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Evaluation of Cardiovascular Health Outcomes Among Survivors


N/A
25 Years
N/A
Open (Enrolling)
Both
Cardiovascular Risk, Cancer

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Trial Information

Evaluation of Cardiovascular Health Outcomes Among Survivors


- 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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

2.5 years

Safety Issue:

No

Principal Investigator

Melissa Hudson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

St. Jude Children's Research Hospital

Authority:

United States: Institutional Review Board

Study ID:

ECHOS

NCT ID:

NCT01003574

Start Date:

March 2010

Completion Date:

February 2014

Related Keywords:

  • Cardiovascular Risk
  • Cancer
  • cardiovascular health outcomes in cancer survivors

Name

Location

St . Jude Children's Research HospitalMemphis, Tennessee  38105