Status:

COMPLETED

Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia

Lead Sponsor:

St. Jude Children's Research Hospital

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Acute Lymphoblastic Leukemia

Eligibility:

All Genders

4-18 years

Phase:

NA

Brief Summary

This will be the first multidisciplinary, randomized, longitudinal trial of a tailored, parent- and child-focused physical activity program for children (ages 4- \<19 years) with newly diagnosed ALL. ...

Detailed Description

An advanced practice nurse (APN) will meet twice weekly with the patient and family for the first 4 weeks of the intervention to initiate the motivation-based dialogue and therapeutic interaction; thi...

Eligibility Criteria

Inclusion

  • An immunophenotypic diagnosis of non-B cell ALL
  • Age 4 years through \<19 years at diagnosis
  • 2-8 days on or per front line ALL treatment protocol
  • One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language
  • Participant speaks and understands the English language
  • Written informed consent and child assent

Exclusion

  • Age \< 4 years or ≥19 years at diagnosis
  • A diagnosis of cerebral palsy or down syndrome
  • Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency
  • Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent
  • Females who are pregnant.

Key Trial Info

Start Date :

November 1 2009

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

May 1 2015

Estimated Enrollment :

122 Patients enrolled

Trial Details

Trial ID

NCT00902213

Start Date

November 1 2009

End Date

May 1 2015

Last Update

November 17 2015

Active Locations (4)

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Page 1 of 1 (4 locations)

1

AFLAC Cancer Center Children's Healthcare of Atlanta

Atlanta, Georgia, United States, 30342

2

St. Jude Children's Research Hospital

Memphis, Tennessee, United States, 38105

3

MD Anderson

Houston, Texas, United States, 77030

4

Toronto Hospital for Sick Children

Toronto, Ontario, Canada, M5G1X8