Evaluation of Cardiovascular Health Outcomes Among Survivors

Not Applicable

Completed

• Conditions: Cancer; Cardiovascular Risk
• Interventions: Behavioral: lifestyle modification and telephone counseling

• Registration Number: NCT01003574
• Lead Sponsor: St. Jude Children's Research Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2009-10-27
• Study First Submitted QC: 2009-10-28
• Study First Posted: 2009-10-29
• Study Start: 2010-03
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-25
• Last Update Posted: 2013-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 509

Inclusion Criteria

1. Childhood Cancer Survivor Study (CCSS) cohort participants
2. Age 25 years or older
3. No CV screening in previous 5 years
4. Received anthracycline chemotherapy and/or irradiation of the chest
5. Previous history of successful independent (non-surrogate) response to CCSS surveys (reading level for non-medical items is 4th-6th grade Flesch-Kincaid level).

Exclusion Criteria

1. Being followed at an institution actively recruiting adults to a long-term follow-up program (ascertained in CCSS follow-up database)
2. Inability or unwillingness of research participant to give written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	lifestyle modification and telephone counseling	Control arm will receive standard care for risk of cardiac sequelae - a mailed, tailored (neither generic nor targeted) print summary of individualized information about the survivor's treatment, late effects risks, and recommended follow-up and lifestyle modifications.
Test Arm	lifestyle modification and telephone counseling	Test arm will receive standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.

Primary Outcome Measures

Name	Time	Method
This study will test the hypothesis that at 1 year post-intervention, a significantly greater proportion of the APN phone counseling group will have undergone cardiovascular screening, as compared to the standard care group	2.5 years

Secondary Outcome Measures

Name	Time	Method
Change in knowledge	Baseline and 2.5 years post intervention
Change in affect	Baseline and 2.5 years post intervention
Change in readiness for medical follow-up	Baseline and 2.5 years post intervention
Change in self-efficacy	Baseline and 2.5 years post intervention
Estimated average cost of intervention per participant	2.5 years
Estimated average cost of standard care per participant in the Control Arm	2.5 years
Estimated average cost of cardiovascular screening per participant in the Test Arm	2.5 years
Change in motivation	Baseline and 2.5 years post intervention
Change in fear	Baseline and 2.5 years post intervention
Change in beliefs	Baseline and 2.5 years post intervention

Trial Locations

Locations (1)

St . Jude Children's Research Hospital; 🇺🇸 Memphis, Tennessee, United States