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 @ 11:40 PM
Ignite Modification Date:
2025-12-24 @ 11:40 PM
NCT ID:
NCT03999151
Eligibility Criteria:
Inclusion Criteria:
1. Age \>=18 years
2. Diagnosed with non-metastatic prostate cancer and choose radical prostatectomy (RP) as primary treatment.
3. Able to speak and read English
4. Regular access to the Internet (via a computer, tablet, or phone) and text messaging capabilities on the phone
5. Ability to understand a written informed consent document, and the willingness to sign it
Exclusion Criteria:
1. Cannot have neoadjuvant radiation or hormone therapy planned at time of enrollment (if enrolling \>4 weeks prior to RP).
2. Men who have contraindications to exercise based the American College of Sports Medicine 2016 Exercise pre-participation screening criteria (https://www.ncbi.nlm.nih.gov/pubmed/26473759), and who do not receive a physician clearance to participate in the moderate to vigorous intensity physical activity with one or more of the following self-reported conditions:
1. Heart attack
2. Heart surgery, cardiac catheterization, or coronary angioplasty
3. Pacemaker/implantable cardiac defibrillator/rhythm disturbance
4. Heart valve disease
5. Heart failure
6. Heart transplantation
7. Congenital heart disease
8. Diabetes
9. Kidney (renal) disease
10. Chest discomfort with exertion
11. Unreasonable breathlessness
12. Dizziness, fainting, or blackouts
13. Ankle swelling
14. Unpleasant awareness of forceful, rapid or irregular heart rate
15. Burning or cramping sensations in your lower legs when walking short distance
3. Men already meeting aerobic AND resistance exercise recommendations. To be eligible, must not meet at least one of the following: (1) 150 minutes per week of planned moderate aerobic exercise or 75 minutes per week of planned vigorous aerobic exercise or combination;(2) Two or more days per week of resistance exercise; (3) Eight or more resistance exercises per session
4. Men who are already meeting all of the 7 prostate-specific dietary recommendations
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03999151
Study Brief:
Protocol Section:
NCT03999151