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 @ 9:26 PM
Ignite Modification Date:
2025-12-24 @ 9:26 PM
NCT ID:
NCT06260332
Eligibility Criteria:
Inclusion Criteria:
* Women who have completed surgery for invasive breast cancer \>= 6 months prior to enrollment
* Any breast surgery (lumpectomy or mastectomy)
* Baseline low to moderate activity level (exercise less than 120 minutes a week)
* PBSPS defined as pain in the area of breast surgery of at least moderate intensity (\>= 4 on a scale of 1-10), located in the ipsilateral beast/chest wall, axilla or arm, lasting at least 6 months, and occurring at least 50% of the time
* Self-identified as Hispanic/Latinx
* Age, \>= 18 and =\< 60 years
* Endocrine therapy and ovarian suppression is allowed
Exclusion Criteria:
* Metastatic or locally recurrent disease with no option for curative intent treatment
* Meeting or exceeding physical activity guidelines (\> 150 minutes per week of moderate-intensity exercise)
* Unable to speak, read, and understand English or Spanish
* Severe impairments (in seeing or hearing) or pre-existing medical limitations for engaging in daily physical activity. This is defined as the ability to walk 3 blocks without stopping to rest and without using an assistive device
* Unwilling to use a study provided smartphone (if do not already own one) and wear activity trackers/monitors
* Adults not able to consent are excluded from participation
* Based on the age criteria (18 years and older), individuals who are not yet adults (infants, children, teenagers) may not participate in this study due to the same age criteria above
* Pregnant women
* Prisoners may not participate in this study as this is a study of free-living individuals
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06260332
Study Brief:
Protocol Section:
NCT06260332