Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Cancer-related Cognitive Dysfunction
Conditions
Brief summary
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.
Interventions
PROCEDUREAccelerometry
Ancillary studies
OTHERAerobic Exercise
Participate in walking program
OTHERElectronic Health Record Review
Ancillary studies
PROCEDUREFunctional Magnetic Resonance Imaging
Undergo fMRI
OTHERGait Assessment Test
Ancillary studies
BEHAVIORALHealth Education
Receive health education
OTHERInterview
Ancillary studies
Ancillary studies
OTHERPhysical Performance Testing
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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: * History of major multiple myocardial infarctions (MI) * Recent electrocardiogram (ECG) changes or recent MI * Resting or unstable angina * Significant multivessel coronary occlusion (\>= 70%) on angiography * Uncontrolled and/or serious arrhythmias * 3rd degree heart block * Acute congestive heart failure or ejection fraction \< 30% * REGISTRATION: Ability to complete assessments by themselves or with assistance * REGISTRATION: Agree to be randomized
Exclusion criteria
* PRE-REGISTRATION: Stage 0 breast cancer diagnosis OR metastatic disease * PRE-REGISTRATION: Currently receiving or \< 3 months since receiving chemotherapy or radiation therapy for cancer, or greater than 36 months post primary treatment * PRE-REGISTRATION: Planned surgery during the intervention period * PRE-REGISTRATION: Secondary cancer diagnosis (excluding non-invasive skin cancers, carcinoma-in-situ for any cancer) * PRE-REGISTRATION: Unable to regularly attend the study locations for intervention sessions and data collection * PRE-REGISTRATION: Unwilling to return to enrolling institution for follow-up * PRE-REGISTRATION: Self-reported inability to walk without assistance or devices * PRE-REGISTRATION: Self-reported pregnancy * REGISTRATION: History of stroke, transient ischemic attack, other neurological disorders, or brain surgery involving tissue removal as confirmed via clinical determination * REGISTRATION: Clinically significant TICS-M score (\< 21) during baseline procedures * REGISTRATION: Not able to provide physician re-clearance for exercise if required based upon clinically significant baseline exercise test (as determined by ECG and blood pressure monitoring) * REGISTRATION: Contraindications to functional magnetic resonance imaging (fMRI) in accordance with the Mayo Clinic Department of Radiology safety protocols * REGISTRATION: Clinically significant magnetic resonance imaging (MRI) scan as determined by physician review in which the following is advised via radiologist overread: remarkable/abnormal limited diagnostic brain image with recommended medical follow-up * REGISTRATION: Enrolled in another physical activity program * REGISTRATION: Unable to walk without assistance or devices * REGISTRATION: Unwilling to complete study requirements * REGISTRATION: Unwilling to be randomized to the exercise group or health education group * REGISTRATION: Unable to regularly attend study locations for intervention sessions and data collection * REGISTRATION: Unwilling to return to enrolling institution for follow-up * REGISTRATION: Unable to complete the study in English or Spanish * REGISTRATION: Self-reported pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in inhibitory control | Baseline to post-intervention (month 6) | Change in interference score on Stroop task, with positive values indicating greater inhibitory control |
| Change in cognitive flexibility | Baseline to post-intervention (month 6) | Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility |
| Change in executive function processing | Baseline to post-intervention (month 6) | Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility |
| Change in short-term memory | Baseline to post-intervention (month 6) | Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory |
| Change in verbal memory | Baseline to post-intervention (month 6) | Change in number recalled on Hopkins Verbal Learning task, with higher values indicating greater verbal memory |
| Change in working memory | Baseline to post-intervention (month 6) | Change in reaction time the 4-part Continuous Performance task, with lower values indicating greater working memory |
| Change in processing speed | Baseline to post-intervention (month 6) | Change in reaction time on Symbol Digit Coding task, with lower values indicating greater processing speed |
| Change in attention | Baseline to post-intervention (month 6) | Change in choice reaction time on Continuous Performance task, with lower values indicating greater sustained attention |
| Change in brain volume | Baseline to post-intervention (month 6) | Change in mean cortical thickness of brain regions of interest as measured by an anatomic MRI brain scan |
| Change in white matter integrity | Baseline to post-intervention (month 6) | Change in fractional anisotropy as measured by diffusion MRI. |
| Change in resting state functional connectivity | Baseline to post-intervention (month 6) | Change in within-network pairwise correlation estimates as measured using a multiband echo planar imaging (mb-EPI) functional MRI sequence |
| Change in self-reported cognitive function - FACT-Cog | Baseline to post-intervention (month 6) | 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. |
Countries
United States
Contacts
Primary ContactClinical Trials Referral Office
Outcome results
None listed