Evaluation of Cardiovascular Health Outcomes Among Survivors

Cancer Clinical Trial

— ECHOS  

Official title:

Evaluation of Cardiovascular Health Outcomes Among Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01003574
• Other study ID #: ECHOS
• Secondary ID: R01NR011322
• Status: Completed
• Phase: N/A
• First received: October 27, 2009
• Last updated: November 25, 2013
• Start date: March 2010
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: St. Jude Children's Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 509
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Cancer
• Cardiovascular Risk

Intervention

Behavioral:
• lifestyle modification and telephone counseling
A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
• 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.

Locations

Country	Name	City	State
United States	St . Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital	National Institute of Nursing Research (NINR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Change in knowledge		Baseline and 2.5 years post intervention	No
Secondary	Change in motivation		Baseline and 2.5 years post intervention	No
Secondary	Change in fear		Baseline and 2.5 years post intervention	No
Secondary	Change in beliefs		Baseline and 2.5 years post intervention	No
Secondary	Change in affect		Baseline and 2.5 years post intervention	No
Secondary	Change in readiness for medical follow-up		Baseline and 2.5 years post intervention	No
Secondary	Change in self-efficacy		Baseline and 2.5 years post intervention	No
Secondary	Estimated average cost of intervention per participant		2.5 years	No
Secondary	Estimated average cost of standard care per participant in the Control Arm		2.5 years	No
Secondary	Estimated average cost of cardiovascular screening per participant in the Test Arm		2.5 years	No

External Links

•   St. Jude Children's Research Hospital