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Programs to Support You During Chemotherapy (Pro-You)

ABSTRACT: This randomized pilot clinical trial studies Yoga Skills Training or attention control in reducing fatigue and depressive symptoms during chemotherapy in patients with stage II-IV colorectal cancer. Yoga Skills Training consists of meditation, movement and breathing practices that aim to promote mindfulness and relaxation. Attention control consists of conversations with a caring professional with a recommendation to complete daily home diaries. It is not yet known whether Yoga Skills Training is better than attention control at reducing fatigue and depressive symptoms in patients undergoing chemotherapy.The purpose of this initial feasibility study is to refine study procedures.

DISEASE(S): Stage Ivb Colon Cancer,Psychosocial Effects Of Cancer And Its Treatment,Stage Iic Colon Cancer,Colorectal Cancer,Fatigue,Depression,Stage Iib Colon Cancer,Stage Iiia Rectal Cancer,Stage Iia Colon Cancer,Stage Iiib Rectal Cancer,Stage Iiib Colon Cancer,Stage Iiic Colon Cancer,Rectal Neoplasms,Depressive Symptoms,Stage Iiic Rectal Cancer,Stage Iva Rectal Cancer,Stage Iic Rectal Cancer,Stage Ivb Rectal Cancer,Stage Iib Rectal Cancer,Stage Iva Colon Cancer,Colonic Neoplasms,Stage Iiia Colon Cancer,Stage Iia Rectal Cancer

PROVIDER: 2167362 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:This study was the first randomized controlled trial to test if mind-body interventions can improve self-regulation in prisoners with different personality disorders, using a combination of gene expression, neural, and behavioral measures.Thirty prisoners with personality disorders who score high on psychopathy were assigned to a mindfulness intervention (n=10), a yoga intervention (n=10), or a wait-list control group (n=10) using stratified random sampling. Both mindfulness and yoga interventions were held at the same time and lasted three hours per day on five consecutive days. At baseline and after the intervention, we measured inflammation-related gene expression; resting state brain activit with electroencephalography (EEG); risk-taking and attention with cognitive tasks; event-related potentials (ERPs) related to the attention task; and stress, emotion regulation and mindfulness with questionnaires. We expected that both yoga and mindfulness would improve self-regulation (i.e., executive attention, emotion regulation and self-awareness), reduce stress and risk-taking behavior, downregulate inflammatory-related gene expression and increase alpha and theta power. Blood was collected for the analysis of changes in gene expression of 38 genes related to inflammation and the immune system (IL-1 signaling pathway). Venipuncture samples were collected into 10ml EDTA tubes, lysed and frozen at -80°C. Peripheral blood mononuclear cells were isolated by density gradient centrifugation. Ribonucleic acid (RNA) was extracted (QiaAmp RNA Blood Mini kit; Qiagen) and tested for suitable mass and integrity (NanoDrop One, Acclaro Sample Intelligence; Thermo Scientific). RNA was then converted to fluorescent cRNA for hybridization to IL-1 signaling pathway plate H96 (Bio-Rad Labs Ltd, UK). Gene expression data were expressed as cycle threshold (CT) values by calculating 2−ΔΔCT, and referencing to the geomean of all genes because endogenous control genes that are supposed to have constant levels of expression were not stable in this case. After normalizing 2−ΔΔCT to the wait-list control group median, the data were imported into SPSS and analyzed by group allocation based on change scores of each normalized 2−ΔΔCT. Intent-to-treat (ITT) principles were used for all the analyses. Post-intervention missing data was handled by running multiple imputations. A p-value of <0.05 was considered significant and Bonferroni correction was implemented to adjust for multiple comparisons (i.e., <.02 was considered significant in individual 2-group comparisons). The data were analyzed with the IBM SPSS 24.0 software (Statistical Package for Social Sciences, SPSS Inc., 237 Chicago, IL). The effectiveness of interventions was tested by calculating changes scores and running non-parametric Kruskal-Wallis test for K independent samples because the assumptions for ANOVA were not met. If there was a significant difference detected, it was followed with Mann-Whitney U test 240 and Kolmogorov-Smirnov Z test to determine specific group differences. Additionally, eta squared was used as a measure of effect size to determine the proportion of variability in outcomes that can be explained by group membership.We found no significant changes in gene expression or any other measures.

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Programs to Support You During Chemotherapy (Pro-You)

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