Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients

NCT04106609 | Completed Results

• 1 other identifier: Maple Tree Exercise
• Study Type: interventional
• Target: 251
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (12)

• 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

• 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

• Encounters

  Number of inpatient and outpatient hospital encounters, 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 Outcomes (2)

• Adherence Rate

  12 weeks

• Percentage of Participants Who Completed the Study (Attrition Rate)

  12 weeks

Study Arms (2)

Exercise Group

EXPERIMENTAL

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

Control Group

ACTIVE COMPARATOR

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

Interventions

Supervised, individualized exercise oncology program OTHER

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.

Exercise Group

Current standard of care OTHER

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.

Control Group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karen Wonders: lead

Study Sites (1)

Maple Tree Cancer Alliance

Dayton, Ohio, 45404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Limitations and Caveats

None to the study itself. Public funding and lack of resources have been identified as a significant barrier to national exercise oncology programs. Other known barriers include lack of general knowledge about the need to stay physically active during and after cancer therapy, qualified personnel, and available programs.

Results Point of Contact

• Title: Dr. Karen Wonders
• Organization: Maple Tree Cancer Alliance

karen.wonders@mapletreecanceralliance.org

937-477-8213

Study Officials

• Karen Wonders, PhD, FACSM

  Maple Tree Cancer Alliance

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Executive Director, Maple Tree Cancer Alliance

Study Record Dates

• First Submitted: September 25, 2019
• First Posted: September 27, 2019
• Study Start: August 23, 2019
• Primary Completion: October 28, 2021
• Study Completion: October 28, 2021
• Last Updated: June 7, 2024
• Results First Posted: June 7, 2024

Record last verified: 2024-06

Locations

US (1)