Schierholz, J.M., Nagelschmidt, K., Nagelschmidt, M., Lefering, R., Yucel, N., & Beuth, J. (2010). Antimicrobial central venous catheters in oncology: Efficacy of a rifampicin-miconazole-releasing catheter. Anticancer Research, 30, 1353–1358.
The purpose of the study was to determine if central venous catheters (CVCs) impregnated with rifampicin and miconazole would decrease growth of bacteria and lead to a decline in catheter-related bloodstream infections as well as the complications associated with them.
Hospitalized adults (aged 18–80 years) who required a CVC for at least two days and were undergoing their first venous catheterization were included in this study. A triple lumen polyurethane CVC supersaturated with rifampicin andmiconazole was compared with the standard version. A segment of the catheter was cultured to evaluate catheter colonization. Catheter colonization was defined as growth of 15 or more colony-forming units detected on a catheter segment by the semi-quantitative roll-plate technique. Catheter-related local infection was defined as a colonized catheter accompanied by at least one of the following criteria: redness, induration/swelling, purulent secretion, and/or pain.
Single inpatient setting in Germany.
Active treatment
Prospective-controlled, non-blinded, randomized clinical trial.
Compared to the standard device, modified CVCs showed significantly lower catheter colonization as well as catheter-related infection during short-term (less than seven days, p = 0.001), as well as during long-term (seven days or more, p = 0.001). In the control group,38 (36.3%) of the 105 standard CVCs were colonized. In the intervention group, 6 of 118 loaded CVCs were colonized (5.1%). The colonization rate in the oncology subgroup did not differ greatly from the rate of the patients without cancer (39% versus 34.4%, p = 0.629); however, the catheter-related infection rate was significantly higher in patients with cancer. The catheter-related infection rate of oncologic patients was reduced from 26.8% to 2.3% using the loaded CVC, indicating its pronounced efficacy in preventing catheter-related infection in patients with cancer (p < 0.001). The main covariate for catheter colonization was colonization of the skin at the catheter site (p = 0.001), underscoring the importance of hygienic site care.
Use of an impregnated antimicrobial catheter in patients with cancer has the potential to decrease the risk of catheter-related bloodstream infections and the associated complications.
CVCs impregnated with rifampicin and miconazole may decrease the risk of catheter-related infections and appear to exert their antimicrobial effect for more than four weeks. Additional study is needed to evaluate these catheters in a general oncology population with a larger sample. Skin colonization was associated with increased risk of catheter colonization, emphasizing the importance of meticulous site care.
Scheier, M.F., Helgeson, V.S., Schulz, R., Colvin, S., Berga, S., Bridges, M.W., . . . Pappert, W.S. (2005). Interventions to enhance physical and psychological functioning among younger women who are ending nonhormonal adjuvant treatment for early-stage breast cancer. Journal of Clinical Oncology, 23, 4298–4311.
This study was designed to evaluate interventions targeted to occur at the point when treatment is ending—a time when distress and concerns are known to increase. It also targets younger women; as some studies report, younger women are at greater risk for psychological distress and face different challenges than older women do.
Women with breast cancer were assigned to a three-arm clinical trial. In the two active arms, the women received either an educational intervention, which provided information about their disease and treatment, or information about nutrition, featuring a low-fat, high-fruit-and-vegetable-eating pattern. Both active treatment arms received four group sessions, meeting once per month for four consecutive months. Sessions were led by professionals, and interactions between participants were kept to a minimum. The control arm was standard medical care. Random assignment assessments occurred at baseline, then 4 months, and 13 months later (corresponding to immediate post-intervention and nine months post-intervention.)
At the 13th-month assessment, participants in the nutrition arm reported significantly fewer depressive symptoms, and in the education arm, marginally fewer depressive symptoms were reported than in the control arm. The difference between the two active treatment arms was not significant. The mediating factors also were identified as contributing by enhancing self-efficacy expectations, reducing some concerns regarding morbidity and mortality, lessening intrusive thoughts about illness, and buffering self-concept perceptions.
