Randomized, Controlled Trial of an Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 251
- 试验地点
- 2
- 主要终点
- Numbers of Breaks in Cancer Treatment
研究概览
简要总结
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.
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
- None
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female; determined from electronic medical record
- •Initial stage 0, 1 or 2 breast cancer diagnosis within the past 12 weeks determined from electronic medical record
- •Age 30-80; determined from electronic medical record
- •Physician clearance to participate in exercise
排除标准
- •Participation in supervised physical exercise within 6 months prior to study enrollment
- •Currently pregnant or planning to become pregnant
- •Non-English speaking
- •Unable to make own medical decisions and/or to follow verbal instructions
结局指标
主要结局
Numbers of Breaks in Cancer Treatment
时间窗: 12 weeks
Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
Encounters
时间窗: 12 weeks
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Missed Fractions
时间窗: 12 weeks
Total number of missed fractions, determined by electronic medical record
Cancer Treatment Adherence
时间窗: 12 weeks
Percentage of patient adherence to their cancer treatment, determined by electronic medical record
Cancer Treatment Symptom Management Medications
时间窗: 12 weeks
Number of the different types of medications taken by patients for symptom management during their cancer treatment. Determined by electronic medical record.
Cancer Treatment Related Side Effects
时间窗: 12 weeks
Total number of cancer treatment related side effects
Cost of Total Unplanned Expenditures
时间窗: 12 weeks
Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Cost of Hospital Inpatient Care
时间窗: 12 weeks
Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Patient Rated Pain Score
时间窗: 12 weeks, measured at the start of their exercise program during their initial assessment and at the 12-week follow-up re-assessment.
The Short Form-36 survey was used to measure pain. A high score defines a more favorable health state. Each item is scored on a 0 to 100 range, with the lowest and highest possible scores being 0 and 100, respectively.
Cost of Emergency Room Visits
时间窗: 12 weeks
Medical expenditure and utilization, for each time a patient utilized an emergency room visit for the purpose of managing health problems in addition to the planned cancer care, determined by electronic medical record.
Cancer TreatmentTtolerance
时间窗: 12 weeks - ECOG performance status measurements were recorded at baseline and at the 12-week follow up appointment.
Measured by the Eastern Cooperative Oncology Group (ECOG) performance status score. Scale is from 0 to 5, with 0 being high functioning and no restriction and 5 being dead.
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire
时间窗: Baseline was at the time of enrollment and follow up was after 12-weeks.
McGill Quality of Life Survey: Physical Wellbeing (questions 1-4) - minimum score is 0, maximum score is 40. A higher score would be good and lower score would be bad. Social Wellbeing (questions 12, 14-16) - minimum score is 0, maximum score is 40. A higher score would be good and lower score would be bad. Emotional Wellbeing(questions 5-7, 13) - minimum score is 0 and maximum score is 40. A higher score would be bad and a lower score would be good Functional wellbeing (questions 8-11) - minimum score is 0, maximum score is 40. A higher score would be good and lower score would be bad. FACT-BREAST Survey: Minimum score is 0 and maximum is 148; 0 is not at all and 4 is very much, "good" or "bad" varies depending on the question; overall a higher score is good and a lower score is bad
次要结局
- Adherence Rate(12 weeks)
- Percentage of Participants Who Completed the Study (Attrition Rate)(12 weeks)
研究者
Karen Wonders
Executive Director, Maple Tree Cancer Alliance
Kettering Health Network