Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia (PAQOL)
November 16, 2015 updated by: St. Jude Children's Research Hospital
Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
122
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
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Toronto, Ontario, Canada, M5G1X8
- Toronto Hospital for Sick Children
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-
-
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Georgia
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Atlanta, Georgia, United States, 30342
- AFLAC Cancer Center Children's Healthcare of Atlanta
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Tennessee
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Memphis, Tennessee, United States, 38105
- St. Jude Children's Research Hospital
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Texas
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Houston, Texas, United States, 77030
- MD Anderson
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: 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 Names:
Visits with an Advanced Practice Nurse to support sustained motivation.
|
|
No Intervention: Minimal movement
Minimal movement group with usual care non-intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Bone Mineral Density/Bone Mineral Content
Time Frame: Assessed at baseline and at completion of therapy
|
Assessed at baseline and at completion of therapy
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Health- related quality of life
Time Frame: Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy
|
Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Cheryl L Cox, RN, PhD, St. Jude Children's Research Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (Actual)
May 1, 2015
Study Completion (Actual)
May 1, 2015
Study Registration Dates
First Submitted
May 13, 2009
First Submitted That Met QC Criteria
May 14, 2009
First Posted (Estimate)
May 15, 2009
Study Record Updates
Last Update Posted (Estimate)
November 17, 2015
Last Update Submitted That Met QC Criteria
November 16, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PAQOL
- R01CA129384 (U.S. NIH Grant/Contract)
- NCI-2012-00017 (Registry Identifier: NCI Clinical Trial Registraiton Program)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.