Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02256137
Study type Observational
Source St. Jude Children's Research Hospital
Contact Kirsten Ness, PT, PhD
Phone 866-278-5833
Email referralinfo@stjude.org
Status Recruiting
Phase
Start date October 8, 2014
Completion date June 2021

See also
  Status Clinical Trial Phase
Recruiting NCT03114865 - A Study of Blinatumomab in Patients With Pre B-cell ALL and B-cell NHL as Post-allo-HSCT Remission Maintenance Early Phase 1
Terminated NCT02231853 - Phase I/II Trial of Early Infusion of Rapidly-generated Multivirus Specific T Cells (MVST) to Prevent Post Transplant Viral Infections Phase 1
Withdrawn NCT02815059 - Study of Pts With Philadelphia Chromosome-Pos ALL With Comb of Ibrutinib, Dasatinib, and Prednisone Phase 1
Not yet recruiting NCT03575325 - Vyxeos(CPX-351) in Adults w R/R Acute Lymphoblastic Leukemia Phase 2
Not yet recruiting NCT03318770 - Post-Frontline Sequential Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
Not yet recruiting NCT03571321 - Ruxolitinib and Chemotherapy in Adolescents and Young Adults With Ph-like Acute Lymphoblastic Leukemia Phase 1
Completed NCT02544438 - Study Evaluating the Safety and Efficacy of Astarabine in Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia Phase 1/Phase 2
Terminated NCT02257684 - A Dose Confirmation and Pharmacokinetic Study of Pegcrisantaspase Administered as Intravenous (IV) Infusion in Children and Young Adults With Acute Lymphoblastic Leukemia (ALL) /Lymphoblastic Lymphoma (LBL). Following Hypersensitivity to Pegaspargase (Oncaspar) Phase 2
Completed NCT02188290 - Transplant-Related Mortality in Patients Undergoing a Peripheral Blood Stem Cell Transplantation or an Umbilical Cord Blood Transplantation N/A
Active, not recruiting NCT01943682 - Safety Study of CPX-351 in Children With Relapsed Leukemia or Lymphoma Phase 1
Completed NCT02010931 - Retrospective Analysis of Survival in Adult MRD Positive Acute Lymphoblastic Leukemia Patients N/A
Completed NCT01684150 - A Phase 1, Open-Label, Dose-Escalation & Expanded Cohort, Continuous IV Infusion, Multi-center Study of the Safety, Tolerability,PK & PD of EPZ-5676 in Treatment Relapsed/Refractory Patients With Leukemias Involving Phase 1
Completed NCT01697020 - Bioequivalence of An Oral Mercaptopurine Suspension 100 Mg / 5 Ml Versus Tablet in Healthy Male Subjects Under Fasting Conditions Phase 1
Completed NCT01188798 - Methotrexate or Pentostatin for Graft-versus-host Disease Prophylaxis in Risk-adapted Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Phase 3
Completed NCT01051154 - Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia Phase 2
Completed NCT01169012 - PK Study of Oral and IV Clofarabine in High Risk Myelodysplasia+Acute Leukemias Phase 1
Terminated NCT01230788 - Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia N/A
Recruiting NCT00982514 - Thromboembolic Complications Related to Asparaginase in Children With Acute Lymphoblastic Leukemia (ALL) Treated According to NOPHO ALL 2008 N/A
Active, not recruiting NCT00983528 - Alemtuzumab and Clofarabine for Relapsed or Refractory Acute Lymphoblastic Leukemia Phase 1/Phase 2
Terminated NCT00866281 - A Study of the Safety and Preliminary Efficacy of Oral Midostaurin (PKC412) in Relapsed or Refractory Pediatric Leukemia Phase 1/Phase 2