Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia (PAQOL)
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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 |
- Bone Mineral Density/Bone Mineral Content [ Time Frame: Assessed at baseline and at completion of therapy ] [ Designated as safety issue: No ]
- 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 |
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.
Contacts and 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 | |
| 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 18, 2012 |
| 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 May 22, 2013