Testing the Effects of Movement Based Interventions on Brain-Body Mechanisms in Fatigued Cancer Survivors
试验速览
- 阶段
- 不适用
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Reduction in Fatigue (via FACIT-Fatigue scale)
研究概览
简要总结
This parallel, randomized, non-inferiority trial will examine whether a ten week qigong intervention is not inferior to a ten week exercise-nutrition comparison group in reducing fatigue in cancer survivors. To build a more mechanistic understanding of physiological changes associated with fatigue reduction, it will secondly collect several different types of data to build an integrative brain-body model of vigor in cancer survivorship including:
- data related to neural correlates of body awareness: cortical EEG data measuring each subject's ability to use attention to control neurons in primary somatosensory cortex (replication of Kerr et al 2011 study in mindfulness), and resting state fMRI measures of insular connectivity with nodes of the default mode network and salience network
- data related to inflammation measured via inflammatory cytokines (e.g., interleukin-6 and tnf-alpha)
- data related to cardiorespiratory functioning including cardiac impedance (ICG) and mechanical lung function
- data related to parasympathetic and sympathetic signaling between the nervous system and the rest of the periphery.
详细描述
The purpose of this study is to examine the therapeutic effects of movement and body awareness on recovery from cancer-related fatigue. In the current study, 60-80 female cancer survivors with cancer-related fatigue will be recruited who have been out of treatment for at least eight weeks. They will be randomized to either a 10-week qigong contemplative movement course or a 10 -week exercise-nutrition course. This study is designed as a non-inferiority trial to test the primary hypothesis that a ten week qigong intervention is not inferior to a ten week exercise-nutrition active comparator group in reducing fatigue in female cancer survivors (assessed via the FACIT-Fatigue scale). If non-inferiority is demonstrated during analysis, the data will be further analyzed to examine whether the qigong group significantly decreases fatigue more than the healthy living comparison group. The FACIT-Fatigue scale will be delivered at three time points: before the intervention starts (T1), after it ends (T2), and three months after the intervention has ended (T3). Further, this study will directly examine the underlying physiological mechanisms by which each intervention exerts its effects. Participants will be tested pre (T1) and post (T2) intervention on a variety of measures across multiple bodily and brain systems (eg EEG, fMRI, EMG, ECG, ICG, mechanical lung function, Doppler flowmetry, serum cytokines, muscle strength, 6 min walk test) to assess changes in these systems that are associated with reduction of fatigue and improvement of the subjective sense of vitality and energy. The data will be used to test whether conscious attention to bodily sensations cultivated in contemplative movement practices (i.e. Qigong) can actually impact levels of inflammation in the periphery as well as cortical measures of interoceptive awareness (ie resting state insula connectivity), and whether these changes will be associated with fatigue reduction. The secondary hypothesis is that decreased inflammation levels in the blood will be correlated with reduction in fatigue at post intervention as well as changes in neural markers of interoceptive and bodily awareness, and that this effect will be stronger in the qigong group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants will not find out what interventional group they are placed in (qigong vs. healthy living) until after they have completed their first testing session.
Pre intervention data collection and post intervention data analysis will be completely masked.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients
- •Aged 18-70 years
- •Have completed a course of chemotherapy cancer treatment (except for ongoing treatment with Herceptin [trastuzumab] or other adjuvant therapies), AND/OR radiation treatment, AND/OR surgery, with no surgery, radiation or chemotherapy received in the past 8 weeks.
- •Endorse a 3/10 or above for the question "On a scale of one to ten, in the last week, how much has your fatigue interfered with your daily life, with 1 being not at all, and 10 being all the time" AND/OR "On a scale of one to ten, in the last week, how much have you felt your sleep has been disturbed or of a quality that you have not felt rested when you wake up, with 1 being not at all, and 10 being all the time"
- •Have a primary care or other physician
- •Ability to understand English
- •Willingness to have blood drawn
- •Willingness to have an EEG, EKG, and EMG taken
- •Willingness to complete questionnaires
- •Willingness and ability to undergo an fMRI scan (screening parameters for this are included below) [optional: participant doesn't have to do this if it will represent too much burden to the participant, or if they have other contraindications to fMRI such as metal in the body, etc.]
- •Ability to pass basic validated physical movement tests (e.g.: standing with feet touching for 30 seconds, twist right to left and back, hold arms out to side in air for 15 seconds, lift arms over head, moving from standing position to seated position on the floor) to verify safety for qigong and exercise practices
排除标准
- •History or current diagnosis of coronary artery or coronary heart disease
- •History or current diagnosis of heart attack, or heart murmur
- •Electrical Pacemaker Implant in heart
- •Peripheral neuropathy in hands
- •History or current diagnosis of any other MAJOR psychiatric disorder (including psychosis, or mania, or suicidal or homicidal ideation) besides depression or anxiety
- •Active alcohol or drug abuse
- •Tobacco use
- •Pregnancy
- •Ingestion of caffeine or cocoa products less than two hours from data collection
- •Inability to participate in gentle exercises (like pilates)
研究组 & 干预措施
Qigong
This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include guided instruction in the theory and background of qigong and healing. Practice will include gentle stretching and guided qigong movement as well as seated and lying down meditations. Participants will be asked to complete about 30 minutes a day of home assignments.
干预措施: Qigong (Behavioral)
Healthy Living (CHIP + Pre-Train)
This course will meet twice weekly for 2 hours and 15 minutes per class for ten weeks. Topics will include plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) as well as core-stretching, strengthening, and light aerobic movements through a Pre-Train exercise program. Participants will be asked to complete about 30 minutes a day of home assignments.
干预措施: Healthy Living (CHIP + Pre-Train) (Behavioral)
结局指标
主要结局
Reduction in Fatigue (via FACIT-Fatigue scale)
时间窗: Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3)
Fatigue assessed via the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire
次要结局
- Electrocardiogram (ECG)(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Impedance Cardiography(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Electroencephalography (EEG)(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Tactile Acuity(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Electromyography (EMG)(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Precision Grip(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Electrodermal Activity (skin conductance)(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Resting State Functional Magnetic Resonance Imaging (rs-fMRI)(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Muscle Strength(Measured at baseline (time 1) and after 10-week intervention (time 2))
- 6 Minute Walk Test(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Working memory capacity (WMC)(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Mechanical lung function(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Inflammatory cytokines (eg Il-1, Il-6) collected via a blood draw(Measured at baseline (time 1) and after 10-week intervention (time 2))
- Patient Health Questionnaire(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
- Functional Assessment of cancer therapy-General (FACT-G) Questionnaire(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
- Multidimensional Assessment of Interoceptive Awareness (MAIA) Questionnaire(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
- Profile of Mood States (POMS) Questionnaire(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
- Pittsburgh Sleep Quality Index (PSQI)(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
- Rand 36-Item Short Form Health Survey (SF-36)(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
- Difficulties in Emotion Regulation Scale (DERS)(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
- Fatigue Symptom Inventory (FSI)(Measured at baseline (time 1) and after 10-week intervention (time 2) and 3 months after end of intervention (time 3))
研究者
Ellen Flynn
MD, Psychiatry
The Miriam Hospital