Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
- Conditions
- Breast Cancer
- Interventions
- Other: Supervised, individualized exercise oncology programOther: Current standard of care
- Registration Number
- NCT04106609
- Lead Sponsor
- Karen Wonders
- Brief Summary
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 251
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise Group Supervised, individualized exercise oncology program 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. Control Group Current standard of care 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.
- Primary Outcome Measures
Name Time Method Numbers of Breaks in Cancer Treatment 12 weeks Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
Encounters 12 weeks Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Missed Fractions 12 weeks Total number of missed fractions, determined by electronic medical record
Cancer Treatment Adherence 12 weeks Percentage of patient adherence to their cancer treatment, determined by electronic medical record
Cancer Treatment Symptom Management Medications 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 12 weeks Total number of cancer treatment related side effects
Cost of Total Unplanned Expenditures 12 weeks Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Patient Rated Pain Score 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 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 12 weeks Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Cancer TreatmentTtolerance 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 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
- Secondary Outcome Measures
Name Time Method Adherence Rate 12 weeks Exercise session adherence rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records. Exercise session adherence rate was measured by dividing the total number of sessions scheduled by the total number of exercise sessions actually attended by the exercise group.
Percentage of Participants Who Completed the Study (Attrition Rate) 12 weeks Exercise program attrition rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records. Attrition was determined by calculating the percent of participants who completed the study by the total number of participants who started the study.
Trial Locations
- Locations (1)
Maple Tree Cancer Alliance
🇺🇸Dayton, Ohio, United States