Schaverien, M.V., Munro, K.J., Baker, P.A., & Munnoch, D.A. (2012). Liposuction for chronic lymphoedema of the upper limb- 5 years of experience. Journal of Plastic, Reconstructive & Aesthetic Surgery, 65, 935–942.
To describe the five-year follow-up results of the use of liposuction for arm lymphedema after breast cancer treatment
Patients who had chronic arm lymphedema who were compliant with use of compression garments were referred for liposuction surgery. Study questionnaires and limb volume measures were performed pre- and postoperatively. Limb volume was measured at 2 and 4 weeks postoperatively and at 3 months, 6 months, and yearly for 5 years. Specific liposuction technique was described. Patients had a custom-made pressure garment applied at the time of the surgery. All received 5-day courses of antibiotics, analgesia, and limb elevation. Patients were discharged on day 4.
The study was conducted at a single site, inpatient and outpatient setting, in the United Kingdom.
This study involved prospective analysis.
No surgical complications occurred. The mean percent reduction in arm volume after surgery was 84%. At one year after surgery, the mean volume difference between operated and unaffected arms was 29 ml. At two years, a mean volume ratio of the operated to nonoperated arm of 0.98 was found, demonstrating that volumes were virtually the same. In 11 patients, postoperative anxiety scores declined (p = 0.049). Researchers noted that ongoing compliance with use of compression garments was essential to continued effect.
Findings suggest that liposuction and ongoing use of compression garments may be a promising approach to manage upper extremity lymphedema in patients after surgery for breast cancer.
Further research into this intervention is needed to further validate these findings in comparison with other approaches. Liposuction may have some benefit for patients with lymphedema that is not adequately controlled by other means. The procedure for this application is very specific and requires specific surgical training in this technique.
Scaffidi, M., Vulpiani, M.C., Vetrano, M., Conforti, F., Marchetti, M.R., Bonifacino, A., . . . Ferretti, A. (2012). Early rehabilitation reduces the onset of complications in the upper limb following breast cancer surgery. European Journal of Physical and Rehabilitation Medicine, 48, 601–611.
To clinically evaluate upper ipilateral limb function and the impact of certain post-surgical consequences arising after invasive or breast-conserving surgery for early breast cancer, by intervening, or not intervening, with an early rehabilitation program
Group A received reoperative information verbally; did not begin physiotherapy during hospitalization. Group B received preoperative information in written form; treated by a dedicated physiotherapist during hospitalization from the day following surgery until the hospital discharge. One physiotherapy session per day, with each session lasting for 30–40 minutes. The exercises were initially focused on deep breathing, relaxation, stretching of the neck muscles, and then on elevation, abduction, external and internal rotation of the shoulder, flexion and extension of the elbows in a neutral position. The patients were instructed on how to position their shoulder-arm in bed and how to carry out exercises at home after discharge. The patients were given an exhaustive brochure containing pictures and explanations of the exercises to carry out at home. All patients were assessed at 15–30, 60, and 180 days after surgery.
SITE: Single site
SETTING TYPE: Inpatient
LOCATION: Rome, Italy
PHASE OF CARE: Transition phase after active treatment
Two-group cohort comparison
Although no differences were identified between two groups in the outcome assessment, statistically significant differences (p < 0.05), in favor of Group B, were encountered at the 180-day follow-up visit, including shoulder-arm mobility, upper limb function (p < 0.001), and presence of lymphedema (p = 0.036).
The early assisted mobilization (beginning on the first postoperative day) and home rehabilitation, in conjunction with written information on precautionary hygienic measures to observe, play a crucial role in reducing the occurrence of postoperative side-effects of the upper limb.
The study findings suggest that nurses should be aware of early rehabilitation (e.g., early assisted mobilization right after the surgery) and home exercises rehabilitation as well as written/educational information may play a critical role to prevent postoperative side-effects in patients with breast cancer. Studies with rigorous design are warranted to further evaluate the study intervention.
Sayles, C., Hickerson, S.C., Bhat, R.R., Hall, J., Garey, K.W., & Trivedi, M.V. (2016). Oral glutamine in preventing treatment-related mucositis in adult patients with cancer: A systematic review. Nutrition in Clinical Practice, 31, 171–179.
