- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02000986
Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
Effect of Non-Pharmacologic Interventions on Risk Factors of Cardiovascular Disease in Survivors of Childhood Leukemia, Lymphoma and Brain Tumor
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Specimen Collection/Risk Factor Assessment -> Diet/Exercise ->
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
Time Frame: At 6 months
|
Will be assessed via paired T test.
|
At 6 months
|
Acceptability level at time of enrollment
Time Frame: At 6 months
|
Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews.
|
At 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marieka A Helou, MD, Massey Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Neoplasms by Site
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Neoplasms
- Lymphoma
- Cardiovascular Diseases
- Leukemia
- Hodgkin Disease
- Lymphoma, Non-Hodgkin
- Brain Neoplasms
Other Study ID Numbers
- MCC-14062
- HM14062 (Other Identifier: Virginia Commonwealth Unniversity IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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