Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04106609
• Other study ID #: Maple Tree Exercise
• Status: Completed
• Phase: N/A
• Start date: August 23, 2019
• Est. completion date: October 28, 2021

Study information

• Verified date: June 2024
• Source: Kettering Health Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: October 28, 2021
• Est. primary completion date: October 28, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Maple Tree Cancer Alliance	Dayton	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Karen Wonders

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Missed Fractions	Total number of missed fractions, determined by electronic medical record	12 weeks
Primary	Numbers of Breaks in Cancer Treatment	Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record	12 weeks
Primary	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
Primary	Encounters	Number of inpatient and outpatient hospital encounters, determined by electronic medical record	12 weeks
Primary	Cost of Total Unplanned Expenditures	Number of hospital readmissions for the same presenting issue, determined by electronic medical record	12 weeks
Primary	Cost of Hospital Inpatient Care	Hospital length of stay, in days, if applicable. Determined by electronic medical record.	12 weeks
Primary	Cancer Treatment Adherence	Percentage of patient adherence to their cancer treatment, determined by electronic medical record	12 weeks
Primary	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
Primary	Cancer Treatment Related Side Effects	Total number of cancer treatment related side effects	12 weeks
Primary	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.
Primary	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.
Primary	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	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
Secondary	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