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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


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
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