FatigueNCT03952624
Patient-Centered Assessment of Symptoms and Outcomes
An observational study of Fatigue and Cancer, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2019to 20 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited via a stepwise approach. Limited recruitment will occur during the first 6 months to 12 months after initial IRB approval, as part of the feasibility assessment. During this time, NIH investigators such as those from NINR, the NIDCR Sjogren s Clinic, and the 16-N-0058 study (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) will be informed about the study. These investigators will not actively recruit their own patients for the study but will be asked to post a recruitment flyer in their clinics. After the first year, the study will open to the general population.
Who may be able to join
- 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.
Show all 10Show fewer
- Healthy Volunteers for the fMRI study
- Right handed
- Not taking any prescribed medications for chronic medical conditions
- Not diagnosed with any chronic medical condition
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the detailed description
Purpose: The purpose of this study is to allow for deep and broad phenotyping of persons with clinically-meaningful fatiguing symptoms, regardless of physiologic or pathologic condition. This protocol will enable the National Institute of Nursing Research (NINR) investigators to describe the clinical characteristics of persons reporting clinically-meaningful fatigue and collect clinical and scientific data for the purpose of making comprehensive phenotypic descriptions.
These phenotypic descriptions will be used to explore the heterogeneity of fatiguing symptoms to clarify the nature of different fatigue phenotypes and their biologic correlates.
The specific goals of this protocol are the following:
- To characterize and phenotype individuals with clinically-meaningful fatigue.
- To explore the heterogeneity of fatiguing conditions to define specific fatigue dimensions.
- To generate hypotheses of the possible mechanism of each fatigue dimension.
Study Population: The study population will consist of up to 692 persons with or without clinically-meaningful fatigue. Approximately 20 will be enrolled in the technical development sub-study to refine the neuroimaging techniques used in this study. Additional 20 healthy volunteers will be enrolled to serve as normative reference. This protocol is open to anyone of any ethnicity, sex, or nationality.
Design: The protocol is designed as an exploratory multi-stage study. Upon receiving inquiry from a potential participant, a phone screening using an eligibility questionnaire and an in-person NIH outpatient screening visit will be conducted. If a treatable medical condition is identified during the screening that directly contributes to the fatigue experience, then the participant will not proceed in the study but will be asked to see their care provider for evaluation and/or management. Those who are under a known treatment (e.g., chemotherapy, antivirals) for a clinical condition or those without a clear clinical explanation for their fatigue will be invited to participate in Stage 1 of the study. Stage 1 is the fatigue assessment stage and includes completion of self-report questionnaires and performance tasks. Stage 2 will include additional clinical and scientific assessments to allow for deeper understanding of the fatigue phenotype.
Before study termination, participants may be referred to appropriate NIH CC services for management recommendations. Participants who complete the study may be re-contacted about other available fatigue intervention studies.
Multi-Stage Study Design
Stage 1 - Fatigue Assessment
Stage 2 - Fatigue Dimension Phenotyping Evaluation
Outcome Measures: The study will use a wide variety of measurement tools for phenotyping purposes. These include: vital signs, medical history, physical exam, blood draw, medical record review, clinical interviews, patient reported outcome measurements, physical, cognitive, affective, and behavioral measurements, structural and functional imaging assessments, nutritional assessment, clinical and research laboratory measurements, and electrocardiogram.
In summary, the NINR Patient-Centered Assessment of Symptoms and Outcomes (P-CASO) protocol will enable investigators to obtain detailed clinical descriptions and to collect phenotyping measurements from research participants who report clinically-meaningful fatigue.
The study will allow NINR investigators to perform descriptive research on fatigue for hypothesis generation.
- Keywords
- Symptom Biology, Symptom Phenotyping, Fatigue, Natural History
- Medical subject headings
- Fatigue, Neoplasms, Fatigue Syndrome, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | FNS <= 3 | |
| Fatigued | FNS >= 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue Level
The primary outcome will be the fatigue level using the Fatigue Numeric Rating Scale (FNS) score.
