Walker, J., Hansen, C., Holm, Martin, P., Symeonides, S., Gourley, C., Wall, L., . . . Sharpe, M. (2014). Integrated collaborative care for major depression comorbid with a poor prognosis cancer (SMaRT Oncology-3): A multicentre randomised controlled trial in patients with lung cancer. Lancet Oncology, 15, 1168–1176.
To assess the efficacy of an integrated treatment program for major depression in patients with lung cancer compared to usual care
Nurses were specially trained to deliver psychological interventions to patients who were physically deteriorating. The training emphasized the achievement of competency and included tutorials and role-play among other methods. The trained nurses provided 10 structured sessions with patients, usually in their homes, immediately following the diagnosis of depression. Additional treatment was provided by phone and, for those patients who did not meet targets, additional treatment was provided.
Randomized, controlled trial
Average depression severity was significantly lower in patients allocated to the intervention group. Care was given by a nurse who usually visited patients in their homes. Depression improvement was self-rated. Improvement was seen in anxiety, quality of life, role functioning, perceived quality of care, and the proportion of patients achieving a 12-week treatment response.
In this study, the intervention proved to be more effective than usual care in reducing depression severity. Participants also saw improvements in anxiety, quality of life, and role functioning.
Walker, J., Sawhney, A., Hansen, C.H., Ahmed, S., Martin, P., Symeonides, S., . . . Sharpe, M. (2013). Treatment of depression in adults with cancer: A systematic review of randomized controlled trials. Psychological Medicine, 44(5), 897–907.
To determine which treatments are effective for patients with diagnoses of both cancer and depression
TYPE OF STUDY: Systematic review
DATABASES USED: MEDLINE, EMBASE, EMBASE Classic, PsycINFO,Cochrane centeral register–all to 2012
INCLUSION CRITERIA: Randomized controlled trial, adult patients, cancer diagnosis, diagnosis of major depression, trial evaluated treatments for depression, depression outcomes were assessed with a standardized measure. Patients with additional psychological diagnoses were included if results were analyzed separately for depression.
EXCLUSION CRITERIA: None specified
TOTAL REFERENCES RETRIEVED: N = 8,442
EVALUATION METHOD AND COMMENTS ON LITERATURE USED: Cochrane risk of bias tool used for quality evaluation
Three trials of antidepressants were included. Two used mianserin, and one compared amitriptyline and paroxetine. One trial of mianserin showed superiority to placebo. No difference in depression outcomes was seen between amitriptyline and paroxetine. One trial of psychological treatment compared eight one-hour sessions of behavioral activation therapy with problem-solving therapy. No differences in depression outcomes were seen. One trial of combined antidepressants and psychological treatment showed better outcomes compared to usual care.
Limited evidence exists for treatment of depression among patients with cancer from this review. Limited evidence exists that antidepressant drugs alone or in combination with psychological treatments are effective.
Twenty-five trials were excluded because they did not use standard psychiatric DSM or ICD criteria for depression. Risk of performance bias was high, and other ratings of bias were deemed unclear. No studies included involved use of newer and more commonly used antidepressants.
This review provides little evidence regarding interventions that are effective for treatment of depression in patients with cancer.
Waldron, E.A., Janke, E.A., Bechtel, C.F., Ramirez, M., & Cohen, A. (2012). A systematic review of psychosocial interventions to improve cancer caregiver quality of life. Psycho-Oncology. [Epub ahead of print]
To evaluate randomized, controlled caregiver-focused intervention studies intended to improve quality of life (QOL) in caregivers of adult patients with cancer
Multiple phases of care
A variety of measurement instruments was used across the six studies, including the Caregiver QOL Index–Cancer in three studies, Functional Assessment of Cancer Therapy (version 3) and Short Form-36 Health Survey administered together in two studies, and Profile of Mood States–Short Form and Caregiver Strain Index administered together in one study. Two of six studies showed a statistically significant improvement in caregiver QOL at the first measurement interval. Effect sizes were available in four studies, with two showing no effect and two illustrating a small effect on caregiver QOL (Cohen’s d = 0.264 [Northouse et al., 2007] and 0.271 [Walsh et al., 2007]). The Northouse et al. (2007) study also illustrated a small effect on caregiver coping (d = 0.392), self-efficacy (0.261), and negative appraisal (-0.191). Studies with interventions to improve caregiver ability to communicate and provide education on coping and specific care skills had the most impact.
High attrition rates in studies of the caregiver population were again noted, as are seen in other studies and reviews. The review included an evaluation of the effect of attrition on results and noted no significant impact on results, but it should be noted that the six studies included in this review were selected for their rigor.
