Budin, W.C., Hoskins, C.N., Haber, J., Sherman, D.W., Maislin, G., Cater, J.R., . . . Shukla, S. (2008). Breast cancer: Education, counseling, and adjustment among patients and partners: A randomized clinical trial. Nursing Research, 57(3), 199–213.
To determine the effects of care phase-specific psychoeducation and telephone counseling on emotional, physical, and social adjustment of patients and partners, compared to standard treatment of disease management
Patients and partners were randomly assigned to one of four groups in dyads.
The partner involved was the person the patient identified as most intimately involved in the breast cancer experience. Care phases were defined as Time 0 (T0) (upon study entry), T1 (diagnostic—when the diagnosis of breast cancer was determined), T2 (postsurgical phase—two days after surgery), T3 (adjuvant therapy phase—when making decisions about therapy), and T4 (ongoing recovery—two weeks after completion of chemotherapy or radiation, or six months after surgery if no adjuvant therapy was done).
Patients' psychological well-being (p = 0.033) improved over time in all groups. There was also a significant difference in improvement over time depending on the study group assigned (group plus time effect) (p = 0.004). The TC group had the highest psychological well-being at the adjuvant therapy stage.
No significant effects were noted among partners. No significant effects related to distress from side effects among patients were noted in any group. For patients in the DM control group (group 1), significantly greater side-effect distress was noted compared to all treatment groups combined (p = 0.02). The side-effect severity for patients had a significant effect over time, and mean severity of side effects was significantly higher from baseline to T4 in the DM control group (p = 0.016). Partners in the SE and TC group (group 4) reported significantly fewer side effects than those in the TC-only group (group 3) (p = 0.017), and a significant overall effect of the intervention (p = 0.024) on physical symptoms was reported. Physical symptoms reported by partners did not demonstrate an effect from time. Partners' overall health scores were not affected, and patients' overall health improved over time for all groups (p < 0.0001). The intervention had no significant effect on vocational adjustment for patients, and in partners, both group assignment and time demonstrated significant main effects in analysis (p </= 0.05). Only time appeared to affect social adjustment.
Most outcomes for patients and partners improved over time, regardless of group assignment. The combination of standardized SE and TC as provided in the study was associated with improved psychological well-being across the timeframe of the study.
Both patient and partner reactions to breast cancer vary over time and tend to improve over time, and findings suggest that patient needs and issues vary at different phases in care, suggesting the need for different strategies and interventions according to the phase of care. SE and supportive counseling activities can be helpful to patients and caregivers in management of physical symptoms and side effects. TC intervention in combination with SE activities as provided by video, as in this study, may provide a practical alternative method to provide this type of intervention.
Buda, A., Ghelardi, A., Fruscio, R., Guelfi, F., La Manna, M., Dell'Orto, F., & Milani, R. (2016). The contribution of a collagen-fibrin patch (Tachosil) to prevent the postoperative lymphatic complications after groin lymphadenectomy: A double institution observational study. European Journal of Obstetrics, Gynecology, and Reproductive Biology, 197, 156–158.
To describe the effects of using a collagen fibrin patch on complications after inguinofemoral lymphadenectomy for gynecologic cancer
Outcomes in consecutive women who underwent groin dissection using the fibrin patch were compared to historical controls who did not use the patch. The same surgical teams performed the procedures. The patch used contained a collagen matrix coated with coagulation factors that cause adhesion between the patch and wound surfaces. Short-term postoperative results and long-term complications, such as cellulitis and late lymphedema, were compared between groups.
Observational with historical control comparison
Method of lymphedema determination or measurement is not described.
In the control group, 24% developed late lymphedema, compared to 4% of patients in the group that did not use the patch. No significant differences were observed between groups in the proportion of those who had mono- or bilateral dissections or the number of lymph nodes removed, although the fibrin patch group had a slightly lower number of lymph nodes removed and fewer underwent adjuvant radiotherapy.
The findings suggest that the use of the fibrin patch may be helpful to prevent some complications of lymphadenectomy; however, stronger research evidence is needed for evaluation.
Various surgical techniques are being examined for their effects on lymphedema-related outcomes after lymph node resections. Ongoing research is needed to determine the overall effectiveness of various techniques. Limited evidence exists for interventions to prevent and manage lower limb lymphedema.
Buchsel, P.C., & Murphy, P.J.M. (2008). Polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair®): a bioadherent oral gel for the treatment of oral mucositis and other painful oral lesions. Expert Opinion on Drug Metabolism and Toxicology, 4, 1449-1454.
PURPOSE: Review the benefit of polyvinylpyrrolidone-sodium hyaluronate gel (Gelclair) for oral mucositis
RESOURCE TYPE: Expert opinion
PHASE OF CARE: Active treatment
Various uses and mechanism of action of hyaluronic gel (Gelclair) are discussed. Six studies/articles are summarized. Only one article provided any significant findings. One other article related to oral mucositis was a case study. The author suggests that Gelclair may be a useful additional therapy to help with pain caused by oral lesions. It may contribute to improved drinking, eating, and swallowing, and may improve nutritional status and quality of life.