Measured: Stage 1 and Stage 2
Secondary outcomes (1)
Secondary outcomes of the study will obtain common fatigue dimension information from participants that will allow us to better define phenotypic clusters that ultimately can be used for hypothesis generation, these include patient-reported outc...
Measured: All time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start13 Sep 2019
- Primary completion20 Apr 2026
- Study completion20 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Miroslav Backonja, M.D., Principal investigator, National Center for Complementary and Integrative Health (NCCIH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03952624
- Sponsor's protocol ID
- 190098
- Other IDs
- 19-NR-0098
- Status last verified
- 7 Oct 2026
- First submitted
- 15 May 2019
- Last updated
- 9 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Saligan LN, Olson K, Filler K, Larkin D, Cramp F, Yennurajalingam S, Escalante CP, del Giglio A, Kober KM, Kamath J, Palesh O, Mustian K; Multinational Association of Supportive Care in Cancer Fatigue Study Group-Biomarker Working Group. The biology of cancer-related fatigue: a review of the literature. Support Care Cancer. 2015 Aug;23(8):2461-78. doi: 10.1007/s00520-015-2763-0. Epub 2015 May 15.
PubMed 25975676Ramsey-Goldman R, Rothrock N. Fatigue in systemic lupus erythematosus and rheumatoid arthritis. PM R. 2010 May;2(5):384-92. doi: 10.1016/j.pmrj.2010.03.026.
PubMed 20656619Sharpe M, Wilks D. Fatigue. BMJ. 2002 Aug 31;325(7362):480-3. doi: 10.1136/bmj.325.7362.480. No abstract available.
PubMed 12202331
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Assessment of Symptoms and Outcomes
- ClinicalTrials.gov ID
- NCT03952624
- Acronym / sponsor ID
- 190098
- Keywords
- Symptom Biology, Symptom Phenotyping, Fatigue, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 20 Apr 2026 (actual)
- Study completion
- 20 Apr 2026 (actual)
- First posted
- 16 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Purpose: The purpose of this study is to allow for deep and broad phenotyping of persons with clinically-meaningful fatiguing symptoms, regardless of physiologic or pathologic condition. This protocol will enable the National Institute of Nursing Research (NINR) investigators to describe the clinical characteristics of persons reporting clinically-meaningful fatigue and collect clinical and scientific data for the purpose of making comprehensive phenotypic descriptions.
These phenotypic descriptions will be used to explore the heterogeneity of fatiguing symptoms to clarify the nature of different fatigue phenotypes and their biologic correlates.
The specific goals of this protocol are the following:
- To characterize and phenotype individuals with clinically-meaningful fatigue.
- To explore the heterogeneity of fatiguing conditions to define specific fatigue dimensions.
- To generate hypotheses of the possible mechanism of each fatigue dimension.
Study Population: The study population will consist of up to 692 persons with or without clinically-meaningful fatigue. Approximately 20 will be enrolled in the technical development sub-study to refine the neuroimaging techniques used in this study. Additional 20 healthy volunteers will be enrolled to serve as normative reference. This protocol is open to anyone of any ethnicity, sex, or nationality.
Design: The protocol is designed as an exploratory multi-stage study. Upon receiving inquiry from a potential participant, a phone screening using an eligibility questionnaire and an in-person NIH outpatient screening visit will be conducted. If a treatable medical condition is identified during the screening that directly contributes to the fatigue experience, then the participant will not proceed in the study but will be asked to see their care provider for evaluation and/or management. Those who are under a known treatment (e.g., chemotherapy, antivirals) for a clinical condition or those without a clear clinical explanation for their fatigue will be invited to participate in Stage 1 of the study. Stage 1 is the fatigue assessment stage and includes completion of self-report questionnaires and performance tasks. Stage 2 will include additional clinical and scientific assessments to allow for deeper understanding of the fatigue phenotype.