The small sample was limited to RCTs of which there are few in the literature (not a fault of this study’s methodology).
More and larger controlled intervention studies are needed to clarify not only which interventions support QOL improvements, but under what circumstances and timing. The authors noted that different approaches may be needed when providing intervention to female versus male spousal caregivers to significantly improve depression. Attention to the optimal format and timing of interventions during phases when distress and need for support may be high, as well as attrition rates due to scheduling and general caregiving burden, is needed.
Wald, T.G., Roger, R.G., Noyes, R., Carroll, B.T., & Clamon, G.H. (1993). Rapid relief of anxiety in cancer patients with both alprazolam and placebo. Psychosomatics, 34, 324–332.
This randomized trial had two arms: alprazolam (0.5 mg) versus placebo. Dose increased over one week to 4 mg/day. Enrollment lasted four weeks.
The study reported on a sample of 36 inpatients and outpatients with cancer receiving treatment and/or follow-up.
A randomized, controlled, double-blinded trial design was used.
There was significant decrease in anxiety in both groups during week 1. There was no significant difference between alprazolam and placebo on anxiety for both self-rated and interviewer-rated scales.
Vuong, T., Franco, E., Lehnert, S., Lambert, C., Portelance, L., Nasr, E., … Freeman, C. (2004). Silver leaf nylon dressing to prevent radiation dermatitis in patients undergoing chemotherapy and external beam radiotherapy to the perineum. International Journal of Radiation Oncology, Biology, Physics, 59, 809–814.
To evaluate silver leaf nylon dressing (SLND) in preventing radiodermatitis in patients undergoing radiation therapy (RT) and concurrent chemotherapy.
Montreal General Hospital, Montreal, Quebec
The study was a phase 2, single-arm trial with a historical control comparison.
The results suggest that SLND can be effective in reducing radiodermatitis.
Vos, P.J., Visser, A.P., Garssen, B., Duivenvoorden, H.J., & de Haes, H. (2007). Effectiveness of group psychotherapy compared to social support groups in patients with primary, non-metastatic breast cancer. Journal of Psychosocial Oncology, 25(4), 37–60.
To compare the effectiveness, for women with a primary breast cancer, of experiential-existential group psychotherapy (incorporating cancer into one’s life) with that of a social-support group in regard to psychosocial adjustment (including psychological, psychosexual, and social adjustment); to examine the effect of age, type of surgery, and stage of disease on psychosocial adjustment indicators at the end of the intervention and at one year after the intervention
After the participants provided informed consent, they were randomly assigned to treatment groups: one group that received group psychotherapy; one group, social support. Data were collected at baseline (T0), then the intervention groups were conducted for three months. Data were collected after the intervention (T1) and at 12 months after completion of the intervention (T2). The interventions consisted of 12 weekly sessions of 2.5 hours each, including a 30-minute coffee break. The two follow-up sessions were at one and two months after the close of the intervention groups. The two follow-up sessions involved only 6–10 women and were conducted by trained leaders. Two trained therapists led the experiential-existential groups, and two trained leaders led the social-support groups. The study method required at least one of the therapists or leaders in each group to be a woman. Each group psychotherapy session, except the 1st and the 12th, followed a specific structure: opening, discussion of a specific topic, choosing the topic for the following week, and closing the session. The first session focused on introduction of the procedures and getting to know others. The 12th session was used to evaluate the group, to discuss what was learned or missed, to suggest improvements, and to say goodbye. Participants were allowed to choose the topics of the two follow-up sessions.
A time-series randomized clinical trial
In regard to distress, vitality, sexual functioning, and social intentions, the psychotherapy group did not benefit more from the intervention than did the social-support group. At the end of the sessions, participants reported positive changes in regard to body image and recreation; the disease had less impact on recreational activities than on body image. Type of surgery was related to body image: Participants who had had breast-conserving surgery reported a more positive body image than did participants who had not.
Psychologically well-adjusted women diagnosed with breast cancer do not benefit from the interventions described in this study: experiential-existential group psychotherapy and social-support groups.
Results do not make clear whether support groups or group psychotherapy are beneficial for women who do not have substantial distress. In clinical practice, screening patients for psychological distress makes sense, as does providing therapy and the specified support interventions only to those patients who have distress and who may benefit.
von Minckwitz, G., Schwenkglenks, M., Skacel, T., Lyman, G.H., Pousa, A.L., Bacon, P., . . . Aapro, M.S. (2009). Febrile neutropenia and related complications in breast cancer patients receiving pegfilgrastim primary prophylaxis versus current practice neutropaenia management: Results from an integrated analysis. European Journal of Cancer, 45, 608–617.
