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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Wonders, PhD, FACSM | Maple Tree Cancer Alliance | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maple Tree Cancer Alliance | Dayton | Ohio | 45404 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exercise Group | Supervised, individualized exercise oncology program: Patients in the supervised exercise intervention group completed 12 weeks of prescribed, individualized exercise that aligned with ACSM exercise guidelines for cancer survivors. Total dose of exercise was one time weekly, with cardiovascular, resistance training, and flexibility components. Cardiovascular exercise was performed on a treadmill. The intensity level for the aerobic exercise began with 30 min at 30% of the individual's predicted VO2max, assessed by heart monitors. Each week, intensity was progressed until the participant reached 45%. Strength training involved a full body workout, with emphasis on all major muscle groups and employed machines, free weights, and tubing. Patients completed 3 sets of 10 repetitions for each exercise. Each exercise program was individualized for each patient, but included the following resistance exercises: chest press, seated row, overhead press, leg extension, leg curl, leg press. Resistance intensity was set at a minimum of 30% of the individual's 1RM, or when the patient felt sufficiently fatigued after 10 repetitions completed with proper form. As the patient's RPE values decreased with each exercise, intensity was progressively increased, accordingly. Flexibility training involved static stretching of all major muscle groups for 15-20 seconds at the completion of each workout. Each session lasted approximately 60 minutes. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Missed Fractions | Total number of missed fractions, determined by electronic medical record | This data was not collected from the medical record. Study personnel could not determine this from the medical record. | Posted | 12 weeks |
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Adverse events were collected over the 12 weeks of the subjects' participation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Karen Wonders | Maple Tree Cancer Alliance | 937-477-8213 | karen.wonders@mapletreecanceralliance.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 17, 2020 | Apr 5, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| 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. |
|
| 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. |
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m2 |
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| Time Since Diagnosis | Mean | Standard Deviation | months |
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| Stage I Breast Cancer | Number | participants |
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| Stage II Breast Cancer | Number | participants |
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| OG001 | 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. |
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| Primary | Numbers of Breaks in Cancer Treatment | Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record | This data was not collected from the medical record. Study personnel could not determine from the medical record. | Posted | 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. | Posted | Mean | Standard Error | Dollars ($) | 12 weeks |
|
|
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| Primary | Encounters | Number of inpatient and outpatient hospital encounters, determined by electronic medical record | Posted | Mean | Standard Error | total number of encounters | 12 weeks |
|
|
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| Primary | Cost of Total Unplanned Expenditures | Number of hospital readmissions for the same presenting issue, determined by electronic medical record | "0" participants were analyzed because study personnel could not determine this from the electronic medical record. | Posted | 12 weeks |
|
|
| Primary | Cost of Hospital Inpatient Care | Hospital length of stay, in days, if applicable. Determined by electronic medical record. | "0" participants were analyzed because study personnel could not determine this from the EMR | Posted | 12 weeks |
|
|
| Primary | Cancer Treatment Adherence | Percentage of patient adherence to their cancer treatment, determined by electronic medical record | This data was not collected from the medical record - "0" participants were analyzed because study personnel could not determine this from the medical record. | Posted | 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. | This data was not collected from the medical record - "0" participants were analyzed because study personnel could not determine this from the medical record. | Posted | 12 weeks |
|
|
| Primary | Cancer Treatment Related Side Effects | Total number of cancer treatment related side effects | This data was not collected from the medical record - "0" participants were analyzed because study personnel could not determine this from the medical record. | Posted | 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. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks, measured at the start of their exercise program during their initial assessment and at the 12-week follow-up re-assessment. |
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| 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. | 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. | Posted | Number | participants | 12 weeks - ECOG performance status measurements were recorded at baseline and at the 12-week follow up appointment. |
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| 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 | Posted | Mean | Standard Error | score on a scale | Baseline was at the time of enrollment and follow up was after 12-weeks. |
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| 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. | Because the control group did not participate in the exercise program, we did not calculate an adherence rate for this group. | Posted | Number | percentage of session | 12 weeks | exercise sessions | exercise sessions |
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| 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. | Posted | Number | percentage of participants | 12 weeks |
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|
| 0 |
| 129 |
| 0 |
| 129 |
| 0 |
| 129 |
| EG001 | 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. | 0 | 122 | 0 | 122 | 0 | 122 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Stage I Score 2 Baseline |
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| Stage I Score 0-1 Follow-up |
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| Stage I Score 2 Follow-up |
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| Stage II Score 0-1 Baseline |
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| Stage II Score 2 Baseline |
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| Stage II Score 0-1 Follow-up |
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| Stage II Score 2 Follow-up |
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| Social Well-Being at Baseline |
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| Social Well-Being Post-Intervention |
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| Emotional Well-Being at Baseline |
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| Emotional Well-Being Post-Intervention |
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| Functional Well-Being at Baseline |
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| Functional Well-Being Post-Intervention |
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| FACT-Breast at Baseline |
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| FACT-Breast Post-Intervention |
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