Before study termination, participants may be referred to appropriate NIH CC services for management recommendations. Participants who complete the study may be re-contacted about other available fatigue intervention studies.
Multi-Stage Study Design
Stage 1 - Fatigue Assessment
Stage 2 - Fatigue Dimension Phenotyping Evaluation
Outcome Measures: The study will use a wide variety of measurement tools for phenotyping purposes. These include: vital signs, medical history, physical exam, blood draw, medical record review, clinical interviews, patient reported outcome measurements, physical, cognitive, affective, and behavioral measurements, structural and functional imaging assessments, nutritional assessment, clinical and research laboratory measurements, and electrocardiogram.
In summary, the NINR Patient-Centered Assessment of Symptoms and Outcomes (P-CASO) protocol will enable investigators to obtain detailed clinical descriptions and to collect phenotyping measurements from research participants who report clinically-meaningful fatigue.
The study will allow NINR investigators to perform descriptive research on fatigue for hypothesis generation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –FNS <= 3 |
| Fatigued | – | –FNS >= 4 |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited via a stepwise approach. Limited recruitment will occur during the first 6 months to 12 months after initial IRB approval, as part of the feasibility assessment. During this time, NIH investigators such as those from NINR, the NIDCR Sjogren s Clinic, and the 16-N-0058 study (Myalgic Encephalomyelitis/Chronic Fatigue Syndrome) will be informed about the study. These investigators will not actively recruit their own patients for the study but will be asked to post a recruitment flyer in their clinics. After the first year, the study will open to the general population.
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (25 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue Level
Time frame: Stage 1 and Stage 2
The primary outcome will be the fatigue level using the Fatigue Numeric Rating Scale (FNS) score.
1 secondary outcome
Secondary outcomes of the study will obtain common fatigue dimension information from participants that will allow us to better define phenotypic clusters that ultimately can be used for hypothesis generation, these include patient-reported outc...
Time frame: All time points
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
- Background: PubMed 25975676Saligan LN, Olson K, Filler K, Larkin D, Cramp F, Yennurajalingam S, Escalante CP, del Giglio A, Kober KM, Kamath J, Palesh O, Mustian K; Multinational Association of Supportive Care in Cancer Fatigue Study Group-Biomarker Working Group. The biology of cancer-related fatigue: a review of the literature. Support Care Cancer. 2015 Aug;23(8):2461-78. doi: 10.1007/s00520-015-2763-0. Epub 2015 May 15.
- Background: PubMed 20656619Ramsey-Goldman R, Rothrock N. Fatigue in systemic lupus erythematosus and rheumatoid arthritis. PM R. 2010 May;2(5):384-92. doi: 10.1016/j.pmrj.2010.03.026.
- Background: PubMed 12202331Sharpe M, Wilks D. Fatigue. BMJ. 2002 Aug 31;325(7362):480-3. doi: 10.1136/bmj.325.7362.480. No abstract available.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
Related trials for Fatigue
Enrolling by invitation
Dance-Based Exercise for Cancer-Related Fatigue in Breast Cancer Patients
Breast Neoplasms
Not yet recruiting
Mind Body Reprogramming Therapy for Adolescents With Chronic Fatigue
Chronic Fatigue
Not yet recruiting
Comparison of Functional Inspiratory Muscle Training and Combined Exercise Training in Individuals With Type 2 Diabetes
Type 2 Diabetes Mellitus
Recruiting
Acute Effects of Post-Exercise Hyperoxia on Recovery in Cycling
Athletic Performance, Hyperbaric Oxygenation
Recruiting
Recovery After Fatigue in Young Athletes: Comparison Between TECAR Therapy and Cycle Ergometer"
Muscle Fatigue, Healthy Adult
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Miroslav Backonja, M.D. principal investigator
National Center for Complementary and Integrative Health (NCCIH)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue and Cancer, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue Level (time frame: Stage 1 and Stage 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03952624, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2026.