ALTE1631: Web-based Exercise Study for Children and Adolescents with Acute Lymphoblastic Leukemia

Web-based Physical Activity Intervention among Children and Adolescents with Acute Lymphoblastic Leukemia

Categories:

Leukemia / Lymphoma

Long-term Effects

Diseases Treated:

Acute lymphoblastic leukemia

Eligibility Overview:

This is a non-therapeutic clinical trial open to patients receiving treatment at a Children’s Oncology Group (COG)-affiliated institution.

  • At least 8 years old and younger than 16 years old
  • Newly diagnosed acute lymphoblastic leukemia (ALL), in first remission
  • Completed chemotherapy within past 90 days
  • Performance status corresponding to ECOG scores of 0, 1, 2
  • Fewer than 420 minutes of moderate to vigorous physical activity (MVPA) over the last week
  • Access to smart phone (Android 4.3 or later, iOS 7.1 or later or computer with connection to the internet)
  • Able to write and read English (patient and at least one parent/guardian)
  • Not pregnant
  1. Brief Summary

    Although very few exercise or physical activity interventions for children with cancer have been reported, there is positive evidence that exercise is safe and improves cardiopulmonary fitness and muscle strength. Past studies have relied on supervised training, which is burdensome for families that must travel to the clinic or hospital. Large multi-site, randomized studies are needed to investigate age-appropriate, motivating, realistic and portable interventions that are easily incorporated into daily life. 

    This study will determine if an interactive, web-based exercise intervention improves fitness, quality of life and school attendance in children and adolescents who have recently completed chemotherapy for acute lymphoblastic leukemia (ALL).

    Primary Objective

    • To evaluate the effects of an interactive, web-based exercise intervention on fitness among children and adolescents who have completed treatment for acute lymphoblastic leukemia (ALL)

    Eligibility Criteria

    Inclusion criteria include:

    • At least 8 years old and younger than 16 years old
    • Newly diagnosed ALL, in first remission
    • Completed chemotherapy within past 90 days
    • Performance status corresponding to ECOG scores of 0, 1, 2
    • Fewer than 420 minutes of moderate to vigorous physical activity (MVPA) over the last week
    • Access to smart phone (Android 4.3 or later, iOS 7.1 or later or computer with connection to the internet)
    • Able to write and read English (patient and at least one parent/guardian)

    Exclusion Criteria include:

    • Previous Hematopoietic Stem Cell Transplant (HSCT)
    • Significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy
    • Pregnancy

    Study Sites

    St. Jude Children’s Research Hospital, Memphis, Tennessee
    Collaborating sites in and outside the U.S.

  2. About this study

    Regular physical activity helps maintain a healthy weight, improves energy levels and overall health. Children and adolescents who have received treatment for cancer are often less active, may gain weight and have more health problems compared to children and adolescents who have not received treatment for cancer. This study looks at exercise and its effect on children and teens who have completed treatment for acute lymphoblastic leukemia, also known as ALL.

    Purpose of this clinical trial

    The main goal of this clinical trial is to study the effect of a reward-based website on fitness and quality of life in children and adolescents who have completed chemotherapy for ALL.

    Eligibility overview

    • At least 8 years old and younger than 16 years old
    • Newly diagnosed ALL, in first remission
    • Completed chemotherapy within past 90 days
    • Performance status corresponding to ECOG scores of 0, 1, 2
    • Fewer than 420 minutes of moderate to vigorous physical activity (MVPA) over the last week
    • Access to smart phone (Android 4.3 or later, iOS 7.1 or later or computer with connection to the internet)
    • Able to write and read English (patient and at least one parent/guardian)
    • Not pregnant
  3. ALTE1631 Quick View
    Sponsors Children’s Oncology Group (COG); National Cancer Institute
    ClinicalTrials.gov identifier NCT03223753
    Trial Start Date August 2017
    Estimated Enrollment 384
    Study Type Interventional
    Conditions Acute lymphoblastic leukemia   
    Ages Between 8 and 15 years old
    Principal investigator Kirsten Ness, PT, PhD (at St. Jude)
    Study Sites St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss ALTE1631 St. Jude Physician/Patient Referral Office
    1-888-226-4343
    referralinfo@stjude.org

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

OR

Sarah Terrell, MS, RD, LDN, CCRP
262 Danny Thomas Place
Memphis, TN 38105
Voice: 901-595-4466
Email: sarah.terrell@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.