Evaluation of Cardiovascular Health Outcomes Among Survivors
NCT ID: NCT01003574
Last Updated: 2013-11-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
509 participants
INTERVENTIONAL
2010-03-31
2013-07-31
Brief Summary
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Detailed Description
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* 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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SCREENING
NONE
Study Groups
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Control Arm
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.
lifestyle modification and telephone counseling
A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
Test Arm
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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Inability or unwillingness of research participant to give written informed consent.
25 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Melissa Hudson, MD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St . Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Hudson MM, Leisenring W, Stratton KK, Tinner N, Steen BD, Ogg S, Barnes L, Oeffinger KC, Robison LL, Cox CL. Increasing cardiomyopathy screening in at-risk adult survivors of pediatric malignancies: a randomized controlled trial. J Clin Oncol. 2014 Dec 10;32(35):3974-81. doi: 10.1200/JCO.2014.57.3493. Epub 2014 Nov 3.
Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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ECHOS
Identifier Type: -
Identifier Source: org_study_id