Improving Physical Functioning in Older Cancer Survivors Through Light-Intensity Physical Activity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Time to Accrual Goal
研究概览
简要总结
The Move for Your Health (MY Health) Pilot Study is a 12-week study for older cancer survivors to promote light physical activity. The home-based study (no travel required) will test whether a Fitbit activity tracker and health coaching can help cancer survivors be more active throughout the day.
详细描述
The objective is to examine the feasibility and acceptability of a home-based lifestyle activity intervention to promote light-intensity activity using a whole-of-day approach. Sixty-four older cancer survivors will be randomized to either a 12-week theory-based intervention or a waitlist control. The intervention uses a Fitbit activity tracker that pairs with a smartphone app to promote awareness and enable self-monitoring of both activity and inactivity. Motivational counseling will be used to individually tailor strategies to achieve goals. Data will be collected at baseline, post-intervention (week 13), and 3-months post-intervention (week 26).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed in New Mexico (NM) with a loco-regionally staged cancer, completed primary treatment (surgery, radiation, chemotherapy), and not currently being treated for a recurrence. Patients with metastatic cancer are eligible with physician approval.
- •Mild-to-moderate physical functional impairment (raw score between 20 and 34 on the 8-item PROMIS Physical Function survey)
- •Able to speak, read, & understand English or Spanish
- •Participating in less than 120 minutes per week of moderate-intensity physical activity
- •Living independently and capable of walking 3 blocks (approximately 1300 steps or 0.25 mile) without an assistive device (e.g., cane, walker) and without stopping to rest
- •Own a smartphone or tablet *OR* be willing to use a study-provided smartphone capable of running the Fitbit app. Also, access to the internet or a Wi-Fi hotspot at least once per week is required. Smartphones and data plans will be provided to those individuals who are eligible but do not currently own a device capable of running the Fitbit app.
- •Availability of a family member or friend to be present (for safety) during the remote assessment of physical performance tests
- •Willingness to be randomized to either study arm and to wear activity trackers
排除标准
- •Adults not able to consent
- •Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily light physical activity (e.g., severe orthopedic conditions, pending hip/knee replacement, dementia, oxygen dependent, chronic vertigo)
- •Paid employment or volunteer position for greater than 20 hours per week (to avoid potential confounding by occupation activity/inactivity)
- •Currently participating in a program (personal program, e.g., wearing an activity monitor, or structured program, e.g., another study) to decrease sedentary time or increase physical activity
- •Planning to move out of New Mexico within the next year
结局指标
主要结局
Time to Accrual Goal
时间窗: up to 1-year
The number of months to accrue the study sample. Accrual is part of assessing feasibility.
Study Participant Retention Rate
时间窗: 24-weeks
The proportion of participants who complete the study out of the number randomized to one of two study arms. Retention is part of assessing feasibility.
Study Participant Adherence Rate
时间窗: 24-weeks
The proportion of participants who complete all five health coaching calls and wear the Fitbit activity tracker at least 67 days (67 days = 80% x 12 weeks). Adherence is part of assessing feasibility.
Number of Adverse Events Attributable to the Study
时间窗: 24-weeks
The number of adverse events attributable to or possibly attributable to the intervention will be tracked; defined as any condition that is life-threatening and results in overnight hospitalization or a physical or cardiac event serious enough to require medical attention. The number of adverse events is part of assessing feasibility.
Change in Self-reported Physical Function
时间窗: 12-weeks
Self-reported physical function will be assessed using the PROMIS® Item Bank v2.0 - Physical Function - Short Form 8b. Raw scores range from 8 to 40, with higher scores indicative of better physical functioning.
次要结局
- Change in Objective Measures of Moderate-intensity Physical Activity(12-weeks)
- Change in Objective Measures of Light-intensity Physical Activity(12-weeks)
- Change in the Number of Chair Stands During the 30-second Chair Stand Test(12-weeks)
- Change in Balance Score During the 4-stage Balance Test.(12-weeks)
- Change in Number of Steps Per Day(12-weeks)
- Change in Objective Measures of Sedentary Activity(12-weeks)
- Change in Self-reported Fatigue(12-weeks)
- Change in Self-reported Pain(12-weeks)
- Change in Self-reported Sleep Disturbance(12-weeks)
- Change in Self-reported Sleep Impairment(12-weeks)
- Change in Self-reported Social Participation(12-weeks)
- Change in Self-reported Anxiety(12-weeks)
- Change in Self-reported Depression(12-weeks)