NCT01003574

Evaluation of Cardiovascular Health Outcomes Among Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 509 (actual)
• Sponsor: St. Jude Children's Research Hospital · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

This study will test a 2-tiered tailored intervention and evaluation of cardiovascular health outcomes among survivors designed to inform childhood cancer survivors about their individual cardiac risk and follow-up recommendations and to provide motivational support for cardiovascular (CV) screening. This study will test if the addition of telephone motivational interviewing, tailored to behavioral constructs, is superior to the current standard of care in increasing survivors' CV screening.

Detailed description

* This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the advanced-practice nurse (APN) phone counseling group will have undergone cardiovascular screening, as compared to the standard care group. Cardiovascular (CV) screening will be defined, based on established CV screening recommendations, as completion of an imaging evaluation of left ventricular systolic function (i.e., echocardiogram, multiple uptake gated acquisition scan, or cardiac magnetic resonance imaging). * This study will measure changes induced by the intervention in survivors' knowledge, motivation, fear, beliefs, affect, readiness for medical follow-up, and self-efficacy and these changes' potential mediating effects on CV screening. * This study will provide a cost analysis of the ECHOS intervention in terms of the cost of left ventricular systolic function imaging per additional survivor screened, an estimate of the cost of standard care per survivor screened, and the cost of screening and follow-up per survivor screened.

Conditions

• Cardiovascular Risk
• Cancer

Interventions

Type	Name	Description
BEHAVIORAL	lifestyle modification and telephone counseling	A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
BEHAVIORAL	lifestyle modification and telephone counseling	Standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.

Timeline

• Start date: 2010-03-01
• Primary completion: 2013-07-01
• Completion: 2013-07-01
• First posted: 2009-10-29
• Last updated: 2013-11-26

Locations

1 site across 1 country: United States