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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G1X8
        • Toronto Hospital for Sick Children
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • AFLAC Cancer Center Children's Healthcare of Atlanta
    • Tennessee
      • Memphis, Tennessee, United States, 38105
        • St. Jude Children's Research Hospital
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson

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:

  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 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
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 Names:
  • Physical Activity to Modify Sequelae and in Childhood ALL.
Behavioral: Support
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.

Sponsor

St. Jude Children's Research Hospital

Collaborators

National Cancer Institute (NCI)

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.

General Publications

Helpful Links

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.

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