Patient-Centered Assessment of Symptoms and Outcomes

Launched by NATIONAL CENTER FOR COMPLEMENTARY AND INTEGRATIVE HEALTH (NCCIH) · May 15, 2019

Keywords

ClinConnect Summary

This clinical trial, called the Patient-Centered Assessment of Symptoms and Outcomes, is studying different types of fatigue that people with conditions like cancer, chronic fatigue syndrome (CFS), lupus, and others may experience. The researchers want to understand how fatigue affects people in various ways and whether treatments for one type of fatigue can be applied to others. To participate, you need to be an adult aged 18 or older who has felt fatigue for more than a month, or someone who does not experience fatigue.

Participants will go through several assessments, including interviews, physical tests, and blood samples, over up to 10 visits, each lasting no more than 4 hours. You'll also track your food intake and daily activities using a wrist monitor. If you qualify, you may also have the option to undergo additional tests, like a brain scan, to learn more about how fatigue affects the body and brain. The study is currently recruiting participants, and it’s important to note that those with certain medical conditions or ongoing health issues may not be eligible.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • All Participants (including returning participants)
• • Adult participants aged \>= 18 years at the time of enrollment.
• • Able to provide written informed consent.
• • Willing and able to complete study procedures.
• • Fatigued Participants
• • -In addition to the above, must experience fatigue for more than a month.
• • Healthy Volunteers for the fMRI study
• • Right handed
• • Not taking any prescribed medications for chronic medical conditions
• • Not diagnosed with any chronic medical condition
• EXCLUSION CRITERIA:
• Exclusion from study entry:
• • Not fluent in English.
• • Have medical health issues that create additional and substantial adverse risks related to study procedures. Medical examples are the acute complications of medical disease, such as unstable hypertension, diabetic ketoacidosis, symptomatic hyperthyroidism, and unstable angina.
• • Have a psychiatric condition that prevents participant from being able to reliably report the fatigue experience (e.g., a psychotic disorder with severely disorganized thinking);
• • Current substance use disorder within the last five years or positive urine toxicology results at enrollment and before Stage 2. Prior marijuana use within the past five years will not be an exclusion.
• • Categorized as a high-risk drinker (\>=5 drinks/day and \>=15 drinks/week for men, \>=4 drinks/day and \>=8 drinks/week for women). ( Dietary Guidelines for Americans 2015-2020," U.S. Department of Health and Human Services and U.S. Department of Agriculture).
• • NIH employees.
• • Pregnant or lactating women.
• • 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.
• Exclusion from specific tests:
• • fMRI Technical Development Sub-Study
• • Implanted cardiac pacemakers, metal aneurysm clips;
• • Broken bones repaired with metal pins, screws, rods, plates;
• • Prosthetic eye implants;
• • Transdermal medications or infusion pumps;
• • Bullet fragments or other metal pieces in body from old wounds;
• • Significant work exposure to metal particles;
• • Clinically relevant claustrophobia;
• • Unable to lie comfortably on back for up to 4 hours;
• • Left-handed. (Participants that are ambidextrous, will complete the Edinburgh Handedness Inventory).
• • EEfRT and Stroop Test
• • Severe essential hand tremor or severe hand pain (e.g., severe arthritis or severe carpel tunnel) that makes it difficult to perform rapid keyboard presses will be an exclusion from the EEfRT and Stroop Test.
• • Color-blindness, verified by scoring \>14 on the Ishihara card test, will exclude a participant from taking the Stroop test. The Ishihara card test will be administered only if the participant states he or she is color-blind.
• • Tilt Table Test
• • --Beta blocker medications.
• • CPET
• • Any neuromuscular conditions (e.g., multiple sclerosis, Parkinson s disease) with significant mobility impairment that prohibits treadmill or bike performance, or any medical condition (e.g., congestive heart failure, coronary artery disease, chronic obstructive pulmonary disease \[COPD\], severe osteoarthritis and poorly controlled asthma) that would make it risky for the participant to exercise (e.g., exercise-induced angina and asthma), will exclude a participant from the CPET.