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A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer

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clinicaltrials.gov/study/NCT02256137
Is a
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Clinical study
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Clinical Study attributes

NCT Number
NCT022561370
Health Conditions in Trial
Acute lymphoblastic leukemia
Acute lymphoblastic leukemia
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Brain tumor
Brain tumor
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Trial Recruitment Size
1,4680
Trial Sponsor
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
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Trial Collaborator
0
Clinical Trial Start Date
October 8, 2014
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Primary Completion Date
August 17, 2025
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Study Completion Date
August 17, 2025
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Clinical Trial Study Type
Observational0
Observational Clinical Trial Type
Cohort0
Observational Study Perspective
Prospective0
Participating Facility
St. Jude Children's Research Hospital
St. Jude Children's Research Hospital
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Official Name
A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer0
Last Updated
July 7, 2023
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Study summary

Advances in cancer therapies have led to increasing numbers of adult survivors of pediatric malignancy. Unfortunately, treatment of childhood cancer continues to require agents designed to destroy malignant cell lines, and normal tissue is not always spared. While early treatment- related organ specific toxicities are not always apparent, many childhood cancer survivors report symptoms that interfere with daily life, including exercise induced shortness of breath, fatigue and reduced capacity to participate in physical activity. These symptoms may be a hallmark of premature aging, or frailty. Frailty is a phenotype most commonly described in older adults; it indicates persons who are highly vulnerable to adverse health outcomes. Frailty may help explain why nearly two thirds of childhood cancer survivors have at least one severe chronic health condition 30 years from diagnosis, why childhood cancer survivors are more likely than peers to be hospitalized for non-obstetrical reasons, and why they have mortality rates more than eight times higher than age-and-gender matched members of the general population. Frailty is a valuable construct because it can be distinguished from disability and co-morbidity, and is designed to capture pre-clinical states of physiologic vulnerability that identify individuals most at risk for adverse health outcomes. These investigators have recently presented data indicating that impaired fitness is present in survivors of childhood acute lymphoblastic leukemia, brain tumor and Hodgkin lymphoma. This is relevant because frailty, characterized by a cluster of five measurements of physical fitness, is predictive of chronic disease onset, frequent hospitalization, and eventually mortality in both the elderly and in persons with chronic conditions. Using a frailty phenotype as an early predictor of later chronic disease onset will allow identification of childhood and adolescent cancer survivors at greatest risk for adverse health. An early indicator of those at risk for adverse health will allow researchers to test, and clinicians to provide, specific interventions designed to remediate functional loss, and prevent or delay onset of chronic health conditions. The investigators goals include characterizing physical frailty over a five year time span in a population of young adult survivors of childhood cancer, as well as assessing the association between frailty and the increase in the number and severity of chronic health conditions.

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