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This clinical trial compares a physical activity program to a health education program for improving memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer. Compared to non-Hispanic White breast cancer survivors (BCS), Hispanic BCS report greater depressive symptoms, emotional distress, anxiety, fear of recurrence, pain, fatigue, and financial toxicity, in addition to more cancer-related psychosocial needs and lower quality of life and social well-being. Cancer-associated cognitive decline (CACD) is a related symptom that has gained increasing attention in clinical research. Based on disparities in other outcomes, it is likely that Hispanic BCS also experience greater CACD than non-Hispanic White BCS, but interventions targeting CACD in Hispanic BCS are non-existent and critically needed. The benefits of aerobic exercise among BCS are well documented and include improvement in health outcomes that are associated with cognitive function including fatigue, anxiety, depression, and sleep. A physical activity program that includes aerobic exercise may be more effective than simple health education for improving cognitive functions like memory and attention in Hispanic women who are 50 years of age or older and are newly-diagnosed with stage I-IIIa breast cancer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (walking program) | Experimental | Patients participate in walking sessions over 60-75 minutes per week in weeks 1-2, 70-90 minutes per week in weeks 3-4, 90-120 minutes per week in weeks 5-8, 120-135 minutes per week in weeks 9-12, 135-150 minutes per week in weeks 13-16, and 150+ minutes per week in weeks 17-24. Patients also undergo fMRI throughout the trial. |
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| Arm B (health education) | Active Comparator | Patients receive health education including monthly classes/webinars for up to 9 sessions and informational materials (PDFs, videos, podcasts, and/or subscription to Mayo Clinic Health Letter). Patients also undergo fMRI throughout the trial. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometry | Procedure | Ancillary studies |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in inhibitory control | Change in interference score on Stroop task, with positive values indicating greater inhibitory control | Baseline to post-intervention (month 6) |
| Change in cognitive flexibility | Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility | Baseline to post-intervention (month 6) |
| Change in executive function processing | Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility | Baseline to post-intervention (month 6) |
| Change in short-term memory | Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory | Baseline to post-intervention (month 6) |
| Change in verbal memory | Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory | Baseline to post-intervention (month 6) |
| Change in working memory | Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory | Baseline to post-intervention (month 6) |
| Change in processing speed | Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed |
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Inclusion Criteria:
PRE-REGISTRATION: Age >= 50 years at time of pre-registration visit according to participant report and/or clinical determination
PRE-REGISTRATION: Self-identifies as Hispanic (any race)
PRE-REGISTRATION: First time, primary diagnosis of Stage I-IIIa breast cancer according to participant report and/or clinical determination
PRE-REGISTRATION: Post-surgery and completed primary adjuvant treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-36 months prior to preregistration according to participant report and/or clinical determination
PRE-REGISTRATION: Sedentary except for casual lifestyle recreation, self-reporting no more than 90 minutes per week of moderate-intensity aerobic exercise within the last 6 months
PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance
REGISTRATION: Age >= 50 years or older as confirmed via clinical determination
REGISTRATION: Self-identifies as Hispanic (any race)
REGISTRATION: Able to provide medical record release to confirm eligibility
REGISTRATION: First time, primary diagnosis of Stage I-IIIa breast cancer as confirmed via clinical determination
REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-36 months prior to pre-registration as confirmed via clinical determination
REGISTRATION: No evidence of possible cognitive impairment as assessed using the Telephone Interview of Cognitive status (13-item modified version) (TICS-M; score >= 21)
REGISTRATION: Receive physician's clearance to participate in an exercise program
NOTE: Individuals with conditions/diagnoses deemed important by the primary investigator will be required to provide clearance for exercise from their cardiologist. Example conditions include:
REGISTRATION: Ability to complete assessments by themselves or with assistance
REGISTRATION: Agree to be randomized
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Diane K. Ehlers, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Aerobic Exercise | Other | Participate in walking program |
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| Electronic Health Record Review | Other | Ancillary studies |
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| Functional Magnetic Resonance Imaging | Procedure | Undergo fMRI |
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| Gait Assessment Test | Other | Ancillary studies |
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| Health Education | Behavioral | Receive health education |
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| Interview | Other | Ancillary studies |
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| Neurocognitive Assessment | Other | Ancillary studies |
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| Physical Performance Testing | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Baseline to post-intervention (month 6) |
| Change in attention | Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention | Baseline to post-intervention (month 6) |
| Change in brain volume | Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan | Baseline to post-intervention (month 6) |
| Change in white matter integrity | Change in fractional anisotropy as measured by diffusion MRI. | Baseline to post-intervention (month 6) |
| Change in resting state functional connectivity | Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence | Baseline to post-intervention (month 6) |
| Change in self-reported cognitive function - FACT-Cog | The perceived cognitive impairments subscale of the Functional Assessment in Cancer Therapy - Cognition (FACT-Cog) will be used to measure self-reported cognition. Scores range from 0-72, with higher scores indicating better cognitive function. | Baseline to post-intervention (month 6) |
| ID | Term |
|---|---|
| D061725 | Accelerometry |
| D015444 | Exercise |
| D007407 | Interviews as Topic |
| D000073216 | Mental Status and Dementia Tests |
| D005080 | Exercise Test |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
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