Physical Activity After Cancer Treatment (PACT): Pilot Study of Exercise in Stage II-III Breast Cancer Survivors

Fred Hutchinson Cancer Center2 个研究点分布在 1 个国家目标入组 20 人开始时间: 2018年4月18日最近更新: 2019年7月22日

适应症

干预措施

试验速览

阶段: 不适用
状态: 已完成
发起方: Fred Hutchinson Cancer Center
入组人数: 20
试验地点: 2
主要终点: Adherence

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This pilot trial studies how well exercise intervention after cancer treatment works in improving physical activity in stage II-III breast cancer survivors. An exercise intervention may promote regular physical activity.

详细描述

PRIMARY OBJECTIVES:

I. Estimate the adherence rate of the experimental exercise program, and deem as feasible if at least 80% of participants complete 80% or more of a 12-week, 180 minute aerobic+resistance training program that combines structured, individualized onsite exercise at the Fred Hutch Prevention Center with at-home exercise.

II. Identify up to 5 circulating micro ribonucleic acid (c-miRNA) biomarkers that show the largest differential change from baseline when comparing levels in the exercise program to those in the Fitbit-activity control condition.

SECONDARY OBJECTIVES:

I. Explore associations between changes in miRNAs and serum biomarkers (IL-6, lipids, adiponectin and leptin, C-reactive protein [CRP]) and physiological outcomes (resting heart rate, blood pressure, 1 repetition max, 6 minute walk, timed up and go test) of the exercise program.

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: Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围: 19 Years 至 64 Years（Adult）
性别: All
接受健康志愿者: 否

入选标准

•Single malignancy with diagnosis of breast cancer diagnosis of stage II-III, estrogen and progesterone positive, HER-2neu negative, and on stable dose of aromatase inhibitor (AI) for past 3 months, with AI expected to be stable for the study duration
•No evidence of disease
•1-5 years post active treatment for malignancy
•Body mass index 19 to 35
•Sedentary (< 100 minutes of moderate intensity exercise per week)
•English adequate to complete assessments and follow exercise instructions
•Able to independently use transportation to attend 2-day a week onsite exercise training
•Access to a computer or smartphone

排除标准

•Current tobacco use or electronic cigarette smoker
•Diabetes requiring insulin injection
•Lymphedema that restricts range of motion or with worsening symptoms in the past month, or without compression garment
•Weight change of more than 10 pounds in previous 3 months will exclude from study participation at baseline
•Medical or other issue impacting exercise ability or safety, or ability to comply with study procedures (e.g. significant vision or cognitive impairment, major illness, in hospital or other institution), and specifically:
•Have been hospitalized within 3 months prior to screening for major atherosclerotic events (e.g. myocardial infarction, target-vessel revascularization, coronary bypass surgery, stroke or blood clot) or other major medical condition (as determined by an investigator) that may put the subject at risk because of his/her participation in the study;
•Have an implanted cardiac pacemaker or other implanted cardiac device;
•Have chronic, uncontrolled hypertension as judged by the investigator;
•Have a creatinine clearance < 45 mL/min as calculated by the Cockcroft-Gault equation;
•Subject's hand or legs have mobility impairment from fractures, arthritis, surgery, muscle disease or other injury that may interfere with any study procedure or ability to exercise