STUDY PURPOSE: To review the evidence for use of oral glutamine to prevent treatment-related mucositis in adult patients with cancer
PHASE OF CARE: Active antitumor treatment
Seven studies reported actual mucositis outcomes. Other studies measured outcomes such as weight change or time to onset but not mucositis grades. Various methods of mucositis grading were used. In seven studies, statistical significance of differences observed was not reported. In 10 of 11 studies, the percent of patients with grade 3 mucositis was lower with oral glutamine. In two studies, grade 4 mucositis incidence was lower with glutamine, and in two studies, it was higher with glutamine. Duration of mucositis and time to development findings were inconsistent. Dosage and timing of glutamine varied across studies.
The results of this systematic review are insufficient to provide strong support for the efficacy of oral glutamine for the prevention of oral mucositis.
The authors stated that the study samples were small. High heterogeneity in terms of tumor types and treatments were involved, and no subgroup analysis was done.
The findings do not show a strong evidence of efficacy of oral glutamine to prevent oral mucositis in patients with cancer undergoing a variety of treatments. Oral glutamine did not, however, demonstrate adverse effects, and some evidence suggests that the severity of mucositis might be lower with glutamine. The effect dose and timing of oral glutamine for various patients and treatment types is unclear.
Saydam, O., Karapinar, K., Gokce, M., Kilic, L., Metin, M., Oz, I.I., & Tanriverdi, O. (2015). The palliative treatment with intrapleural streptokinase in patients with multiloculated malignant pleural effusion: A double-blind, placebo-controlled, randomized study. Medical Oncology, 32, 179.
To study the effect of using streptokinase in pleurodesis for the management of multiloculated malignant pleural effusion (MPE)
Patients were randomly assigned to either the treatment group, which received streptokinase 250,000 IU into pleural space via a thoracostomy tube, or the control group, which received 50 ml of saline at 24, 36, 48, and 60 hours post tube placement. Data were collected regarding volume of pleural drainage, chest computerized tomography (CT) images before and after treatment, dyspnea before and after treatment, and recurrence rate of effusion. Coagulation profiles were assessed prior to administering streptokinase, and all patients had a chest CT to locate the largest locule of fluid. A 20 Fr chest tube was placed and connected to an underwater seal at a continuous suction of -20 cm H2O. For both groups, daily pleural drainage at 48 and 72 hours were measured. After the third day, a CT thorax was taken and read by one radiologist. On the fourth day, pleurodesis was performed using 4 g of sterile talc. On the fifth day, the chest tubes were removed. Patients that continued to be dyspneic (oxygen dependent) were not discharged from the hospital, and nondyspneic patients were discharged (n = 29) and later evaluated in regard to whether or not they required a repeat pleural catheterization within 30 days because of the redevelopment of dyspnea.
Measurements were given as mean and standard deviations, and the two groups were compared using the Mann-Whitney U test. The chi-square test was used to compare the improvement scores of the groups via CT evaluation, dyspnea scores, and recurrence rate. SPSS, version 15.0, was also used.
The differences between drainage volumes between groups was statistically significant. Mean drainage volumes for the intervention group versus the control was 493/248 at 24–48 hours, 446/198 at 48–72 hours, and 939/446 overall (p < 0.001). Dyspnea symptoms (defined as oxygen dependent) improved in 90% of the fibrinolytic group and 55% of the control group (p = 0.03). Post discharge of 29 nondyspneic (nonoxygen dependent) patients, 11% of fibrinolytic group had recurrence versus 45% of the control group (p = 0.07). A thorax CT demonstrated a 40% or greater improvement in 85% of the fibrinolytic group and 35% of the control group (p = 0.001).
The treatment group receiving streptokinase via a chest tube prior to pleurodesis had greater improvement in symptoms of dyspnea, greater reduction in volume of MPE, and a lower rate of effusion recurrence.
