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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00902213
First Posted: May 15, 2009
Last Update Posted: November 17, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
  Purpose
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. It will test the ability of the intervention to prevent or diminish early physical function limitations and improve health-related quality of life (HRQL). The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL. This multi-site trial will test the intervention in 76 evaluable children with ALL (38 receiving the intervention and 38 receiving a placebo "minimal movement" standard care strategy).

Condition Intervention
Acute Lymphoblastic Leukemia Behavioral: Physical Therapy Behavioral: Support

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial

Resource links provided by NLM:


Further study details as provided by St. Jude Children's Research Hospital:

Primary Outcome Measures:
  • Bone Mineral Density/Bone Mineral Content [ Time Frame: Assessed at baseline and at completion of therapy ]

Secondary Outcome Measures:
  • Health- related quality of life [ Time Frame: Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy ]

Enrollment: 122
Study Start Date: November 2009
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Minimal movement
Minimal movement group with usual care non-intervention.
Active Comparator: Physical Therapy Behavioral: Physical Therapy
Each patient in this group will have physical therapy performed. The intervention will be tested for its effect on: 1) physical function outcomes (muscle strength, range of motion, endurance, gross motor skills), bone density and bone mineral content (end of therapy only); and 2) HRQL.
Other Name: Physical Activity to Modify Sequelae and in Childhood ALL.
Behavioral: Support
Visits with an Advanced Practice Nurse to support sustained motivation.

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; this will be followed by once weekly visits during weeks 5-8 of the intervention; and monthly visits during weeks 9-through end of therapy. The physical therapist (PT) will meet at least once weekly with the patient and family during weeks 1-4 to initiate the prescriptive tailored exercise program; subsequent visits to reinforce and modify the program will occur at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135 of the intervention. The PT will visit at least once weekly during weeks 1-4, at least once every other week during weeks 5-8, and at least once monthly during weeks 9-135. During weeks 9-135 of the intervention, the APN will call between the monthly in person-visits, if needed to those randomized to the MAP group to assure fidelity to the intervention and to provide booster support to the intervention where needed.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. An immunophenotypic diagnosis of non-B cell ALL
  2. Age 4 years through <19 years at diagnosis
  3. 2-8 days on or per front line ALL treatment protocol
  4. One parent or legal guardian (≥ 18 years) of the study subject who speaks and understands the English Language
  5. Participant speaks and understands the English language
  6. Written informed consent and child assent

Exclusion Criteria:

  1. Age < 4 years or ≥19 years at diagnosis
  2. A diagnosis of cerebral palsy or down syndrome
  3. Second malignancy, chromosome breakage syndrome, or severe congenital immunodeficiency
  4. Inability or unwillingness of research participant or legal guardian/representative to give written informed consent/assent
  5. Females who are pregnant.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00902213


Locations
United States, Georgia
AFLAC Cancer Center Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30342
United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
United States, Texas
MD Anderson
Houston, Texas, United States, 77030
Canada, Ontario
Toronto Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Sponsors and Collaborators
St. Jude Children's Research Hospital
National Cancer Institute (NCI)
Investigators
Principal Investigator: Cheryl L Cox, RN, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00902213     History of Changes
Other Study ID Numbers: PAQOL
R01CA129384 ( U.S. NIH Grant/Contract )
NCI-2012-00017 ( Registry Identifier: NCI Clinical Trial Registraiton Program )
First Submitted: May 13, 2009
First Posted: May 15, 2009
Last Update Posted: November 17, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Leukemia
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases