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 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT07116161
Eligibility Criteria:
Inclusion Criteria:
1. Female
2. ≥21 years of age
3. Stage I-III hormone receptor (HR)-positive breast cancer regardless of HER2 status
4. Completed surgery
5. Completed adjuvant chemotherapy, if indicated
6. Receiving adjuvant endocrine therapy, with or without CDK4/6 inhibitors
7. Reported fatigue (One-item fatigue scale score ≥ 4).
8. Ability to read and communicate in English or Mandarin.
9. Willing to provide informed consent for the study participation.
Exclusion Criteria:
1. Pregnant or lactating
2. Presence of dementia or major psychiatric disease
3. Deemed medically unsuitable by medical team for low to moderate intensity exercise
4. Unable or unwilling for tele-counselling sessions
5. Uncontrolled pain or undiagnosed pain
6. Low blood counts: Hb \<8.0, Platelet \<50K, ANC \<1
7. Electrolyte imbalances: K \<3.0, Na \<130
8. Cardiovascular diseases, including but not limited to: LVEF \<35%, uncontrolled arrhythmias, severe coronary artery disease, severe valvular heart disease, uncontrolled hypertension etc. not cleared by a cardiologist
9. Active infection
10. Currently engaged in moderate to vigorous physical activity
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
21 Years
Study:
NCT07116161
Study Brief:
Protocol Section:
NCT07116161