A Physical Activity Program Compared to Health Education for Improving Memory and Attention in Hispanic Women With Newly-Diagnosed Stage I-IIIa Breast Cancer, MAMA Trial

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age50+
SponsorMayo Clinic

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Accelerometry

    Procedure/Surgery

    Ancillary studies

  • Aerobic Exercise

    Other intervention

    Participate in walking program

  • Electronic Health Record Review

    Other intervention

    Ancillary studies

  • Functional Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo fMRI

  • Gait Assessment Test

    Other intervention

    Ancillary studies

  • Health Education

    Behavioral

    Receive health education

  • Interview

    Other intervention

    Ancillary studies

  • Neurocognitive Assessment

    Other intervention

    Ancillary studies

  • Physical Performance Testing

    Other intervention

    Ancillary studies

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: Arm A (walking program)Experimental treatment 9 interventions
Group B: Arm B (health education)Active comparator 8 interventions

Trial outcomes

Primary outcomes

1

Change in inhibitory control

Change in interference score on Stroop task, with positive values indicating greater inhibitory control

Time frame
Baseline to post-intervention (month 6)
2

Change in cognitive flexibility

Change in accuracy on Shifting Attention task, with higher values indicating greater cognitive flexibility

Time frame
Baseline to post-intervention (month 6)
3

Change in executive function processing

Change in reaction time on Shifting Attention task, with lower values indicating greater cognitive flexibility

Time frame
Baseline to post-intervention (month 6)
4

Change in short-term memory

Change in accuracy on Visual Memory task, with higher accuracy indicating greater short-term memory

Time frame
Baseline to post-intervention (month 6)

Secondary outcomes

Other outcomes

Sponsors and contacts

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