Lengacher, C.A., Johnson-Mallard, V., Post-White, J., Moscoso, M.S., Jacobsen, P.B., Klein, T.W., … Kip, K.E. (2009). Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psycho-Oncology, 18, 1261–1272.
To determine whether, compared to usual care, a mindfulness-based stress-reduction (MBSR) intervention involving breast cancer (BC) survivors is efficacious in improving psychological and physical status
Patients were randomized into one of two arms: the group receiving MBSR for BC patients (MBSR (BC)) and the group receiving usual care. Assignment to group was random and stratified by stage of cancer and treatment received; if desired, members of the usual-care group were wait-listed to receive the MBSR (BC) intervention. Assessments were completed at an initial baseline orientation and within two weeks of the end of the six-week intervention or control period. Data collectors were blinded to treatment assignment. The MBSR (BC) group received six weekly two-hour sessions led by a single trained psychologist. Class size was 4–8. Subjects received a training manual and four audiotapes to support home meditation practices. Members of the MBSR (BC) group kept a daily diary. Participants completed various activities during the six-week period. The intervention comprised three specific components:
Transition phase
Randomized controlled trial
Compared to usual care, the six-week MBSR (BC) program for BC survivors, within 18 months of treatment, resulted in significant improvements in psychological status and quality of life.
The symptoms this study addressed continue to be of great concern to patients with cancer. Nurses must know how to help patients with these symptoms during and after treatment. Nurses should explore alternative ways to educate patients about interventions that can improve outcomes.
Lengacher, C.A., Johnson-Mallard, V., Post-White, J., Moscoso, M.S., Jacobsen, P. B., Klein, T. W., . . . Kip, K.E. (2009). Randomized controlled trial of mindfulness-based stress reduction (MBSR) for survivors of breast cancer. Psycho-Oncology, 18, 1261–1272.
To determine if a mindfulness-based stress reduction (MBSR) intervention is effective in improving psychological and physical status in breast cancer survivors
The intervention was six group sessions of an MBSR program using meditation and body scan techniques. Participants received a training manual and audiotapes to support home practice of various forms of meditation and gentle yoga. The training manual included weekly objectives, exercises, program content, and a daily diary for recording practice activities.
A randomized controlled trial design was used.
Seventy percent of participants were determined to be compliant with the program. Intervention participants had better mean scores for state anxiety and depression compared to the control group at six weeks (p = 0.004; p = 0.03).
The MBSR program improved psychological distress, fear of recurrence, and quality of life among patients with breast cancer who recently transitioned from active treatment. The extent of practice of MBSR activities appears to influence the overall degree of benefit derived. A large percentage of patients were able to comply with a complex MBSR intervention.
Whether benefits seen were due to the actual intervention or the supportive aspects of the group was unable to be determined. More than half of eligible patients approached for enrollment declined due to scheduling issues, travel distance, lack of interest, and other issues. This suggests that such a program is limited in application related to these types of issues.
Lengacher, C.A., Shelton, M.M., Reich, R.R., Barta, M.K., Johnson-Mallard, V., Moscoso, M.S., . . . Kip, K.E. (2014). Mindfulness based stress reduction (MBSR [BC]) in breast cancer: Evaluating fear of recurrence (FOR) as a mediator of psychological and physical symptoms in a randomized control trial (RCT). Journal of Behavioral Medicine, 37, 185–195.
To investigate the mechanisms of action of elements of mindfulness-based stress reduction (MBSR) that lead to specific clinical improvements, specifically to postulate and examine how changes in fear of recurrence as a result of participation in MBSR program may mediate a range of positive changes in psychological and physical symptoms and quality of life
At orientation, subjects were consented and randomized, and they completed baseline assessments. The assessments were completed again at two and six weeks following the MBSR program or control period. The program was adapted from the 1990 Jon Kabat-Zinn program. Subjects who were randomized to the MBSR group (n = 40) attended six, weekly, two-hour MBSR sessions with a trained psychologist. Participants learned four meditative practices, sitting meditation, walking meditation, body scan, and yoga, while integrating mindful attention to self-regulate and manage stressful symptoms. Participant materials included a training manual and audio tapes for home practice. Subjects completed a diary daily. Home meditation was advised for 15–45 minutes daily. The usual care (UC) group was offered the MBSR program after the six-week study period.
This was a randomized, controlled trial. Subjects were randomly assigned in a one-to-one ratio to either the MBSR or UC group. Randomization was stratified in an unblocked manner. Study personnel were blinded initially.
