Sleep disturbances in children with autism spectrum disorder (ASD) are significantly more prevalent than found in typically developing (TD) children. Given the detrimental impact of poor sleep on cognitive, emotional, and behavioral functioning, it is imperative to screen and assess for sleep disturbances in this population. In this paper, we describe the screening and assessment process, as well as specific measures commonly used for assessing sleep in children with ASD. Advantages and limitations for use in children with ASD are discussed. While subjective measures, such as parent-report questionnaires and sleep diaries, are the most widely used, more objective measures such as actigraphy, polysomnography, and videosomnography provide additional valuable information for both diagnostic purposes and treatment planning. These objective measures, nonetheless, are limited by cost, availability, and feasibility of use with children with ASD. The current review provides an argument for the complementary uses of both subjective and objective measures of sleep specifically for use in children with ASD.
Background: Minority and older adult patients remain underrepresented in cancer clinical trials (CCTs). The current study sought to examine sociodemographic inequities in CCT interest, eligibility, enrollment, decline motivation, and attrition across two psychosocial CCTs for gynecologic, gastrointestinal, and thoracic cancers. Methods: Patients were approached for recruitment to one of two interventions: (1) a randomized control trial (RCT) examining effects of a cognitive-behavioral intervention targeting sleep, pain, mood, cytokines, and cortisol following surgery, or (2) a yoga intervention to determine its feasibility, acceptability, and effects on mitigating distress. Prospective RCT participants were queried about interest and screened for eligibility. All eligible patients across trials were offered enrollment. Patients who declined yoga intervention enrollment provided reasons for decline. Sociodemographic predictors of enrollment decisions and attrition were explored. Results: No sociodemographic differences in RCT interest were observed, and older patients were more likely to be ineligible. Eligible Hispanic patients across trials were significantly more likely to enroll than non-Hispanic patients. Sociodemographic factors predicted differences in decline motivation. In one trial, individuals originating from more urban areas were more likely to prematurely discontinue participation. Discussion: These results corroborate evidence of no significant differences in CCT interest across minority groups, with older adults less likely to fulfill eligibility criteria. While absolute Hispanic enrollment was modest, Hispanic patients were more likely to enroll relative to non-Hispanic patients. Additional sociodemographic trends were noted in decline motivation and geographical prediction of attrition. Further investigation is necessary to better understand inequities, barriers, and best recruitment practices for representative CCTs.
40 Background: Despite reporting similar levels of willingness to participate in clinical trials, minority cancer patients remain underrepresented in research interventions. The purpose of this analysis was to examine participant age, race, and ethnicity as predictors of study interest, eligibility, enrollment decision, and attrition in an intervention providing supportive care for women with cancer. Methods: Patients from the UF&Shands Gynecologic Oncology Service (N = 568) were approached for recruitment to either a six-week cognitive-behavioral intervention for insomnia and pain or a psychoeducational control condition. These women were queried about their willingness to participate in the study, interest level, and reasons for declining participation if they did not wish to enroll in the trial. Among enrolled patients (N = 64), predictors of attrition were explored. Results: Of approached patients, 57.2% were older than age 60, 14.7% were non-White, and 3.2% were Hispanic. Chi-square analyses indicated that there were no significant differences in interest level by age [χ2(2,441) = 2.732, p = .255], race [χ2(2,439) = 2.019, p = .364], or ethnicity [χ2(2,431) = 3.242, p = .198]. Eligible minority patients were significantly more likely to enroll than were non-Hispanic Whites [χ2(1,364) = 4.125, p = .042], with Hispanic recruitment driving this difference (p = .011). Survival analyses demonstrated no differences in attrition hazard based on age (B = -.088, p = .825), race (B = .583, p = .275), or ethnicity (B = -19.518, p = .999) among enrolled patients. Conclusions: In our supportive cancer clinical trial (CCT), there were no significant differences in trial interest across racial and ethnic minority groups. In fact, Hispanics were more likely to enroll than non-Hispanics. Furthermore, neither race nor ethnicity was a significant predictor of trial attrition. Future investigation is needed to better understand racial and ethnic disparities in cancer research enrollment, motivators and barriers to participation in supportive cancer care trials, potential inconsistencies in accrual patterns among minority cancer patients, and best practices for enrolling and retaining diverse participants for supportive CCTs. Clinical trial information: NCT02609880.
