Logothetis, C.J., Basch, E., Molina, A., Fizazi, K., North, S.A., Chi, K.N., . . . de Bono, J.S. (2012). Effect of abiraterone acetate and prednisone compared with placebo and prednisone on pain control and skeletal-related events in patients with metastatic castration-resistant prostate cancer: Exploratory analysis of data from the COU-AA-301 randomised trial. The Lancet Oncology, 13, 1210–1217.
To assess data to determine the effect of abiraterone acetate on pain and skeletal events in patients with castration-resistant prostate cancer
Patients were randomized to receive either 1 g abiraterone acetate or placebo orally once a day, along with 5 mg prednisone twice daily for 28-day cycles. Concomitant bisphosphonates were allowed during the study, if patients were already taking them or if a skeletal event indicated their use. Assessments occurred at baseline, on day 15, and on day 1 of the first 28-day cycle and during each subsequent 28-day cycle until the end of the study or treatment discontinuation.
Randomized double-blind, placebo-controlled trial
Brief Pain Inventory
Compared to placebo, abiraterone acetate and prednisone were associated with favorable effects on pain and a longer time to skeletal events in patients with metastatic castration-resistant prostate cancer.
Findings show that prednisone and abiraterone acetate appeared to improve pain control in patients with castration-resistant prostate cancer. Chronic bone-related pain can be a severe problem for late-stage patients with prostate cancer. For these patients, abiraterone acetate and prednisone can be helpful in reducing pain and delaying skeletal events.
Loerzel, V.W., Crosby, W.W., Reising, E., & Sole, M.L. (2014). Developing the Tracheostomy Care Anxiety Relief through Education and Support (T-CARES) Program. Clinical Journal of Oncology Nursing, 18, 522–527.
To evaluate the effectiveness of thee Tracheostomy Care Anxiety Relief through Education and Support (T-CARES) educational program for decreasing caregiver anxiety and increasing caregiver competence with tracheostomy suctioning
T-CARES is a one-hour course for caregivers about caring for a tracheostomy. The course is offered once a week in the hospital unit in a group setting. It involves an 18-minute video, group discussion, hands-on practice, and a return demonstration of tracheostomy care. The course covers the following topics: the introduction to airway anatomy, components of a tracheostomy tube, tracheostomy suctioning, stoma care, changing the ties securing the tracheostomy, cleaning the inner cannula, preparing for the unexpected, reinsertion of the tracheostomy tube after accidental decannulation, how to handle a mucous plug, when to call the doctor, and self-care. Evaluations were done at baseline and postintervention.
Nonexperimental, self-selected to receive the intervention pre- and post-test pilot study
Mean STAI scores dropped from 50.5 to 34.3 after the intervention (p = 0.008). All participants were able to perform nine of the 14 skills needed for tracheostomy suctioning. Course evaluations were positive.
T-CARES is an effective intervention for reducing caregiver anxiety and increasing caregiver competency of tracheostomy care.
Nurse-developed caregiver educational programs may be useful in decreasing anxiety and increasing competency for the development of new caregiver skills required for quality patient care. Additional research in this area is indicated.
Loening-Baucke, V., & Pashankar, D.S. (2006). A randomized, prospective, comparison study of polyethylene glycol 3350 without electrolytes and milk of magnesia for children with constipation and fecal incontinence. Pediatrics, 118, 528–535.
To compare and evaluate the efficacy, safety, acceptance, and one-year outcome of two laxatives, polyethylene glycol (PEG) without electrolytes and milk of magnesia (MOM).
Patients were randomly assigned to intervention with PEG 3350 without electrolytes (Miralax®) or MOM by drawing a sealed envelope. Patients initially received 0.7 g/kg of PEG or 2 ml/kg of MOM daily.
Children’s Hospital of Iowa
Randomized controlled trial
PEG and MOM are effective and safe in long-term treatment, with PEG having better acceptance.
Lodge, J.P.A., Jonas, S., Oussoultzoglou, E., Malagó, M., Jayr, C., Cherqui, D., . . . Mimoz, O. (2005). Recombinant coagulation factor VIIa in major liver resection: A randomized, placebo-controlled, double-blind clinical trial. Anesthesiology, 102, 269–275.
Placebo versus two treatment arms of recombinant coagulation factor VIIa: 20 mcg/kg and 80 mcg/kg
Perioperative transfusion difference approached significance (P = 0.09). Mean requirements decreased with rFVIIa (P = 0.78). Blood loss during surgery decreased (P = 0.07).
A larger trial is needed for better evaluation.
Lockhart, P.B., Brennan, M.T., Kent, M.L., Packman, C.H., Norton, H.J., Fox, P.C., & Frenette, G. (2005). Randomized controlled trial of pilocarpine hydrochloride for the moderation of oral mucositis during autologous blood stem cell transplantation. Bone Marrow Transplantation, 35, 713–720.
