Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2025-12-25 @ 3:45 AM
NCT ID:
NCT05000502
Eligibility Criteria:
Inclusion Criteria:
* Non-Hispanic white or black women
* Age 18-70 years
* History of breast cancer stage 0, I, II, or III
* ≥1 year post-primary cancer treatment completion
* English speaking
* Ambulates without assistance
* No antibiotics in past 90 days
* Willing to avoid taking probiotics during the study
* Has access to a safe place to perform aerobic exercise (e.g., willing to walk in neighborhood or has gym membership or owns relevant exercise equipment at home, etc.)
* Has access to good internet and WIFI and device capable of videoconferencing (the study has limited resources to loan tablets and hotspots)
Exclusion Criteria:
* Metastatic or recurrent cancer
* Another cancer diagnosis in the past 5 years (not including skin or cervical cancer in situ)
* Unstable angina
* New York Heart Association class II, III, or IV congestive heart failure
* Uncontrolled asthma
* Interstitial lung disease
* Current steroid use
* Told by a physician to only do exercise prescribed by a physician
* Dementia or organic brain syndrome
* Schizophrenia or active psychosis
* Connective tissue or rheumatologic disease
* Participating in \>30 minutes of exercise on ≥3 days/week in the past six months
* Anticipate elective surgery, medication changes or antibiotics during the study
* Contraindication to ≥moderate intensity aerobic exercise
* Physical limitations that prevent engaging in ≥moderate intensity aerobic exercise
* Breastfeeding, pregnant or anticipate pregnancy during the study
* Plan to move residence during the study
* Plan to travel for more than 1 week during the study
* Anticipate trouble attending the weekly study videoconference calls
* History of bariatric surgery
* Body weight greater than 440 lbs
* Any social, psychological, or physical condition that interferes with the participant's ability to complete study activities or unduly increases study risk
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT05000502
Study Brief:
Protocol Section:
NCT05000502