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Completed

NCT Number: NCT00902213

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

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).

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Key information

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Hospital for Sick Children, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Therapy

Behavioral

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.

SUPPORT

Behavioral

Visits with an Advanced Practice Nurse to support sustained motivation.

Primary outcomes

  1. Bone Mineral Density/Bone Mineral Content

    Time frame: Assessed at baseline and at completion of therapy

Secondary outcomes

  1. Health- related quality of life

    Time frame: Assessed at baseline, 8 and 15 weeks after baseline and at completion of therapy

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Acronym: PAQOL

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
May 15, 2009
Registry last updated
Nov 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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