Patient-Centered Assessment of Symptoms and Outcomes

Cancer Clinical Trial

Official title: Patient-Centered Assessment of Symptoms and Outcomes

Status Recruiting

Clinical 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. 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.

Clinical Trial 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 672 persons with or without clinically-meaningful fatigue. Approximately 20 will be enrolled in the technical development substudy to refine the neuroimaging techniques used in this study. This protocol is open to anyone of any ethnicity, gender, 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. ;

Related Conditions & MeSH terms

• Cancer
• CFS
• Encephalomyelitis
• Fatigue
• Fatigue Syndrome, Chronic
• Lupus
• ME/CFS
• Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
• Systemic Lupus Erthematosus

• NCT number: NCT03952624
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Alexander Ross, R.N.
• Phone: (301) 841-5068
• Email: alexander.ross2@nih.gov
• Status: Recruiting
• Start date: September 13, 2019
• Completion date: July 1, 2025