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 @ 9:58 PM
Ignite Modification Date:
2025-12-24 @ 9:58 PM
NCT ID:
NCT01231932
Eligibility Criteria:
* INCLUSION CRITERIA:
To be included, patients must meet all of the following criteria:
* Medical documentation confirming diagnosis of:
--Clinically localized or metastatic cancer as determined by diagnostic testing such as cytology and imaging (such as, but not limited to non-metastatic head and neck cancer, lung cancer, breast cancer, renal cancer); OR completed primary treatment for cancer (e.g., cancer survivors) OR on active surveillance for localized cancer;
* Able to provide written informed consent;
* Women and men greater than or equal to 18 years of age;
* NIH employees and staff are eligible to participate.
EXCLUSION CRITERIA:
* Progressive or unstable disease other than cancer of any body system causing clinically significant fatigue (e.g. class IV congestive heart failure, end-stage renal disease, stage IV chronic obstructive pulmonary disease) including patients with
* Systemic infections (e.g., human immunodeficiency virus \[HIV\], active hepatitis);
* Documented history of unstable major depression, bipolar disease, psychosis, or alcohol/drug dependence/abuse; requiring hospitalization/institutionalization;
* Uncorrected hypothyroidism;
* Untreated anemia;
* Chronic inflammatory disease (e.g. rheumatoid arthritis, systemic lupus erythematosus).
* Patients regularly taking antipsychotics, and anticonvulsants, since these medications cause significant fatigue.
* NINR employees or subordinates, relatives, and/or co-workers of NINR employees/staff or study investigators.
* Self-report of color-blindness verified by taking the Ishihara card test with scores \>14 (10 minutes) will be an exclusion from the Stroop Test. This card test will be administered only if the patient reports being color blind.
* Severe essential hand tremor or severe hand pain (e.g., severe arthritis or severe carpel tunnel) will be an exclusion from the computerized tests and the skeletal muscle strength test.
* Ongoing medical condition that is deemed by the Principal Investigator to interfere with the conduct or assessments of the study or safety of the participant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT01231932
Study Brief:
Protocol Section:
NCT01231932