Cancer, Cardiovascular Risk
Conditions
Keywords
cardiovascular health outcomes in cancer survivors
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.
Detailed 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.
Interventions
BEHAVIORALlifestyle modification and telephone counseling
A mailed individualized cancer treatment summary with recommendations for CV follow-up and lifestyle modification (standard care).
Sponsors
National Institute of Nursing Research (NINR)
St. Jude Children's Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Change in fear | Baseline and 2.5 years post intervention |
| Estimated average cost of standard care per participant in the Control Arm | 2.5 years |
| Change in knowledge | Baseline and 2.5 years post intervention |
| Change in motivation | Baseline and 2.5 years post intervention |
| Estimated average cost of cardiovascular screening per participant in the Test Arm | 2.5 years |
| Estimated average cost of intervention per participant | 2.5 years |
Countries
United States
Outcome results
None listed