The purpose of this systematic review was to compare the efficacy of pegfilgrastim primary prophylaxis (PPP) with current practice (CP [short course of treatment and not beginning in the first cycle]) neutropenia management in breast cancer.
MEDLINE, a clinical trial database at Amgen, and abstracts from the American Society of Clinical Oncology meetings from 2000–2005 were researched.
Key words were taxoids, (pegylated) doxorubicin, adriamycin, epirubicin, docetaxel, paclitaxel, cyclophosphamide, methotrexate, and fluorouracil combined with febrile neutropenia, neutropenia, leucopenia, and infection
Inclusion was based on English-language studies (randomized, controlled trials [RCTs], prospective observational studies, retrospective studies) on human subjects who received common breast cancer chemotherapy regimens associated with a febrile neutropenia risk 15% or greater.
Studies were excluded if they had patients who received two weekly treatment cycles.
513 total references were retrieved.
The proportion of patients with febrile neutropenia across all cycles and the proportion of patients with febrile neutropenia in cycle 1, febrile neutropenia-related hospitalizations, chemotherapy dose delays of three or more days, dose reductions of 15% or greater, and grades 3 and 4 hematologic toxicities. An integrated analysis was conducted on individual patient data. Descriptive summaries of demographic information and disease characteristics for individual and integrated populations within each group (PPP versus CP). G-CSF was characterized by administration. For the comparative analysis homogeneity of patient populations within each group and then between each group was evaluated. A generalized linear mixed model was fitted for the outcome of febrile neutropenia across all cycles and for cycle 1 per type of prophylactic treatment (PPP or CP). Other variables in the model included age, disease stage, and prior chemotherapy/radiation treatment. Variables were adjusted using the least square means. Sensitivity analyses also were conducted. Studies that included G-CSF given within seven days of the last chemotherapy dose in cycle one were removed for the CP group in the analysis.
Active treatment
The incidence of febrile neutropenia for all cycles and in cycle one were lower in patients who received PPP compared to those who received CP (p < 0.0001). An increased risk of febrile neutropenia was found for older patients and for those with stage IV disease. Hospitalizations associated with febrile neutropenia also were lower for the PPP group compared to the CP group. Grades 3 and 4 neutropenia were lower in the PPP group (47%, 95% CI [9%, 89%]) compared to the CP group (96%, 95% CI [70%, 99%]) adjusted rates and similarly for leucopenia were also lower in the PPP group (47%, 95% CI [15%, 82%]) compared to the CP group (94%, 95% CI [74%, 99%]).
The use pegfilgrastim primary prophylaxis for the prevention of febrile neutropenia, grades 3 and 4 neutropenia, and neutropenia-related hospitalizations is more effective than current practice use of G-CSF (short course of treatment and not beginning in the first cycle) for patients receiving myelosuppressive chemotherapy for treatment of breast cancer.
Oncology nurses can advocate for the use of PPP for this patient population.
Vondracek, P., Oslejskova, H., Kepak, T., Mazanek, P., Sterba, J., Rysava, M., & Gal, P. (2009). Efficacy of pregabalin in neuropathic pain in paediatric oncological patients. European Journal of Paediatric Neurology, 13, 332–336.
The aim of the study was to evaluate the safety and efficacy of pregabalin in the management of chemotherapy-induced neuropathic pain.
Children were medicated with pregabalin twice daily starting at 75 mg per day and titrated upwards by 75 mg daily with doses ranging from 150–300 mg for eight weeks. No patient was receiving chemotherapy at the time of pregabalin administration. Patients were evaluated prior to treatment and at weeks 2, 4, 6, and 8 of treatment using a visual analog scale. Patients were asked about side effects.
The study was conducted at a single outpatient setting in the Czech Republic.
The study had a prospective trial design.
Visual analog scale
The mean visual analog scale score decreased by 59% from baseline during eight weeks of pregabalin with statistically significant improvement in pain symptoms (p < 0.001). A marked pain relief was noted in 14, moderate pain relief in 10, mild pain relief in two, and no pain relief in two patients. Adverse effects were mild or moderate.
Pregabalin appears to be safe and effective in treating pediatric patients with cancer suffering from chemotherapy-induced peripheral neuropathy. Pregabalin has mild to moderate adverse effects.
Pregabalin has been shown to be effective in relieving pain from chemotherapy in pediatric patients; however, pregabalin is expensive and a controlled drug. Preagabalin has mild to moderate side effects and was tolerated without major complications.
Von Ah, D., Carpenter, J.S., Saykin, A., Monahan, P., Wu, J., Yu, M., . . . Unverzagt, F. (2012). Advanced cognitive training for breast cancer survivors: A randomized controlled trial. Breast Cancer Research and Treatment, 135, 799–809.
