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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier:
NCT00902213
First received: May 13, 2009
Last updated: December 5, 2013
Last verified: December 2013
  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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Health- related quality of life [ Time Frame: Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy ] [ Designated as safety issue: No ]

Enrollment: 122
Study Start Date: November 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Principal Investigator: Cheryl L Cox, RN, PhD St. Jude Children's Research Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT00902213     History of Changes
Other Study ID Numbers: PAQOL, R01CA129384
Study First Received: May 13, 2009
Last Updated: December 5, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 28, 2014