The use of fibrinolytic agents for management of MPE prior to pleurodesis may improve outcomes for reducing dyspnea and reducing recurrence post-pleurodesis leading to enhanced patient quality of life. Additional large-scale studies are indicated for validation. Having a basic understanding of pathophysiology and rationale is important for self-knowledge, patient monitoring, and education in settings using fibrinolytic therapy to treat MPE.
Sawan, S., Mugnai, R., Lopes Ade, B., Hughes, A., & Edmondson, R.J. (2009). Lower-limb lymphedema and vulval cancer: Feasibility of prophylactic compression garments and validation of leg volume measurement. International Journal of Gynecological Cancer: Official Journal of the International Gynecological Cancer Society, 19(9), 1649–1654.
To determine the feasibility of conducting a larger trial to investigate effectiveness with use of compression stockings to prevent leg lymphedema after vulval cancer
Fourteen patients undergoing inguinofemoral lymphadenectomy were randomized to either the best supportive care (control group) or best supportive care plus the use of graduated compression stockings for six months. Patients were seen preoperatively and followed at four weeks, three months, and six months after surgery. Patients were asked to wear treatment stockings during the daytime for six months once mobile beginning no later than three days after surgery. Expected compliance with stockings was 10 hours per day for 180 days.
The study was a randomized controlled feasibility design.
Lower-limb volume was calculated just above the ankle to at least 4 cm below the perineum. Circumference of the limb was measured using an ordinary tape measure at 4 cm intervals commencing approximately 2 cm from the lateral malleolus. The Nottingham Health Profile was used.
Eleven of 14 patients complied with the entire visit schedule. Two patients in the study group had travel hardship and one patient was frail and therefore dropped off. Three patients in the control group failed to comply. Patients in the control group showed greater increase in mean leg volume while those in the treatment arm showed better performance based on leg symptoms and clinical examination.
Prophylactic use of stockings is feasible.
Although a small sample, quality-of-life measurements were equal in both groups. Further studies are needed to evaluate the role of compression garments in prevention of lower-extremity lymphedema.
Savard, J., Ivers, H., Savard, M.H., & Morin, C.M. (2015). Long-term effects of two formats of cognitive behavioral therapy for insomnia comorbid with breast cancer. Sleep, 39, 813–823.
To assess the long-term efficacy of a video-based behavioral therapy for insomnia (VCBT-I) as compared to a professionally administered intervention (PCBT-I) and to a no treatment group (CTL).
Participants were randomized to receive one of two types of CBT for insomnia or a control arm with no intervention. The PCBT-I arm received six weekly individual treatment sessions (50 minutes each) with a companion booklet at each session. This was administered by a psychologist or PhD student with CBT experience. The VCBT-I group received a 60-minute video, and they were instructed to watch 5–20 minutes each week and to read a companion booklet each week. They had telephone access to a licensed psychologist if they had questions. All received pre- and postintervention evaluations, as well as long-term follow-up evaluation at 3, 6, and 12 months.
Post-treatment to follow-up in PCBT-I arm showed significant increase in EMA and TST. The VCBT-I group showed a significant increase in WASA. The control arm showed a significant increase in all sleep variables. There was a reduction, albeit nonsignificant, in the use of hypnotics in the PCBT-I arm, a significant reduction in the VCBT-I arm, and an increase in the control arm. Insomnia remission rates were significantly higher for the PCBT-I group at three and six months when compared to the VCBT-I group. No difference existed at 12 months.
The PCBT-I and VCBT-I groups showed immediate and sustained improvement in several sleep outcomes at three- and six-month follow-ups. When compared, the face-to-face intervention was superior to the video-delivered intervention. The remission rate remained highest in the PCBT-I group. With that said, results should be interpreted with caution because of secondary to selection bias, attrition with significant differences in those who dropped out, and differences in study groups.
Further study is needed to document alternative ways to deliver CBT interventions for improving sleep outcomes. Personalized 1:1 CBT appears to be the most effective, although when resources are limited, a video-based intervention can be substituted and does show efficacy.
Savard, J., Villa, J., Simard, S., Ivers, H., & Morin, C. M. (2011). Feasibility of a self-help treatment for insomnia comorbid with cancer. Psycho-Oncology, 20, 1013–1019.
