Purpose Cancer-related fatigue (CRF) is a disruptive symptom for many survivors. Despite promising evidence for efficacy of Mindfulness-Based Stress Reduction (MBSR) in reducing CRF, no trials comparing it to an active comparator for fatigued survivors have been published. The purpose of this trial was to compare MBSR to psychoeducation for CRF and associated symptoms. Methods Breast (n=60) and colorectal (n=11) cancer survivors (stage 0–III) with clinically significant CRF after completing chemotherapy and/or radiation therapy an average of 28 months prior to enrollment were randomized to MBSR or psychoeducation/support groups (PES). MBSR focused on mindfulness training; PES focused on CRF self-management. Outcomes included CRF interference (primary), CRF severity and global improvement, vitality, depression, anxiety, sleep disturbance, and pain. Outcomes were assessed at baseline (T1), post-intervention (T2), and 6-month follow-up (T3) using intent-to-treat analysis. Results Between-group differences in CRF interference were not significant at any time point; however, there was a trend favoring MBSR (d=−0.46, p=0.073) at T2. MBSR participants reported significantly greater improvement in vitality (d=0.53, p=0.003) and were more likely to report CRF as moderately-to-completely improved compared to the PES group (χ2 (1)=4.1765, p=0.041) at T2. MBSR participants also reported significantly greater reductions in pain at T2 (d=0.53, p=0.014). In addition, both MBSR and PES produced moderate-to-large and significant within-group improvements in all fatigue outcomes, depression, anxiety, and sleep at T2 and T3 compared to T1. Conclusion MBSR and PES appear efficacious for CRF and related symptoms. Larger trials including a usual care arm are warranted.
OBJECTIVE To evaluate the weight loss effectiveness of a ‘YMCA Model’ for the Diabetes Prevention Program (DPP) lifestyle intervention METHODS 509 overweight/obese, low-income, non-diabetic, adult primary care patients with elevated blood glucose were individually randomized to (1) standard care plus brief lifestyle counseling (SC); or (2) being offered a group-based adaption of the DPP offered free-of-charge by the YMCA (YDPP). Primary outcome was mean difference in weight loss at 12 months. Intention-to-treat (ITT) analyses used longitudinal linear or logistic regression, with missing observations multiply imputed. Instrumental variables (IV) regression estimated weight loss effectiveness among participants completing ≥9 intervention lessons. RESULTS In the YDPP arm, 161 (62.6%) participants attended ≥1 lesson and 103 (40.0%) completed ≥9 lessons. In ITT analysis, mean 12-month weight loss was 2.3 kg (95% CI 1.1 to 3.4 kg) more for YDPP arm participants, compared to SC. In IV analyses, persons attending ≥9 lessons had a 5.3 kg (95% CI, 2.8 to 7.9 kg) greater weight loss than with standard care alone. CONCLUSIONS The YMCA model for DPP delivery achieves meaningful weight losses at 12 months among low income adults. TRIAL REGISTRATION National Clinical Trials Registry (NCT00656682)
Purpose/Objectives The purpose of this report is to describe retention strategies that were useful and those that were not in a longitudinal study of emerging adults. Background of Project A longitudinal study examining the transition to young adulthood among emerging adults with type 1 diabetes, which had success in retention, provided the context for describing retention strategies. Rationale A challenge in longitudinally designed studies is retention of participants since their loss decreases power for statistical analysis. Given that emerging adulthood is a period of instability, retention is particularly challenging among this population. However, longitudinal studies are the best way to understand developmental changes, and it is also important to increase our knowledge of health outcomes during emerging adulthood. Description Retention strategies used in the study are described, including promoting a positive relationship with participants, maintaining contact with participants, having a study staff with good interpersonal skills, using incentives, conveying respect for participants, and employing user-friendly data collection. Outcomes Useful strategies to promote a positive relationship included sending cards and newsletters to participants, maintaining consistency of contact person, and expressing appreciation for participant's time and effort. Useful strategies for maintaining contact with participants included obtaining contact information at every data collection point, maintaining birthdates and chart numbers in tracking data bases, monitoring returned mail, and using Web search engines. Other useful strategies were providing incentives to participants, employing staff with good interpersonal skills, providing participants with choices when appropriate, and employing user-friendly data collection. One strategy, using contests, was not found useful. Conclusions Despite the challenges of conducting longitudinally designed studies with emerging adults, multiple retention strategies can be employed that are useful to retention. Implications It is feasible to conduct longitudinal studies with emerging adults despite the challenges.
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