From baseline to six-weeks, the MBSR group experience more favorable changes than the UC group for several potential mediators including fear of recurrence concerns (2.8 versus .2, p = .007); fear of recurrence problems (11.4 versus .2, p = .02); depression (7.2 versus 4, p = .04); physical functioning (3.8 versus .5, p = .01) and energy (8.8 versus 5, p = .07). After removing direct effects of MBSR on outcomes of interest, the strongest and most consistent evidence for mediating effects (how MBSR works) was for change in fear of recurrence problems and change in physical functioning. The results indicate that MBSR is associated with reduced fear of recurrence and improved physical functioning which in turn are associated with reduced perceived stress and state and trait anxiety. The women in the UC group who experienced reduced fear of recurrence and improved physical functioning by mechanisms other than MBSR also experienced significantly reduced perceived stress and anxiety. Both groups experienced reduced anxiety and depression over time. There were no significant differences in anxiety between groups. Postintervention, the MBSR group had significantly higher depression scores (p = .04).
The fear of recurrence is highly prevalent in breast cancer survivors and is associated with considerable psychological distress. The results of this study may indicate that one of the mechanisms for how MBSR (BC) works is through the cognitive process of self-regulation of fear of recurrence to improve stress, anxiety, and physical functioning. The fear of recurrence influence by MBSR (BC) appeared to be reliable and clinically relevant. The findings did not demonstrate a direct effect on anxiety or depression scores.
The findings of this study show a clustering of multiple symptoms among breast cancer survivors. Interventions to simultaneously address multiple symptoms should be studied. MBSR is supported as being beneficial in reducing fear of recurrence and improving physical functioning. Training programs and awareness for nurses and staff members should be supported in cancer centers and survivorship programs.
Legert, K.G., Remberger, M., Ringden, O., Heimdahl, A., & Dahllof, G. (2014). Reduced intensity conditioning and oral care measures prevent oral mucositis and reduces days of hospitalization in allogeneic stem cell transplantation recipients. Supportive Care in Cancer, 22, 2133–2140.
To compare the incidence of oral mucositis (OM) in patients conditioned with myloablative conditioning (MAC) versus reduced-intensity conditioning (RIC) and to determine the effect of a new oral care protocol
A radiographic full-mouth exam and an oral exam by an investigating dentist were performed one week prior to hematopoietic stem cell transplantation (HSCT). Prior to the start of conditioning, daily oral exams began three days prior to HSCT for 25 days or until discharge. A dentist or dental hygienist assessed oral cavities three times per week. From 2007 to 2010, 142 patients used a protocol (soft tooth brushing twice daily only; no interdental brushes, toothpicks, or flossing were allowed). From 2010 to 2011, 29 patients received the intensive protocol (intensive protocol brushing, interdental brushes or flossing, sucking on ice chips every two to three hours while awake, rinsing normal saline solution every two hours while awake from transplantation until neutrophil count was > 0.5). Dental infections foci were treated conservatively.
Quasi-experimental
Patients treated with the oral protocol in 2011 had significantly lower OM scores than those treated with the previous protocol (p = 0.013).
MAC conditioning was correlated with significantly higher OM scores (p < 0.001). Lower OM scores were associated with the intensive oral protocol intervention. Patients treated in later years (2011) demonstrated a decrease in OM scores, which were caused by an increased use of RIC and improved standards of oral care.
Oral mucositis is a side effect of the conditioning regimens for HSCT. This study revealed that with consistent assessment, support, and a more intensive oral care protocol using ice and normal saline rinses, there is a potential to reduce the severity of this side effect. More nursing research is needed in this area.
Legeby, M., Jurell, G., Beausang-Linder, M., & Olofsson, C. (2009). Placebo-controlled trial of local anaesthesia for treatment of pain after breast reconstruction. Scandinavian Journal of Plastic and Reconstructive Surgery and Hand Surgery/Nordisk Plastikkirurgisk Forening [and] Nordisk Klubb for Handkirurgi, 43(6), 315–319.
To compare, in patients undergoing breast reconstruction, the efficacy of levobupivacaine in conjunction with oral paracetamol and IV morphine to the efficacy of placebo in conjunction with oral paracetamol and IV morphine
Levobupivacaine 2.5 mg/ml or normal saline (NS) was administered through an indwelling catheter every 3 hours for 45 hours with
Prospective placebo-controlled, double-blind study
When patients were at rest, levobupivacaine significantly reduced pain (p < 0.05) 15 hours postoperatively. With movement, levobupivacaine significantly reduced pain for 6 hours (p = 0.01) and significantly reduced pain for 18–24 hours (p = 0.045). Total dose of morphine used did not differ between groups. Two patients in the levobupivacaine group became infected. Authors noted no significant intergroup differences related to nausea or length of hospital stay.
