About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Trial design
Parallel
Treatments tested in this trial
Accelerometry
Procedure/SurgeryAncillary studies
Aerobic Exercise
Other interventionParticipate in walking program
Electronic Health Record Review
Other interventionAncillary studies
Functional Magnetic Resonance Imaging
Procedure/SurgeryUndergo fMRI
Gait Assessment Test
Other interventionAncillary studies
Health Education
BehavioralReceive health education
Interview
Other interventionAncillary studies
Neurocognitive Assessment
Other interventionAncillary studies
Physical Performance Testing
Other interventionAncillary studies
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
Trial outcomes
Primary outcomes
Change in inhibitory control
Change in interference score on Stroop task, with positive values indicating greater inhibitory control
Change in cognitive flexibility
Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility
Change in executive function processing
Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility
Change in short-term memory
Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory
Sponsors and contacts
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