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 @ 11:15 PM
Ignite Modification Date:
2025-12-24 @ 11:15 PM
NCT ID:
NCT03905356
Eligibility Criteria:
Inclusion Criteria:
* Males and females ≥18 years of age
* Fluent in written and spoken English
* Must be able to provide and understand informed consent
* Must have an ECOG PS of ≤ 2
* Diagnosed with metastatic disease
* Cancer patients (stage 1-4)
* Treatment to primary site or metastatic disease
* Scheduled to receive radiation therapy at Penn State Cancer Institute
* Absence of absolute contraindications for exercise according to the American Heart Association (see below)
* Primary attending oncologist approval
* Receiving treatment as an outpatient
Exclusion Criteria:
* Receiving radiation therapy at a location other than Penn State Cancer Institute
* Not fluent in written and spoken English
* Evidence in the medical record of an absolute contraindication for exercise
* Performing \> 90 minutes/week of physical activity at the time of initial evaluation
* Cardiac exclusion criteria:
* Class II, III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system
* History of acute coronary syndromes (including myocardial infarction and unstable angina), coronary angioplasty or stenting within the past 6 months prior to the start of radiation therapy
* Uncontrolled arrhythmias; patients with rate controlled atrial fibrillation for \>1 month prior to start of radiation therapy may be eligible
* syncope
* acute myocarditis, pericarditis, or endocarditis
* acute pulmonary embolus or pulmonary infarction
* thrombosis of lower extremities
* suspected dissecting aneurysm
* pulmonary edema
* respiratory failure
* acute non-cardiopulmonary disorder that may affect exercise performance or be aggravated by exercise
* mental impairment leading to inability to cooperate
* Pregnant women
* In-patient receiving radiation therapy for a radiation emergency (e.g. cord compression, SVC syndrome, brain metastases)
* High risk of fracture or spine instability (Mirels score ≥7, SINS ≥7)
* Children (the protocol will only include individuals 18 and older)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03905356
Study Brief:
Protocol Section:
NCT03905356