Compared with patients who received placebo, those who were intermittently injected with levobupivacaine had better pain relief at rest for the first 15 hours after surgery. Those who received intermittently injected levobupivacaine also had better pain relief during mobilization, for the first 6 hours and for 18–24 hours.
Boluses of local anesthetic, delivered via patient-controlled anesthesia, tend to have good results because patients prefer to control their own treatment.
Lee, M.S., Kim, K.H., Choi, S.M., & Ernst, E. (2009). Acupuncture for treating hot flashes in breast cancer patients: A systematic review. Breast Cancer Research and Treatment, 115, 497–503.
STUDY PURPOSE: To access the effectiveness of acupuncture as a treatment option for hot flashes in patients with breast cancer through a systematic review
TYPE OF STUDY: Systematic review
PHASE OF CARE: Transition phase after active treatment
Of the six studies that were reviewed, three compared the effects of manual acupuncture with sham acupuncture, one compared the effects of electroacupuncture (EA) with hormone replacement therapy, one compared acupuncture with venlafaxine, and one compared manual acupuncture with relaxation therapy. Of the studies examined, all were randomized, controlled trials. Of the three comparing manual acupuncture with sham, one showed favorable results of acupuncture reducing the frequency of hot flashes, whereas the other two studies failed to do so. The study comparing EA with hormone therapy demonstrated that hormone replacement therapy was more effective in controlling hot flashes than EA. The study comparing acupuncture and venlafaxine showed no difference. When relaxation therapy was compared with acupuncture, no intergroup difference occurred.
This systematic review of six articles using acupuncture to treat hot flashes in women with breast cancer failed to demonstrate that acupuncture was a clearly effective treatment tool. When comparing acupuncture with sham acupuncture, the three studies were not consistent in their findings, with one demonstrating that acupuncture was effective and two that did not. In the additional three studies, acupuncture was not found to be superior to hormone replacement therapy, venlafaxine, or relaxation therapy.
This review of randomized studies did not demonstrate that acupuncture was a superior therapy to hormone replacement, venlafaxine, or relaxation therapy in controlling hot flashes in women with breast cancer.
Lee, M.S., Kim, K.H., Shin, B.C., Choi, S.M., & Ernst, E. (2009). Acupuncture for treating hot flushes in men with prostate cancer: A systematic review. Supportive Care in Cancer, 17, 763–770.
STUDY PURPOSE: To evaluate the effect of acupuncture on hot flashes in men with prostate cancer
TYPE OF STUDY: Systematic review
PHASE OF CARE: Not specified or not applicable
APPLICATIONS: Elder care
Five of the six studies included were uncontrolled observational studies. All six studies showed a reduction in the severity and frequency of hot flashes in men with prostate cancer. Some studies reported no follow-up; one study followed patients for 12 months. Mild adverse effects reported included distress, fatigue, hematoma at the insertion site, and a very short (few seconds) increase of vasomotor symptoms.
The researchers concluded that the evidence from these six studies is not convincing to recommend acupuncture as an effective treatment for hot flashes in men treated for prostate cancer. The researchers recommended more research with larger randomized, controlled trials. Mild adverse effects were noted with acupuncture.
The six studies did not provide convincing evidence that acupuncture is an effective treatment for reducing hot flash frequency and severity in men diagnosed with prostate cancer. More large randomized, clinical trials are need to evaluate the effectiveness of acupuncture. Such studies should include longer periods of follow-up to determine the long-term effectiveness.
Lee, H., Schmidt, K., & Ernst, E. (2005). Acupuncture for the relief of cancer-related pain—A systematic review. European Journal of Pain, 9, 437–444.
To summarize a systematic review of existing evidence regarding the effect of acupuncture on cancer-related pain
Databases searched were MEDLINE, EMBASE, CINAHL, Allied and Complementary Medicine Database (AMED), PsycINFO, British Nursing Index, the Cochrane Library, and databases relative to Journal of Korean Society for Acupuncture and Moxibustion and Journal of Korean Oriental Medicine. Investigators performed manual searches of department files and the reference lists of all located articles.
Search keywords were acupuncture, electroacupuncture, cancer, neoplasm, and tumor.
