Leach, H.J., Danyluk, J.M., Nishimura, K.C., & Culos-Reed, S.N. (2016). Benefits of 24 versus 12 weeks of exercise and wellness programming for women undergoing treatment for breast cancer. Supportive Care in Cancer, 24, 4597–4606.
Pre-post design
Lazzari, M., Greco, M.T., Marcassa, C., Finocchi, S., Caldarulo, C., & Corli, O. (2015). Efficacy and tolerability of oral oxycodone and oxycodone/naloxone combination in opioid-naive cancer patients: A propensity analysis. Drug Design, Development and Therapy, 9, 5863–5872.
To compare the analgesic efficacy and safety, and quality of life of oxycodone (OXY) compared with oxycodone/naloxone (OXN) combination in treating opioid-naïve patients
Patients were seen at three or four different times when starting long-acting oxycodone products.
PHASE OF CARE: Multiple phases of care
Retrospective, observational, three data collection time periods—T0, T30, and T60. T15 available for patients who needed closer monitoring.
The patients who received OXN had better early improvement in bowel function than the patients who received OXY (p < 0.001).
OXN and OXY have similar analgesic effects, but OXN seems to have better bowel outcomes.
OXN may have better bowel function outcomes compared with OXY in patients starting analgesics.
Lawson, L.M., Williams, P., Glennon, C., Carithers, K., Schnabel, E., Andrejack, A., & Wright, N. (2012). Effect of art making on cancer-related symptoms of blood and marrow transplantation recipients. Oncology Nursing Forum, 39, E353–E360.
To examine the effects of a one-hour art-making session during bone marrow transplantation (BMT) treatment
Interested patients were randomly assigned to the sequence to receive either the art-making session or the control condition first and were then crossed over to the other condition. Art-making sessions were 40–60 minutes. Patients were provided with a ceramic tile, brushes, and paint to create a tile at no cost. Measurements were obtained pre- and postintervention. Patients waited an average of 6.8 days between the treatment and control conditions.
Patients were undergoing active antitumor treatment.
A crossover pre/post-test design was used.
Symptoms declined in post-test measures in both conditions, with significant decline post art making (p = 0.01). There was no significant change in anxiety scores. Salivary cortisol levels declined significantly in both conditions. Time between conditions ranged from 1 to 28 days.
Art making appeared to reduce treatment-related symptoms but had no apparent effect on anxiety.
This pilot study showed that the art-making session appeared to have an effect in reducing treatment-related symptoms; it is not clear if the art making specifically was effective, or if any diversional activity would have the same result. Findings do not support an effect of art making on anxiety.
Lawrence, J.A., Balcueva, E.P., Groteluschen, D.L., Samuel, T.A., Lesser, G.J., Naughton, M.J., . . . Rapp, S.R. (2016). A study of donepezil in female breast cancer survivors with self-reported cognitive dysfunction 1 to 5 years following adjuvant chemotherapy. Journal of Cancer Survivorship, 10, 176–184.
To evaluate the feasibility of taking daily donepezil, an acetylcholinesterase inhibitor, to improve cognitive function in women who report cognitive impairment one to five years after completing adjuvant chemotherapy for breast cancer
This study evaluated the feasibility of a randomized, controlled trial of 24 weeks of donepezil (5 mg/day for 6 weeks, then 10 mg/day for 18 weeks) versus placebo. Potential participants were prescreened for moderate-to-severe self-reported cognitive impairment, and those enrolled were stratified by menopausal status and time since chemotherapy. Self-reported cognitive function, co-occurring symptoms, and quality of life were measured before the trial, halfway through the trial (i.e., 12 weeks), and at the completion of the trial (i.e., 24 weeks). Neuropsychological testing was conducted at baseline and 24 weeks.
Double-blind, randomized, controlled trial of donepezil versus placebo with repeated measures
Donepezil may have some benefit for patients related to changes in cognitive function. Further research is needed to provide strong evidence.
This study primarily showed that future large studies of donepezil in women with breast cancer are feasible. The findings suggest that donepezil may improve memory in breast cancer survivors who report moderate-to-severe cognitive problems. Executive function may improve for some women. Anxiety and insomnia are potential side effects.
Lavu, H., Lengel, H.B., Sell, N.M., Baiocco, J.A., Kennedy, E.P., Yeo, T.P., . . . Yeo, C.J. (2015). A prospective, randomized, double-blind, placebo controlled trial on the efficacy of ethanol celiac plexus neurolysis in patients with operable pancreatic and periampullary adenocarcinoma. Journal of the American College of Surgeons, 220, 497–508.
