Dietary and Exercise Interventions in Preventing Cardiovascular Disease in Younger Survivors of Leukemia, Lymphoma, or Brain Tumors
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|ClinicalTrials.gov Identifier: NCT02000986|
Recruitment Status : Withdrawn (Slow accrual)
First Posted : December 4, 2013
Last Update Posted : November 20, 2015
|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||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|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 :||August 2012|
|Actual Primary Completion Date :||March 2015|
|Actual Study Completion Date :||July 2015|
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
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000986
|Principal Investigator:||Marieka A Helou, MD||Massey Cancer Center|