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

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Karen Wonders, PhD, FACSM; Phone Number: 937-688-3940; Email: karen.wonders@mapletreecanceralliance.org

Study Locations

• United States
  • Ohio
    • Dayton, Ohio, United States, 45404
      • Recruiting
      • Maple Tree Cancer Alliance
      • Contact: Karen Wonders, PhD, FACSM; Phone Number: 937-688-3940; Email: karen.wonders@mapletreecanceralliance.org

Participation Criteria

Eligibility Criteria

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

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
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

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 (Anticipated): December 1, 2021
• Study Completion (Anticipated): December 1, 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): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 8, 2020
• Last Verified: December 1, 2020

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