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Clinical Trial VICCPED1309

Title

ALL-Active: A Family-Based Lifestyle Program for Pediatric Acute Leukemia Patients

Principal Investigator(s)

Adam Esbenshade

Details

  • Protocol No. VICCPED1309
  • Open Date: 03/29/2013
  • Staging: Pilot
  • Age Group: Children
  • Scope: Local
  • Objective: A family-based nutrition and exercise intervention in pediatric acute lymphoblastic leukemia (ALL) patients during maintenance therapy will demonstrate feasibility, as determined by participant enrollment, adherence, completion and satisfaction.
  • Disease Sites: Pediatric Leukemia
  • Therapies: None Specified
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01901367
  • Secondary Protocol No: Not Specified

Description

None Provided.

Eligibility

Ages Eligible for Study:2 Years to 18 Years
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
• 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 Criteria:
• 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.