ECHOS: Evaluation of Cardiovascular Health Outcomes Among Survivors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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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).
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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.
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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. |
Behavioral: lifestyle modification and telephone counseling
A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
Other Names:
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| Other: 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. |
Behavioral: 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 Names:
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Outcome Measures
Primary Outcome Measures
- 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
- Change in knowledge [Baseline and 2.5 years post intervention]
- 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]
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Childhood Cancer Survivor Study (CCSS) cohort participants
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Age 25 years or older
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No CV screening in previous 5 years
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Received anthracycline chemotherapy and/or irradiation of the chest
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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:
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Being followed at an institution actively recruiting adults to a long-term follow-up program (ascertained in CCSS follow-up database)
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Inability or unwillingness of research participant to give written informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St . Jude Children's Research Hospital | Memphis | Tennessee | United States | 38105 |
Sponsors and Collaborators
- St. Jude Children's Research Hospital
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Melissa Hudson, MD, St. Jude Children's Research Hospital
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ECHOS
- R01NR011322