RightFit
RecruitingNot applicable

Breast Cancer, Reasoning, and Activity Intervention

Enhancing Cognitive Function in Breast Cancer Survivors Through Community-based Exercise Training

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
50 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Patients undergo a gait assessment and magnetic resonance imaging (MRI), as well as wear an accelerometer throughout the study."
  • "Patients undergo a gait assessment and MRI, as well as wear an accelerometer throughout the study."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase II study tests whether exercise improves memory, attention, and brain health compared with health education. It is for women age 50 or older who have finished treatment for breast cancer and do little exercise.

This phase II trial tests whether an exercise intervention works to improve cognitive function in breast cancer survivors. Many breast cancer survivors report cancer-related cognitive impairment, which this has recently become a priority in clinical research due to its dramatic impact on daily functioning, quality of life, and long-term health. Aerobic exercise has the potential to improve cognitive function and brain health in older adults and is recommended as a safe, tolerable, and accessible complementary therapy for breast cancer survivors. This study aims to understand the effects of physical activity compared with health education on memory, attention, and brain health in women with breast cancer. Study findings may help researchers design more programs that can improve memory, attention, and brain health in other women with breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are age 50 or older.
  • Your first breast cancer diagnosis was stage I–IIIa.
  • You have had surgery and finished your main cancer treatment 3–60 months before signing up.
  • In the past 6 months, you have done no more than 90 minutes a week of moderate aerobic exercise, such as brisk walking.
  • You can complete study tests on your own or with help.
  • You allow the study team to check your medical records to confirm you qualify.
  • You score above 21 on a phone test of memory and thinking.
  • Your doctor clears you to exercise. Some heart conditions also require clearance from a heart doctor.

Who can't join

  • You have stage 0 breast cancer, cancer that has spread to distant body parts, or a second cancer diagnosis. Non-invasive skin cancers and carcinoma in situ—cancer that has not grown into nearby tissue—are exceptions.
  • You are receiving chemotherapy or radiation, finished either less than 3 months ago, finished main treatment more than 60 months ago, or plan surgery during the study.
  • You have had a stroke, a brief stroke-like event, another brain or nerve disorder, or brain surgery that removed tissue; or you score below 21 on the study’s thinking test.
  • You cannot walk without help or a device, or cannot get renewed doctor clearance if the study’s exercise test shows a concern.
  • You cannot safely have a functional MRI, a scan of brain activity, or your brain scan shows a problem that needs medical follow-up.
  • You are in another physical activity program or will not accept being assigned by chance to exercise or health education.
  • You cannot travel regularly to study visits or will not return to the study center for follow-up.
  • You will not complete study tasks, or cannot or will not wear an activity tracker continuously and regularly charge it and send its data.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria * PRE-REGISTRATION: Age ≥50 years at time of pre-registration visit according to participant report and/or clinical determination * PRE-REGISTRATION: First, primary diagnosis of stage I-IIIa breast cancer according to participant report and/or clinical determination * PRE-REGISTRATION: Post-surgery and completed primary treatment (i.e., surgery, chemotherapy, and/or radiation therapy) 3-60 months prior to registration according to participant report and/or clinical determination * PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as 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 as confirmed via clinical determination * REGISTRATION: Able to provide medical record release to confirm eligibility * REGISTRATION: First, 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) 3-60 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) NOTE: Only individuals who pass the TICS-M during pre-registration will be invited to participate in the urine substudy * 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 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 60 months post primary treatment * PRE-REGISTRATION: Planned surgery during the intervention period * PRE-REGISTRATION: Second cancer diagnosis (excluding non-invasive skin cancers or carcinoma-in-situ for any cancer) * PRE-REGISTRATION: Unable to travel regularly to 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 * 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 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 or unwilling to continuously wear and regularly sync/charge an activity tracker during the study period * REGISTRATION: Unable to travel regularly to the study locations for intervention sessions and data collection * REGISTRATION: Unwilling to return to enrolling institution for follow-up

Study sites (1)

AZ