Buragadda, S., Alhusaini, A.A., Melam, G.R., & Arora, N. (2015). Effect of complete decongestive therapy and a home program for patients with post mastectomy lymphedema. Journal of Physical Therapy Science, 27, 2743–2748.
To compare lymphedema-related outcomes between women receiving complete decongestive therapy (CDT) and a home program versus those receiving manual drainage and compression garments
Patients were divided into two groups. One group received manual drainage, compression garments, glenohumeral mobilization, and deep breathing exercises. The other received CDT including manual drainage, compression garments, and a home self-massage and exercise program. Participants received initial training for the home program to be completed daily. Both groups received treatment from a therapist five days per week for six weeks. Study assessments were done a baseline, week 4, and week 6.
Pre- and post-test design
Subjects in both groups had significant reductions in arm volume, pain, and DASH scores.
Both CDT with a home program of manual drainage and exercise and standard manual lymphatic drainage with compression garments resulted in significant improvements in arm volume, associated pain, and disability scores.
Both the combination of manual lymphatic drainage with compression garment use and CDT with a daily home program were associated with significant improvements in lymphedema symptoms.
Bundy, D.G., Gaur, A.H., Billett, A.L., He, B., Colantuoni, E.A., Miller, M.R., & Children's Hospital Association Hematology/Oncology CLABSI Collaborative. (2014). Preventing CLABSIs among pediatric hematology/oncology inpatients: National collaborative results. Pediatrics, 134, e1678-e1685.
To assess the feasibility of instituting a multicenter effort to standardize central line (CL) care and CL-associated bloodstream infection (CLABSI) tracking while quantifying the impact of standardizing these processes on CLABSI rates among pediatric patients
A CL maintenance bundle was developed using Centers for Disease control and Prevention guidelines and recommendations as well as best practices from previous pediatric CLABSI efforts. These guidelines included (a) a reduction in the number of CL manipulations and entries, (b) the maintenance of a sterile entry to CL (hand hygiene and sterilization of port), (c) and standardized CL care practices (date and time cap, tubing/dressing/needle changes, standardized procedure). Tubing changes were every 96 hours and every 24 hours for blood products and lipids. Staff members audited the CLABSI bundle practice monthly using a standard form and submitted unit profile information. Teams met in two-day learning sessions annually and interacted monthly via webinars.
Cohort comparison study
Teams reported baseline data regarding CLABSI from January 2006 and October 2009. These data were compared to the intervention period from November 2009 to August 2012. CLABSIs were tracked as number per 1,000 CL days per month. CLABSIs occurring more than 48 hours after hospital admission and less than 48 hours prior to hospital discharge were deemed inpatient events and included in measurements.
Across 46 months, precollaborative effort CLABSI rates were 2.85 per 1,000 CL days. During the first 34 months after the intervention, that rate was 2.04 per 1,000 CL days (p = 0.05). The odds for having no CLABSIs per unit per month was 2.59 higher during the collaborative intervention (p = 0.01). The compliance with recommended CL maintenance increased rapidly over the first year from 38% at baseline to 79% by the end of the first year. It remained at a rate of 81%–86% during the remainder of the intervention period.
The 28% reduction during the first 2.5 years suggested the elimination of about 290 CLABSIs over that period with an estimated reported cost savings of about $11 million. It was feasible to implement a standardized CL maintenance care bundle, track CL infections with standardized definitions, and generate benchmark data across a large network of centers. The implementation of a standardized catheter care bundle in a multi-instutituional collaborative effort was associated with reduced CLABSI rates.
Nurses are on the front lines when it comes to CLABSI prevention. This report demonstrated the effectiveness of a multisite collaborative initiative to reduce CLABSI rates. The implementation of a specific care bundle, monthly practice auditing, monthly webinars, and annual education of care teams involved was reported to be effective. This report provides suggested approaches for such initiatives and demonstrates associated improvement in quality and cost reduction.
