Recruiting NA Breast Cancer

New treatment option for Breast Cancer

Official title Breast Cancer, Reasoning, and Activity Intervention

ClinicalTrials.gov ID: NCT04816006

What this study is testing

What it's testing
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.
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 50 and older, women only

You may be able to join if

  • 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) 3-36 months prior to...
  • PRE-REGISTRATION: Sedentary except for casual lifestyle recreation defined as self-reporting no more than 90 minutes per week of moderate-intensity...
  • PRE-REGISTRATION: Self-reported ability to complete assessments by themselves or with assistance

You likely can't join if

  • 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...
  • 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
See the full eligibility criteria
Who can join
  • 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) 3-36 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) 3-36 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) NOTE: Only individuals who pass the TICS-M during...
  • 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...
  • 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
What rules you out
  • 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: 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...
  • 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 assigned by chance 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

The study team makes the final eligibility decision.

Where it's taking place

  • Phoenix, Arizona, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 50 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.