Bisphosphonates provide a supportive, albeit expensive and non-life-prolonging, benefit to many patients with bone metastases. Current research is focusing on bisphosphonates as adjuvant therapy. Although new data addressing when to stop therapy, alternative doses or schedules for administration, and how to best coordinate bisphosphonates with other palliative therapies are needed, they are not currently being investigated.
OBJECTIVETo compare the effectiveness of diabetes prevention strategies addressing postpartum weight retention for women with gestational diabetes mellitus (GDM) delivered at the health system level: mailed recommendations (usual care) versus usual care plus a Diabetes Prevention Program (DPP)–derived lifestyle intervention.RESEARCH DESIGN AND METHODSThis study was a cluster randomized controlled trial of 44 medical facilities (including 2,280 women with GDM) randomized to intervention or usual care. The intervention included mailed gestational weight gain recommendations plus 13 telephone sessions between 6 weeks and 6 months postpartum. Primary outcomes included the following: proportion meeting the postpartum goals of 1) reaching pregravid weight if pregravid BMI <25.0 kg/m2 or 2) losing 5% of pregravid weight if BMI ≥25.0 kg/m2; and pregravid to postpartum weight change.RESULTSOn average, over the 12-month postpartum period, women in the intervention had significantly higher odds of meeting weight goals than women in usual care (odds ratio [OR] 1.28 [95% CI 1.10, 1.47]). The proportion meeting weight goals was significantly higher in the intervention than usual care at 6 weeks (25.5 vs. 22.4%; OR 1.17 [1.01, 1.36]) and 6 months (30.6 vs. 23.9%; OR 1.45 [1.14, 1.83]). Condition differences were reduced at 12 months (33.0 vs. 28.0%; OR 1.25 [0.96, 1.62]). At 6 months, women in the intervention retained significantly less weight than women in usual care (mean 0.39 kg [SD 5.5] vs. 0.95 kg [5.5]; mean condition difference −0.64 kg [95% CI −1.13, −0.14]) and had greater increases in vigorous-intensity physical activity (mean condition difference 15.4 min/week [4.9, 25.8]).CONCLUSIONSA DPP-derived lifestyle intervention modestly reduced postpartum weight retention and increased vigorous-intensity physical activity.
Context-Multiple complex symptoms from cancer treatment can interfere with functioning.Objectives-To evaluate the efficacy of an "energy and sleep enhancement" (EASE) intervention to relieve fatigue and sleep disturbance and improve health-related functional status.Methods-Individuals receiving chemotherapy were randomized to the EASE (n = 153) or a control intervention (n = 139). The EASE intervention included information and behavioral skills taught by an oncology nurse in three telephone sessions. The primary outcomes of fatigue, sleep disturbance and functional status were measured before chemotherapy, Day 4 after first treatment (baseline) and 43-46 or 57-60 days later (follow-up) depending on chemotherapy cycle length.Results-The sample was primarily female (82%) and non-Hispanic white (89%) with mean age of 53.9 years. Fatigue and patient-reported sleep disturbance were elevated in both groups at baseline and follow-up. Actigraphy revealed total sleep time was almost eight hours and sleep percent was over 85% for both groups at both time points (normal range). Physical functioning was diminished and at the same level as a sample with serious illness. Mental functioning was in normal range. A repeated measures analysis of variance revealed no statistically significant groupby-time effects for fatigue, sleep disturbance, or functional status. Unemployed individuals showed greater benefit from the EASE intervention, reporting less pain and symptom interference.Conclusion-Potential explanations include high variability and/or floor effect for fatigue; incorrect timing of measures; insufficient amount or dose of the intervention; and confounding effects of gender. Future research should consider screening for symptom severity and tailoring interventions.
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