Clinical trial NCT02256137: A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Official title: A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Acute Lymphoblastic Leukemia
Brain Tumor
Hodgkin Lymphoma
Keywords: Frailty phenotype
Physical fitness
Childhood cancer
Late onset of chronic health conditions
Physical frailty
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-10-03
Enrollment: 1468
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will evaluate 1493 members of the St. Jude Lifetime Cohort Study (SJLIFE) who have completed a baseline functional assessment six or less years ago when 18-45 years of age.

Brief 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.

Detailed description: PRIMARY OBJECTIVES:

* Evaluate the change in the proportion of young adult cancer survivors who are frail from baseline to a point five years later.
* Evaluate the association between frailty and worsening of chronic health conditions.
* Describe the association between demographic and treatment factors and risk for prevalent frailty.
* Estimate the effects of physical activity, diet and smoking on risk for prevalent frailty.

Participants will complete a study questionnaire to assess social support, complete body composition studies, walking speed test, physical activity monitoring, and difficulties in daily activities due to health condition. In addition, any data collected as part of the SJLIFE protocol, including questionnaires, medical history and physical, height and weight measurements, physical functioning assessment results (i.e. hand grip strength), and neuropsychological evaluation results, may also be used as part of the evaluation for this study. The information collected for this study will be compared to information collected at a previous SJLIFE clinic visit within the previous 6 years.

Eligibility criteria: Inclusion Criteria:

* Enrollment on the SJLIFE protocol.
* Completed baseline assessment between July 1, 2008 and June 30, 2015.
* Completed the baseline assessment between the ages of 18-45.

Exclusion Criteria:

* Currently pregnant (assessed by serum pregnancy test).
* Currently receiving treatment for cancer.

Primary outcomes:
measure: Change in proportion of participants who are frail from baseline to 5 years later
timeFrame: Baseline and 5 years later (± 1 year)
measure: Association between frailty at baseline and worsening of chronic health conditions 5 years later
timeFrame: Baseline and 5 years later (± 1 year)
measure: Association between demographic and treatment factors and lifestyle on prevalent frailty.
timeFrame: 5 years (± 1 year) after baseline evaluation
measure: Effects of physical activity, diet and smoking on prevalent frailty
timeFrame: 5 years (± 1 year) after baseline evaluation
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Kirsten Ness, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: