Breast Cancer
Conditions
Brief summary
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.
Interventions
OTHERSupervised, 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.
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.
Sponsors
Karen Wonders
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| Missed Fractions | 12 weeks | Total number of missed fractions, determined by electronic medical record |
| Numbers of Breaks in Cancer Treatment | 12 weeks | Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record |
| 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. |
| Encounters | 12 weeks | Number of inpatient and outpatient hospital encounters, determined by electronic medical record |
| Cost of Total Unplanned Expenditures | 12 weeks | Number of hospital readmissions for the same presenting issue, 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exercise Group 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. | 129 |
| 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.
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. | 122 |
| Total | 251 |
Baseline characteristics
| Characteristic | Control Group | Total | Exercise Group |
|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 0.15 | 56.45 years STANDARD_DEVIATION 0.18 | 55.9 years STANDARD_DEVIATION 0.19 |
| BMI | 30.24 kg/m2 STANDARD_DEVIATION 0.56 | 29.48 kg/m2 STANDARD_DEVIATION 0.62 | 28.74 kg/m2 STANDARD_DEVIATION 0.68 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 11 Participants | 25 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 108 Participants | 216 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 10 Participants | 7 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 9 Participants | 20 Participants | 11 Participants |
| Race (NIH/OMB) Black or African American | 21 Participants | 38 Participants | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 35 Participants | 21 Participants |
| Race (NIH/OMB) White | 78 Participants | 158 Participants | 80 Participants |
| Sex: Female, Male Female | 122 Participants | 251 Participants | 129 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stage I Breast Cancer | 51 participants | 104 participants | 53 participants |
| Stage II Breast Cancer | 71 participants | 147 participants | 76 participants |
| Time Since Diagnosis | 2.1 months STANDARD_DEVIATION 0.82 | 1.65 months STANDARD_DEVIATION 0.85 | 1.2 months STANDARD_DEVIATION 0.88 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 129 | 0 / 122 |
| other Total, other adverse events | 0 / 129 | 0 / 122 |
| serious Total, serious adverse events | 0 / 129 | 0 / 122 |
Outcome results
Primary
Cancer Treatment Adherence
Percentage of patient adherence to their cancer treatment, determined by electronic medical record
Time frame: 12 weeks
Population: This data was not collected from the medical record - 0 participants were analyzed because study personnel could not determine this from the medical record.
Primary
Cancer Treatment Related Side Effects
Total number of cancer treatment related side effects
Time frame: 12 weeks
Population: This data was not collected from the medical record - 0 participants were analyzed because study personnel could not determine this from the medical record.
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.
Time frame: 12 weeks
Population: This data was not collected from the medical record - 0 participants were analyzed because study personnel could not determine this from the medical record.
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.
Time frame: 12 weeks - ECOG performance status measurements were recorded at baseline and at the 12-week follow up appointment.
Population: Note that at baseline, there were 129 people in the control group (CG) and 122 people in the exercise group (EX). At follow up, there were 120 people in CG and 123 people in EX.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exercise Group | Cancer TreatmentTtolerance | Stage II Score 2 Follow-up | 24 participants |
| Exercise Group | Cancer TreatmentTtolerance | Stage II Score 2 Baseline | 18 participants |
| Exercise Group | Cancer TreatmentTtolerance | Stage I Score 0-1 Baseline | 57 participants |
| Exercise Group | Cancer TreatmentTtolerance | Stage I Score 2 Baseline | 15 participants |
| Exercise Group | Cancer TreatmentTtolerance | Stage I Score 0-1 Follow-up | 46 participants |
| Exercise Group | Cancer TreatmentTtolerance | Stage I Score 2 Follow-up | 17 participants |
| Exercise Group | Cancer TreatmentTtolerance | Stage II Score 0-1 Baseline | 39 participants |
| Exercise Group | Cancer TreatmentTtolerance | Stage II Score 0-1 Follow-up | 36 participants |
| Control Group | Cancer TreatmentTtolerance | Stage II Score 2 Follow-up | 33 participants |
| Control Group | Cancer TreatmentTtolerance | Stage I Score 2 Follow-up | 21 participants |
| Control Group | Cancer TreatmentTtolerance | Stage II Score 0-1 Follow-up | 21 participants |
| Control Group | Cancer TreatmentTtolerance | Stage I Score 0-1 Baseline | 51 participants |
| Control Group | Cancer TreatmentTtolerance | Stage II Score 0-1 Baseline | 36 participants |
| Control Group | Cancer TreatmentTtolerance | Stage I Score 2 Baseline | 14 participants |
| Control Group | Cancer TreatmentTtolerance | Stage II Score 2 Baseline | 21 participants |
| Control Group | Cancer TreatmentTtolerance | Stage I Score 0-1 Follow-up | 45 participants |
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.
