Invasive Breast Carcinoma Clinical Trial
Official title:
Exercise to Improve Health and Quality-of-Life in Breast Cancer Survivors: A Feasibility Pilot Trial
Verified date | August 2023 |
Source | Roswell Park Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This randomized pilot trial studies how well exercise works in improving health and quality of life in breast cancer survivors. Participating in an exercise program to maintain physical activity may help to improve health and quality of life in breast cancer survivors.
Status | Completed |
Enrollment | 83 |
Est. completion date | June 2, 2022 |
Est. primary completion date | June 2, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure - Have a previous history of invasive breast cancer who have completed treatment except for hormonal therapy and zoledronic acid (Zometa) - Do not meet the United States (U.S.) Center for Disease Control and Prevention's physical activity guidelines (150 minutes or 2 hours and 30 minutes a week of moderate-intensity exercise) - Meets criteria for participation in low to moderate risk exercise based on the American College of Sports Medicine guideline (ACSM) Exclusion Criteria: - Have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements - Are pregnant or nursing - Are unwilling or unable to follow protocol requirements - Have any condition which in the investigator's opinion deems the subject an unsuitable candidate to participate in this study - Have metastatic breast cancer - Have orthopedic or neuromuscular disorders or arthritis that preclude participation in exercise |
Country | Name | City | State |
---|---|---|---|
United States | Roswell Park Cancer Institute | Buffalo | New York |
Lead Sponsor | Collaborator |
---|---|
Roswell Park Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Cardiovascular fitness | Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. | At baseline and 12 weeks | |
Other | Body composition | Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. | At baseline and 12 weeks | |
Other | Quality of life | Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. Will be assessed by the Functional Assessment of Cancer Therapy, Breast (FACTB+4). | At baseline and 12 weeks | |
Other | Cognitive function | Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. | At baseline and 12 weeks | |
Other | Stress and immune function biomarkers | Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. | At baseline and 12 weeks | |
Other | Mitochondrial function | Will determine how it's affected by a 12 week exercise intervention and how it differs by type of intervention program. | At baseline and 12 weeks | |
Primary | Proportion of randomized patients who are still on study at the end of the 12 week intervention | The feasibility outcomes will be assessed by a multivariable logistic regression model for the relative odds of remaining on the study (ref: not). Each of the active treatment arms will be compared to the control. The model will be supported by the randomized patient set, counting patients who withdraw from the study as feasibility failures. No variable selection steps will be taken; inferences will be based on the estimates and 95% confidence intervals from the full model. Optimism adjusted odds ratio estimates will also be reported, to better inform design of future studies. | At 12 weeks | |
Secondary | Adherence rate in each of the active intervention arms | Will be defined as the proportion of patients on study after 12 weeks who complete = 80% of the intervention activities. One-sided 90% Jeffrey's confidence limits will define a plausible lower limit on the range of values for true (unobserved) feasibility rate for each arm. | Up to 12 weeks |
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