Patients were given a 5-mg pilocarpine tablet or placebo starting the day before the conditioning regimen, every 4 hours, for a total of 4 tablets per day. Patients continued taking tablets until absolute neutrophil count (ANC) was greater than 500 for 48 hours, discharge from hospital, or mucosal recovery.
This was a prospective, double-blind, randomized, placebo-controlled trial. Patients were stratified by diagnosis and randomized by a computer-generated numbering scheme.
Despite prior small trials that showed a benefit, this study clearly did not. The intervention was not effective.
A standardized scoring system is needed.
Locke, D.E., Cerhan, J.H., Wu, W., Malec, J.F., Clark, M.M., Rummans, T.A., & Brown, P.D. (2008). Cognitive rehabilitation and problem-solving to improve quality of life of patients with primary brain tumors: A pilot study. Journal of Supportive Oncology, 6, 383–391.
*Withdrawals were due to tumor progression; new onset seizures; time commitment; caregiver issues; and fatigue.
Randomized controlled trial; longitudinal
Lloyd-Williams, M., Cobb, M., O'Connor, C., Dunn, L., & Shiels, C. (2012). A pilot randomised controlled trial to reduce suffering and emotional distress in patients with advanced cancer. Journal of Affective Disorders, 148(1), 141–145.
To determine if a focused narrative-interview intervention can alleviate symptoms of suffering, anxiety, and depression in patients with advanced cancer
Patients in a hospice day unit were randomized to one of two groups. In one, patients received the study intervention; in the other, usual care. The intervention was a single focused narrative interview in which a patient was encouraged to discuss his or her perspectives; sense of meaning; sense of suffering; and psychological, physical, and spiritual well-being. The emphasis was on enabling each patient to tell his or her story. Study assessments were done at baseline and at two, four, and eight weeks after the intervention.
Randomized controlled trial
Baseline scores indicated, on average, probable depression. At four weeks investigators noted a slight, but nonsignificant improvement in the depression score. Authors noted no other changes or differences between groups.
As result of narrative interview intervention in a hospice day program, findings did not show any substantial improvement in measures of depression or other symptoms.
Findings do not suggest that narrative interview, used as an intervention for depression and other symptoms, had any effect in this study.
Lloyd-Williams, M., Payne, S., Reeve, J., & Kolamunnage Dona, R. (2013). Antidepressant medication in patients with advanced cancer: An observational study. QJM, 106, 995–1001.
To observe the longitudinal effects of antidepressant medication in a cohort of patients with advanced cancer
Of the 628 patients with advanced cancer in the study, 25% were receiving antidepressants for a median of 9.5 weeks. Patients were followed for six months or until death. Consecutive patients in the daycare unit were eligible for inclusion. Patients completed study assessments at baseline and at eight, 16, and 24 weeks. A patient self-report was used to identify patients taking antidepressants.
Observational
Patients who stated that they took antidepressants had significantly higher depression scores on both measures. A subgroup analysis was completed for those with the highest PHQ-9 scores, assuming that effects might be seen in those with greater depression levels. However, there were no differences in results between those taking and not taking antidepressants.
The observational findings of this study suggest that antidepressant medication had little impact in reducing depression scores for patients attending Hospice daycare service.
This observational study did not show that antidepressants reduced depression among patients receiving Hospice care. However, there were several study design and measurement limitations. The role and effectiveness of antidepressants may vary among patients at different phases in the trajectory of cancer.
Ljungman, P., Engelhard, D., de la Cámara, R., Einsele, H., Locasciulli, A., Martino, R., . . . Infectious Diseases Working Party of the European Group for Blood and Marrow Transplantation. (2005). Vaccination of stem cell transplant recipients: recommendations of the Infectious Diseases Working Party of the EBMT. Bone Marrow Transplantation, 35, 737–746.
To update previous recommendations (released in 1995 and last updated in 1999) for vaccinations in pediatric and adult hematopoietic stem cell transplantation (HSCT) recipients.
This resource was classified as a guideline.
Recommendations for 18 vaccinations were drawn from published data, most of which were specific to stem cell transplantation recipients. The strength of each recommendation and the quality of evidence supporting it are noted in a summary table, using grading standards endorsed by the Centers for Disease Control and Prevention (CDC).
Patients undergoing HSCT are advised to be vaccinated against bacterial and viral infections beginning six to 12 months after transplantation, with the exception of meningococcal vaccine. Because polysaccharide pneumococcal vaccines are ineffective in patients with chronic graft-versus-host disease (GVHD), antibiotic prophylaxis should be given to patients with GVHD in addition to the pneumococcal vaccine. Three doses of Haemophilus influenzae type B (Hib) conjugate vaccine, tetanus toxoid vaccine, and diphtheria toxoid vaccine should be given beginning six months posttransplantation and spaced one to three months apart. Routine vaccination against pertussis was not recommended. Bacillus Calmette-Guerin vaccine was specifically contraindicated in this population.