May be effective for pain related to mucositis
A large control trial is needed to increase the strength of recommending Gelclair. Evidence provided here is weak and very limited regarding examination of Gelclair for oral mucositis in patients with cancer.
Buchan, J., Janda, M., Box, R., Schmitz, K., & Hayes, S. (2016). A randomized trial on the effect of exercise mode on breast cancer-related lymphedema. Medicine and Science in Sports and Exercise, 48, 1866–1874.
To compare the effects of resistance versus aerobic exercise on lymphedema and fitness in women with breast cancer
Women were randomly assigned to exercise mode. Resistance exercise included a full-body strength training program with a gradual introduction of additional exercises for a total of 12 exercises by week 7. The aerobic group was involved in a range of exercises depending upon preference, such as walking, jogging, cycling, or swimming. Both groups were assigned to 150 minutes of supervised and unsupervised exercise each week at a metabolic equivalent of task (MET) level of 5 in weeks 7–12. Supervised one-on-one exercise sessions were held at the patients’ homes or other selected locations. Assessments were conducted at 12 and 24 weeks.
PHASE OF CARE: Late effects and survivorship
Randomized, two-group trial stratified by lymphedema stage
Ninety-two percent completed at least 75% of exercise sessions. No differences existed between groups or over time in lymphedema or associated symptoms. The aerobic group showed a decline in the number of symptoms at 12 weeks (–1.5 change in score, p = 0.05). Both groups improved upper body strength, and improvements were greater in the resistance exercise group (p < 0.01). Both groups had improved lower body strength and FACT-B measures.
Neither resistance nor aerobic exercise significantly improved objective measures of lymphedema. Both exercise modes were associated with improvement in fitness, strength, and quality of life.
Results from this study did not show that either resistance or aerobic exercise resulted in volume reduction of lymphedema. Both forms of exercise were associated with improved fitness, strength, endurance, and aspects of quality of life. Exercise has been shown not to increase lymphedema in several studies, and although it may not reduce lymphedema volume, it can be beneficial in other aspects. Nurses can educate patients to engage in physical activity and exercise.
Bucaneve, G., Micozzi, A., Menichetti, F., Martino, P., Dionisi, M.S., Martinelli, G., . . . Del Favero, A. (2005). Levofloxacin to prevent bacterial infection in patients with cancer and neutropenia. New England Journal of Medicine, 353, 977–987.
Adult patients with cancer whose chemotherapy-induced neutropenia (absolute neutrophil count [ANC] greater than 1,000) was expected to occur for more than seven days were treated with oral levofloxacin 500 mg or placebo from the start of chemotherapy until the resolution of neutropenia.
Primary endpoint:
Secondary endpoints:
the study was a prospective, multicenter, randomized, double-blind, placebo-controlled trial,
The incidence of fever (axillary temperature 38.5°C or higher, or 38°C at least twice during a 12-hour period) was 65% in the levofloxacin prophylaxis group versus 85% in the placebo group (p = 0.001). Microbiologically documented infection occurred in 22% of patients in the levofloxacin group and 39% of patients in the control group (absolute risk reduction 17%, 95% confidence interval [CI] [24, 10], p < 0.001).
In the levofloxacin group, the incidence of bacteremias (risk reduction 16%, 95% CI [22, 9], p < 0.001) and single-agent gram-negative bacteremias (risk reduction of 7%, 95% CI [10, 2], p < 0.01) was lower.
Death from infection occurred in 2.4% of patients in the levofloxacin group and 3.8% of patients in control group (p = 0.36).
The median duration of prophylaxis was 14 days for patients with solid tumors or lymphoma and 25 days for patients with leukemia.
Overall mortality was 3% in the levofloxacin group and 5% in the placebo group (p = 0.15). Infection-related mortality was 2% in the levofloxacin group and 4% in the placebo group (p = 0.36).
Compliance and reported adverse events were similar in both groups.
The prevalence of fluoroquinolone-resistant bacteremias was 41 of 339 (12%) in the levofloxacin group and 32 of 336 (9.5%) in the control group, but this result was not statistically significant.
The total cost of antibiotics per patient was less in the levofloxacin-treated group. The mean cost of antibiotics was €1,953 in the levofloxacin group and €2,841 in the control group.
Most of the patients had hematologic malignancies, so the study supports the use of antibacterial prophylaxis in this population. However, survival advantage with antibiotic prophylaxis was not demonstrated in the study.
There is concern that routine use of antibiotics is associated with an increase in resistant organisms.
The discussion section states that the study provides evidence that prophylaxis is economical because risk of fever is reduced.
Brugnatelli, S., Gattoni, E., Grasso, D., Rossetti, F., Perrone, T., & Danova, M. (2011). Single-dose palonosetron and dexamethasone in preventing nausea and vomiting induced by moderately emetogenic chemotherapy in breast and colorectal cancer patients. Tumori, 97(3), 362–366.
