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
- 1
- 主要终点
- Patient Rated Pain Score
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
研究组 & 干预措施
Exercise Group
Patients will complete a 60-minute exercise session once per week for 12 weeks. The exercise sessions will be individualized to the patient's needs and fitness level by a trainer. A patient will work with the same trainer throughout the study, who will plan the patient's individualized exercise regimen, and who will provide one-on-one supervision for the duration of each 60-minute session. Each 60-minute session will include cardiovascular, strength, and flexibility training. The intensity level for the aerobic exercise ranges from 30-45% of the individual's predicted VO2max, controlled by heart monitors and lasting 30 min. Strength training will involve a full body workout, with emphasis on all major muscle groups and employing machines, free weights, and resistance tubing. Patients will complete 3 sets of 10 repetitions for each strength exercise. Flexibility training will involve static stretching of all major muscle groups for 15-20 seconds at the completion of each workout.
干预措施: Supervised, individualized exercise oncology program (Other)
Control Group
The control group will receive the current standard of care, which includes a resource guide with various options available to the cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
干预措施: Current standard of care (Other)
结局指标
主要结局
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.
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 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.
Cost of Hospital Inpatient Care
时间窗: 12 weeks
Hospital length of stay, in days, if applicable. 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