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Completed

NCT Number: NCT04106609

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.

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Key information

Conditions

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

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Maple Tree Cancer Alliance

Dayton, Ohio, 45404, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Missed Fractions

    Time frame: 12 weeks

    Total number of missed fractions, determined by electronic medical record

  2. Numbers of Breaks in Cancer Treatment

    Time frame: 12 weeks

    Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record

  3. Cost of Emergency Room Visits

    Time frame: 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.

  4. Encounters

    Time frame: 12 weeks

    Number of inpatient and outpatient hospital encounters, determined by electronic medical record

  5. Cost of Total Unplanned Expenditures

    Time frame: 12 weeks

    Number of hospital readmissions for the same presenting issue, determined by electronic medical record

  6. Cost of Hospital Inpatient Care

    Time frame: 12 weeks

    Hospital length of stay, in days, if applicable. Determined by electronic medical record.

  7. Cancer Treatment Adherence

    Time frame: 12 weeks

    Percentage of patient adherence to their cancer treatment, determined by electronic medical record

  8. Cancer Treatment Symptom Management Medications

    Time frame: 12 weeks

    Number of the different types of medications taken by patients for symptom management during their cancer treatment. Determined by electronic medical record.

  9. Cancer Treatment Related Side Effects

    Time frame: 12 weeks

    Total number of cancer treatment related side effects

  10. Patient Rated Pain Score

    Time frame: 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.

  11. Cancer TreatmentTtolerance

    Time frame: 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.

  12. Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire

    Time frame: 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 outcomes

  1. Adherence Rate

    Time frame: 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.

  2. Percentage of Participants Who Completed the Study (Attrition Rate)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Karen Wonders

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Sep 27, 2019
Registry last updated
Jun 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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