Mindfulness Based Stress Reduction for Psycho-Immune Dysregulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 主要终点
- Change in Natural Killer Cell Activity
研究概览
简要总结
The purpose of this study is to evaluate the benefits of a Mindfulness Based Stress Reduction (MBSR) program for psycho-immune dysregulation in women newly diagnosed with breast cancer compared to women with breast cancer completing an attention control condition (health education classes). Women will be randomized to either the MBSR or health education classes. They will complete psychometric instruments evaluating psychological outcomes and will provide blood samples for immune outcomes. They will also provide saliva samples for cortisol diurnal rhythm determination. Measures will be done longitudinally pre and post MBSR or health education program. It is hypothesized that MBSR participants will exhibit improved psychological and immunological outcomes over time, as compared to women randomized to the health education classes.
详细描述
The Mindfulness-Based Stress Reduction (MBSR) program is designed to cultivate conscious awareness (i.e., mindfulness) of one's experience in a non-judgmental or accepting manner (Kabat-Zinn, et al., 1990). Mindfulness programs may facilitate recovery from cancer. However, most prior mindfulness investigations for women with breast cancer focused on cancer survivors, well beyond the acute period of cancer diagnosis and treatment. Moreover, few of these studies evaluated immune measures with relevance to cancer.
Women diagnosed with early stage breast cancer (Stages 0, 1, 2, and 3) will be enrolled. Eligible women will be identified after completion of their breast surgery and when surgical pathology reports are available. Women will complete psychometric instruments and study questionnaires. They will provide blood for immune measures and saliva for cortisol diurnal rhythm. Measures will be done at five separate time points. These are pre-, mid-, and completion of either the MBSR or the attention control program, as well as at 1- and 6-months post-program. Demographic information and information about health behaviors will be collected by self-report. Wrist actigraphy for an additional assessment of sleep quality will be done in an exploratory manner. Hierarchical linear modeling will be used to compute multilevel model for change, based on full maximum likelihood estimation (Raudenbush, S. W., and A. S. Bryk. 2002). Hierarchical linear modeling will be applied to examine intra-individual and inter-individual differences in initial status (baseline) and trajectories of change over time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 28 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Early Stage Breast Cancer
排除标准
- •Prior training in MBSR,
- •Recurrent breast cancer,
- •Metastatic breast cancer,
- •Other cancers (except basal cell carcinoma),
- •Immune-based disease,
- •Psychoses,
- •Cognitive dysfunction,
- •Unable to read or write English,
- •History of substance abuse,
- •Use of immune-altering medications
研究组 & 干预措施
Mindfulness Based Stress Reduction
The Mindfulness Based Stress Reduction (MBSR) program consists of an 8-week (2.5 hr/wk) program with a 6-hour silent mindful practice retreat after the fifth week. A licensed clinical psychologist, certified as an MBSR instructor, will provide instruction to all groups. Mindfulness will be taught using breath awareness, sitting and walking meditation, and mindful yoga. Participants will be given a standardized session-by-session program workbook containing weekly objectives and assignments, as well as two practice recordings and the book, Full Catastrophe Living (Kabat-Zinn, J, 1990).
干预措施: Mindfulness Based Stress Reduction (Behavioral)
Health Education Series
The active comparator condition consists of an 8-week educational series, administered in group-format, and matched in duration and frequency to the MBSR program. Session topics include: 1) Understanding Breast Cancer and Risks for Breast Cancer, 2) Breast Cancer Treatment, 3) Communicating Effectively with your Health Care Providers; Keeping your Medical Records, 4) Genetic Testing and Cancer, 5) Nutrition and Cancer, (6) Cooking Demonstration, 7) Bone Health, and 8) Image and Cancer (American Cancer Society - Look Good, Feel Better). The program content and objectives were reviewed by four content experts (oncology clinicians) and two breast cancer survivors.
干预措施: Health Education Series (Other)
结局指标
主要结局
Change in Natural Killer Cell Activity
时间窗: Change from baseline NKCA to 36 weeks.
Natural killer cell lytic activity (NKCA) against tumor targets will be assessed ex vivo using participant peripheral blood mononuclear cells (PBMC) in a standard chromium release assay, as we described previously (Witek-Janusek, L. et al., 2007).
Change in Cytokine Levels
时间窗: Change from baseline cytokine level to 36 weeks.
Plasma levels of cytokines, Interleukin 6 (IL-6) and Tumor Necrosis Factor (TNF) alpha and PBMC cytokine production of these cytokines and interferon (IFN) gamma will be determined. Measurement of individual cytokines will be by quantitative sandwich enzyme immunoassay (R \& D Systems, Minneapolis, MN), as we described previously (Witek-Janusek, L. et al., 2007; Witek-Janusek, et al., 2008).
Change in Perceived Stress
时间窗: Change from baseline perceived stress level to 36 weeks.
The construct, perceived stress, will be measured using the Perceived Stress Scale (Cohen, S. et al., 1983). The Perceived Stress Scale is a 10-item instrument that assesses the degree to which life experiences are appraised as uncontrollable. Individual items are summed, with scores ranging from 0 (minimum) to 40 (maximum); higher scores indicate higher perceived stress.
Change in Depression
时间窗: Change from baseline depression level to 36 weeks.
The construct, depression, will be measured using the Center for Epidemiologic Studies - Depression scale. This is a 20-item measure that asks individuals to rate how often over the past week they experienced symptoms associated with depression. Individual items are summed with scores ranging from 0 (minimum) to 60 (maximum); higher scores indicate greater depressive symptoms (Radloff, LS, 1977).
Change in Fatigue
时间窗: Change from baseline fatigue level to 36 weeks.
The construct, fatigue, refers to a subjective sense of tiredness. Fatigue will be measured using the Multidimensional Fatigue Symptom Inventory-Short Form, which consists of 30 items that assess the extent of fatigue experienced by the respondent. Individual items are summed with scores ranging from -24 to 96. Higher score indicates greater fatigue (Stein, KD, et al., 2004).
Change in Sleep
时间窗: Change from baseline sleep quality level to 36 weeks.
The construct, sleep quality, will be measured using the Pittsburgh Sleep Quality Index, which consists of 19 items that measure a person's perception of their sleep quality. An overall score is calculated by summing items. Scores range from 0 (minimum) to 21 (maximum), where lower scores denote a better sleep quality (Buysse, DJ, et al., 1989).
次要结局
- Change in Cortisol(Change from baseline cortisol level to 36 weeks.)
- Change in Quality of Life in Cancer(Change from baseline quality of life level to 36 weeks.)
- Change in Social Support(Change from baseline social support level to 36 weeks.)
- Change in Coping(Change from baseline to 36 weeks.)
- Change in Wrist Actigraphy Measure of Sleep Quality(Change from baseline actigraphy to 36 weeks.)
研究者
Linda Janusek
Professor
Loyola University