Community-Based Physical Activity Across the Cancer Continuum
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Proportion of patients referred to the intervention (Feasibility)
研究概览
简要总结
This clinical trial evaluates a community-based physical activity program for underserved cancer survivors. Cancer and its treatment significantly influence physical, psychosocial, and cognitive functioning. Historically, community sites (local and national) have not been staffed to offer support services such as physical, and occupational therapies (everyday life activities to promote health and well-being) or nutrition counselling, and do not offer a whole-person model of care. In this study, researchers have partnered with the YMCA to provide tailored home-based exercise programs for underserved cancer patients and survivors. Accessing exercise professionals may allow patients to prevent acute problems from becoming chronic, long-lasting physically weak impairments that directly influence patients' quality of life.
详细描述
PRIMARY OBJECTIVE:
I. To assess the feasibility and acceptability of a community-based 12-week physical activity intervention.
SECONDARY OBJECTIVE:
I. To assess the effectiveness of a virtual physical activity intervention by evaluating pre-post changes in quality of life (QoL).
EXPLORATORY OBJECTIVE (OPTIONAL):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have had a previous cancer diagnosis OR are a caregiver for a patient who has had a previous cancer diagnosis
- •Not in active treatment for cancer
- •Over 18 years of age
排除标准
- •Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, atrial fibrillation (AFIB), multiple myeloma, or psychiatric illness/social situations that would limit compliance with study requirements
- •Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise
- •Are pregnant or nursing - self reported by participant
- •Are unwilling or unable to follow protocol requirements
- •Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study
研究组 & 干预措施
Supportive Care (virtual exercise classes)
Participants participate in virtual exercise classes at least TIW over 20-60 minutes for 12 weeks. Participants are expected to work towards achieving the national physical activity exercise guidelines of 150 minutes of moderate intensity aerobic based physical activity and 2-3 strength training sessions each week.
干预措施: Exercise Intervention (Other)
Supportive Care (virtual exercise classes)
Participants participate in virtual exercise classes at least TIW over 20-60 minutes for 12 weeks. Participants are expected to work towards achieving the national physical activity exercise guidelines of 150 minutes of moderate intensity aerobic based physical activity and 2-3 strength training sessions each week.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Proportion of patients referred to the intervention (Feasibility)
时间窗: Up to 12 weeks
At the provider level, feasibility will be defined as the proportion of patients that were referred to the intervention versus (vs.) the proportion of patients that enrolled in the study. Will estimate the referral rates with 95% confidence intervals obtained from generalized estimating equation (GEE) logistic regression models, accounting for the within provider clustering.
Proportion of patients that enrolled in the study (Feasibility)
时间窗: Up to 12 weeks
At the provider level, feasibility will be defined as the proportion of patients that were referred to the intervention vs. the proportion of patients that enrolled in the study.
Retention rate (Feasibility)
时间窗: At the end of the 12-week intervention
At the patient level, feasibility will be defined as the proportion of patients still on study. Will estimate with 95% confidence intervals obtained from GEE logistic regression models, accounting for the within provider clustering.
Adherence rate (Acceptability)
时间窗: At post 12-weeks
Adherence will be defined as the percentage of patients on study after 12-weeks who complete at least 70% of the intervention videos. Will estimate with 95% confidence intervals obtained from GEE logistic regression models, accounting for the within provider clustering.
Patient satisfaction (Acceptability)
时间窗: Up to 12 weeks
Acceptability will be determined by measuring adherence to the intervention and by measuring patient satisfaction. Patient satisfaction will be determined through pre-post intervention surveys. Will use the appropriate generalized linear model (ex. linear or logistic), as determined by the question type and accounting for the within provider clustering.
次要结局
- Overall quality of life(Up to 12 weeks)