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 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 12:35 AM
NCT ID:
NCT04282967
Eligibility Criteria:
Inclusion Criteria:
* Male previously diagnosed with prostate cancer or female previously diagnosed with breast cancer.
* For breast cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable.
* For prostate cancer, minimum of 3 months post-active treatment completion. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for androgen receptor-targeted therapies (such as enzalutamide, apalutamide, darolutamide, or abiraterone). Patients currently on active surveillance are eligible even if they have not received prior anti-cancer treatment.
* Has access to tablet, laptop, or desktop computer with video capabilities connected to the internet with a screen at least 13 inches across.
* Physically able to complete modified Bruce submaximal treadmill test, leg strength test, grip strength test, and InBody per patient self-assessment.
* Physician clearance to participate in this study. Can be done through review of patients' medical records.
* Ability to read, write, and understand English.
* Has a chair at home to use for exercise that is not on wheels and has a solid back (not a reclining chair).
* Ambulatory without assistance.
* Has a clear 5 x 6-foot space at home in which to exercise.
* Age \>18 years.
* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
* Active treatment planned within the next 6 months. Active treatment includes chemotherapy, biologic therapy, radiation therapy, surgery, and any combination. Long-term hormonal/biologic treatments are acceptable, except for AR-targeted therapies for prostate cancer.
* Known metastatic disease.
* Grade 3 or higher peripheral neuropathy.
* Major surgery within 3 months of baseline visit.
* Positive pregnancy test for women of child-bearing potential.
* Answers yes to any question on the Physical Activity Readiness Questionnaire unless study participation is cleared by a physician.
* Known allergy to Fitbit device.
* Currently meeting physical activity guidelines (score of \>23 on Godin-Shephard Leisure-Time Physical Activity Questionnaire).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04282967
Study Brief:
Protocol Section:
NCT04282967