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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 45 Years
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02256137
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

St. Jude Children's Research Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kirsten Ness, PT, PhD
Principal Investigator Affiliation St. Jude Children's Research Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Acute Lymphoblastic Leukemia, Brain Tumor, Hodgkin Lymphoma
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

: Childhood Cancer Survivors

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.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

St. Jude Children's Research Hospital, Memphis, Tennessee

Status

Recruiting

Address

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105

Site Contact

Kirsten Ness, PT, PhD

referralinfo@stjude.org

866-278-5833

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