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ABSTRACT: Randomized clinical trials support the efficacy of a wide range of psychoeducational interventions. However, the mechanisms through which these interventions improve outcomes are not always clear. At times, the theoretically specified factors within interventions have been shown to have specific effects on patient outcomes. But it has also been argued that other factors not identified in the intervention theory (e.g., "nonspecific" factors such as patient expectations and therapeutic patient-clinician alliances) have powerful nonspecific effects that account for most, if not all, of the observed efficacy of psychoeducational interventions. This article describes important concepts in this debate and discusses key issues in distinguishing between specific and nonspecific effects of psychoeducational nursing interventions. Four examples are used to illustrate potential methods of identifying and controlling for nonspecific effects in clinical intervention trials.
Western Journal of Nursing Research 08/2009; 31(8):983-98. · 1.19 Impact Factor
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ABSTRACT: To identify and compare symptom clusters in individuals with chronic health problems with cancer as a comorbidity versus individuals with chronic health problems who do not have cancer as a comorbidity and to explore the effect of symptoms on their quality of life.
Secondary analysis of data from two studies. Study 1 was an investigation of the efficacy of an intervention to improve medication adherence in patients with rheumatoid arthritis (RA). Study 2 was an investigation of the efficacy of an intervention for urinary incontinence (UI) in older adults.
School of Nursing at the University of Pittsburgh.
The sample for study 1 was comprised of 639 adults with RA. The sample for study 2 was comprised of 407 adults with UI. A total of 154 (15%) subjects had a history of cancer, 56 (9%) of the subjects with RA and 98 (25%) of the subjects with UI.
Analysis of existing comorbidity and symptom data collected from both studies.
Symptom clusters, chronic disease, and cancer as a comorbidity.
Individuals with chronic health problems who have cancer may not have unique symptom clusters compared to individuals with chronic health problems who do not have cancer.
The symptom clusters experienced by the study participants may be more related to their primary chronic health problems and comorbidities.
Additional studies are needed to examine symptom clusters in cancer survivors. As individuals are living longer with the disease, a comprehensive understanding of the symptom clusters that may be unique to cancer survivors with comorbidities is critical.
Oncology Nursing Forum 02/2008; 35(1):E1-E11. · 1.91 Impact Factor
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Margaret Q Rosenzweig
Journal of Clinical Oncology 09/2006; 24(22):3710-1; author reply 3711-2. · 18.37 Impact Factor
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ABSTRACT: To discuss the process, considerations, benefits, and challenges of the nurse as principal investigator in a cancer care drug trial.
Published articles, anecdotal experience, and completed research studies.
The specific processes that must be considered are funding sources, protocol development, trial implementation, dissemination of results, and ethical implications involved in industry sponsorship. Specific protocols are designed for evaluating adverse events. Working with pharmaceutical companies to receive financial support offers advantages but poses additional issues for consideration.
Nurses can serve successfully as principal investigators in medication trials for cancer care. Regulatory bodies and specific procedures, as well as general considerations, mandate and guide investigator conduct when embarking on a pharmaceutical trial.
Oncology nurse researchers can look to pharmaceutical companies for potential funding in the evaluation of medications used in cancer care.
Oncology Nursing Forum 04/2005; 32(2):293-9. · 1.91 Impact Factor
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ABSTRACT: Recombinant human erythropoietin (r-HuEPO) corrects cancer-related anemia and, thereby, improves quality of life. The purpose of the present study was to measure the impact of erythropoietin on hemoglobin and mood state in patients with metastatic breast cancer and mild anemia (Hgb < 12.0 g/dL). Women were randomized to receive usual care (G1) or usual care plus r-HuEPO (G2). Usual care included transfusions as necessary and fatigue education. R-HuEPO was begun at 40,000U subcutaneously per week. At 4 weeks, the dose was increased to 60,000U if Hgb had not increased > or = 1.0 g/dL. The drug was discontinued at 8 weeks if hemoglobin improvement was < 1.0 g/dL. The study was terminated early (n = 27, G1 = 13, G2 = 14) when 4/14 (28.5%) subjects in G2 developed thrombotic events (deep vein thrombosis [DVT] in 1; DVT plus pulmonary embolism [PE] in 1; DVT plus PE 1 month after drug discontinuation in 1; and brachial vein thrombosis with infected Mediport in 1). In all four patients, Hgb levels were normal at the time of the event. No patient in G1 developed a thrombotic event. There were no significant differences in demographic characteristics or current chemotherapy regimen in G1 vs. G2. The decision to terminate the trial was made after considerable deliberation. The increased incidence of thrombotic events in the r-HuEPO (G2) arm of this study exceeds that in prior studies in this population and prior r-HuEPO trials. This may relate to the administration of r-HuEPO in this high-risk population, but the small sample size and possible predisposing risk factors preclude definitive conclusions.
Journal of Pain and Symptom Management 03/2004; 27(2):185-90. · 2.50 Impact Factor
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ABSTRACT: The purpose of this exploratory, secondary analysis was to compare the prevalence of symptoms attributable to breast cancer or its treatment and to identify and describe symptom clusters across 3 phases of the disease. A pooled analysis was conducted by combining existing symptom data collected at the baseline assessment from 3 independent studies of women with breast cancer. Study I had 40 women with early-stage breast cancer following primary surgery for their disease and prior to the initiation of adjuvant therapy. Study II had 88 women with stage I, II, or III breast cancer who had completed surgery and adjuvant chemotherapy and may have been receiving hormonal therapy. Study III had 26 women with metastatic breast cancer (stage IV). Three symptom clusters were identified corresponding to 3 different phases of the breast cancer experience. Each cluster was composed of symptoms related to fatigue, perceived cognitive impairment, and mood problems. Future studies are needed to prospectively examine whether these symptoms cluster across 3 phases of breast cancer and the effect of these clusters on the functional ability and quality of life in women with breast cancer.
Cancer Nursing 28(3):219-25. · 1.79 Impact Factor