Patient-Centered Assessment of Symptoms and Outcomes

StatusCompleted
PhaseNot specified
Started

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Record History

The 50 most recent of 339 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Enrollment target: 37 to 40
  2. Re-verified, no change to tracked fields
  3. Primary and study completion dates: Sep 21, 2026 to Apr 20, 2026
  4. Trial completed
    • Primary completion date changed from estimate of Jun 1, 2027 to Sep 21, 2026
    • Eligibility criteria expanded, about 31 words
    • Study description expanded, about 3 words
  5. 6 versions Re-verified since Jul 15, 2026, no change to tracked fieldsv330-v335
  6. Enrollment reduced: 692 → 37 participants
    • Trial status changed: Recruiting → Active, Not Recruiting
    v329
  7. Primary completion pushed from Jun 1, 2026 to Jun 1, 2027
    • Study completion pushed from Jul 1, 2026 to Jun 1, 2027
    v328
  8. 25 versions Re-verified since Jun 14, 2025, no change to tracked fieldsv303-v327
  9. Primary completion date: Jun 1, 2025 to Jun 1, 2026
    • Study completion date: Jul 1, 2025 to Jul 1, 2026
    v302
  10. 6 versions Re-verified since Apr 3, 2025, no change to tracked fieldsv296-v301
  11. Lead sponsor: National Institute of Nursing Research (NINR) to National Center for Complementary and Integrative Health (NCCIH)v295
  12. 3 versions Re-verified since Mar 19, 2025, no change to tracked fieldsv292-v294
  13. Study Status, Study Description, Eligibility, Contacts/Locationsv291
  14. Re-verified, no change to tracked fieldsv290
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background: The cause of fatigue is not well understood. It can be felt differently by different people. Some people think there are different types of fatigue, with different causes. Researchers think a therapy to treat one type of fatigue in one condition should be able to treat that type of fatigue in other conditions. Objective: To understand the types of fatigue. Eligibility: Adults 18 and older who have felt fatigue for more than a month, and non-fatigued adults Design: Participants will be screened with a physical exam, their medical history, a vision test, and blood and urine tests. Participants will begin to track the foods they eat. This study will involve up to 10 visits. Each visit will last no more than 4 hours. In Stage 1, participants will have an interview, fill out questionnaires, and play computer games. They will take walking and handgrip tests. They will give blood, urine, and saliva samples. They will wear a wrist monitor at home for 7 days and write down their activities. They will be put into a group: fatigue or non-fatigued control. In Stage 2, participants will answer questionnaires and give a blood sample. They will have heart tests. They may take exercise and lung function tests that include wearing a nose clip. They may have an optional brain MRI: They may wear an electrode cap on their head during the scan to measure brain activity. They will lie on table that slides into a cylinder. They may perform tasks in the scanner. After the study, participants might be contacted about other studies.
Trial Details
NCT Number NCT03952624
Lead Sponsor National Center for Complementary and Integrative Health (NCCIH)
Conditions
(from sponsor)		 Fatigue, Cancer, CFS, ME/CFS, Myalgic Encephalomyelitis/Chronic Fatigue Syndrome, Lupus, Systemic Lupus Erthematosus, Sjogrens
Related terms Fatigue, Fatigue Syndrome, Chronic, Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov