Adults 30 to 80, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Cost of Emergency Room VisitsPrimary· 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.
Group
Value
95% CI
Exercise Group
661
± 210
Control Group
989
± 241
EncountersPrimary· 12 weeks
Number of inpatient and outpatient hospital encounters, determined by electronic medical record
Group
Value
95% CI
Exercise Group
7
± 7
Control Group
12
± 6
Patient Rated Pain ScorePrimary· 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.
At baseline
Group
Value
95% CI
Exercise Group
50.4
± 3.1
Control Group
50.5
± 3.16
At Follow-up (after 12 weeks of exercise training)
Group
Value
95% CI
Exercise Group
62.3
± 3.3
Control Group
49.7
± 3.2
Cancer TreatmentTtolerancePrimary· 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.
Stage I Score 0-1 Baseline
Group
Value
95% CI
Exercise Group
57
Control Group
51
Stage I Score 2 Baseline
Group
Value
95% CI
Exercise Group
15
Control Group
14
Stage I Score 0-1 Follow-up
Group
Value
95% CI
Exercise Group
46
Control Group
45
Stage I Score 2 Follow-up
Group
Value
95% CI
Exercise Group
17
Control Group
21
Stage II Score 0-1 Baseline
Group
Value
95% CI
Exercise Group
39
Control Group
36
Stage II Score 2 Baseline
Group
Value
95% CI
Exercise Group
18
Control Group
21
Stage II Score 0-1 Follow-up
Group
Value
95% CI
Exercise Group
36
Control Group
21
Stage II Score 2 Follow-up
Group
Value
95% CI
Exercise Group
24
Control Group
33
Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B QuestionnairePrimary· 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.
FA
Physical Well-Being at Baseline
Group
Value
95% CI
Exercise Group
19.1
± 1.7
Control Group
19.2
± 1.8
Physical Well-Being Post-Intervention
Group
Value
95% CI
Exercise Group
23.1
± 1.6
Control Group
19.2
± 1.9
Social Well-Being at Baseline
Group
Value
95% CI
Exercise Group
19.6
± 1.6
Control Group
19.5
± 1.7
Social Well-Being Post-Intervention
Group
Value
95% CI
Exercise Group
23.1
± 1.6
Control Group
19.3
± 1.6
Emotional Well-Being at Baseline
Group
Value
95% CI
Exercise Group
18.7
± 1.5
Control Group
18.7
± 1.4
Emotional Well-Being Post-Intervention
Group
Value
95% CI
Exercise Group
20.2
± 1.7
Control Group
18.6
± 1.2
Functional Well-Being at Baseline
Group
Value
95% CI
Exercise Group
19.8
± 1.5
Control Group
19.9
± 1.6
Functional Well-Being Post-Intervention
Group
Value
95% CI
Exercise Group
23.2
± 1.5
Control Group
19.8
± 1.7
Adherence RateSecondary· 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.
Group
Value
95% CI
Exercise Group
95
Percentage of Participants Who Completed the Study (Attrition Rate)Secondary· 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.
Group
Value
95% CI
Exercise Group
95.3
Control Group
98.3
Sponsor's own description
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Karen Wonders
Last refreshed: 7 June 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04106609.