Purpose To determine the effects of a home-based reflexology intervention delivered by a friend/family caregiver compared to attention control on health-related quality of life of women with advanced breast cancer undergoing chemotherapy, targeted and/or hormonal therapy. Methods Patient-caregiver dyads (N=256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained in a 30-minute protocol. During the 4 weeks, both groups had telephone symptom assessments, and intervention group had fidelity assessments. The intervention effects were assessed using linear mixed effects models at weeks 5 and 11 for symptom severity and interference with daily activities, functioning, social support, quality of patient-caregiver relationship, and satisfaction with life. Results Significant reductions in average symptom severity (p=.02) and interference (p<.01) over 11 weeks were found in the reflexology group compared to control, with no group differences in functioning, social support, quality of relationship or satisfaction with life at weeks 5 and 11. Stronger quality of relationship was associated with lower symptom interference in the entire sample (p=.02), but controlling for it did not diminish the effect of intervention on symptoms. Significant reductions in symptom severity in the reflexology group compared to attention control were seen during weeks 2–5, but were reduced at week 11. Discussion Efficacy findings of caregiver-delivered reflexology with respect to symptom reduction open a new evidence-based avenue for home-based symptom management.

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The phenomenon of intermittency has been widely discussed in physics literature. This paper provides a model of intermittency based on Lévy driven Ornstein-Uhlenbeck (OU) type processes. Discrete superpositions of these processes can be constructed to incorporate non-Gaussian marginal distributions and long or short range dependence. While the partial sums of finite superpositions of OU type processes obey the central limit theorem, we show that the partial sums of a large class of infinite long range dependent superpositions are intermittent. We discuss the property of intermittency and behavior of the cumulants for the superpositions of OU type processes.

Purpose Interruptions in medical treatment such as dose delays, reductions, or stoppages can lead to suboptimal treatment of cancer. Knowing how and for whom symptom severity and symptom interference with activities of daily living (ADL) are associated with treatment interruptions can guide behavioral interventions for supportive care. The purpose of this analysis is to inform research and clinical practice by bringing attention to specific patient symptoms that may hinder dose completion. Methods A secondary analysis of data collected in a randomized clinical trial (RCT) of reflexology for symptom management was performed. The trial enrolled women with advanced breast cancer undergoing treatment (N=385). Outcome data were collected at baseline, weeks 5 and 11 using a valid and reliable measure. Medical records provided data on treatment interruptions and metastasis. The association between alterations in medical treatment during the study period with symptom severity, symptom interference with ADL and metastatic status were tested using generalized estimating equations (GEE) models. Results The relationship between dose delays and dose reductions and symptom severity was differential according to metastatic status, with the higher strength of association among women with distant metastasis compared to those with loco-regional disease (p=0.02). The interaction of symptom interference and metastatic status was also significantly related to dose delays and reductions (p=0.04). Severity of pain was a stronger predictor of dose delays or reductions among patients with distant metastasis compared to those with loco-regional disease (p<0.01). Conclusion The analysis highlights the importance of understanding symptom outcomes that impact research, practice, and treatment decisions.

Aim To evaluate and quantify intervention fidelity of a symptom management protocol through implementation of a scorecard, using an exemplar study of caregiver-delivered reflexology for breast cancer patients. Background Studies on caregiver-delivered symptom management interventions seldom include adequate information on protocol fidelity, contributing to potentially suboptimal provision of the therapeutic intervention, hindering reproducibility and generalizability of the results. Design Fidelity assessment of a 4-week intervention protocol in a randomized controlled trial (RCT) with data collection between 2012 - 2016. Methods The National Institutes of Health Behavior Change Consortium (NIH-BCC) conceptual model for intervention fidelity guided the study. The five NIH-BCC fidelity elements are: 1) dose; 2) provider training; 3) intervention delivery; 4) intervention receipt; and 5) enactment. To illustrate the elements, an intervention protocol was deconstructed and each element quantified using a newly developed fidelity scorecard. Results Mean scores and frequency distributions were derived for the scorecard elements. For dose, the mean number of sessions was 4.4, 96% used the correct intervention duration and 29% had 4 weeks with at least 1 session. Provider training was achieved at 80% of the maximum score, intervention delivery was 96%, intervention receipt was 99% and enactment indicated moderate adoption at 3.8 sessions per patient. The sample mean score was 15.4 out of 16, indicating high overall fidelity. Conclusion Research findings that include description of how fidelity is both addressed and evaluated are necessary for clinical translation. Clinicians can confidently recommend symptom management strategies to patients and caregivers when fidelity standards are explicitly reported and measured.