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Rybarczyk B.,Virginia Commonwealth University | Mack L.,Virginia Commonwealth University | Harris J.H.,Southwestern University | Stepanski E.,ACORN Research LLC
Rehabilitation Psychology | Year: 2011

Objective: The present study tested two methods of self-help cognitive-behavioral therapy for insomnia (CBT-I) for 106 older adults (mean age = 68) with osteoarthritis (n = 33) or coronary artery disease (n = 33) or no significant medical condition (n = 40). The latter was employed as a comparison group to test the differential efficacy between primary and comorbid insomnia. Method: Self-help CBT-I has demonstrated efficacy in previous studies, so two treatments were compared rather than employing a no treatment control group. Participants were randomly assigned to a book version or an enhanced multimedia version of CBT-I. Results: Both versions of CBT-I demonstrated efficacy in improving all measures of sleep at posttreatment, using intent-to-treat analyses. These sleep improvements were maintained among 86 treatment completers who participated in 1-year follow-up assessment. There were no significant differences in treatment response between primary (no medical condition) and comorbid insomnia participants and no significant differences between the two types of self-help according to sleep log measure. However, multimedia participants compared to book participants showed more improvement on three global sleep measures administered at posttreatment only. Conclusions: Although outcomes were attenuated relative to those obtained in therapist led intervention studies, the results suggest that self-help CBT-I has good potential to serve as a first-line, cost-effective treatment for both primary and comorbid insomnia in older adults. © 2011 American Psychological Association. Source

Walker M.S.,ACORN Research LLC | Miller P.J.E.,ACORN Research LLC | Namjoshi M.,Novartis | Houts A.C.,ACORN Research LLC | And 2 more authors.
Journal of Medical Economics | Year: 2013

Objective This retrospective observational study describes treatment patterns and longitudinal health-related quality-of-life (HRQoL) among metastatic breast cancer patients with bone metastasis from nine community oncology clinics. Methods For description of treatment patterns, patients were classified as treated if they started zoledronic acid within 60 days of diagnosis of bone metastasis, were considered untreated if they had not, and were considered unclassified if they died or experienced fracture before 60 days had elapsed. Medical record review provided demographic and disease characteristics as well as history of treatment. Patients completed Patient Care Monitor (PCM) assessments of patient reported outcomes during routine care for up to 2 years from the date of bone metastasis diagnosis. Results The overall rate of fracture in the sample was 17.4%. Of the 321 patients enrolled, 160 were treated as of 60 days after diagnosis of bone metastasis, 147 were untreated, and 14 were unclassified. Of the 147 untreated as of 60 days, 82 did eventually receive zoledronic acid. More than half of all patients treated with zoledronic acid delayed the start of treatment by more than 30 days after diagnosis of bone metastasis. Patients who had a fracture showed decreased mobility and increased pain and anxiety at fracture, with recovery taking ∼16 months. Limitations: Key limitations included: convenience sample with information limited to medical record content, low rate of observed fractures possibly due to limited 2-year follow-up, and exclusion of non-zoledronic acid bisphosphonate use. Conclusions Whereas the proportion of patients experiencing a fracture was small, the impact of fracture on HRQoL was significant and was more prominently seen to impact specific dimensions of HRQoL. © 2013 Informa UK Ltd. Source

Schwartzberg L.S.,West Clinic | Wang G.,Advanced Medical Specialties | Somer B.G.,West Clinic | Wheeler B.M.,West Clinic | And 3 more authors.
Clinical Breast Cancer | Year: 2014