Inactivated influenza vaccine was recommended for all patients undergoing HSCT, beginning no earlier than four to six months posttransplantation. For patients undergoing allogeneic HSCT, influenza vaccination should be given annually (prior to influenza season) and continue at least as long as the patient remains immunocompromised. For patients undergoing autologous HSCT, the duration of yearly influenza vaccination should be assessed individually. Patients undergoing HSCT and those in close contact with them (e.g., family members and hospital staff who care for these patients) should be vaccinated against polio using the inactivated poliovirus vaccine only.
Patients undergoing HSCT should receive three doses of the inactivated vaccine, beginning six to 12 months following transplantation, with subsequent doses one to three months apart. Hepatitis B vaccination (HBV) is recommended for patients undergoing HSCT living in countries where HBV is recommended for the general public and should be given six to 12 months following HSCT. Vaccination with two doses of hepatitis A may be considered for patients who live or plan to travel to areas where the disease is endemic. The measles, mumps, and rubella (MMR) vaccine is generally recommended to begin no sooner that 24 months after HSCT but may be considered earlier if there is a high risk of measles. MMR is contraindicated in patients with chronic GVHD or ongoing immunosuppression. To prevent varicella, seronegative family members should be immunized with the varicella-zoster virus (VZV) vaccine. Seronegative patients undergoing HSCT may be considered for the VZV vaccine two years following transplantation, provided they are free of GVHD or ongoing immunosuppression. Vaccination of seropositive patients undergoing HSCT is not recommended.
Vaccination against yellow fever should only be considered in patients undergoing HSCT who must travel to areas of the world where yellow fever is endemic. Guidelines for serological testing of immune status are also included, again following the CDC grading standards. Immunity testing before vaccination is not necessary for tetanus toxoid, diphtheria toxoid, polio, influenza, pneumococcal, and Hib but is recommended for HBV, measles, mumps, and rubella (MMR), and varicella-zoster virus (VZV). Postvaccination testing to assess immune response is not recommended for tetanus toxoid, diphtheria toxoid, polio, Hib, or influenza. It is recommended for hepatitis B, MMR, and VZV and also may be considered for pneumococcal vaccine for patients at increased risk of poor response.
This article provided a concise summary for providers to use when considering the vaccination needs of HSCT recipients. It rated the strength of each recommendation using CDC guidelines. The article was extensively referenced to aid readers who wish to delve more deeply into the studies supporting each recommendation.
Li, J.R., Yang, C.R., Cheng, C.L., Ho, H.C., Chiu, K.Y., Su, C.K., . . . Ou, Y.C. (2013). Efficacy of a protocol including heparin ointment for treatment of multikinase inhibitor-induced hand-foot skin reactions. Supportive Care in Cancer, 21, 907–911.
To evaluate the efficacy of a protocol including topical heparin therapy for hand-foot skin reactions (HFSR) during multikinase (MKI) treatment
Heparin Z ointment contains 500 IU unfractionated heparin sodium in each 1 g. Heparin, a member of the glycosaminoglycan family, has anti-inflammatory properties and is effective in the treatment of ulcerative wounds. All patients experiencing HFSR received mutifaceted care, including thick socks, shock-absorbing shoes, and topical treatment with heparin Z ointment (Zeria Pharmaceutical Co., Ltd., Japan), twice daily, integrated with urea-containing cream twice daily. Treatment with heparin Z ointment continued daily until grade of toxicity was downgraded to 0. All patients were seen monthly, and those with HFSR were seen weekly. Patients whose grade was downgraded to 0 were considered cured of HFSR. Treatment responders were recorded as the sum of cured and improved patients.
Of patients whose grading was downgraded to 0, the highest percentage was in the axitinib group (50%), while 31.8% of the sunitinib group were downgraded to 0, which equated to the cure of HFSR. Patients with CRPC had a higher response rate on sunitinib therapy (80% to MRCC of 66.7%). A higher rate of HFSR was seen in patients with CRPC treated with sunitinib than those with MRCC treated with sunitinib. Only four patients required MKI dose reduction, and none of the 26 patients who experienced HFSR dropped out.
This study provides a new protocol for the treatment of HFSR in patients on MKI therapies who experience HFSR. It would appear beneficial for keeping patients on treatment with minimal need to decrease the dose.
Nurses are aware of the need for supportive care to decrease the incidence and severity of skin toxicities with MKI therapies. The use of heparin Z ointment as an additive intervention seems appropriate, particularly in light of heparin use in burned skin and wound healing. However, this study does not allow for inclusion as a new guideline intervention. More investigation with better designed trials is needed.