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

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.

Official Title
-----------------
Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor

Conditions
-----------------
Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma, Malignant Childhood Neoplasm

Intervention / Treatment
-----------------
* Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum Age: 17 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -><br>Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy | Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy<br>* Participants will be taught by a registered dietician about energy balance and how body weight relates to energy intake and expenditure, although specific calorie prescriptions will not be given. An exercise physiologist will create a personalized exercise plan and prescription which is tailored to his / her needs and current level of activity and fitness<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility determined by average attendance and retention | Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews. | At 3 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hodgkin's Lymphoma, Brain and Nervous System, Non-Hodgkin's Lymphoma, Leukemia, not otherwise specified