Bull, J., Wellman, C.V., Israel, R., Barrett, A.C., Paterson, C., & Forbes, W.P. (2015). Fixed-dose subcutaneous methylnaltrexone in patients with advanced illness and opioid-induced constipation: Results of a randomized, placebo-controlled study and open-label extension. Journal of Palliative Medicine, 18, 593–600.
To determine safety and efficacy of fixed doses of methylnaltrexone (MNTX) in patients with advanced disease
After participation in a two-week placebo randomized controlled trial (RCT), patients were eligible to enroll in a 10-week open-label extension study to evaluate the use of MNTX at a fixed dose based on weight using as-needed dosing. Patients were dosed at 8 mg SC for weight of 38 kg to less than 62 kg or, if 62 kg or greater, at a dose of 12 mg. Doses were administered as needed but not more often than daily. Rescue doses of other bowel medications were permitted if the MNTX was not effective. Patients were taking stable laxative regimens and a stable dose of opioids.
MNTX was effective in the management of opioid-induced constipation in both the RCT and the open-label extension study. The results were based on rescue free bowel movements after doses of MNTX. For the MNTX arm in the RCT component, 62.9% of patients had bowel function compared with 9.6% of the placebo control group (p < 0.0001). Weight did not have an effect on outcome. Secondary end points were all in favor of MNTX, including time to bowel function after first dose. The most common side effects were abdominal pain and nausea.
A fixed dose of MNTX is safe and effective in the management of opioid-induced constipation in patients with advanced disease.
This study adds support to the data that MNTX is safe and effective for opioid-induced constipation.
Bulfone, T., Quattrin, R., Zanotti, R., Regattin, L., & Brusaferro, S. (2009). Effectiveness of music therapy for anxiety reduction in women with breast cancer in chemotherapy treatment. Holistic Nursing Practice, 23, 238–242.
To evaluate the effect of musical therapy on anxiety in patients with breast cancer receiving conventional treatment
Patients were randomly assigned to the music or control group. While in the waiting room for 30 minutes prior to chemotherapy treatment, those assigned to the music group had the opportunity to choose and listen to pretaped musical themes with a Walkman and earphones for 15 minutes. Control patients received standard care. Anxiety levels were measured at baseline and after 15 minutes.
Patients were undergoing the active treatment phase of care.
A randomized controlled trial design was used.
Speilberger State and Trait Anxiety Inventories
There were no differences between groups in pretreatment anxiety levels. Both groups demonstrated moderate pretreatment anxiety levels. Pretreatment state anxiety levels were higher than trait anxiety levels in both groups (p < 0.05). Post-test anxiety scores in the experimental group decreased by 9.9 (p < 0.001). In the control group, there was no significant change, although anxiety increased slightly after 15 minutes. There were no significant relationships between anxiety scores and demographic variables.
Listening to music may reduce anxiety related to chemotherapy administration. The levels of state anxiety compared to trait anxiety indicates that chemotherapy treatment is a stressful situation for patients.
Chemotherapy administration can be stressful for patients, and listening to music prior to treatment may be helpful to them. Providing the opportunity to listen to music is a simple intervention that has no inherent risks to patients and could easily be incorporated into practice in healthcare settings.
Bukki, J., Stanga, Z., Tellez, F.B., Duclos, K., Kolev, M., Krahenmann, P., . . . Juni, P. (2013). Omega-3 poly-unsaturated fatty acids for the prevention of severe neutropenic enterocolitis in patients with acute myeloid leukemia. Nutrition and Cancer, 65, 834–842.
To explore the safety and effectiveness of omega-3 poly-unsaturated fatty acid (PUFA) added to parenteral nutrition in protecting patients with leukemia from severe enterocolitis
Fourteen patients with acute myeloid leukemia (AML) who received omega-3 PUFA in a phase II trial were compared with 66 consecutive control patients not getting this intervention. Total parenteral nutrition (TPN) was given as a standard emulsion containing the full supply of carbohydrates, amino acids, and lipids, with a total energy content of 2,215 kcal in a 1,875 mL volume via central venous catheter over 24 hours. Patients included in the phase II study additionally were administered 100 mL/d of a commercially available IV omega-3 PUFA formulation over four hours. TPN and omega-3 PUFA were given up to duration of four weeks.