To examine the efficacy of celiac plexus neurolysis on pain in patients receiving surgical resection for locally advanced disease
Patients who were identified as having unresectable disease underwent open biopsies if indicated and palliative biliary or gastrointestinal bypasses as deemed appropriate. Once it was determined that resection was appropriate, patients were randomly assigned to receive the study intervention or a placebo of normal saline injections. Postoperative pain control consisted of intravenous patient-controlled analgesia. For the analysis, patients were grouped according to resectability and the presence of pain at baseline. Patients were followed for 24 months. Pain was evaluated via patient surveys done every three months. Celiac plexus neurolysis has been shown to reduce pain in patients with advanced pancreatic cancer.
Double-blinded, placebo-controlled, randomized, controlled trial
There were no significant differences in postoperative complications between groups. There were no overall significant differences in pain scores over time between groups. A subgroup analysis showed a reduction in pain at three to nine months among patients with pain at baseline who received surgical resection. There were no differences in pain results from the addition of neurolysis.
This study showed that palliative surgical resection reduced pain as many as nine months after surgery, and that there was no added benefit from celiac neurolysis.
A number of studies have shown that celiac neurolysis is effective in reducing pain among patients with chronic pain associated with unresectable pancreatic cancer. This study suggested that, for those patients where palliative resection is possible, that resection is more effective than neurolysis and that neurolysis in addition to resection did not appear to have additional benefit. There were a number of important limitations in this study. However, it pointed to the value of additional research in this area to determine the most beneficial approaches for long-term pain control in this group of patients.
Lavigne, J.E., Heckler, C., Mathews, J.L., Palesh, O., Kirshner, J.J., Lord, R., . . . Mustian, K. (2012). A randomized, controlled, double-blinded clinical trial of gabapentin 300 versus 900 mg versus placebo for anxiety symptoms in breast cancer survivors. Breast Cancer Research and Treatment, 136, 479–486.
To compare the efficacy of gabapentin 300 mg and 900 mg for controlling anxiety symptoms among breast cancer survivors
Patients were randomly assigned to receive 300 mg or 900 mg of gabapentin or placebo daily. Outcomes were assessed at baseline, four weeks, and eight weeks.
Patients were undergoing the transition phase of care after initial treatment.
A double-blind, placebo-controlled, randomized controlled trial design was used.
At four weeks, patients on gabapentin showed significant reduction in anxiety scores (p = 0.005). Patients with the highest baseline anxiety scores had the greatest improvement, and those with low anxiety levels had little change. These patterns were maintained at the eight-week follow-up. The greatest improvement in anxiety was seen in those getting 300 mg of gabapentin. Anxiety scores of those on placebo also declined, but changes were not significant.
Gabapentin 300 mg daily was effective in reducing symptoms of anxiety in these breast cancer survivors.
This study demonstrated that 300 mg of gabapentin daily was effective in controlling anxiety symptoms among breast cancer survivors who had been experiencing hot flashes and had relatively high baseline anxiety. Gabapentin is currently off label in psychiatry to treat anxiety symptoms and commonly used to treat hot flashes and neuropathic pain in breast cancer survivors. As shown in other research, improvement in anxiety symptoms tends to be found in patients who have clinically relevant levels of anxiety to begin with. Nurses can consider and advocate for use of gabapentin to manage anxiety in these patients.
Lauritano, D., Petruzzi, M., Di Stasio, D., & Lucchese, A. (2014). Clinical effectiveness of palifermin in prevention and treatment of oral mucositis in children with acute lymphoblastic leukaemia: A case-control study. International Journal of Oral Science, 6, 27–30.
To evaluate the efficacy of palifermin, an N-terminal truncated version of endogenous keratinocyte growth factor, in the control of oral mucositis during antiblastic therapy for pediatric patients with acute lymphoblastic leukemia
Twenty patients received palifermin and other 20 patients didn’t. The palifermin group received a 60 mg/kg IV bolus per day for three consecutive days before and three consecutive days after transplant (a total of six doses). All patients were evaluated for 30 days.
Case-controlled study
This study demonstrated a statistically significant reduction in the duration of parenteral nutrition (p = .002), duration of mucositis (p = .003), and the average grade of mucositis (p = .03). Other measures were not significant. The statistical analysis showed that the drug decreased the severity of mucositis.
These data suggest that palifermin could be a valid therapeutic adjuvant to improve quality of life for pediatric patients with leukemia.
Palifermin decreased the duration of oral mucositis in pediatric patients being treated for leukemia. Nurses should be aware that this intervention may compliment other interventions to reduce oral mucositis in this population.
Laudenslager, M.L., Simoneau, T.L., Kilbourn, K., Natvig, C., Philips, S., Spradley, J., . . . Mikulich-Gilbertson, S.K. (2015). A randomized control trial of a psychosocial intervention for caregivers of allogeneic hematopoietic stem cell transplant patients: Effects on distress. Bone Marrow Transplantation, 50, 1110–1118.
