Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

Study Overview
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Brief Summary
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To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.

Official Title
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Randomized, Controlled Trial of an Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Supervised, individualized exercise oncology program
* Other: Current standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise Group<br>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. | Other: Supervised, individualized exercise oncology program<br>* The study intervention is a supervised, individualized exercise oncology program described in previous literature2,3,12 and provided by Maple Tree Cancer Alliance, a non-profit organization providing exercise training to individuals with cancer (https://www.mapletreecanceralliance.org/). This organization was founded in 2011 and currently operates in 9 hospitals serving Ohio and Pennsylvania, offering free exercise programs and nutritional guidance to approximately 500 patients annually to help relieve side effects related to cancer treatment.<br>|
| Active Comparator: Control Group<br>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. | Other: Current standard of care<br>* Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Missed Fractions | Total number of missed fractions, determined by electronic medical record | 12 weeks | 
| Numbers of Breaks in Cancer Treatment | Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record | 12 weeks | 
| Emergency room visits | Number of emergency room visits, determined by electronic medical record | 12 weeks | 
| Encounters | Number of inpatient and outpatient hospital encounters, determined by electronic medical record | 12 weeks | 
| Hospital readmission | Number of hospital readmissions for the same presenting issue, determined by electronic medical record | 12 weeks | 
| Hospital length of stay | Hospital length of stay, in days, if applicable. Determined by electronic medical record. | 12 weeks | 
| Cancer treatment adherence | Percentage of patient adherence to their cancer treatment, determined by electronic medical record | 12 weeks | 
| Cancer treatment symptom management medications | Number of the different types of medications taken by patients for symptom management during their cancer treatment. Determined by electronic medical record. | 12 weeks | 
| Cancer treatment related side effects | Total number of cancer treatment related side effects | 12 weeks | 
| Patient rated pain score | patient rated pain measured by visual analog scale, determined by electronic. medical record. Scale is measured 0 to 10, with 0 being no pain and 10 being worst pain. | 12 weeks | 
| Cancer treatment tolerance: Eastern Cooperative Oncology Group (ECOG) performance status score | 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 | 12 weeks | 
| Quality of life measure: McGill Quality of Life survey | MQOL was designed to measure quality of life of people at all stages of a life-threatening illness, from diagnosis to cure or death. MQOL assesses general domains applicable to all patients, incorporates the existential domain, balances physical and non-physical aspects of quality of life, and includes both positive and negative influences on quality of life. MQOL is a patient-reported instrument that employs 16 items plus a single-item global scale, each with a 2-day time frame. Five domains (physical well-being, physical symptoms, psychological, existential, and support) were identified through principal component analysis, and each of the domains is scored as a separate sub-scale. An overall index score can be calculated from the means of the five sub-scales. The single-item global quality of life scale is included as a validity variable but also can be used in conjunction with the overall MQOL and sub-scale scores.Each question uses a 0-10 scale with anchors at each end. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate | Exercise session adherence rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records. | 12 weeks | 
| Attrition rate | Exercise program attrition rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records | 12 weeks |