Gladkov, O., Moiseyenko, V., Bondarenko, I.N., Shparyk, Y., Barash, S., Adar, L., & Avisar, N. (2016). A phase III study of balugrastim versus pegfilgrastim in breast cancer patients receiving chemotherapy with doxorubicin and docetaxel. Oncologist, 21, 7–15.
To evaluate the efficacy and safety of balugrastim compared to pegfilgrastim
Patients were randomized to receive either once per cycle 40–50 mg balugrastim or 6 mg pegfilgrastim by subcutaneous injection 24 hours after administration of chemotherapy. Blood samples were obtained twice weekly after post-nadir absolute neutrophil count (ANC) was greater than two, and temperature was measured twice daily.
Difference in duration of severe neutropenia was less than one day between balugrastim and pegfilgrastim, and was similar in both dosages of balugrastim. Duration and incidence of severe neutropenia were reduced in subsequent cycles in all groups. There were no significant differences in incidence of febrile neutropenia. In cycle one, time to ANC recovery was shorted in the balugrastim group (2.0–2.1 days versus 2.6 days, p = 0.005). Adverse effects were similar in both groups. Presence of antibodies to the medication was similar in both groups.
A single fixed dose of balugrastim was not inferior to pegfilgrastim for management of neutropenia.
Balugrastim is an effective alternative to pegfilgrastim in patients with breast cancer receiving myelosuppressive chemotherapy. A single fixed dose per cycle was as effective as pegfilgrastim. Further research comparing various colony-stimulating factors (CSFs) and biosimilar agents are needed to continue to identify the most acceptable and cost-effective methods for hematopoetic support in patients receiving myelosuppressive chemotherapy with a high risk of febrile neutropenia.
Gjerset, G. M., Fosså, S. D., Dahl, A. A., Loge, J. H., Ensby, T., & Thorsen, L. (2011). Effects of a 1-week inpatient course including information, physical activity, and group sessions for prostate cancer patients. Journal of Cancer Education, 26, 754–760.
To explore the effects of a prostate-specific program on physical activity, fatigue, mental distress, and quality of life (QOL).
Courses were conducted by a multidisciplinary team, including lectures, physical activity, and group sessions, lasting for six days. Activity was performed in groups of six to nine patients twice daily, including water gymnastics, walking, Nordic walking, resistance training, pelvic floor training, stretching, and relaxation for 60 to 90 minutes. Group sessions met for one hour daily and were led by a nurse with experience in group counseling. Lectures involved presentation of medical facts, treatment modalities, late effects, and social and other benefits of physical activity. Study measurements were obtained at baseline and at three-month follow-up.
Patients were undergoing the active treatment phase of care.
This was a prospective, observational study.
Total fatigue scores declined from 16.1 to 14.0 (p = 0.001), and physical fatigue declined from 11.1 to 9.2 (p = 0.001). Those who did not complete the entire program had higher baseline fatigue scores. Anxiety results were mixed: anxiety declined on the prostate specific measure (p = 0.001), but there was no change on the HADS scale. QOL measures did not change significantly.
Although there was a significant reduction in fatigue, the degree of change was small (2 of 33 points possible). The study did not provide strong support for the effectiveness of this program.
The results suggested a small effect of this type of program on fatigue and no significant impact on overall anxiety or QOL.
Given, B., Given, C.W., McCorkle, R., Kozachik, S., Cimprich, B., Rahbar, M.H., & Wojcik, C. (2002). Pain and fatigue management: Results of a nursing randomized clinical trial. Oncology Nursing Forum, 29, 949–956.
To compare, in a population of initial-chemotherapy patients reporting pain and fatigue, a supportive nursing intervention plus conventional care versus conventional care
The intervention consisted of an 18-week, 10-contact approach that included problem-solving strategies to manage symptoms and improve physical functioning and emotional health. Investigators conducted interviews at baseline and at 10 and 20 weeks.
Phase of care: active treatment
Randomized clinical trial
At 22 weeks, patients in the experimental group reported 3.3 symptoms and patients in the control group reported 4.4 symptoms. Of those in both groups who reported neither pain nor fatigue at 20 weeks, the average number of other symptoms reported per patient was less than one symptom. At 20 weeks, authors noted no significant differences between groups in regard to pain or fatigue.
Patients who received the intervention reported a significant reduction in the number of symptoms experienced and improved physical and social functioning. Fewer patients in the experimental arm reported both pain and fatigue at 20 weeks.
Findings suggest that behavioral interventions targeted to patients with pain and fatigue can reduce the symptom burden, improve the quality of the daily lives of patients, and demonstrate the value-added role of nursing care for patients undergoing chemotherapy. This study supports the work of Thomas et al. (2012), which evaluated a nursing-led cognitive behavioral intervention focused on improving symptom management and overall quality of life.
