Back to resultsIndividualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Primary Purpose
Breast Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Supervised, individualized exercise oncology program
Current standard of care
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer
Eligibility 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
Sites / Locations
- Maple Tree Cancer AllianceRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Exercise Group
Control Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Missed Fractions
Total number of missed fractions, determined by electronic medical record
Numbers of Breaks in Cancer Treatment
Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
Emergency room visits
Number of emergency room visits, determined by electronic medical record
Encounters
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Hospital readmission
Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Hospital length of stay
Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Cancer treatment adherence
Percentage of patient adherence to their cancer treatment, determined by electronic medical record
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.
Cancer treatment related side effects
Total number of cancer treatment related side effects
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.
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
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.
Secondary Outcome Measures
Adherence rate
Exercise session adherence rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records.
Attrition rate
Exercise program attrition rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04106609
Brief Title
Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Official Title
Randomized, Controlled Trial of an Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 23, 2019 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Wonders
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Supervised, individualized exercise oncology program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Current standard of care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Missed Fractions
Description
Total number of missed fractions, determined by electronic medical record
Time Frame
12 weeks
Title
Numbers of Breaks in Cancer Treatment
Description
Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
Time Frame
12 weeks
Title
Emergency room visits
Description
Number of emergency room visits, determined by electronic medical record
Time Frame
12 weeks
Title
Encounters
Description
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Time Frame
12 weeks
Title
Hospital readmission
Description
Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Time Frame
12 weeks
Title
Hospital length of stay
Description
Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Time Frame
12 weeks
Title
Cancer treatment adherence
Description
Percentage of patient adherence to their cancer treatment, determined by electronic medical record
Time Frame
12 weeks
Title
Cancer treatment symptom management medications
Description
Number of the different types of medications taken by patients for symptom management during their cancer treatment. Determined by electronic medical record.
Time Frame
12 weeks
Title
Cancer treatment related side effects
Description
Total number of cancer treatment related side effects
Time Frame
12 weeks
Title
Patient rated pain score
Description
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.
Time Frame
12 weeks
Title
Cancer treatment tolerance: Eastern Cooperative Oncology Group (ECOG) performance status score
Description
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
Time Frame
12 weeks
Title
Quality of life measure: McGill Quality of Life survey
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adherence rate
Description
Exercise session adherence rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records.
Time Frame
12 weeks
Title
Attrition rate
Description
Exercise program attrition rate among the Exercise Group, collected from the Maple Tree Cancer Alliance participant records
Time Frame
12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen Wonders, PhD, FACSM
Phone
937-688-3940
Email
karen.wonders@mapletreecanceralliance.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Wonders, PhD, FACSM
Organizational Affiliation
Maple Tree Cancer Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maple Tree Cancer Alliance
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen Wonders, PhD, FACSM
Phone
937-688-3940
Email
karen.wonders@mapletreecanceralliance.org
12. IPD Sharing Statement
Learn more about this trial
Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
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