Acute Lymphoblastic LeukemiaNCT02256137
A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
An observational study of Acute Lymphoblastic Leukemia and Brain Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, Brain Tumor, Hodgkin Lymphoma
- How many people
- 1,564 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2014to 1 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Currently pregnant (assessed by serum pregnancy test).
- Currently receiving treatment for cancer.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
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.
Read the 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.
- Conditions
- Acute Lymphoblastic Leukemia, Brain Tumor, Hodgkin Lymphoma
- Keywords
- Frailty phenotype, Physical fitness, Childhood cancer, Late onset of chronic health conditions, Physical frailty
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Brain Neoplasms, Hodgkin Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in proportion of participants who are frail from baseline to 5 years later
We will use McNemar's test to assess if the prevalence of frailty has significantly increased over the 5-year time period.
Measured: Baseline and 5 years later (± 1 year)
Association between frailty at baseline and worsening of chronic health conditions 5 years later
The event of interest, worsening of chronic condition, will be defined as binary outcome which will take value of 1 if, compared to baseline evaluation, a survivor develops a new chronic condition (grade ≥3) or if the chronic condition worsens over the 5-year time period (i.e. goes from grades 1-2 to grade ≥3 or dies due to chronic condition); otherwise it will take a value of 0.
Measured: Baseline and 5 years later (± 1 year)
Association between demographic and treatment factors and lifestyle on prevalent frailty.
We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.
Measured: 5 years (± 1 year) after baseline evaluation
Effects of physical activity, diet and smoking on prevalent frailty
We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.
Measured: 5 years (± 1 year) after baseline evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2014 (estimated)
- Study start8 Oct 2014
- Primary completion21 Sep 2018
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,564 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Kirsten Ness, PT, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02256137
- Sponsor's protocol ID
- FRAILTY
- Other IDs
- R01CA174851
- Status last verified
- Jun 2026
- First submitted
- 1 Oct 2014
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Assessment of Frailty in Young Adult Survivors of Childhood Cancer
- ClinicalTrials.gov ID
- NCT02256137
- Acronym / sponsor ID
- FRAILTY
- Conditions
- Acute Lymphoblastic Leukemia, Brain Tumor, Hodgkin Lymphoma
- Keywords
- Frailty phenotype, Physical fitness, Childhood cancer, Late onset of chronic health conditions, Physical frailty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,564 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Oct 2014 (actual)
- Primary completion
- 21 Sep 2018 (actual)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 3 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Currently pregnant (assessed by serum pregnancy test).
- Currently receiving treatment for cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in proportion of participants who are frail from baseline to 5 years later
Time frame: Baseline and 5 years later (± 1 year)
We will use McNemar's test to assess if the prevalence of frailty has significantly increased over the 5-year time period.
Association between frailty at baseline and worsening of chronic health conditions 5 years later
Time frame: Baseline and 5 years later (± 1 year)
The event of interest, worsening of chronic condition, will be defined as binary outcome which will take value of 1 if, compared to baseline evaluation, a survivor develops a new chronic condition (grade ≥3) or if the chronic condition worsens over the 5-year time period (i.e. goes from grades 1-2 to grade ≥3 or dies due to chronic condition); otherwise it will take a value of 0.
Association between demographic and treatment factors and lifestyle on prevalent frailty.
Time frame: 5 years (± 1 year) after baseline evaluation
We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.
Effects of physical activity, diet and smoking on prevalent frailty
Time frame: 5 years (± 1 year) after baseline evaluation
We will examine the association in a path model (all variables are measured) as lifestyle factors are likely to be mediators of the association between treatment and the frailty outcome at the five year time point. Sex, age at diagnosis, radiation exposure, specific chemotherapy agent doses, and age will be included in the initial theoretical model as exogenous variables and physical activity, diet, smoking status and frailty will be included as endogenous variables. Other variables, like medication use, baseline chronic disease, etc. will be evaluated for their contributions to the outcomes.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kirsten Ness, PT, PhD principal investigator
St. Jude Children's Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and Brain Tumor, run by St. Jude Children's Research Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in proportion of participants who are frail from baseline to 5 years later (time frame: Baseline and 5 years later (± 1 year)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.