Studies were included if they were
Studies were excluded if they related to laser acupuncture, acupressure, or moxibustion or used transcutaneous electrical nerve stimulation or other cointerventions that were complementary or alternative medicine modalities; were case series, case reports, or abstracts with no details about the intervention; and involved acupuncture for postoperative pain in patients with cancer.
Investigators reviewed 29 studies initially and chose 7 for analysis. Two authors, working independently, read all articles in full and extracted data about trial methods, study design, participants, interventions, type of pain, pain outcomes, and adverse effects. Authors used a modified Jadad scale to rate the studies. (The study summary cites rating criteria.) Authors met to reach consensus, and discrepancies were settled by discussion with the third author. The Jadad scale was modified because of the near impossibility of blinding the acupuncturist to the treatment.
Data from this study do not support the use of acupuncture as an effective analgesic adjunctive method for the treatment of cancer pain. Note that 2003 is the most recent date of an article in this systematic review; articles excluded were published 1974–2003.
Appropriately powered randomized controlled trials that investigate the efficacy of acupuncture are needed.
Lee, E.Q., Muzikansky, A., Drappatz, J., Kesari, S., Wong, E.T., Fadul, C.E., . . . Wen, P.Y. (2016). A randomized, placebo-controlled pilot trial of armodafinil for fatigue in patients with gliomas undergoing radiotherapy. Neuro-Oncology, 18, 849–854.
To evaluate if armodafinil versus placebo reduced fatigue and improved quality of life when measured via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) subscale at baseline and 42 days.
Prior to starting treatment, participants completed several questionnaires rating fatigue and quality of life. The participants were randomly assigned 1:1 to the armodafinil group or placebo group, and questionnaires were completed again at day 22, day 43, and day 56, with the primary end point being day 43, as this was the end of radiation therapy for most patients enrolled. Participants in the armodafinil group received 150 mg daily for eight weeks.
PHASE OF CARE: Active antitumor treatment
Randomized, placebo-controlled, pilot trial
No statistically significant findings using any questionnaire were reported between the treatment arm and the placebo arm at any point measured (day 21, 42, or 26).
Based on this study, one can conclude that armodafinil is not effective in reducing fatigue or improving quality of life in this patient population. It would be helpful to know if the FACIT-F questionnaire has been used in this patient population previously with no concurrent interventions.
The findings of this study indicate that more education regarding the multiple factors that can cause fatigue in this patient population is needed, as well as tools to measure this fatigue more effectively to better gauge interventions. The study stated that fatigue is reported during radiation therapy in this patient population, but the questionnaires used did not capture that.
Lee, C., You, D., Jeong, I.G., Hong, J.H., Choo, M.S., Ahn, H., . . . Kim, C.S. (2015). Antibiotic prophylaxis with intravenous ceftriaxone and fluoroquinolone reduces infectious complications after transrectal ultrasound-guided prostatic biopsy. Korean Journal of Urology, 56, 466–472.
To compare the effectiveness of standard fluoroquinolone prophylaxis with fluoroquinolone plus ceftriaxone in the prevention of infection post prostate biopsy
Patients received one of three prophylaxis regimens: (a) 500 mg fluoroquinolone by mouth twice a day for three days, (b) 500 mg fluoroquinolone by mouth twice a day for three days plus 2 g IV ceftriaxone once before biopsy, or (c) 500 mg fluoroquinolone by mouth twice a day for more than seven days plus 2 grams IV ceftriaxone once before biopsy.
Infection post prostate biopsy was defined as any of the following: a temperature greater than 38 degrees Celsius, a white blood cell count greater than 12,000/mm3, a urinary tract infection, or acute prostatitis.
A significant decrease of infections was observed post prostate biopsy for patients that received prophylaxis with fluoroquinolone plus ceftriaxone (p < 0.001). One percent of patients who received fluoroquinolone prophylaxis had infectious complications compared to 0.3% of patients who received fluoroquinolone plus ceftriaxone. Patients who received fluoroquinolone prophylaxis for more than seven days had no added reduction of infection compared to patients who received fluoroquinolone prophylaxis for three days.
Infection prophylaxis with fluoroquinolone alone after prostate biopsy may be insufficient because of increasing resistance among pathogens, including Escherichia coli. The addition of 2 grams IV ceftriaxone before prostate biopsy was correlated with a significant reduction in infectious complications at one hospital in South Korea.
Adequate patient education on potential infectious complications is necessary post prostate biopsies. To tailor infection prophylaxis, nurses should consider assessing for individual risk factors for infection (e.g., diabetes, history of organ transplant, etc.) and collect rectal swabs to identify quinolone-resistance organisms.