To evaluate the efficacy and safety of palonosetron followed by dexamethasone administered as a single dose for the prevention of vomiting and nausea in patients receiving moderately emetogenic chemotherapy for breast and colorectal cancer
A bolus dose of 0.25 mg IV palonosetron was given over 30 seconds beginning 30 minutes before chemotherapy, followed by 8 mg IV dexamethasone. Patients were asked to complete diaries to assess antiemetic response during the acute, delayed, and overall phases (days 1–5).
This study was conducted at a single outpatient site in Cinisello Balsamo, Italy.
This was a phase II, open label, nonrandomized prospective study.
Palonosetron followed by dexamethasone in a single administration before chemotherapy to patients with breast or colorectal cancer provides significant protection during the overall phases of chemotherapy. Patients reported high satisfaction with this regimen.
Palonosetron followed by dexamethasone should be considered as premedication on day 1 in moderately emetogenic chemotherapy regimens in patients with breast or colorectal cancer.
Although a complete response was observed in 67% of patients, 33% did not experience complete response. Despite this, the authors stated that this medication regimen adequately controlled CINV during the entire period of emetic risk. Additionally, the 33% of nonresponders does not include high-risk patients who were excluded from this study because of a history of previous nausea and vomiting.
The key takeaway for nurses is that a significant number of patients may require both pharmacologic and nonpharmacologic strategies to help them through this time.
Bruera, E., Driver, L., Barnes, E. A., Willey, J., Shen, L., Palmer, J. L., . . . Escalante C. (2003). Patient-controlled methylphenidate for the management of fatigue in patients with advanced cancer: a preliminary report. Journal of Clinical Oncology, 21, 4439–4443.
The study involved patient-controlled administration of immediate-release methylphenidate 5 to 20 mg per day, taken as often as every two hours based on the hypothesis that treatment with a psychostimulant (methylphenidate) would reduce perceived fatigue.
Patients were recruited from a palliative care outpatient clinic or a pain clinic of a large university cancer center.
Unspecified
The study used a single-center pilot study prospective, open-label design; no comparison group was included.
Of the patients, 93% (n = 28) reported improvements in fatigue from baseline to day 7 of study participation (as measured by the fatigue item on the ESAS and FACIT-F). Of the patients, 93% took three or more methylphenidate tablets daily. All patients chose to continue methylphenidate for at least four weeks beyond the initial study period of seven days. The following side effects were reported by two or less participants: restlessness, dizziness, anorexia, skin rash, and self-limited vertigo and tachycardia.
No special training is required to deliver the intervention; the costs are related to drug acquisition.
Bruera, E., Strasser, F., Palmer, J. L., Willey, J., Calder, K., Amyotte, G., & Baracos, V. (2003). Effect of fish oil on appetite and other symptoms in patients with advanced cancer and anorexia/cachexia: a double-blind, placebo-controlled study. Journal of Clinical Oncology, 21, 129–134.
Patients were given a daily dose of up to 18 gel capsules, including
The study was conducted at a Canadian acute palliative care unit and the inpatient and outpatient units of a cancer center.
The study was a double-blind, placebo-controlled trial.
Patients could not take 18 large capsules every day; the mean was 12 per day, with five patients in each group dropping out.
A strong trend was observed toward improved appetite in both groups. With the fish oil group, a trend existed toward less tiredness, but no significant change existed with appetite, weight loss, or calories.
Side effects of fish oil capsules included belching and fish oil taste.
Bruera, E., El Osta, B., Valero, V., Driver, L.C., Pei, B.L., Shen, L., . . . Palmer, J.L. (2007). Donepezil for cancer fatigue: A double-blind, randomized, placebo-controlled trial. Journal of Clinical Oncology, 25, 3475–3481.
Patients received either donepezil or placebo (5 mg) orally every morning for seven days. A research nurse contacted patients by daily telephone calls to assess symptoms and treatment toxicity. Patients were evaluated at the clinic on day 8. Patients returned for a final assessment on day 15, and those who chose to continue taking donepezil were provided with a two-week supply of the drug. Fatigue outcomes were assessed at baseline, day 8, and day 15.
The donepezil intervention did not show any improvement in fatigue in comparison to the placebo, as no significant difference was seen between groups at baseline and on day 8 for FACIT-F fatigue intensity scores.
Bruera, E., Strasser, F., Shen, L., Palmer, J.L., Willey, J., Driver, L.C., & Burton, A.W. (2003). The effect of donepezil on sedation and other symptoms in patients receiving opioids for cancer pain: A pilot study. Journal of Pain and Symptom Management, 26, 1049–1054.
Donepezil 5 mg every morning for seven days
Fatigue significantly was improved following a seven-day course of treatment with donepezil. Significant improvement was noted in anxiety, well-being, sleep problems, depression, and anorexia. Pain level was unchanged. Of the initial 27 patients enrolled in the study, 7 patients were discontinued from the study due to cellulitis (1 patient), concern about a possible drug-drug interaction (1 patient), transient arterial hypertension (1 patient), increasing muscle cramps (1 patient), and mild to moderate nausea (3 patients).