Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
Primary Purpose
Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Childhood Brain Tumor focused on measuring Hodgkin's Lymphoma, Brain and Nervous System, Non-Hodgkin's Lymphoma, Leukemia, not otherwise specified
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->
Arm Description
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
Outcomes
Primary Outcome Measures
Feasibility determined by average attendance and retention
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
Will be assessed via paired T test.
Acceptability level at time of enrollment
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
Full Information
NCT ID
NCT02000986
First Posted
November 26, 2013
Last Updated
November 19, 2015
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT02000986
Brief Title
Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
Official Title
Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Slow accrual
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
July 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Childhood Brain Tumor, Childhood Hodgkin Lymphoma, Childhood Non-Hodgkin Lymphoma, Malignant Childhood Neoplasm
Keywords
Hodgkin's Lymphoma, Brain and Nervous System, Non-Hodgkin's Lymphoma, Leukemia, not otherwise specified
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->
Arm Type
Experimental
Arm Description
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
Intervention Type
Behavioral
Intervention Name(s)
Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Feasibility determined by average attendance and retention
Description
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
Time Frame
At 3 months
Secondary Outcome Measure Information:
Title
Feasibility determined by average attendance and retention from the blood pressure at enrollment
Description
Will be assessed via paired T test.
Time Frame
At 6 months
Title
Acceptability level at time of enrollment
Description
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
Time Frame
At 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marieka A Helou, MD
Organizational Affiliation
Massey Cancer Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
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