e24125 Background: Gynecologic, gastrointestinal (GI), and thoracic cancers account for significant morbidity and mortality in the U.S. Women with these types of cancers frequently experience psychological distress, among other poor outcomes. Previous research has indicated that mindfulness-based interventions, such as yoga, can be effective in decreasing distress in cancer patients. Notably, this research has primarily been conducted in a breast cancer population with limited research assessing the feasibility, acceptability, and/or efficacy of this type of intervention in other prevalent and impactful cancers among women. The purpose of the present study was to assess the Feasibility and Acceptability of a yoga intervention for women with gynecologic, GI, or thoracic cancers. Methods: A total of 124 women diagnosed with a gynecologic, GI, or thoracic cancer in the prior year were recruited via outpatient oncology clinics to participate in a 10-week, group-based manualized yoga intervention entitled “Stilling the Waters of Uncertainty” (Author: E. Kacel) that is nearing the end of accrual. Participants completed an Acceptability evaluation following each yoga session with ratings on a 5-point Likert scale from “not at all” to “extremely.” Feasibility of the study was operationalized as percentage of eligible participants who (a) enrolled, (b) attended sessions, and (c) completed post-intervention assessment. Acceptability was operationalized as the percentage of participants with average session ratings of “very” or “extremely” for intervention usefulness, enjoyableness, safety, clarity, relevance, and likelihood of continuing to practice skills. Criteria for operationalizing Feasibility and Acceptability for this study were defined a priori based on recommendations of Bowen and colleagues (2009). A minimum of 80% for each measure of feasibility and acceptability was set as the a priori threshold of success in each domain. Results: All measures of Feasibility were below the a priori benchmark of 80%: Of the 318 eligible patients approached for participation, (a) 124 patients (39.0%) enrolled; 49/124 (39.5%) attended at least 1 yoga session; 44/124 (35.4%) attended at least 8 sessions; and (c) 41/124 (33.1%) completed post-intervention assessment procedures. At least 80% of attendees rated the intervention as “very” or “extremely” useful, enjoyable, safe, and clear; 75.5% and 79.6% of attendees rated the intervention as “very” or “extremely” relevant and likely to be continued to be practiced. Conclusions: The results of this study indicate that a yoga intervention for women with prevalent non-breast cancer types did not meet a priori criteria for feasibility. However, participants who attended at least 1 session rated the intervention as generally acceptable. Future research is needed to improve study/intervention feasibility in this population. Clinical trial information: NCT03385577.
12129 Background: Depression, anxiety, and fear of cancer recurrence (FCR) constitute prevalent psychological concerns necessitating further attention in developing supportive care interventions for women with gynecologic, gastrointestinal, and thoracic cancers. Recent evidence indicates that such concerns may be especially severe among underserved women of color and women affected by low-socioeconomic status (SES). The purpose of the present study is to evaluate the magnitude of changes in depression, anxiety, and FCR associated with a mindfulness-based yoga intervention among a diverse sample of women with these cancers. A second aim is to identify how changes in these concerns may differ across sociodemographic groups. Methods: Women with gynecologic ( n=86), gastrointestinal ( n=17), or thoracic ( n=20) cancers were enrolled in a group-based 10-week yoga intervention utilizing mindfulness meditation, relaxation, and gentle yoga. Prior to and following intervention, participants were administered assessments, including the Beck Depression Inventory – Second Edition (BDI-II) to measure depression, the State-Trait Anxiety Inventory (STAI) to assess anxiety, and the Fear of Cancer Recurrence Inventory (FCRI) to evaluate aspects of FCR. Mixed-linear models evaluated change in outcomes from pre- to post-intervention, with conditional models assessing the effects of age, race/ethnicity, and SES on change. Analyses were conducted prior to trial completion due to approaching accrual period termination. Results: The sample demonstrated a mean age of 58.46 ( SD=10.82) and mean SES score of 3.98 ( SD=1.55) using a 1 to 7 composite scale. Twenty-six percent of participants were of racial and/or ethnic minority status ( n=32). Significant declines in total depressive symptoms, somatic depressive symptoms, state anxiety, and psychological distress due to FCR were observed across the sample. Higher SES was associated with significantly greater reductions in total depressive symptoms and affective depressive symptoms, specifically. Women of color experienced significantly greater declines in somatic symptoms compared to non-Hispanic White women. Conclusions: This mindfulness-based yoga intervention was associated with significant reductions in depressive symptoms, state anxiety, and psychological distress related to FCR among women with gynecologic, gastrointestinal, and thoracic cancers. Higher SES and underserved race/ethnicity status moderated some of these effects. Future research should explore the efficacy of this intervention among diverse women in a randomized clinical trial context. Clinical trial information: NCT03385577.
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