To evaluate the efficacy of memory and speed of processing training for improving cognitive function in breast cancer survivors
Patients were randomly assigned to one of three groups: training in speed of processing, memory training, or a wait list control group. The intervention included 10 one-hour sessions of memory and speed of processing training delivered in small groups of three to five patients over six to eight weeks. Specific intervention strategies were adapted from the Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) trials. Follow-up was done at two months.
Patients were in the late effects and survivorship phases of care.
Single-blind, three-group randomized controlled trial
The memory training group demonstrated better immediate (d = 0.59, p = 0.036) and delayed memory performance (d = 0.70, p = 0.013) at the two-month follow-up compared to the control group. Those trained in speed of processing improved immediate memory post-intervention (d = 0.75) and at the two-month follow-up (d = 0.82) (p < 0.01). The memory and speed of processing training groups had significant improvement in perceived cognitive functioning on questionnaires. Compared to controls, speed of processing training was associated with lower symptom distress. Memory training also had a positive effect on anxiety at the two-month follow-up (p = 0.017)
Memory and speed of processing training had significant positive effects on objectively measured and perceived cognitive function among female breast cancer survivors.
Cognitive training as provided here had a significant and at least a moderate positive effect on cognitive function in breast cancer survivors. Cognitive deficits with cancer treatment have substantial negative impacts on quality of life and functioning. Cognitive training is a promising intervention to address these problems.
von Minckwitz, G., Kummel, S., du Bois, A., Eiermann, W., Eidtmann, H., Gerber, B., . . . German Breast Group. (2008). Pegfilgrastim +/- ciprofloxacin for primary prophylaxis with TAC (docetaxel/doxorubicin/cyclophosphamide) chemotherapy for breast cancer. Results from the GEPARTRIO study. Annals of Oncology, 19, 292–298.
The purpose of the study was to compare rates of febrile neutropenia between four treatments: (a) ciprofloxacin 500 mg PO BID on days 5–14, (b) G-CSF (filgrastim 5 mg/kg per day or lenograstim 150 mg/m2 per day) on days 5–10, (c) pegfilgratim 6 mg on day 2, and (d) pegfilgrastim plus ciprofloxacin.
A secondary aim was to compare the incidence of neutropenia and other hematologic toxic effects, infection, nonhematologic toxic effects, and hospitalization.
Patients enrolled in the German GeparTrio study from April 2001 and June 2005 who received one of the four neutropenia prophylactic regimens were analyzed. Patients analyzed had completed at least one cycle of TAC and were not randomized to no treatment.
89 outpatient sites in Germany
Active treatment
Retrospective cohort study of women with breast cancer enrolled in the Germany GeparTrio study.
Among the 1,256 patients in the analyses, 1,057 completed all planned cycles of treatment (six cycles, n = 793; eight cycles, n = 264). The combination of pegfilgrastim and ciprofloxacin was statistically significantly better than other regimens for the prevention of overall febrile neutropenia (p < 0.001), febrile neutropenia during the first chemotherapy cycle (p < 0.001), lower incidences of grade 4 neutropenia, prevention of leukopenia and anemia (p < 0.001), fewer hospitalizations (p < 0.001), and for the reduction of stomatitis/mucositis, dysphagia/esophagitis, and diarrhea. Pegfilgrastim alone was as effective as pegfilgrastim and cipro for overall febrile neutropenia (p < 0.001) and for the reduction of grade 4 neutropenia, leukopenia, and anemia (p < 0.01). Daily G-CSF was better than cipro alone for the reduction of grade 4 neutropenia. Thrombocytopenia was lowest for cipro alone (p < 0.001). Infection with neutropenia was not statistically different between groups.
The use of pegfilgratim, especially in combination with ciprofloxacin, is superior to ciprofloxacin alone or daily G-CSF for the reduction of febrile neutropenia, grade 4 neutropenia, and related hospitalizations. No regimen proved superior over others for the prevention of infection with neutropenia.
The administration of daily G-CSF was not given according to protocol of beginning 24 hours after the last dose of chemotherapy with continuation until absolute neutrophil count (ANC) has returned to normal range or for a maximum of 14 days. G-CSF was started at a later time in the cohorts who received G-CSF which could have skewed the results in favor of pegfilgrastim, which was given according to protocol.
The use of pegfilgratim, especially with ciprofloxacin, for the prevention of febrile neutropenia, grade 4 neutropenia, and neutropenic-related hospitalizations appears beneficial for women with stage T2–T4 primary breast cancer. Oncology nurses can advocate for use of this regimen for their patients.