N/A
N=251
Individualized Exercise Oncology Program for Newly Diagnosed Breast Cancer Patients
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04106609 ↗Enrolled (actual)
251
Serious AEs
0.0%
Results posted
Jun 2024
Primary outcome: Primary: Missed Fractions
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Supervised, individualized exercise oncology program (Other); Current standard of care (Other)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Female
- Sponsor
- Karen Wonders
- Primary completion
- Oct 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Missed Fractions |
— | — |
| PRIMARY Numbers of Breaks in Cancer Treatment |
— | — |
| PRIMARY Cost of Emergency Room Visits |
661; 989 | — |
| PRIMARY Encounters |
7; 12 | — |
| PRIMARY Cost of Total Unplanned Expenditures |
— | — |
| PRIMARY Cost of Hospital Inpatient Care |
— | — |
| PRIMARY Cancer Treatment Adherence |
— | — |
| PRIMARY Cancer Treatment Symptom Management Medications |
— | — |
| PRIMARY Cancer Treatment Related Side Effects |
— | — |
| PRIMARY Patient Rated Pain Score |
50.4; 50.5; 62.3; 49.7 | — |
| PRIMARY Cancer TreatmentTtolerance |
57; 51; 15; 14; 46; 45 | — |
| PRIMARY Quality of Life Measure: Utilizing McGill Quality of Life Survey and FACT-B Questionnaire |
19.1; 19.2; 23.1; 19.2; 19.6; 19.5 | — |
| SECONDARY Adherence Rate |
95 | — |
| SECONDARY Percentage of Participants Who Completed the Study (Attrition Rate) |
95.3; 98.3 | — |
Summary
To test the effect of an individualized exercise oncology program on healthcare utilization, 30-day hospital readmission, pain, and cancer treatment tolerance.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04106609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.