Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

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

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

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Supervised, individualized exercise oncology program; Other: Current standard of care

• Study Type: Interventional
• Enrollment (Actual): 251
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45404
      • Maple Tree Cancer Alliance

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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
Encounters	Number of inpatient and outpatient hospital encounters, determined by electronic medical record	12 weeks
Cost of Emergency Room Visits	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.	12 weeks
Cost of Total Unplanned Expenditures	Number of hospital readmissions for the same presenting issue, determined by electronic medical record	12 weeks
Cost of Hospital Inpatient Care	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	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.	12 weeks, measured at the start of their exercise program during their initial assessment and at the 12-week follow-up re-assessment.
Cancer TreatmentTtolerance	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 - ECOG performance status measurements were recorded at baseline and at the 12-week follow up appointment.
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire	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	Baseline was at the time of enrollment and follow up was after 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. 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.	12 weeks
Percentage of Participants Who Completed the Study (Attrition Rate)	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.	12 weeks

Collaborators and Investigators

• Sponsor: Karen Wonders
• Investigators: Principal Investigator: Karen Wonders, PhD, FACSM, Maple Tree Cancer Alliance

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Actual): October 28, 2021
• Study Completion (Actual): October 28, 2021

Study Registration Dates

• First Submitted: September 25, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (Actual): September 27, 2019

Study Record Updates

• Last Update Posted (Actual): June 7, 2024
• Last Update Submitted That Met QC Criteria: June 5, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Maple Tree Exercise

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No