Protocol for the Pilot Study of Group Video Yogic Breathing App in Breast Cancer Survivors.

INTRODUCTION: Breast cancer remains a leading cause of cancer deaths; however, recent improvements in treatment have improved survivorship. As a result of this improvement, more individuals are living with the long-term side effects of cancer treatment. Therefore, methods that incorporate lifestyle and mind-body approaches are becoming increasingly used in the patient treatment pathway. METHODS: In this study, PranaScience Institute will develop and test a group video mobile application for Yogic Breathing (YB). YB is shown to reduce symptomatic conditions associated with several conditions including breast cancer. For this initial feasibility study, PranaScience will collaborate with the Medical University of South Carolina to implement the study app-based program in breast cancer survivors. This research is aimed to understand if the YB could be delivered via an app, if participants are able to practice it satisfactorily, and if there is any symptom relief by the YB practice. In the control group, participants will be directed to the Attention Control (AC) feature of the app, which guides users to focus on a mindfulness activity not involving YB. Participants will be randomly assigned to the YB or AC study plan (N = 20 per group). Breast cancer survivors who have completed radiation therapy within last 2 months will be recruited for this study and provided access to the app for a 12-weeks program. The study app will record total practice times. Virtual visits by a study yoga instructor during group video sessions will measure participant compliance with proper technique. Feasibility will be examined by evaluating intervention delivery factors and resource needs. Acceptability of using the mobile study app to support symptom management will be evaluated using a satisfaction and system usability scale. Behavioral survey measures will help guide effect sizes and power calculations for the next larger-scale study. Biomarkers in the saliva (tumor suppressors, cytokines), and fingernails (cortisol, differential proteomics) will be measured at baseline and end of study at 12 weeks. DISCUSSION: All findings from this pilot study will be synthesized to refine the mobile study app in preparation for large-scale evaluation in Phase II involving all-study site participants with cancer. ClinicalTrials.gov Identifier NCT05161260.

Peer-to-Peer Mentoring for African American Women With Lupus: A Feasibility Pilot.

OBJECTIVE: To examine the feasibility and potential benefits of peer mentoring to improve the disease self-management and quality of life of individuals with systemic lupus erythematosus (SLE). METHODS: Peer mentors were trained and paired with up to 3 mentees to receive self-management education and support by telephone over 12 weeks. This study took place at an academic teaching hospital in Charleston, South Carolina. Seven quads consisting of 1 peer mentor and 3 mentees were matched, based on factors such as age, area of residence, and marital and work status. Mentee outcomes of self-management, health-related quality of life, and disease activity were measured using validated tools at baseline, mid-intervention, and post-intervention. Descriptive statistics and effect sizes were calculated to determine clinically important (>0.3) changes from baseline. RESULTS: Mentees showed trends toward lower disease activity (P = 0.004) and improved health-related quality of life, in the form of decreased anxiety (P = 0.018) and decreased depression (P = 0.057). Other improvements in health-related quality of life were observed with effect sizes >0.3, but did not reach statistical significance. In addition, both mentees and mentors gave very high scores for perceived treatment credibility and service delivery. CONCLUSION: The intervention was well received. Training, the peer-mentoring program, and outcome measures were demonstrated to be feasible with modifications. This result provides preliminary support for the efficacy, acceptability, and perceived credibility of a peer-mentoring approach to improve disease self-management and health-related quality of life in African American women with SLE. Peer mentoring may augment current rheumatologic care.

Cytokine balance and behavioral intervention; findings from the Peer Approaches to Lupus Self-Management (PALS) project.

The Peer Approaches to Lupus Self-Management program sought to address the disparate impact of systemic lupus erythematosus (SLE) on African American women through a peer mentoring intervention with aims of reducing stress, anxiety, and depression. Given the association between psychological health and immune function this study examines the relationship between patient reported outcomes (PROs) in these domains and immunologic indicators of disease activity. Twenty-three African American women with SLE served as mentees in the intervention from whom PRO measures were collected at the outset, midpoint, and end of the 12week pilot study. Blood samples were collected pre- and post-intervention. Plasma was collected from the samples and cryopreserved for subsequent analyses. The strongest correlations were between the Generalized Anxiety Disorder measure and Th1/Th2 cytokine balance. Weaker correlations existed between depression and the Th1/Th2 cytokine balance. Assessment of fresh versus cryopreserved samples revealed that changes in Th1/Th2 cytokine balance within the intervention were generally equivalent, regardless of sample type. The PALS intervention resulted in significant improvements to anxiety and depression levels which were significantly associated with positive changes in Th1/Th2 cytokine balance indicating a possible underlying mechanism of action. The nature of this relationship warrants further study.

Nebulized fentanyl citrate improves patients' perception of breathing, respiratory rate, and oxygen saturation in dyspnea.

Dyspnea, a subjective symptom of impaired breathing, occurs in 70% of terminally ill cancer patients. Current treatments are suboptimal and little is known about the patient's perception of effect. We tested nebulized inhaled fentanyl citrate on patient perceptions, respiratory rate, and oxygen saturation. The study was conducted using a convenience sample of 35 cancer patients on a dedicated oncology unit. We assessed patient perception (did breathing stay the same, worsen, or improve), respiratory rate, and oxygen saturation by pulse oximetry at baseline, 5 minutes, and 60 minutes. Twenty-six of 32 (81%) patients reported improvement in breathing, 3 (9%) were unsure, and 3 (9%) reported no improvement. Oxygen saturation improved from 94.6% at baseline to 96.8% at 5 minutes and 96.7% at 60 minutes (P = 0.0069 compared to baseline). Respiratory rates improved from a baseline of 28.4/min to 25.9/min at 5 minutes and 24.1/min at 60 minutes (P = 0.0251 compared to baseline). No side effects were observed. Inhaled nebulized fentanyl citrate significantly improved patient perception of breathing, respiratory rate, and oxygen saturation. This inexpensive and readily available treatment may offer substantial relief of end-of-life dyspnea. Randomized trials, dose, and length of effect trials are underway.

Multiple factor interactions in biomimetic mineralization of electrospun scaffolds.

One of the major limitations in scaffold-based bone tissue engineering has been the inability to increase the loading of biologically active inorganic mineral. The present study introduces a novel two step strategy to increase overall mineral content of electrospun scaffolds and employs multiple factor interaction as a statistic to identify the combination of factors that yields maximal scaffold mineralization. Different amounts of nHA (0, 10, 25 and 50% by wt. of polymer) were electrospun in combination with polydioxanone (PDO) or poly(glycolide: lactide) to generate composite scaffolds. Successful incorporation of nHA within, on and in between nanofibers was confirmed by transmission and scanning electron microscopy. These scaffolds were immersed in different types (conventional, revised, ionic and modified) of simulated body fluid (SBF), prepared at 1x and 4x concentrations and the incubation was carried out either in static or dynamic setting at biomimetic conditions. At 2 weeks, the total amount of mineral within the scaffold was quantified using a modified Alizarin Red-based assay. Each of the five independent factors was analyzed independently and tested for interaction using random effects ANOVA. Statistics revealed significant higher order interactions among factors and the combination of PDO containing 50% nHA incubated in 1x revised SBF resulted in maximum mineralization.