The TiME Trial: A Fully Embedded, Cluster-Randomized, Pragmatic Trial of Hemodialysis Session Duration.

BACKGROUND: Data from clinical trials to inform practice in maintenance hemodialysis are limited. Incorporating randomized trials into dialysis clinical care delivery should help generate practice-guiding evidence, but the feasibility of this approach has not been established. METHODS: To develop approaches for embedding trials into routine delivery of maintenance hemodialysis, we performed a cluster-randomized, pragmatic trial demonstration project, the Time to Reduce Mortality in ESRD (TiME) trial, evaluating effects of session duration on mortality (primary outcome) and hospitalization rate. Dialysis facilities randomized to the intervention adopted a default session duration ≥4.25 hours (255 minutes) for incident patients; those randomized to usual care had no trial-driven approach to session duration. Implementation was highly centralized, with no on-site research personnel and complete reliance on clinically acquired data. We used multiple strategies to engage facility personnel and participating patients. RESULTS: The trial enrolled 7035 incident patients from 266 dialysis units. We discontinued the trial at a median follow-up of 1.1 years because of an inadequate between-group difference in session duration. For the primary analysis population (participants with estimated body water ≤42.5 L), mean session duration was 216 minutes for the intervention group and 207 minutes for the usual care group. We found no reduction in mortality or hospitalization rate for the intervention versus usual care. CONCLUSIONS: Although a highly pragmatic design allowed efficient enrollment, data acquisition, and monitoring, intervention uptake was insufficient to determine whether longer hemodialysis sessions improve outcomes. More effective strategies for engaging clinical personnel and patients are likely required to evaluate clinical trial interventions that are fully embedded in care delivery.

Physical activity and cognitive function: A comparison of rural and urban breast cancer survivors.

PURPOSE: Increasing evidence suggests rural breast cancer survivors (BCS) may experience greater burden in symptoms known to be associated with cancer-associated cognitive decline (CACD). Yet, little is known about CACD in rural BCS. This study (1) examined differences in cognitive function, moderate-to-vigorous physical activity (MVPA), and other CACD correlates and (2) tested the effects of MVPA on cognitive function in rural versus urban BCS. METHODS: Rural and urban BCS (N = 80), matched on age, education, and time since diagnosis from a larger study, completed cognitive tasks assessing processing speed (Trails-B, Mazes, Task-Switch) and working memory (spatial working memory) and questionnaires assessing subjective memory impairment (SMI), MVPA, and CACD correlates (i.e., sleep quality, fatigue, anxiety/depression). Some participants (n = 62) wore an accelerometer to objectively estimate MVPA. Multiple linear regression and multivariate analysis of covariance were used to test study aims. RESULTS: Rural BCS (n = 40, M = 61.1±8.4 years-old) performed significantly slower on Trails-B (p<0.01) compared with urban BCS (n = 40, M = 61.0±8.2 years-old) and engaged in less objectively-estimated daily MVPA (mean difference = 13.83±4.73 minutes; p = 0.01). No significant differences in SMI, self-reported MVPA, or CACD correlates were observed (all p>0.28). Regression models did not reveal a significant interaction between MVPA and cognitive performance (all p>0.1); however, estimated marginal means models indicated that the effect of MVPA on processing speed was evident only among rural BCS (Trails-B, p = 0.04; Mazes, p = 0.03). CONCLUSIONS: Findings suggest rural BCS may suffer greater CACD and engage in less MVPA. Additional research is warranted to further examine CACD and more effectively promote MVPA in rural BCS.