The biology of cancer-related fatigue: a review of the literature.
Leorey N Saligan, Karin Olson, Kristin Filler...
https://pubmed.ncbi.nlm.nih.gov/25975676Actively Recruiting
Age: 18Years +
All Genders
Healthy Volunteers
ID03952624
Patient-Centered Assessment of Symptoms and Outcomes Study of Fatigue Types and Characteristics Using Clinical and Biological Measurements
Led by National Center for Complementary and Integrative Health (NCCIH) · Updated on 2026-06-08
692
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying fatigue, a symptom that varies widely among individuals and may have different causes. This research aims to better understand the different types of fatigue by deeply analyzing people with clinically meaningful fatigue and comparing them to those without fatigue. The study is exploratory and involves detailed clinical descriptions to clarify fatigue types and their biological links. Participants will be involved in a multi-stage observational study. In Stage 1, they will undergo interviews, questionnaires, computer tasks, physical tests such as walking and handgrip, and provide blood, urine, and saliva samples. They will wear wrist monitors for seven days at home and record activities. Participants will be grouped as fatigued or non-fatigued controls. Stage 2 includes further questionnaires, blood samples, heart tests, optional exercise and lung function tests, and an optional brain MRI with brain activity monitoring during tasks. Participation involves up to ten visits lasting up to four hours each. Assessments include physical exams, vision tests, medical history review, and various biological sample collections. Participants may have electrocardiograms and neuroimaging procedures to assess fatigue dimensions. The primary measurement is fatigue level across both study stages. After completing the study, participants may be contacted for other related research opportunities. The study involves adults aged 18 and older, including healthy volunteers and those with fatigue lasting more than a month.
CONDITIONS
Brief Title
Patient-Centered Assessment of Symptoms and Outcomes
Who Can Participate
Age: 18Years +
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older at enrollment
- Able to provide written informed consent
- Willing and able to complete study procedures
- Fatigued participants must have experienced fatigue for more than one month
- Healthy volunteers for the fMRI study must be right-handed, not taking prescribed medications for chronic conditions, and have no diagnosed chronic medical condition
You will not qualify if you...
- Not fluent in English
- Medical issues posing substantial risks during study procedures (e.g., unstable hypertension, diabetic ketoacidosis, symptomatic hyperthyroidism, unstable angina)
- Psychiatric conditions preventing reliable fatigue reporting (e.g., psychotic disorder with severely disorganized thinking)
- Substance use disorder within the last five years or positive urine toxicology at enrollment and before Stage 2 (prior marijuana use within five years allowed)
- High-risk drinking based on specified daily and weekly limits for men and women
- NIH employees
- Pregnant or lactating women
- Ongoing medical conditions interfering with study conduct or safety
- Specific exclusions for fMRI sub-study, including implanted metal devices, metal fragments, claustrophobia, inability to lie on back, and left-handedness
- Exclusions from EEfRT and Stroop tests due to severe hand tremor, hand pain, or color-blindness
- Exclusion from Tilt Table Test if taking beta blockers
- Exclusions from CPET for neuromuscular or medical conditions that impair safe exercise performance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) and phone screening
Fatigue Assessment
Duration - Not specified
Participants complete self-report questionnaires and performance tasks to assess fatigue levels and characteristics.
1 visit (in-person)
Fatigue Dimension Phenotyping Evaluation
Duration - Not specified
Participants undergo additional clinical and scientific assessments including vital signs, physical exams, blood draws, imaging assessments, and other measurements to better understand fatigue phenotypes.
1 or more visits depending on participant subgroup and assessments
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
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Research Team
A
Alexander L Ross, R.N.
M
Miroslav Backonja, M.D.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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Published Research Related To This Trial
Fatigue in systemic lupus erythematosus and rheumatoid arthritis.
Rosalind Ramsey-Goldman, Nan Rothrock
https://pubmed.ncbi.nlm.nih.gov/20656619Fatigue.
Michael Sharpe, David Wilks
https://pubmed.ncbi.nlm.nih.gov/12202331