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Group | Cost of Emergency Room Visits | 661 Dollars ($) | Standard Error 210 |
| Control Group | Cost of Emergency Room Visits | 989 Dollars ($) | Standard Error 241 |
Primary
Cost of Hospital Inpatient Care
Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Time frame: 12 weeks
Population: 0 participants were analyzed because study personnel could not determine this from the EMR
Primary
Cost of Total Unplanned Expenditures
Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Time frame: 12 weeks
Population: 0 participants were analyzed because study personnel could not determine this from the electronic medical record.
Primary
Encounters
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Exercise Group | Encounters | 7 total number of encounters | Standard Error 7 |
| Control Group | Encounters | 12 total number of encounters | Standard Error 6 |
Primary
Missed Fractions
Total number of missed fractions, determined by electronic medical record
Time frame: 12 weeks
Population: This data was not collected from the medical record. Study personnel could not determine this from the medical record.
Primary
Numbers of Breaks in Cancer Treatment
Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
Time frame: 12 weeks
Population: This data was not collected from the medical record. Study personnel could not determine from the medical record.
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.
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise Group | Patient Rated Pain Score | At baseline | 50.4 score on a scale | Standard Deviation 3.1 |
| Exercise Group | Patient Rated Pain Score | At Follow-up (after 12 weeks of exercise training) | 62.3 score on a scale | Standard Deviation 3.3 |
| Control Group | Patient Rated Pain Score | At baseline | 50.5 score on a scale | Standard Deviation 3.16 |
| Control Group | Patient Rated Pain Score | At Follow-up (after 12 weeks of exercise training) | 49.7 score on a scale | Standard Deviation 3.2 |
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
Time frame: Baseline was at the time of enrollment and follow up was after 12-weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Social Well-Being at Baseline | 19.6 score on a scale | Standard Error 1.6 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Emotional Well-Being Post-Intervention | 20.2 score on a scale | Standard Error 1.7 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Physical Well-Being Post-Intervention | 23.1 score on a scale | Standard Error 1.6 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Functional Well-Being at Baseline | 19.8 score on a scale | Standard Error 1.5 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Social Well-Being Post-Intervention | 23.1 score on a scale | Standard Error 1.6 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Functional Well-Being Post-Intervention | 23.2 score on a scale | Standard Error 1.5 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Physical Well-Being at Baseline | 19.1 score on a scale | Standard Error 1.7 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | FACT-Breast at Baseline | 98.2 score on a scale | Standard Error 3.4 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Emotional Well-Being at Baseline | 18.7 score on a scale | Standard Error 1.5 |
| Exercise Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | FACT-Breast Post-Intervention | 114.2 score on a scale | Standard Error 3.7 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Emotional Well-Being at Baseline | 18.7 score on a scale | Standard Error 1.4 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Physical Well-Being at Baseline | 19.2 score on a scale | Standard Error 1.8 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Physical Well-Being Post-Intervention | 19.2 score on a scale | Standard Error 1.9 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Social Well-Being at Baseline | 19.5 score on a scale | Standard Error 1.7 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Social Well-Being Post-Intervention | 19.3 score on a scale | Standard Error 1.6 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | FACT-Breast Post-Intervention | 96.7 score on a scale | Standard Error 3.5 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Emotional Well-Being Post-Intervention | 18.6 score on a scale | Standard Error 1.2 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Functional Well-Being at Baseline | 19.9 score on a scale | Standard Error 1.6 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | Functional Well-Being Post-Intervention | 19.8 score on a scale | Standard Error 1.7 |
| Control Group | Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire | FACT-Breast at Baseline | 98.3 score on a scale | Standard Error 3.5 |
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.
Time frame: 12 weeks
Population: Because the control group did not participate in the exercise program, we did not calculate an adherence rate for this group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exercise Group | Adherence Rate | 95 percentage of session |
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.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exercise Group | Percentage of Participants Who Completed the Study (Attrition Rate) | 95.3 percentage of participants |
| Control Group | Percentage of Participants Who Completed the Study (Attrition Rate) | 98.3 percentage of participants |