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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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 Summary:

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.


Sponsor: Virginia Commonwealth University

Current Primary Outcome: 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.


Original Primary Outcome: Feasibility and acceptability of a lifestyle intervention in cancer survivors [ Time Frame: 3 months ]

Session attendance will be compared to previous lifestyle interventions with non-cancer survivors in this age group (70-80 %.) We will measure retention at 3 months with a goal of attaining comparable retention rates in non-cancer survivor adolescents (70-80%). Acceptability will be determined by responses on feedback measures and qualitative analysis of exit interviews


Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Adherence to changes in dietary and physical activity behaviors during the course of this planned intervention [ Time Frame: 3 months ]

We will examine each participants' changes on the dietary and physical activity measures with the analysis involving changes at the 6 month time point


Information By: Virginia Commonwealth University

Dates:
Date Received: November 26, 2013
Date Started: August 2012
Date Completion:
Last Updated: November 19, 2015
Last Verified: November 2015