Motor Proficiency And Physical Activity in Adult Survivors of Childhood Acute Lymphoblastic Leukemia (ALL)

NCT01047020 | Completed

• 2 other identifiers: MTRPALR01CA132901
• Study Type: observational
• Target: 807
• Locations: 1 country
• Sites: 1

Brief Summary

The primary goal of this study is to provide comprehensive and objective information on impairments of musculoskeletal health, sensory function, and fitness among a large group of childhood ALL survivors, and to define high risk groups by assessing treatment factors that contribute to impaired function. This study includes a direct, objective evaluation of musculoskeletal function, sensory capacity, fitness, and physical activity patterns among adults who were treated for childhood ALL at St. Jude Children's Research Hospital (SJCRH) between 1980 and 1999. Among 899 ALL survivors, all of whom are eligible for an institutionally funded clinical study of medical late effects, the study will recruit 364 to participate in our evaluations. The study will also recruit 364 individuals for a comparison group, frequency matching on race/ethnicity, age and gender.

Conditions

Acute Lymphoblastic Leukemia

Keywords

Impairments of musculoskeletal Health;; Physical activity;; Motor Proficiency;

Outcome Measures

Primary Outcomes (1)

• Ascertain the prevalence of musculoskeletal, sensory, and fitness impairments among adult survivors of childhood ALL.

  Day 1-2

Secondary Outcomes (3)

• Compare physical activity patterns between adult survivors of childhood ALL and a frequency matched control group.

  Day 1-7

• Describe the association between habitual physical activity and energy expenditure among ALL survivors.

  Day 1-7

• Explore the associations between musculoskeletal and sensory health, and physical activity patterns among adult survivors of childhood ALL.

  Day 1-7

Study Arms (2)

ALL survivors

The study sample for this research will be recruited from participants in an institutionally funded cohort study, St. Jude Life, as well as from active ACT patients that meet eligibility criteria. The young adults in St. Jude Life are a highly motivated group who were followed in the After Completion of Therapy Clinic until age 18 years and a minimum of 10 years after their treatment ended if they were older than age 11 at the end of therapy

Comparison Group

Potentially eligible comparison group participants will be recruited from the parent, older sibling, relative or friend population who accompany the ACT patient for follow-up at SJCRH. Parents (or siblings, relatives or friends who are 18 years or older) of children in remission, both from the active follow-up cohort (within five years of last treatment) and the After Completion of Therapy (ACT) cohort will be invited to complete the same assessments that the ALL survivor participants will complete. Comparison group participants are frequency matched to potentially eligible participants by race/ethnicity (white, black, other) age group (18 to 29, 30-39, 40-49 years) and gender.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study sample for this research will be recruited from participants in an institutionally funded cohort study, St. Jude Life, as well as from active ACT patients that meet eligibility criteria. The young adults in St. Jude Life are a highly motivated group who were followed in the After Completion of Therapy Clinic until age 18 years and a minimum of 10 years after their treatment ended if they were older than age 11 at the end of therapy. Potentially eligible comparison group participants will be recruited from the parent, older sibling, relative or friend population who accompany the ACT patient for follow-up at SJCRH. Parents (or siblings, relatives or friends who are 18 years or older) of children in remission, both from the active follow-up cohort (within five years of last treatment) and the After Completion of Therapy (ACT) cohort will be invited to complete the same assessments that the ALL survivor participants will complete.

You may qualify if:

• Research participant who is a survivor of childhood ALL who was treated at St. Jude Children's Research Hospital between 1980 and 1999
• Research participant must be at least ten years from diagnosis
• Research participant must be at least 18 years of age at the time of the scheduled evaluation

You may not qualify if:

• Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
• Research participant currently pregnant or lactating
• Research participant age 17 years or less
• Research participant undergoing active treatment for cancer
• Research participant is a sibling, parent, relative or friend of a current or former St. Jude patient.
• Research participant must be at least 18 years of age at the time of the scheduled evaluation
• Research participant who has Down Syndrome or congenital cognitive, musculoskeletal or cardiopulmonary impairments that interfere with motor function
• Research participant currently pregnant or lactating
• Research participant age 17 years or less
• Research participant has a medical history of cancer
• Research participant is a first degree relative of a survivor participating in MTRPAL

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead
• National Cancer Institute (NCI): collaborator
• University of Tennessee: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Links

• St. Jude Children's Research Hospital

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Motor Activity

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Behavior

Study Officials

• Kirsten K Ness, PT, Ph.D

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2010
• First Posted: January 12, 2010
• Study Start: June 1, 2009
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 27, 2015

Record last verified: 2013-08

Locations

US (1)