Two out of 14 patients included in the phase II trial experienced grade 3 colitis after initiation of chemotherapy (14%), and none experienced grades 4 or 5. Conversely, 16 out of 66 control patients experienced grade 3 colitis (24%), 3 experienced grade 4 (5%), and 2 died of grade 5 colitis (3%). According to blind assessments, 3 out of 14 patients included in the phase II trial experienced grade 3 colitis after initiation of chemotherapy (21%), and 1 had grade 4 colitis (7%), whereas 7 out of 66 control patients experienced grade 3 colitis (11%), 4 experienced grade 4 (6%), and 4 died of grade 5 colitis (6%). Among the 13 patients who actually received omega-3 PUFA, two were deemed to have grade 3 colitis (15%) according to open assessment, whereas three were deemed to have grade 3 colitis (23%) and one was deemed to have grade 4 colitis (8%) according to blind assessment. Odds ratios of colitis were grades 3 and above. The benefit of omega-3 PUFA was more pronounced in adjusted as compared with crude analyses and more pronounced according to open as compared with blind assessments. Formal statistical significance at the conventional α level of 0.05 was reached only for the adjusted analyses of colitis grades as determined by the open assessor, with an odds ratio of 0.27 (95% CI 0.11–0.65). The IPT weighted analysis according to blind assessments yielded a non-significant odds ratio of 0.79 (95% CI 0.35–1.78).
The study showed little evidence to suggest that the addition of omega-3 PUFA to TPN in patients with AML undergoing myeloablative chemotherapy is effective in reducing the incidence of severe neutropenic enterocolitis. Results depended on the approach chosen in assessing colitis grades (open versus blind assessment), and the nature of the analysis (crude or adjusted using inverse probability of treatment weighting).
Therapeutic interventions remain limited in neutropenic colitis. To truly answer the question of whether this intervention would benefit patients, trials should be centrally randomized with adequate placebo controls to blind patients, blind adjudication of colitis grades, and an intention-to-treat analysis.
Buijs, C., Mom, C.H., Willemse, P.H., Marike Boezen, H., Maurer, J.M., Wymenga, A.N., … Mourits, M.J. (2009). Venlafaxine versus clonidine for the treatment of hot flashes in breast cancer patients: A double-blind, randomized cross-over study. Breast Cancer Research and Treatment, 115, 573–580.
Comparison of venlafaxine versus clonidine for the treatment of hot flashes with regard to side effects, efficacy, QOL, and sexual functioning in patients with breast cancer.
Patients randomly assigned to receive venlafaxine for eight weeks, followed by a wash-out period of two weeks, then eight weeks of clonidine or vice versa
N = 60 (30 assigned to venlafaxine and 30 to clonidine). Patients with a primary or metastatic breast cancer age 60 years or younger, allowed antitumor hormonal treatment if started one month prior and continued taking throughout treatment period.
Double-blind, randomized, cross-over study.
Assessment took place before the start of each drug, then at 2, 8, 12, 18 weeks after treatment began. Six questionnaires were used to compare the drugs' effects on adverse events, efficacy, QOL, and sexual functioning: daily diary on hot flashes, hot flash–related daily interface questionnaire, Medical Outcomes Study Short Form (SF-36), sexual activity questionnaire, and Zung Self-Rating Depression Scale.
Forty patients completed all treatments, 12 patients only one treatment, 8 patients neither. Dropout rates during venlafaxine were 15 out of 59, versus clonidine, 5 out of 53. Withdrawal rateswere not affected by sequence of treatment. Efficacy: After eight weeks, no difference was seen between the two drugs in reduction of hot flash scores: median 49% for venlafaxine and 55% for clonidine. The drug that the patient received first caused the greatest reduction in hot flash score.
