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:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2025-12-24 @ 11:17 PM
NCT ID:
NCT05432856
Eligibility Criteria:
Inclusion Criteria:
* Female biological sex at birth
* \>18 years
* Diagnosis of stage I, II, or III breast cancer
* starting neoadjuvant or adjuvant intravenous chemotherapy
* ECOG \<3;
* Oncologist approval to participate;
* English speaking (all study materials and study staff will be in English)
* Willing and able to adhere to study intervention
Exclusion Criteria:
* Individuals who do not have access to a smart phone with Bluetooth capability (required for Fitbit and for responding to intervention text messages) or at least a shared cell phone with someone in the same household (i.e., some couples may share a phone).
* Type 1 or type 2 diabetes who require exogenous insulin (due to the potential need to adjust insulin dosing with TRE) or with hemoglobin A1c \>10%
* Research MRI contraindications (e.g., pacemaker, magnetic implants, pregnancy)
* Uncontrolled thyroid disorder
* Self-reported eating disorder history
* Body mass index \<18.5 kg/m2 or clinical signs of cachexia (discretion of treating oncologist)
* ≥5% body weight loss within last 6 months
* Those who are currently working night/rotating shifts, eating within ≤10-hour window or consistently eating less than 3 meals/day in the past 3 months.
* patients who meet the criteria for medical clearance prior to exercise using the Physical Activity Readiness Questionnaire+ and are not cleared by their treating oncologist or family physician to perform maximal exercise testing.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT05432856
Study Brief:
Protocol Section:
NCT05432856