Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Primary Endpoint
- Feasibility determined by average attendance and retention
Study Overview
Brief Summary
This clinical trial studies dietary and exercise interventions in preventing cardiovascular disease in younger survivors of childhood cancer. Eating a healthy diet and exercising regularly may reduce the risk of cardiovascular disease in younger survivors of childhood cancer.
Detailed Description
Participants receive personalized exercise plan and prescription tailored to individual needs and current level of activity and fitness, and they also receive 2 one-hour individual exercise training sessions consisting of 20-30 minutes cardiovascular activity and strength training. Participants receive nutritional education consisting of energy balance, appropriate portion sizes, calorie count, and basic nutrition skills such as label reading every 2 weeks for 12 weeks.
After completion of study treatment, patients are followed for up to 6 months.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 11 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of pediatric cancer
- •Patients 3 months to 1 year after completion of therapy
Exclusion Criteria
- •Patients who are already on antihypertensive or insulin or cholesterol lowering medication
- •Patients who have not been evaluated for exercise tolerance and cleared by their physician for participation
- •Inability to understand program instructions due to language barrier or mental disability
- •Unable to participate in the outlined exercise program due to a physical disability
Arms & Interventions
Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
Intervention: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy (Behavioral)
Outcomes
Primary Outcomes
Feasibility determined by average attendance and retention
Time Frame: At 3 months
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
Secondary Outcomes
- Acceptability level at time of enrollment(At 6 months)
- Feasibility determined by average attendance and retention from the blood pressure at enrollment(At 6 months)