Statistics: based on the testing used to calculate the number of patients needed to detect differences, the sample size was too small to detect difference, which may be the reason no statistical difference was found between the interventions.
Buffart, L.M., van Uffelen, J. G., Riphagen, I. I., Brug, J., van Mechelen, W., Brown, W. J., & Chinapaw, M. J. (2012). Physical and psychosocial benefits of yoga in cancer patients and survivors, a systematic review and meta-analysis of randomized controlled trials. BMC Cancer, 12, 559.
STUDY PURPOSE: Evaluate effects of yoga on physical and psychosocial symptoms
TYPE OF STUDY: Meta Analysis & Systematic Review
DATABASES USED: AMED, CINAHL, British Nursing Index, CENTRAL, EMBASE, PEDro, psycINFO, PubMed and SPORT-Discus
KEYWORDS: States detailed search profiles available on request
INCLUSION CRITERIA: RCT, adults with any cancer diagnosis, yoga intervention including physical postures, control group non exercise
EXCLUSION CRITERIA: Yoga included as part of a larger intervention such as mindfulness based stress reduction were excluded
TOTAL REFERENCES RETRIEVED : N = 1909
EVALUATION METHOD AND COMMENTS ON LITERATURE USED Study method quality evaluated using a Delphi list previously developed and tested. Low quality defined as <50% of possible total score.
FINAL NUMBER STUDIES INCLUDED; N(studies) = 13
SAMPLE RANGE ACROSS STUDIES, TOTAL PATIENTS INCLUDED IN REVIEW: Range 18-128
KEY SAMPLE CHARACTERISTICS: 12 studies involved breast cancer patients, 1 was in lymphoma
PHASE OF CARE: Multiple phases of care
Physical outcomes: Pain was evaluated in 4 studies, meta analysis of 2 of these showed a large effect size (d=-0.63, 95% CI -0.98, -0.31)
Psychosocial outcomes: Reduced anxiety (d=-0.77; 095% CI -1.08, -0.46) fatigue (d=-.051, 95% CI -0.79,-0.22) Effects on sleep disturbance were small and insignificant.
Dropout rates ranged from 0-38%
Interventions ranged from planned 6 -15 sessions. Some studies involved supervised yoga classes, and some involved home practice only. Studies involved patients in active treatment and others involved cancer survivors who had completed treatment.
Findings suggest that yoga may be helpful to reduce anxiety and fatigue in patients with cancer.
States 3 studies included participant blinding or double blinding – it is unclear how a participant would not know they were receiving a yoga intervention. Varied methods of measurement were used in the studies included – there is no description of how these were handled in meta analysis. There is no report of heterogeneity findings. Most studies were very small sample sizes. There was a wide range of drop -out rates and no information about how this was handled in analysis. Studies did not include attentional control conditions, so it is unclear how much effect was due to group support versus the actual yoga activity. No differentiation was made between group session interventions versus patients who did home practice alone after instruction.
Findings do not provide strong support for effectiveness of yoga for sleep. Findings do suggest that yoga may be helpful for patients to reduce anxiety and fatigue. Nurses can support involvement in this type of activity for patients who are interested in participating in yoga.
Buentzel, J., Micke, O., Adamietz, I.A., Monnier, A., Glatzel, M., & deVries, A. (2006). Intravenous amifostine during chemoradiotherapy for head-and-neck cancer: A randomized placebo-controlled phase III study. International Journal of Radiation Oncology, Biology, Physics, 64, 684–691.
To evaluate the efficacy and safety of IV amifostine during radiochemotherapy for head-and-neck cancer
Patients in the study group received 300 mg/m2 IV amifostine on the days in which they received carboplatin and radiation therapy (RT). On the days in which they received only RT, they were given 200 mg/m2 IV amifostine.
The study was conducted between October 1996 and October 1999.
The intervention was not found to be effective in the management of mucositis toxicity.
This was the first randomized and placebo-controlled study of amifostine in the head and neck cancer population.
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.