Given, B., Given, C. W., McCorkle, R., Kozachik, S., Cimprich, B., Rahbar, M. H., . . . Wojcik, C. (2002). Pain and fatigue management: results of a nursing randomized clinical trial. Oncology Nursing Forum, 29, 949–956.
The symptom-tailored, evidence-based intervention was delivered at two-week intervals over a 20-week period. Six contacts were delivered in person and four via telephone. The intervention was targeted to systematically assess and intervene when patients experienced symptoms of nausea, vomiting, pain, fatigue, insomnia, difficulty breathing, coordination problems, fever, cough, dry mouth, constipation, anorexia, diarrhea, or mouth sores. Pain and fatigue were sentinel symptoms in this study, and the supportive nursing intervention was directed toward these symptoms, as well as 12 other common symptoms. When symptoms (as evaluated every two weeks) reached a threshold level of intensity or bother/interference with function and quality of life, interventions to manage the symptom were selected collaboratively by the nurse and patient and were initiated and continued until the symptom resolved or until the 20-week intervention period ended. Once a symptom had reached such a threshold, the interventions (including teaching, counseling, support, coordination, and communication) were initiated. Every two weeks, the efficacy of the intervention strategies and the status of problem resolution were reevaluated. Intervention strategies were then adjusted or stopped based on the result.
Patients were undergoing the active treatment phase of care.
This was a randomized, controlled trial with a usual care control group.
Substantially more patients in the experimental group (n = 10) reported neither pain nor fatigue at the end of the 20-week intervention, compared with only three patients who reported neither pain nor fatigue, although it was not statistically significant. There were statistically significant benefits of the intervention relative to other outcomes, such as total symptom distress, role, and social functioning.
Given, C., Given, B., Rahbar, M., Jean, S., McCorkle, R., & Cimprich, B. (2004). Does a symptom management intervention affect depression among cancer patients: Results from a clinical trial. Psycho-Oncology, 13, 818–830.
Patients underwent a focused assessment that corresponded with specific symptom management interventions. The interventions recommended were based on a cognitive behavioral approach. The control arm received usual care. Patients were assessed for symptoms such as nausea, vomiting, insomnia, dyspnea, anorexia, fever, cough, dry mouth, constipation, mouth sores, pain, and fatigue. Symptoms identified with depression—fatigue, insomnia, anorexia, and poor concentration—were placed in a subindex.
Of 609 eligible patients, 237 patients and their family caregivers participated in the study. Patients had been diagnosed with a solid tumor and were within two months of the first cycle of chemotherapy. Patients who were receiving radiation or who had had previous chemotherapy were ineligible. The study include men and women who had been diagnosed with a variety of tumor types in various cancer stages.
Randomized control trial
Among those with higher levels of baseline symptoms except depression, cognitive behavioral interventions lowered depression at 10 weeks. In patients with a higher level of depression at baseline, the cognitive behavioral interventions were less effective.
Cognitive behavioral interventions may lower depression indirectly by managing symptoms that do not have a component that is primarily affective. Symptoms with a physiologic and psychological component may be more difficult to modify and require long-term intervention.
Given, B., Given, C.W., Sikorski, A., Jeon, S., Sherwood, P., & Rahbar, M. (2006). The impact of providing symptom management assistance on caregiver reaction: Results of a randomized trial. Journal of Pain and Symptom Management, 32(5), 433–443.
Dyads in the experimental group received four contacts over a 10-week intervention. (Two in-person contacts coinciding with regular visits to the oncology center; alternated with two telephone contacts approximately two weeks following each in-person contact.)
Cognitive behavioral intervention was directed toward the patient and caregiver dyad. Patients received information on self-care, cognitive reframing, coping strategies, and techniques for communicating needs for assistance with family members. Interventions for caregivers focused on etiology and strategies for managing symptoms, how to integrate into everyday activities, and how to better communicate with the patient and healthcare providers about symptom management. The intervention nurse assessed the caregivers’ perception of their involvement in and reaction to assisting the patient with symptom management; collaboratively selected strategies to implement; and evaulated the success of strategies to either continue or be revised.
A properly designed randomized clinical trial was used.
Caregivers in the experimental intervention group reported significantly lower total negative reactions and fewer assistances at 10 weeks than caregivers in the standard of care arm (p < 0.01).
Patients of caregivers in the experimental group reported significantly lower levels of symptom severity for which caregivers provided assistance.
Female caregivers in the experimental group reported less negative reactions to providing assistance than female caregivers in the control group (p < 0.01). Males in the control group reported less negative reactions per assistance than males in the experimental group (p = 0.08).
