Evaluation of Cardiovascular Health Outcomes Among Survivors

Study Overview
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Brief Summary
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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.

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). 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.

Official Title
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Evaluation of Cardiovascular Health Outcomes Among Survivors

Conditions
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Cardiovascular Risk, Cancer

Intervention / Treatment
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* Behavioral: lifestyle modification and telephone counseling
* Behavioral: lifestyle modification and telephone counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Childhood Cancer Survivor Study (CCSS) cohort participants Age 25 years or older No CV screening in previous 5 years Received anthracycline chemotherapy and/or irradiation of the chest 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: Being followed at an institution actively recruiting adults to a long-term follow-up program (ascertained in CCSS follow-up database) Inability or unwillingness of research participant to give written informed consent.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control Arm<br>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<br>* A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).<br>* Other names: Cardiovascular Health Outcomes;|
| Other: Test Arm<br>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<br>* Standard care plus motivational, autonomy-supportive APN counseling (2 phone sessions) that targets two categories of behavioral constructs likely to influence screening.<br>* Other names: Cardiovascular Health Outcomes;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular health outcomes in cancer survivors