Center-Based and Home-Based Walking Exercise Intervention to Reduce Fatigue in Older Breast Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Self-Reported Fatigue
研究概览
简要总结
About 20%-70% of breast cancer survivors experience fatigue after cancer therapy. Because epidemiologic evidence shows that old age is a risk factor for fatigue in adults with cancer history, older breast cancer survivors suffer from even more fatigue than younger survivors. The purpose of this study is to test types of walking exercise interventions and their ability to reduce fatigue in older breast cancer survivors.
详细描述
Women with breast cancer often experience severe fatigue (asthenia) after cancer therapy, seen in approximately 40% of breast cancer survivors. Because older age is a risk factor for fatigue, older breast cancer survivors are at an increased risk versus those in younger age groups. Prior evidence suggests that aerobic exercise reduces inflammation and bioenergenesis disturbance, which are key factors that drive the pathogenesis of fatigue. Although interventional studies suggest that aerobic exercise can improve fatigue in younger breast cancer survivors, anti-fatigue effects of aerobic exercise tended to decrease with increasing age. The investigators postulate that novel interventions combined with aerobic exercise can enhance its effectiveness and alleviate severe fatigue further in older breast cancer survivors.
In this pilot randomized clinical trial, the investigators will enroll 24 female cancer survivors aged ≥ 60 years who were diagnosed with invasive breast cancer but have completed adjuvant therapy for at least 3 months but no more than 1 year. Participants will be randomly assigned to either a center-based walking exercise intervention or a home-based walking exercise intervention for an 8 week period. By completing this pilot study, the investigators will be able to collect preliminary data; refine the recruitment, measurement, randomization, and retention strategy; and adjust the statistical strategy and timeline for the potential full-scale randomized clinical trial.
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
- None
入排标准
- 年龄范围
- 60 Years 至 105 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Consent to participate in the study
- •Age ≥ 60 years old
- •Had stage I-III invasive breast cancer
- •The cancer is diagnosed in 2021 or 2022
- •Completed adjuvant therapy for at least 3 months but no more than 1 year
- •Willingness to participate in all study procedures
- •Had at least moderate-level fatigue (defined as raw score ≥ 8 on the PROMIS Measure)
排除标准
- •Failure to provide informed consent
- •Current involvement in rehabilitation program
- •Absolute contraindications to exercise training
- •Significant cognitive impairment
- •Progressive, degenerative neurologic disease
- •Hip fracture, hip or knee replacement, or spinal surgery within past 4 months
- •Other significant comorbidities that may impair ability to participate in the exercise intervention
- •Regular consumption of nicotinamide riboside supplement
- •Simultaneous participation in other interventional studies
- •Had no or very mild fatigue (defined as raw score ≤7 in PROMIS)
- •Diagnosis of any of the following medical conditions in past three years (coronary heart disease, angina, heart attack, heart failure, stroke, high blood pressure, chronic obstructive pulmonary disease, chronic bronchitis, arthritis, diabetes mellitus, and chronic kidney disease), as measured by Behavioral Risk Factor Surveillance System
- •Receipt of any oral or intravenous antibiotic 4 weeks prior to screening
- •Receipt of any probiotics within 4 weeks of screening
- •History of active treatment for HIV, hepatitis B, or hepatitis C infection
- •Positive stool cultures for enteric pathogens, including Clostridium difficile
- •Excessive alcohol use (i.e., > 14 drinks/week) or alcohol abuse (i.e., > 5 drinks/day for males or > 4 drinks/day for females)
- •Other substance abuse within the past 3 years
- •Smoking history in past 3 years
研究组 & 干预措施
Center-Based Walking Exercise
Subjects will be randomly assigned to receive a center-based walking exercise intervention 3 days per week for the duration of the study.
干预措施: Center-Based Walking Exercise (Behavioral)
Home-Based Walking Exercise
Subjects will be randomly assigned to walk for exercise in their community five days/week.
干预措施: Home-Based Walking Exercise (Behavioral)
结局指标
主要结局
Self-Reported Fatigue
时间窗: Baseline up to Week 8
Patient Reported Outcomes Measurement Information System (PROMIS) is a set of person-centered measures that evaluate and monitor physical, psychological, and social health based on experts' review of items reflecting general health, functional status, and quality of life. All items are measured based on a 5-point scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) and PROMIS reverse scores item 7. Scores of all items are summed, with higher scores indicating greater fatigue. Raw total scores will range from 7 to 35.
次要结局
- Mental Distress (Depression and Anxiety)(Baseline up to Week 8)
- Self-Reported Pain(Baseline up to Week 8)
- Self-Reported Sleep Disturbance(Baseline up to Week 8)
- Habitual Physical Activity(Baseline up to Week 8)
- Treatment-Induced Peripheral Neuropathy (TIPN)(Baseline up to Week 8)
- Perceived Stress(Baseline up to Week 8)
- Gait Speed(Baseline up to Week 8)
- Physical Function(Baseline up to Week 8)
- Functional Assessment of Cancer Therapy - Breast (FACT-B)(Baseline up to Week 8)
- Dispositional Gratitude(Baseline up to Week 8)