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

Sponsor

Virginia Commonwealth University (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02000986

Collaborator

(none)

Enrollment

Arm

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Childhood Brain Tumor Childhood Hodgkin Lymphoma Childhood Non-Hodgkin Lymphoma Malignant Childhood Neoplasm	Behavioral: Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy	N/A

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

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Aug 1, 2012

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->

Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy

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

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

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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