Background Cancer patients and their oncologists often report differing perceptions of consultation discussions and discordant expectations regarding treatment outcomes. CONNECT™, a computer-based communication aid, was developed to improve communication between patients and oncologists. Methods CONNECT includes assessment of patient values, goals, and communication preferences; patient communication skills training; and a pre-consult physician summary report. CONNECT was tested in a three-arm, prospective, randomized clinical trial. Prior to the initial medical oncology consultation, adult patients with advanced cancer were randomized to (a) control; (b) CONNECT with physician summary, or (c) CONNECT without physician summary. Outcomes were assessed with post-consultation surveys. Results Of 743 patients randomized, 629 completed post-consultation surveys. Patients in the intervention arms (versus control) felt that the CONNECT program made treatment decisions easier to reach (p=0.003) and helped them to be more satisfied with these decisions (p<0.001). In addition, patients in the intervention arms reported higher levels of satisfaction with physician communication format (p=0.026) and discussion regarding support services (p=0.029) and quality of life concerns (p=0.042). The physician summary did not impact outcomes. Patients with higher levels of education and poorer physical functioning experienced greater benefit from CONNECT. Conclusion This prospective randomized clinical trial demonstrates that computer-based communication skills training can positively affect patient satisfaction with communication and decision making. Measureable patient characteristics may be used to identify subgroups most likely to benefit from an intervention such as CONNECT.

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Antipsychotic drugs (AP) are highly efficacious treatments for psychiatric disorders but are associated with significant metabolic side-effects. The circadian clock maintains metabolic homeostasis by sustaining daily rhythms in feeding, fasting and hormone regulation but how circadian rhythms interact with AP and its associated metabolic side-effects is not well-known. We hypothesized that time of AP dosing impacts the development of metabolic side-effects. Weight gain and metabolic side-effects were compared in C57Bl/6 mice and humans dosed with APs in either the morning or evening. In mice, AP dosing at the start of the light cycle/rest period (AM) resulted in significant increase in food intake and weight gain compared with equivalent dose before the onset of darkness/active period (PM). Time of AP dosing also impacted circadian gene expression, metabolic hormones and inflammatory pathways and their diurnal expression patterns. We also conducted a retrospective examination of weight and metabolic outcomes in patients who received risperidone (RIS) for the treatment of serious mental illness and observed a significant association between time of dosing and severity of RIS-induced metabolic side-effects. Time restricted feeding (TRF) has been shown in both mouse and some human studies to be an effective therapeutic intervention against obesity and metabolic disease. We demonstrate, for the first time, that TRF is an effective intervention to reduce AP-induced metabolic side effects in mice. These studies identify highly effective and translatable interventions with potential to mitigate AP-induced metabolic side effects.

Antipsychotic drugs (AP) are highly efficacious treatments for psychiatric disorders but are associated with significant metabolic side effects. The circadian clock maintains metabolic homeostasis by sustaining daily rhythms in feeding, fasting and hormone regulation but how circadian rhythms interact with AP and its associated metabolic side effects is not well known. In these studies, we investigated the impact of time of AP dosing on the development of metabolic side effects. In mice, AP dosing at the start of the light cycle (AM) resulted in significant increase in food intake, weight gain compared with equivalent dose before the onset of darkness (PM). Time of AP dosing also impacted circadian gene expression, metabolic hormones and inflammatory pathways and their diurnal expression patterns. To examine the possibility of time-dependent AP effects in humans, we conducted a retrospective examination of weight and metabolic outcomes in patients who received risperidone (RIS) for the treatment of serious mental illness. Using pharmacy records to estimate the time of RIS dosing, we observed a significant association between time of dosing and severity of RIS-induced metabolic side effects. Eating within a restricted time window (Time restricted feeding/eating, TRF/TRE) has been shown in both mouse and human studies to be an effective therapeutic intervention against obesity and metabolic disease. We demonstrate, for the first time, that TRF is an effective intervention to reduce AP-induced metabolic side effects in mice. These studies identify highly effective and translatable interventions to mitigate AP-induced metabolic side effects.