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 @ 4:27 AM
Ignite Modification Date:
2025-12-25 @ 4:27 AM
NCT ID:
NCT06960720
Eligibility Criteria:
Inclusion Criteria:
* Subjects must have histologically or cytologically confirmed Breast Cancer; any tumor molecular subtype can be enrolled.
* Subjects must have been diagnosed with non-metastatic breast cancer, defined as stage 0, I, II, or III (according to the American Joint Committee on Cancer Tumor, Node, Metastasis staging system), and must be between one and three years post-diagnosis at the time of enrollment. With treatment being received from the West Virginia University (WVU) Cancer Institute.
* Any severity or report of fatigue. This can be done through a subjective report documented by any healthcare professional or through a screening tool like the enhanced distress thermometer.
* Subjects must have the ability to understand and the willingness to sign a written informed consent document.
* Subjects who are pregnant (first or second trimester) or breastfeeding must receive additional approval from their obstetrics and gynecology physician for participation. Only individuals with a singleton pregnancy (no multiple gestations) will be eligible for participation. Pregnant participants must be in their first or second trimester at the time of enrollment to ensure they can complete the full three-month program before childbirth. Multiple gestations are associated with higher risks of pregnancy complications, increased physical limitations, and a greater likelihood of preterm delivery, which may prevent completion of the program.
Exclusion Criteria:
* Male biological gender. Males will be excluded from the study due to the rarity of male breast cancer and the variability gender creates on AL scores.
* Subjects with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, active alcoholism, or psychiatric illness/social situations that would limit compliance with study requirements.
* Subjects with pregnancy beyond the second trimester at the time of enrollment, as later stages of pregnancy may prevent completion of the full three-month program.
* Subjects who are pregnant with multiple gestations (e.g., twins, triplets, or higher-order pregnancies) due to the increased risk of pregnancy-related complications, physical limitations, and the likelihood of preterm delivery, which may interfere with program completion.
* Subjects whose self-reported household income is above or below the median household income in Appalachia ($61,688) and for whom the target enrollment of 30 participants in that respective SES group (higher or lower) has already been met at the time of screening, as representation of both SES groups is required for the study.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06960720
Study Brief:
Protocol Section:
NCT06960720