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Objective To investigate (1) circadian rest-activity rhythm disturbances among endometrial cancer patients as they recover from surgery in comparison to a historical reference group of women with no cancer history; and (2) health- and treatment-related predictors of dysregulated rest-activity rhythms in endometrial cancer patients. Methods 60 endometrial cancer patients participated in a prospective, longitudinal study with actigraphic assessment at 1 week, 1 month, and 4 months post-surgery. 60 women without cancer from an epidemiological sample completed one actigraphic assessment, acting as a reference group. Results On average, results revealed initial significant rest-activity dysregulation at 1 week and 1 month post-surgery for the endometrial cancer group and then significant recovery in rest-activity patterns at 4 months post-surgery. Similarly, the cancer group had significantly more impaired rhythms than the reference group at 1 week post-surgery, but demonstrated comparable rhythms by 4 months post-surgery. Among the health and treatment-related variables examined, obesity and receipt of more invasive surgery were found to predict more impaired rhythms at all time points. Conclusion(s) The current study highlights significant disturbances in rest-activity patterns for endometrial cancer patients initially during surgical recovery followed by improvement in these patterns by 4 months post-surgery; however, obese patients and those having more invasive surgery demonstrated more impaired rest-activity patterns throughout the 4-month recovery period. Further research is warranted to understand how more impaired rest-activity patterns relate to health and quality of life outcomes.

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Background/Aims Suicide is a major public health concern, yet there are very few randomized clinical trials that have been conducted to reduce suicidal ideation in patients at risk for suicide. We describe the rationale and refinements of such a trial that is designed to assess the effect of a hypnotic medication on suicidal ideation in adult outpatients currently experiencing suicidal ideation. Methods “Reducing Suicidal Ideation Through Insomnia Treatment (REST-IT)” is a multi-site randomized clinical trial that includes 3 recruiting sites and one data management site. This 4-year study is in its second year of recruitment. The purpose of the study is to compare hypnotic medication versus placebo as an add-on treatment to a selective serotonin reuptake inhibitor as a means of reducing suicidal ideation in depressed adult outpatients with insomnia and suicidal ideation. The safety features of the study follow the 2001 NIH guidelines for studies that include patients at risk of suicide. Results Five hundred and eighty-four potential participants have undergone telephone screening; 67% of these failed the phone screen, most often due to an absence of expressed suicidal ideation (26% of the telephone screen fails). One hundred and twelve persons appeared for a face-to-face baseline assessment, and 40 of these had completed a taper of their ineffective psychotropic medications before the baseline assessments. Sixty-four% of those who completed baseline assessments failed to proceed to randomization, most commonly because of no clinically significant suicidal ideation (51% of those excluded at baseline). One participant was offered and accepted voluntary psychiatric hospitalization in lieu of study participation. Thus far, 40 participants have been randomized into the study, 88.7% of scheduled visits have been attended, with 93.8% adherence for the SSRI and 91.6% adherence for the randomized hypnotic versus placebo. None of the randomized participants have required hospitalization or had a suicide attempt. Conclusions By carefully considering the inclusion and exclusion criteria and other safety features, the safe conduct of randomized clinical trials in suicidal adult patients is possible, including the inclusion of participants who have undergone a prescribed tapering of psychotropic medications prior to baseline assessment.