Background In this phase II study, we explored efficacy and toxicity of combined endocrine and low-dose metronomic chemotherapy therapy consisting of fulvestrant and capecitabine in estrogen and/or progesterone receptor-positive, HER2-negative MBC. Patients and Methods Patients with ≤ 1 previous hormonal treatment in the metastatic setting received an injection fulvestrant loading dose 500 mg on day 1, 250 mg on days 15 and 29 followed by 250 mg every 28 days along with continuous oral capecitabine in divided doses. The total fixed daily dose of capecitabine was either 1500 mg or 2000 mg, depending on the patient's weight (< 80 kg vs. ≥ 80 kg). Primary end points were PFS and TTP. Toxicity was assessed by continuous evaluations of treatment-emergent adverse events (AEs) and changes from baseline in laboratory values. Results Forty-one women, with a mean age of 64.5 years, were enrolled. Patients completed a median of 11 monthly treatment cycles. Median PFS was 14.98 months (95% confidence interval [CI], 7.26-upper limit [UL] not estimated) and median TTP was 26.94 months (95% CI, 7.26-UL not estimated). Median overall survival was 28.65 months (95% CI, 23.95-UL not estimated). Treatment was well tolerated with < 10% Grade 3 palmar-plantar erythrodysesthesia. Overall, the most frequent AEs were palmar-plantar erythrodysesthesia, fatigue, and nausea. Conclusion Fulvestrant with metronomic capecitabine demonstrates substantial activity in hormone receptor-positive MBC and is well tolerated. Combined chemoendocrine approaches should be further explored considering the low toxicity of the combination with meaningful TTP. © 2014 Elsevier Inc. All rights reserved. Source

Walker M.S.,ACORN Research LLC | Hasan M.,ACORN Research LLC | Mi Yim Y.,Genentech | Yu E.,Genentech | And 2 more authors.
Health and Quality of Life Outcomes | Year: 2011

Background: This retrospective study evaluated the impact of disease progression and of specific sites of metastasis on patient reported outcomes (PROs) that assess symptom burden and health related quality of life (HRQoL) in women with metastatic breast cancer (mBC).Methods: HER-2 negative mBC patients (n = 102) were enrolled from 7 U.S. community oncology practices. Demographic, disease and treatment characteristics were abstracted from electronic medical records and linked to archived Patient Care Monitor (PCM) assessments. The PCM is a self-report measure of symptom burden and HRQoL administered as part of routine care in participating practices. Linear mixed models were used to examine change in PCM scores over time.Results: Mean age was 57 years, with 72% of patients Caucasian, and 25% African American. Median time from mBC diagnosis to first disease progression was 8.8 months. Metastasis to bone (60%), lung (28%) and liver (26%) predominated at initial metastatic diagnosis. Results showed that PCM items assessing fatigue, physical pain and trouble sleeping were sensitive to either general effects of disease progression or to effects associated with specific sites of metastasis. Progression of disease was also associated with modest but significant worsening of General Physical Symptoms, Treatment Side Effects, Acute Distress and Impaired Performance index scores. In addition, there were marked detrimental effects of liver metastasis on Treatment Side Effects, and of brain metastasis on Acute Distress.Conclusions: Disease progression has a detrimental impact on cancer-related symptoms. Delaying disease progression may have a positive impact on patients' HRQoL. © 2011 Walker et al; licensee BioMed Central Ltd. Source

Stepanski E.J.,ACORN Research LLC | Reyes C.,Genentech | Walker M.S.,ACORN Research LLC | Satram-Hoang S.,Q.D. Research Inc. | And 5 more authors.
Pancreas | Year: 2013

OBJECTIVES: This retrospective study examined pancreatic cancer patients who received combination gemcitabine and erlotinib to determine if the association between rash and outcomes observed in clinical trials would be observed in 'real-world' community oncology settings. METHODS: Medical records from 10 community oncology practices were used to identify eligible patients. Rash severity was classified as High (moderate/severe) versus Low (absent/mild) based on medical record review. Kaplan-Meier analysis assessed progression-free survival (PFS) and overall survival (OS) by rash status from a landmark of 42 days after treatment initiation. Cox regression with time-varying covariates tested whether high-severity rash predicted longer OS and PFS. RESULTS: The High Severity group (n = 34) had longer median OS from the landmark than the Low Severity group (n = 134; 7.58 months vs 5.03 months, P = 0.0339). Cox regression analysis (n = 174) confirmed a reduced risk of death with High Rash Severity (hazard ratio [HR] = 0.67, P = 0.0389). Progression-free survival results showed a similar pattern (median PFS 2.37 months from landmark vs 2.04 months for High vs Low Severity groups, P = 0.0485). CONCLUSIONS: Results from this community sample were consistent with findings from randomized clinical trials, showing that longer OS is predicted by high-severity rash in erlotinib-treated pancreatic cancer patients. Copyright © 2012 by Lippincott Williams & Wilkins. Source

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