To determine feasibility and assess patient satisfaction with a self-administered format of cognitive-behavioral therapy (CBT) for insomnia comorbid with cancer.
To provide initial information on the effect of self-administered CBT on subjective measures of sleep and other symptoms.
Patients were given a battery of self-report scales to complete for baseline evaluation and were then contacted by an interviewer. They underwent a 75-minute interview followed by instructions to complete a sleep diary for two weeks. Then, patients were given the self-help CBT module for insomnia. It was comprised of six modules, each with a video segment and booklet covering the following topics on sleep and insomnia: (1) insomnia facts, (2) stimulus control therapy and sleep restriction strategies, (3) cognitive restructuring strategies, (4) revision of maladaptive sleep cognitions, (5) sleep hygiene, and (6) relapse prevention strategies. They were instructed to read one module per week for six weeks. At posttreatment and follow-up, they completed the same battery of self-report scales and sleep diaries.
Patients were undergoing the transition phase after initial treatment.
The study used a single-group, nonrandomized pre-/post design.
All patients adhered to the treatment, and all found the format to be excellent and interesting. All patients reported subjective improvement in their sleep quality and motivation to continue the strategies in the future. Sleep measures showed effect sizes of large magnitude in total ISI score, wake after sleep onset, sleep onset latency, sleep efficiency, and total DBAS score. There were moderate effect sizes of HADS–Depression (HADS-D) and QOL scores, with small effect sizes for total sleep time, hypnotics usage, HADS–Anxiety (HADS-A), and MFI scores. These results were sustained at three months.
A self-help CBT strategy for insomnia in patients with breast cancer is feasible. It appears to improve sleep outcomes and dysfunctional beliefs and may improve QOL and depression.
Self-administered CBT for insomnia may be a good first line strategy to treat insomnia in patients with cancer. It allows for treatment at a time that is convenient to the patient and for improved access to care because it can be performed without a sleep expert present.
Savard, J., Ivers, H., Savard, M.H., & Morin, C.M. (2014). Is a video-based cognitive behavioral therapy for insomnia as efficacious as a professionally administered treatment in breast cancer? Results of a randomized controlled trial. Sleep, 37, 1305–1314.
To test the short-term efficacy of a video-based delivery of cognitive behavioral therapy for insomnia compared to a professionally administered method and a no-treatment group
Patients with breast cancer postradiation therapy who were 18 months post-treatment with insomnia were randomized into one of three groups: a video-based cognitive behavioral therapy intervention (VB-CBTI) (60 minute video with six booklets), a professionally delivered CBTI (six weekly, 50-minute, in-person sessions), or a no-treatment group.
Randomized, controlled, three-arm intervention study
Group-by-time interactions were significant for sleep variables with video-based CBTI being associated with greater sleep improvements compared to the control group for sleep variables other than early-morning awakening and total sleep time (p < 0.001). There were no significant differences between in-person and video-based CBTI for sleep onset latency, wake after sleep onset, total wake time, and sleep efficiency. In-person treatment was associated with a greater reduction in ISI scores, early morning awakening, and total wake time compared to video-based CBTI. The magnitude of change over time was greater with in-person CBTI compared to video CBTI. Both interventions demonstrated a greater improvement in sleep outcomes than the control group. Actigraphy showed a significant reduction (pre/post) in the in-person group only. Secondary outcomes among the in-person group included a significant reduction in depression (p < 0.001), fatigue (p < 0.001), and dysfunctional beliefs about sleep (p < 0.001).
Both CBTIs were effective in improving sleep compared to usual care. The video format seems to be an effective treatment option, but in-person therapy continues to show better efficacy. CBTI also was associated with improvements in fatigue and depression scores.
CBTIs can be challenging to implement because access to care for patients with cancer is varied. Although in-person therapy was most effective, the video-based intervention also was effective in improving sleep, fatigue, and depression outcomes. Providing options to rural populations without access to in-person care is essential for increasing efficacy in a wider population with insomnia. The findings of this study regarding the efficacy of a video-based CBTI provide nurses with another option that warrants its use as a treatment with longer effects.