Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors

Not Applicable

Withdrawn

• Conditions: Childhood Brain Tumor; Childhood Non-Hodgkin Lymphoma; Childhood Hodgkin Lymphoma; Malignant Childhood Neoplasm
• Interventions: Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy

• Registration Number: NCT02000986
• Lead Sponsor: Virginia Commonwealth University

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 Timeline

• Study Start: 2012-08
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-04
• Primary Completion: 2015-03
• Study Completion: 2015-07
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-19
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->	Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy	Specimen Collection/Risk Factor Assessment -\> Diet/Exercise -\> Chemotherapy

Primary Outcome Measures

Name	Time	Method
Feasibility determined by average attendance and retention	At 3 months	Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.

Secondary Outcome Measures

Name	Time	Method
Feasibility determined by average attendance and retention from the blood pressure at enrollment	At 6 months	Will be assessed via paired T test.
Acceptability level at time of enrollment	At 6 months	Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.