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

Acute Lymphoblastic Leukemia Clinical Trial

— PAQOL  

Official title:

Physical Activity to Modify Sequelae and Quality of Life in Childhood Acute Lymphoblastic Leukemia: A Nursing Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902213
• Other study ID #: PAQOL
• Secondary ID: R01CA129384NCI-2
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: November 16, 2015
• Start date: November 2009
• Est. completion date: May 2015

Study information

• Verified date: November 2015
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.
• Support
Visits with an Advanced Practice Nurse to support sustained motivation.

Locations

Country	Name	City	State
Canada	Toronto Hospital for Sick Children	Toronto	Ontario
United States	AFLAC Cancer Center Children's Healthcare of Atlanta	Atlanta	Georgia
United States	MD Anderson	Houston	Texas
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone Mineral Density/Bone Mineral Content		Assessed at baseline and at completion of therapy	No
Secondary	Health- related quality of life		Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy	No

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital