Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors
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|ClinicalTrials.gov Identifier: NCT01231932|
Recruitment Status : Recruiting
First Posted : November 1, 2010
Last Update Posted : October 22, 2020
- Fatigue is a common side effect of cancer and its treatment. Up to 96% of patients with cancer have fatigue. The cause of fatigue in people with cancer or those receiving treatment is poorly understood, making fatigue hard to treat. More research is necessary to understand why cancer patients experience fatigue. Previous research has shown that fatigue may be caused by a number of factors, including problems with the immune system response of the body while undergoing cancer treatment. The researchers of this study are trying to understand how the immune system and other chemicals of the body change while a person receives cancer treatment and how these changes play a role in causing fatigue. The researchers are also interested in how a person s quality of life is affected by fatigue.
- To study fatigue in individuals who have cancer, are receiving cancer treatment, or have recently completed cancer treatment.
- Individuals at least 18 years of age.
- Receiving cancer treatment, OR recently completed primary treatment for cancer (e.g., cancer survivors), OR on active surveillance for localized cancer.
- This study involves an initial screening visit and up to three outpatient visits.
- Participants will be screened with a medical history review (can be done virtually) and blood tests. A physical exam might also occur.
Participants undergoing cancer treatment that has a clear completion date, will have the following visits:
- Before the start of treatment.
- At the end of treatment.
- At least 3 months after treatment ends.
Participants not receiving treatment, are cancer survivors, or undergoing cancer treatment that does not have a clear completion date, will have up to 3 visits:
- Before the start of treatment or whenever you begin the study.
- At least 3 months after your first visit.
- At least 3 months after your second visit.
At each study visit, participants will complete the following tasks (some of the tasks can be done from home or virtually):
- Questionnaires about physical activity, fatigue, depression, and quality of life (can be done at home or virtually).
- Have blood drawn.
- Physical activity device and journals to study how fatigue affects physical activity.
- Computer games testing your memory, attention, and ability to follow directions.
- Hand grip strength test to evaluate physical strength.
- Treatment will not be provided under this study.
|Condition or disease|
Although the underlying mechanisms of fatigue have been studied in several disease conditions, the etiology, mechanisms, and risk factors remain elusive, and this symptom remains poorly managed at present. Longitudinal studies related to treatment-related fatigue in cancer patients have been conducted but there are limited data showing changes in molecular mechanisms before and after cancer therapy which can identify individuals who are at risk to experience fatigue during and after therapy. Fatigue is conceptualized as a multidimensional symptom which incorporates temporal, sensory, cognitive/mental, affective/emotional, behavioral, and physiological dimensions. This prospective, observational study will explore the molecular-genetic mechanisms underlying fatigue experienced by cancer patients receiving various therapies (e.g. immune therapy, hormone therapy, radiation therapy and chemotherapy).
The primary objective of the study is to describe the changes in the self-reported fatigue experienced by cancer patients over time. The secondary objectives of this study are to (1) investigate the associations between inflammatory, neurometabolic, stress, and mitochondrial markers with fatigue intensification over time during the course of treatments, (2) determine changes in gene expression from peripheral blood samples over time during the course of treatments, (3) relate changes in the levels of these biological markers (i.e., inflammatory/metabolic/stress profiles and gene expression) to patient reported outcomes (PROs) of self-reported fatigue, sleep disturbance, depression, and health-related quality of life (HRQOL) scores, (4) measure cognitive functioning, skeletal muscle strength, physical activity levels and energy expenditure of patients and relate these findings with changes in PRO scores, the inflammatory/metabolic/stress profiles and gene expression, and (5) investigate the psychometric property of the Saligan-Walitt Integrated Fatigue Tool (SWIFT).
|Study Type :||Observational|
|Estimated Enrollment :||414 participants|
|Official Title:||Characterizing Fatigue Experienced by Cancer Patients Receiving Primary Treatment and Cancer Survivors|
|Actual Study Start Date :||February 4, 2011|
Individuals recently completed primary treatment for cancer
Individuals receiving cancer treatment
Individuals receiving cancer treatment
Individuals with cancer
Individuals with cancer
- Self-reported fatigue [ Time Frame: Up to 3 times throughout study ]Self-reported fatigue
- The inflammatory/metabolic/stress profile; gene expression changes; self reported fatigue; sleep disturbance; depression; HRQOL scores; cognitive function; skeletal muscle strength; physical activity levels and energy expenditure; SWIFT scores. [ Time Frame: Up to 3 times throughoutr study ]The inflammatory/metabolic/stress profile; gene expression changes; self reported fatigue; sleep disturbance; depression; HRQOL scores; cognitive function; skeletal muscle strength; physical activity levels and energy expenditure; SWIFT scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01231932
|Contact: Angela Wang, R.N.||(301) firstname.lastname@example.org|
|Contact: Leorey N Saligan, C.R.N.P.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Leorey N Saligan, C.R.N.P.||National Institute of Nursing Research (NINR)|