used as derived from Archimedes’ principle.
All patients experienced a reduction after four treatments of ESWT. The mean reduction volume was 188.6 ml (p = .018). Those who received physical therapy and ESWT showed a reduction rate of 39.46%, and those without physical therapy showed a rate of 34.25%. The difference was not significant. The mean decrease in circumference was 1.1 cm, with a range of 0.4–1.7 cm.The mean decrease in skin fold was 7.7 mm, with a range of 4–16 mm. The mean subjective edema was decreased significantly from 7.3 to 5.6 (p = .027). No patients experienced side effects.
ESWT appears to be effective in treating stage III secondary lymphedema in women after being treated for breast cancer. The circumference and thickness of patients' arms decreased after treatment. However, the sample size is very small and therefore is not representative of a diverse population of people.
ESWT treatment may provide a noninvasive treatment alternative for patients with stage III lymphedema that has a high rate of effectiveness.
Badr, H., Smith, C.B., Goldstein, N.E., Gomez, J.E., & Redd, W.H. (2015). Dyadic psychosocial intervention for advanced lung cancer patients and their family caregivers: Results of a randomized pilot trial. Cancer, 121, 150–158.
To test the initial efficacy, acceptability, and feasibility of a dyadic (patient–caregiver) psychosocial, phone-delivered intervention to improve the quality of life of the families of patients with advanced lung cancer within one month of the first cancer treatment
The dyads were randomly assigned to a usual medical care (UMC) or a six-week intervention group. Intervention patients and caregivers received separate standardized, tailored manuals. Manuals addressed self-care, stress and coping, symptom management, effective communication, problem solving, and maintaining and enhancing relationships. Patients and caregivers shared half of the topic information, but other content was tailored to the patient or caregiver role. Patients-tailored content included ways to balance autonomy with asking for and accepting support, sharing support needs, and ways to show caregiver appreciation. Caregiver-tailored content included ways to minimize patient overprotection, show effective communication, and ways to support patient self-care goals. Intervention dyads participated in six weekly 60-minute telephone counseling sessions aimed at alleviating caregiver burden with a trained interventionist who reviewed weekly patient and caregiver homework and manual content. The interventionist mentored participants through sessions and homework assignments to reinforce session skills for patients and caregivers. Participants in UMC and intervention groups completed six paper-and-pencil surveys at baseline and eight-weeks after baseline.
Randomized clinical trial
The study's recruitment rate was 60%, which is comparable to rates reported in other telephone-based cancer dyadic interventions, supporting the feasibility of recruiting advanced LC patients on active treatment and their caregivers for this trial. Patient and caregiver telephone-session participation was 90%. Participants rated the intervention as relevant, convenient, and helpful. Retention was excellent, and dyads completed the majority (88%) of homework assignments. This suggests a highly acceptable intervention. Large effect sizes were found for the impact of the intervention on outcomes of patient and caregiver depression, anxiety, and caregiver burden as contrasted with UMC group outcomes. Large effect sizes for impact of the intervention were also found for additional patient and caregiver outcomes relevant to competence and relatedness and caregiver free choice to provide patient care. Highly depressed and anxious caregivers, identified at the baseline assessment in the intervention group, showed greater improvements in psychological functioning than did those in the UMC group.
This pilot study demonstrated the feasibility and acceptance of a six-session, telephone-based dyadic psychosocial intervention developed for patients with advanced lung cancer and their caregivers and its positive effects on their rates of depression, anxiety, and caregiver burden.
Telephone-based interventions addressing patients with late-stage lung cancer and their caregivers may improve overall dyadic quality of life. This study indicated support for separate patient and caregiver sessions to address private issues posing challenges in a dyadic discussion. Additional research focused on separate sessions balanced with dyadic sessions may strengthen the evidence for telephone interventions.