Breast CancerNCT04106609
Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
A study testing Supervised, individualized exercise oncology program in people with Breast Cancer, run by Karen Wonders at 1 site in United States.
Trial summary
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance. Read more about this study
- Who is it for?
- Ages 30 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Supervised, individualized exercise oncology program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 251 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2019to 28 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled Trial of an 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.
- Conditions
- Breast Cancer
- Being tested
- Supervised, individualized exercise oncology program, Current standard of care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised, individualized exercise oncology programOther
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 careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Current standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Missed Fractions
Total number of missed fractions, determined by electronic medical record
Measured: 12 weeks
Numbers of Breaks in Cancer Treatment
Defined as missing 3 or more fractions due to patient condition, determined by electronic medical record
Measured: 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.
Measured: 12 weeks
Encounters
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Measured: 12 weeks
Cost of Total Unplanned Expenditures
Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Measured: 12 weeks
Cost of Hospital Inpatient Care
Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Measured: 12 weeks
Cancer Treatment Adherence
Percentage of patient adherence to their cancer treatment, determined by electronic medical record
Measured: 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.
Measured: 12 weeks
Cancer Treatment Related Side Effects
Total number of cancer treatment related side effects
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline was at the time of enrollment and follow up was after 12-weeks.
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start23 Aug 2019
- Primary completion28 Oct 2021
- Study completion28 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Wonders
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karen Wonders, Kettering Health Network
- Investigators
- Karen Wonders, PhD, FACSM, Principal investigator, Maple Tree Cancer Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04106609
- Sponsor's protocol ID
- Maple Tree Exercise
- Status last verified
- Jun 2024
- First submitted
- 25 Sep 2019
- Last updated
- 7 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled Trial of an Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04106609
- Acronym / sponsor ID
- Maple Tree Exercise
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Karen WondersUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 28 Oct 2021 (actual)
- Study completion
- 28 Oct 2021 (actual)
- First posted
- 27 Sep 2019 (actual)
- Results
- Posted 7 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group | Experimental | Other: Supervised, individualized exercise oncology programPatients 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 | Other: Current standard of careThe 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. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Supervised, individualized exercise oncology programThe 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. | Other | Exercise Group |
| Current standard of careResource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness. | Other | Control Group |
Primary outcome
Missed Fractions
Time frame: 12 weeks
Total number of missed fractions, determined by electronic medical record
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
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.
Encounters
Time frame: 12 weeks
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Cost of Total Unplanned Expenditures
Time frame: 12 weeks
Number of hospital readmissions for the same presenting issue, determined by electronic medical record
Cost of Hospital Inpatient Care
Time frame: 12 weeks
Hospital length of stay, in days, if applicable. Determined by electronic medical record.
Cancer Treatment Adherence
Time frame: 12 weeks
Percentage of patient adherence to their cancer treatment, determined by electronic medical record
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.
Cancer Treatment Related Side Effects
Time frame: 12 weeks
Total number of cancer treatment related side effects
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.
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.
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
2 secondary outcomes
Adherence Rate
Time frame: 12 weeks
Percentage of Participants Who Completed the Study (Attrition Rate)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Wonders, PhD, FACSM principal investigator
Maple Tree Cancer Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised, individualized exercise oncology program in people with Breast Cancer, run by Karen Wonders at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Missed Fractions (time frame: 12 weeks). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2024.