Status:
COMPLETED
ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients
Lead Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Childhood Acute Lymphoblastic Leukemia in Remission
Eligibility:
All Genders
2-18 years
Phase:
NA
Brief Summary
This randomized pilot phase II trial studies how well nutritional intervention and exercise intervention works in preventing metabolic syndrome in younger patients with acute lymphoblastic leukemia. N...
Detailed Description
PRIMARY OBJECTIVES: I. To evaluate feasibility, adherence, completion rates and participant satisfaction associated with a family based lifestyle intervention for overweight pediatric acute lymphobla...
Eligibility Criteria
Inclusion
- Diagnosis of pre-B cell or T cell ALL and in continuous first remission; at least 3 months into maintenance therapy with at least 7 months remaining before therapy completion
- English speaking patient and primary caregiver
- BMI \>= 75th percentile at time of study enrollment; (patients \>= 75th percentile were selected as they were the group in our preliminary data that had a high risk of becoming overweight during maintenance therapy)
- Provision of informed consent by primary caregiver
Exclusion
- Any physical or mental limitation that would prevent participation in study activities (Including but not limited to grade 4 neuropathy or inability to ambulate)
- As this is intended to be a family-based intervention, all family members will be invited to participate, including those living in more than one household, however endpoints will only be assessed formally in the patient and identified primary caregiver; siblings are not required for participation.
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01901367
Start Date
May 1 2013
End Date
September 1 2015
Last Update
May 8 2018
Active Locations (1)
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1
Vanderbilt University
Nashville, Tennessee, United States, 37232