Biobehavioral Effects of Tai Chi Qigong (TCQ) for Male Cancer Survivors With Fatigue (HERO)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Functional Assessment of Chronic Illness (FACIT)-Fatigue Scale
研究概览
简要总结
Project HERO is a 12-week study of the efficacy of Body Mind Training (BMT, i.e. Tai Chi and Qigong in this project) for reducing fatigue in male cancer survivors. This 3-arm randomized clinical trial will examine inflammatory biology and selected gene-expression pathways that are hypothesized to contribute to the intervention's effect.
详细描述
This study will establish the efficacy of a 12-week Body Mind Training (BMT) for reductions in fatigue (the study's primary outcome). Secondary patient-reported outcomes include quality of life changes (e.g., changes in sleep and perceived psychological distress), changes in the biomarkers of inflammation, including genome-wide transcriptional factors, and expression of fatigue-related genes. Post-award, the target sample size was revised to (n=166) with NCI permission.
There are over 9 million cancer survivors who are 55 years of age or older. Cancer survivors in this age group have unique challenges coping with the late and long-term effects of having had a cancer diagnosis and treatment, coupled with age-related declines and comorbidities. This may influence their ability to engage in lifestyle interventions because of slower post-treatment recovery, increased functional limitations, and other quality of life (QOL) impairments. Fatigue is common, under-recognized, undertreated, and correlated with impairments in psychological distress, social and functional well-being, and health-related QOL in cancer survivors. For male cancer survivors suffering from fatigue, Tai Chi and Qigong (TCQ) may be more appealing because it is not overly physically exertive and is safe for people 55 years of age or older. In this study, we referred to the intervention groups as follows: TCQ intervention was referred to as body-mind training (BMT), and the exercise intensity-matched condition was referred to as body training (BT). This was done to help reduce bias by minimizing participants' expectations or perceived differences between the groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Participants will be instructed not to discuss their arm assignment with study personnel during their assessments. We avoided the use of the terms Tai Chi and Qigong for participant recruitment, patient-faced materials, and intervention implementation. Questionnaires will be self-administered, administered in person or by telephone based on participant need and preference. Some investigators, the data manager, biostatisticians, biometric testing and lab technicians will be blinded to intervention allocation. The technicians who analyze biospecimens will be blinded to all other data.
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 55 years
- •Previous diagnosis of local, regional, or metastatic cancer. If treated for cancer, prostate cancer therapy completed, 3+ months. If on ADT/ hormone manipulation, must be for 4 or more months
- •Previous diagnosis of small intestine, thyroid, oral, non-muscle invasive bladder, kidney/renal, lung, colon, rectum, soft tissue, or other cancer
- •Meet study criteria for fatigue: Medical Health Outcome Study Short Form Vitality/Fatigue subscale (SF-36 Vitality scale-4 items; 5 Likert scale) using a fatigue cut-off value of ≤13; or the Patient-Reported Outcomes Measurement Information System Fatigue scale (PROMIS Fatigue scale) using a cut-off value of ≥9
- •Live within 75 miles of New Brunswick or Newark
- •Inactive (<150 minutes of vigorous exercise/week within the past 3 months)
- •Has transportation to attend on-site classes and assessments
排除标准
- •Patient Health Questionnaire PHQ-9 Score >12
- •Indication of suicidality from PHQ-9 reports that he has several or more days of "thoughts that you would be better off dead, or of hurting yourself."
- •Karnofsky performance status score of 50 or below
- •Current regular practice within the past year (2-3 times a week over a period of two months that is not interrupted) of BMT or other complementary and alternative medicine that shares similar principles of BMT.
- •Inability to speak and read English proficiently
- •Unable to understand informed consent
- •Current health conditions that may interfere with the intervention: respiratory, cardiovascular, or neurological problems unless released by a physician
- •Medical conditions or activities that can cause severe fatigue: Severe hearing loss that would cause difficulty following an instructor in a group setting, chronic fatigue syndrome, current major depression, alcohol use disorder, shift work
- •Prostate cancer that has metastasized to the liver, brain, or lungs
- •Currently receiving chemotherapy with VePesid, Cytoxan, Enzalutamide (XTANDI®), intravenous chemotherapy or radionucleotides (Strontium-89, Samarium (Quadramet®), Radium-223 (Xofigo®)), or other therapy (as confirmed by study team)
- •Unwilling to be randomized to study arms and/or commit to 12 weeks of classes and assessments
- •Have had a diagnosis of another cancer, unless:
- •Non-melanoma skin cancer or
- •Completed treatment AND cancer-free for 5 or more years.
- •We will not include any of the following special populations:
- •Adults unable to consent
- •Individuals who are not yet adults (infants, children, teenagers)
- •Pregnant women
- •Prisoners
研究组 & 干预措施
Body Mind Training (BMT)
Body mind training
干预措施: Body Mind Training (BMT) (Behavioral)
Body Training (BT)
Body training only
干预措施: Body Training (BT): (Behavioral)
Usual care (UC):
Control
干预措施: Usual Care (UC) (Behavioral)
结局指标
主要结局
Functional Assessment of Chronic Illness (FACIT)-Fatigue Scale
时间窗: Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months
Change in fatigue levels from baseline to 3-months post intervention: measured with 13-item scale assessing the level of fatigue during usual activities over the 7 days prior to the measurement timepoint, with higher scores indicating less fatigue. Administered at several time points to measure the effect the intervention.
次要结局
- Pittsburgh Sleep Quality Index (PSQI)(Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months)
- Inflammation Biology Measures: Changes in circulating levels pro- and anti-inflammatory biomarkers will be assessed by measuring NF-κB and AP-1.(Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months)
- Gene Expression(Baseline (2 weeks pre-intervention), and post-intervention at week 13, 3 months, and 12 months)
- Brief Symptom Inventory-18 (BSI-18)(Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months)
- SF-36v2 Health-Related Quality of Life Survey (Mental and Physical)(Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months)
- Consensus Sleep Diary(Baseline (2 weeks pre-intervention) and week 6, and post-intervention at week 13, 3 months, and 12 months)
研究者
Anita Y. Kinney, PhD, RN
Study Principal Investigator; Associate Director for Cancer Health Equity
Rutgers, The State University of New Jersey