Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04106609
• Lead Sponsor: Karen Wonders

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-08-23
• Study First Submitted: 2019-09-25
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Primary Completion: 2021-10-28
• Study Completion: 2021-10-28
• Results First Submitted: 2022-04-05
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-05
• Last Update Submitted: 2024-06-05
• Results First Posted: 2024-06-07
• Last Update Posted: 2024-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 251

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Numbers of Breaks in Cancer Treatment	12 weeks	Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
Encounters	12 weeks	Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Missed Fractions	12 weeks	Total number of missed fractions, 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
Cost of Total Unplanned Expenditures	12 weeks	Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Patient Rated Pain Score	12 weeks, measured at the start of their exercise program during their initial assessment and at the 12-week follow-up re-assessment.	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.
Cost of Emergency Room Visits	12 weeks	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.
Cost of Hospital Inpatient Care	12 weeks	Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Cancer TreatmentTtolerance	12 weeks - ECOG performance status measurements were recorded at baseline and at the 12-week follow up appointment.	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: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire	Baseline was at the time of enrollment and follow up was after 12-weeks.	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

Secondary Outcome Measures

Name	Time	Method
Adherence Rate	12 weeks	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.
Percentage of Participants Who Completed the Study (Attrition Rate)	12 weeks	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.

Trial Locations

Locations (1)

Maple Tree Cancer Alliance; 🇺🇸 Dayton, Ohio, United States