To determine if a modified cognitive behavioral stress management program would have a beneficial effect for caregivers on stress reduction
Caregivers were randomized to either the experimental intervention or usual care groups. The experimental intervention consisted of eight one on one sessions with a social worker beginning post-transplantation and continued weekly prior to evaluation at three months. Sessions were psychoeducational in nature, including coping skills training, health behaviors, improving partner communication, and relaxation as well as other components. Caregivers in the experimental group were given a biofeedback device and asked to use it four to five times weekly to facilitate relaxation. All caregivers from both study groups were encouraged to participate in programs at the facility designed to provide support for patients, families, and caregivers. Study data were obtained at baseline, one month, and three months.
Randomized, controlled trial
Baseline results showed higher than normal perceived stress, clinically relevant levels of depression, elevated anxiety, and poor sleep in caregivers. Caregivers in the intervention group had lower stress at three months (p = 0.039) and consistent declines in depression (p = 0.016) and anxiety scores (p = 0.0009) over time compared to controls. There were no differences between groups over time in measures of physical function and well-being. The composite score for caregiver distress was significantly lower among those in the intervention group (p = 0.019).
The psychoeducational intervention tested here demonstrated benefit in the reduction of caregiver psychological distress, depression, and anxiety.
The findings of this study demonstrated that psychoeducational interventions can be helpful to caregivers in reducing the psychological components of caregiver stress and burden. Educational and supportive interventions are low-risk and can be provided to caregivers in a variety of ways. Reducing caregiver burden can improve their well-being and permit the caregiver to be more effective in fulfilling care needs.
Lau, R.W., & Cheing, G.L. (2009). Managing postmastectomy lymphedema with low-level laser therapy. Photomedicine and Laser Surgery, 27(5), 763–769.
To investigate effects of low-level laser therapy in managing lymphedema
Women were randomly assigned to laser treatment or usual care. Subjects in the laser group received low-level laser therapy (LLLT) three times a week for four weeks to the axillary region. Outcome measures were assessed at baseline, after four weeks of treatment and again at a four-week follow-up.
The study took place in an outpatient setting in China.
The study used a single-blind, randomized controlled trial design.
In the laser group, arm volume decreased significantly (p = 0.000), whereas those in the control group had a significant increase at the four-week follow-up. Group differences were significant (p = 0.044) at the four-week follow-up time point. For the first month, there were no significant differences between groups. Over time, the laser group showed a significant increase in tonomety readings at some sites (p = 0.000), indicating less tissue hardness, while there were no changes in the control group. Mean DASH scorers decreased significantly from baseline in the laser group (p = 0.04). There were no significant changes in DASH scores in the control group.
Low-level laser treatment in the study appeared to improve subjective pain and disability, improve tissue tone, and reduce lymphedema.
Low-level laser therapy is promising for management of lymphedema postmastectomy.
Lasinski, B.B., McKillip Thrift, K., Squire, D., Austin, M.K., Smith, K.M., Wanchai, A., … Armer, J.M. (2012). A systematic review of the evidence for complete decongestive therapy in the treatment of lymphedema from 2004 to 2011. PM & R: The Journal of Injury, Function, and Rehabilitation, 4(8), 580–601.
To analyze the evidence on complete decongestive therapy (CDT) as a bundled intervention for the treatment of lymphedema
A total of 5,927 references were found and evaluated using the Oncology Nursing Society (ONS) Putting Evidence Into Practice (PEP) Levels of Evidence.
The final review involved 27 studies, 14 reviews, and 2 consensus documents.
Patients were undergoing multiple treatment phases of care.
Most studies considered CDT as a bundled intervention. Follow-up studies showed that pain decreased with longer length of treatment as well as patient adherence. Results of one long-term study in 356 patients after one year correlated with adherence in using compression sleeves by day or bandaging at least three nights per week. Findings regarding the effect of MLD as a component of CDT were contradictory. Discrepancies may be because of differences in lymphedema measurement and variations in how MLD was applied by both technique and dosage. Studies of compression bandaging showed that no differences were found between high- and low-pressure bandaging and that low pressure was better tolerated. One study showed that up to 48% of pressure loss under the bandage because of limb volume reduction. Adherence to compression bandage use has a direct correlation with reduction in volumes.
CDT is effective in the management of lymphedema; however, the relative roles of the components of CDT are unclear. Levels of evidence in this area are seen to be weak. The role of patient adherence requires further examination.
CDT as a bundled intervention for lymphedema management appears to be effective. Patient adherence is a key component of treatment. Nurses need to educate and assist patients to maintain the use of compression garments and bandaging as prescribed to achieve effective lymphedema management. The evidence in this area is relatively weak, and further research continues to be needed. Research could benefit from more consistent definition and measurement approaches and examination of techniques for facial, breast, truncal, and genital lymphedema as well as effective risk reduction strategies. More standardization of treatment protocols would be helpful.