Evaluating a Physical Activity Assessment and Counseling Index for Breast and Colon Cancer Survivors in Clinical Practice (The PAI Trial)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Use of Actigraph to measure changes in activity and sedentary behavior
研究概览
简要总结
The purpose of the study is to determine if a Physical Activity Index (PAI) tool that collects measures on physical activity, strength training and sedentary behavior can be used in a clinical setting to monitor patient behavior and provide specific recommendations on how to achieve and maintain behavior goals. The tool will be used after treatment is completed in breast and colon cancer survivors and will test if physician counseling combined with patient self-monitoring improves physical activity and reduces sedentary behavior over time.
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)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Women ages 60 years or older diagnosed with breast cancer and women or men ages 60 years or older diagnosed with colon cancer within the last 5 years
- •≥ 3 months post-completion of last prescribed treatment (i.e., Chemotherapy, radiation therapy or surgery)
- •Stages I-III (no stage 0 or metastatic cases will be included)
- •Able to understand spoken and written instructions in English
- •Participate in 60 minutes or more of MVPA (moderate to vigorous-intensity physical activity)/week for previous 6 months
- •Have internet access or access to data sharing plan
- •Willing to come to four Penn State Health visits over the course of a year, completing requested questionnaires
- •Willing to use Garmin Vivofit device, participate in exercise coaching sessions and complete exercise logs between visits
排除标准
- •Prior respiratory, joint or cardiovascular problems precluding PA
- •Metastatic disease
- •Planned elective surgery during intervention/follow-up
- •Exhibit gross cognitive impairment
- •We will not include any of the following vulnerable populations: adults unable to consent, individuals who are not yet adults, pregnant women, neonates, or prisoners.
结局指标
主要结局
Use of Actigraph to measure changes in activity and sedentary behavior
时间窗: 7 days prior to each clinical visit (Baseline, 3 months, 6 months, 12 months)
Activity patterns and sedentary behavior based on 7 days of wear before clinical visit
Introduce PAI tool to increase PA and reduce sedentary behavior
时间窗: 7 days prior to each visit clinical visit (Baseline, 3 months, 6 months, 12 months)
PAI Tool: frequency and time spent in strenuous moderate and mild PA over 7 days and self reported television time or sedentary screen time per week
Change in activity as measured by Community Healthy Activities Model Program for Seniors (CHAMPS) Questionnaire for Older Adults
时间窗: Baseline, 3 months, 6 months,12 months
This self-report questionnaire assesses weekly frequency and duration of a variety of lifestyle physical activities that are meaningful and appropriate for older adults. Scores are recorded based on number of repetitions the activity was completed and the hours spent doing the activity from less than 1 hour to 9 or more hours.
次要结局
- Exercise Self-Efficacy Scale This scale assesses an individual's beliefs in their ability to continue exercising on a 3 time/week basis at moderate intensities for 40+ min. per session in the future.(Baseline, 3 months, 6 months, 12 months)
- Modified Cancer and Aging Research Group (CARG) plus National Health and Nutrition Examination Survey (NHANES) and Patient-Reported Outcomes Measurement Information System (PROMIS) Geriatric Assessment Study Patient Questionnaire(Baseline, 3 months, 6 months,12 months)
研究者
Shirley Bluethmann
Assistant Professor
Milton S. Hershey Medical Center