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


N/A
4 Years
18 Years
Open (Enrolling)
Both
Acute Lymphoblastic Leukemia

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Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Bone Mineral Density/Bone Mineral Content

Outcome Time Frame:

Assessed at baseline and at completion of therapy

Safety Issue:

No

Principal Investigator

Cheryl L Cox, RN, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

PAQOL

NCT ID:

NCT00902213

Start Date:

November 2009

Completion Date:

March 2015

Related Keywords:

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

Name

Location

St. Jude Children's Research HospitalMemphis, Tennessee  38105-2794
MD AndersonHouston, Texas  77230
AFLAC Cancer Center Children's Healthcare of AtlantaAtlanta, Georgia  30342