NCT00902213

Brief 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).

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
122

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
2 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 15, 2009

Completed
6 months until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

Enrollment Period

5.5 years

First QC Date

May 13, 2009

Last Update Submit

November 16, 2015

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

  • Bone Mineral Density/Bone Mineral Content

    Assessed at baseline and at completion of therapy

Secondary Outcomes (1)

  • Health- related quality of life

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

Study Arms (2)

Minimal movement

NO INTERVENTION

Minimal movement group with usual care non-intervention.

Physical Therapy

ACTIVE COMPARATOR
Behavioral: Physical TherapyBehavioral: Support

Interventions

Physical TherapyBEHAVIORAL

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.

Also known as: Physical Activity to Modify Sequelae and in Childhood ALL.
Physical Therapy
SupportBEHAVIORAL

Visits with an Advanced Practice Nurse to support sustained motivation.

Physical Therapy

Eligibility Criteria

Age4 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • An immunophenotypic diagnosis of non-B cell ALL
  • Age 4 years through \<19 years at diagnosis
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

AFLAC Cancer Center Children's Healthcare of Atlanta

Atlanta, Georgia, 30342, United States

Location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

MD Anderson

Houston, Texas, 77030, United States

Location

Toronto Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Related Publications (1)

  • Ness KK, Kaste SC, Zhu L, Pui CH, Jeha S, Nathan PC, Inaba H, Wasilewski-Masker K, Shah D, Wells RJ, Karlage RE, Robison LL, Cox CL. Skeletal, neuromuscular and fitness impairments among children with newly diagnosed acute lymphoblastic leukemia. Leuk Lymphoma. 2015 Apr;56(4):1004-11. doi: 10.3109/10428194.2014.944519. Epub 2014 Aug 20.

    PMID: 25030039DERIVED

Related Links

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Physical Therapy ModalitiesPalliative Care

Condition Hierarchy (Ancestors)

Leukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitationPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Cheryl L Cox, RN, PhD

    St. Jude Children's Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2009

First Posted

May 15, 2009

Study Start

November 1, 2009

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

US(3)CA(1)