Caregivers who were younger than their patients reported less negative reactions to assisting with symptom management than caregivers who were the same age or older than their patients (p = 0.06).
Girmenia, C., Barosi, G., Piciocchi, A., Arcese, W., Aversa, F., Bacigalupo, A., . . . Rambaldi, A. (2014). Primary prophylaxis of invasive fungal diseases in allogeneic stem cell transplantation: Revised recommendations from a consensus process by Gruppo Italiano Trapianto Midollo Osseo (GITMO). Biology of Blood and Marrow Transplantation, 20, 1080–1088.
PHASE OF CARE: Transition phase after treatment
Volume of articles retrieved is not reported. Provides a three-level strength of recommendation and three-level grading of evidence quality. Ten studies are summarized.
The studies defined risk factors for patients to be considered high risk in early, late, and very late phases post-transplantation. It is recommended that high-risk patients receive mold-active prophylaxis and all remaining patients receive Candida-active prophylaxis in the early and late phases. In the very late phase, it is recommended that those at high risk, based on severity and steroid refractory graft-versus-host disease, receive mold-active prophylaxis; those with a standard risk receive Candida-active prophylaxis; and those at low risk receive no prophylaxis. The studies provide an extensive definition of risk levels for use.
Studies provide information to determine level of risk in various transplantation phases and gives guidance regarding antifungal prophylaxis in each phase. Nurses need to be aware of changing risk in various transplantation phases of care.
Girgis, A., Breen, S., Stacey, F., & Lecathelinais, C. (2009). Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Journal of Clinical Oncology, 27, 6180–6190.
To determine if, compared to individuals receiving usual care, participants in intervention groups would report lower levels of anxiety, depression, and unmet supportive care needs along with improved physical and emotional functioning
Parallel-group, prospective randomized controlled trial
Authors noted no significant intervention effect in this study, with the exception of improved physical functioning at six months for the TCW group.
Nurses should continue to explore ways to reach patients, at the time of diagnosis and beyond treatment, that can assist patients in psychosocial functioning. The field needs tools to make this easier; nurses need ways to implement care efficiently. The study did not show telephonic intervention to be effective.
Girgis, A., Breen, S., Stacey, F., & Lecathelinais, C. (2009). Impact of two supportive care interventions on anxiety, depression, quality of life, and unmet needs in patients with nonlocalized breast and colorectal cancers. Journal of Clinical Oncology, 27, 6180–6190.
To determine if patients assigned to either of two interventions for supportive care would report decreased levels of anxiety, depression, and unmet supportive care needs compared to patients receiving usual care
Patients were surveyed via computer-assisted telephone interview (CATI) to provide feedback to a telephone caseworker (TCW) or the patient’s physician at baseline, three months, and six months. The information obtained from the CATI was used to provide feedback to the caseworker in the TCW model, or to the physician in the oncologist/general practitioner (O/GP) model. In the TCW model, participant feedback information from CATIs was forwarded to the caseworker via email. The TCW then contacted participants to address areas of concern and refer to appropriate resources. In the O/GP model, feedback generated from the CATIs was mailed to both oncologists and GPs for discussion with the patients at the next appointment.
A randomized controlled trial design was used.
No overall intervention effect was observed. TCW participants were more likely to have referrals for unmet psychological needs, daily living, health service/information, and physical needs (p < 0.01).
Findings suggest that use of a TCW can be helpful in improving supportive care in terms of communication and provision of referrals for care in patients with cancer. Neither of the models tested demonstrated any significant intervention effect for anxiety, depression, or quality of life over the time frame of this study.
Additional research in this area should incorporate at-risk populations at a time closer to diagnosis. Results suggest that CATIs and involvement of caseworkers may be helpful to enhance supportive care and patient communication with providers.
Giralt, S.A., Mangan, K.F., Maziarz, R.T., Bubalo, J.S., Beveridge, R., Hurd, D.D., … Schuster, M.W. (2011). Three palonosetron regimens to prevent CINV in myeloma patients receiving multiple-day high-dose melphalan and hematopoietic stem cell transplantation. Annals of Oncology, 22, 939–946.
The study was conducted in an outpatient setting at Memorial Sloan Kettering Cancer Center in New York.
All patients were in active treatment.
This was a double-blind, randomized pilot study.
A multiple-dose schedule of palonosetron as used here was not associated with any increase in adverse events. No definitive conclusions can be drawn regarding the benefit of multiple-day administration of palonosetron.
Further evaluation of multiple-day schedules of palonosetron are warranted. Even with multiple dosing, 80% of these patients had episodes of emesis or required rescue medication, pointing to the continuing challenge to determine more effective methods and combinations to meet this patient need.