Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Study Details
Study Description
Brief Summary
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
Other: Supervised, individualized exercise oncology program
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.
|
| Active Comparator: 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. |
Other: Current standard of care
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.
|
Outcome Measures
Primary Outcome Measures
- Missed Fractions [12 weeks]
Total number of missed fractions, determined by electronic medical record
- Numbers of Breaks in Cancer Treatment [12 weeks]
Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
- Emergency room visits [12 weeks]
Number of emergency room visits, determined by electronic medical record
- Encounters [12 weeks]
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
- Hospital readmission [12 weeks]
Number of hospital readmissions for the same presenting issue, determined by electronic medical record
- Hospital length of stay [12 weeks]
Hospital length of stay, in days, if applicable. 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
- Patient rated pain score [12 weeks]
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.
- Cancer treatment tolerance: Eastern Cooperative Oncology Group (ECOG) performance status score [12 weeks]
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: McGill Quality of Life survey [12 weeks]
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.
Secondary Outcome Measures
- Adherence rate [12 weeks]
Exercise session adherence rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records.
- Attrition rate [12 weeks]
Exercise program attrition rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Maple Tree Cancer Alliance | Dayton | Ohio | United States | 45404 |
Sponsors and Collaborators
- Karen Wonders
Investigators
- Principal Investigator: Karen Wonders, PhD, FACSM, Maple Tree Cancer Alliance
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Maple Tree Exercise